Section 4: treatment and management
Section 4: Treatment and management Anaphylaxis.....................................................................................................................2 Atrophic vaginitis . ..........................................................................................................5 Bacterial vaginosis (BV)................................................................................................. 8 Balanitis and balanoposthitis....................................................................................... 15 Candidiasis....................................................................................................................18 Cervicitis........................................................................................................................25 Chancroid......................................................................................................................27 Chlamydia..................................................................................................................... 37 Donovanosis..................................................................................................................43 Dyspareunia . ................................................................................................................50 Epididymo-orchitis........................................................................................................ 57 Genital herpes (HSV)..................................................................................................... 71 Genital warts – human papilloma virus (HPV)............................................................. 82 Gonorrhoea................................................................................................................... 94 HIV and AIDS............................................................................................................... 105 Lymphogranuloma venereum (LGV)............................................................................ 119 Molluscum contagiosum.............................................................................................126 Non gonococcal urethritis (NGU)..................................................................................131 Pelvic inflammatory disease (PID).............................................................................. 137 Proctitis ......................................................................................................................149 Pubic lice.....................................................................................................................160 Scabies........................................................................................................................ 163 Syphilis.......................................................................................................................166 Tinea cruris..................................................................................................................180 Trichomoniasis............................................................................................................183 Urinary tract infection (UTI)........................................................................................189 Vaccination - Hepatitis A (HAV)...................................................................................196 Vaccination - Hepatitis B (HBV)...................................................................................199 Vaccination – HPV .......................................................................................................205 References.................................................................................................................. 209 SECTION 4 2010 1 Anaphylaxis 1 Anaphylaxis is a severe adverse event with rapid onset, usually occurring within 5 - 30 minutes, but can occur within hours of administration of medication. It is characterised by respiratory distress, hypotension and/or circulatory collapse. Symptoms can range from mild to severe with early signs such as generalised widespread erythema and urticaria. Signs / Symptoms1 Mild • urticaria (large itchy red patches or lesions on the skin) • erythema • swelling around eyes • gastrointestinal disturbance i.e. abdominal cramps, diarrhoea, and/or vomiting • no airway obstruction. These signs may progress to become severe anaphylaxis. Moderate • feeling worried or frightened • flushed face. These signs may progress to become severe anaphylaxis. Severe • coughing or wheezing • swelling of the tongue, lips and tissue of the face and neck • limpness and pallor (particularly in children) • noisy inspiration or expiration – indicating obstruction of the upper airway from angioedema of the hypopharynx, epiglottis, and larynx) • subjective feeling of retrosternal tightness, dyspnoea with audible expiratory wheeze – indicating lower airway obstruction from bronchospasm • profound hypotension, shock, rapid or thready pulse • tachycardia and central pulse weak or absent • loss of consciousness or fitting. Management 2 • stop giving medication • call for assistance and stay with the client QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • immediately notify a MO • call emergency or ambulance (as per internal policy/procedure). • maintain Airway, Breathing, and Circulation • commence basic life support as indicated • if client is conscious, place supine in “head down and feet up” position (unless this results in breathing difficulties) • if client is unconscious, place him/her on the left side in ‘recovery’ position and keep the airway clear • give adrenaline by deep intramuscular injection (see below for dosage or Australian Immunisation Handbook) – adrenaline is indicated for any signs of anaphylaxis with respiratory and/or cardiovascular symptoms or signs – adrenaline is not indicated if erythema (flushing) or itching is the only presenting symptom – if there is no improvement in the client’s condition within five minutes, repeat dose of adrenaline every five minutes until there is improvement. • give 100% oxygen at high flow rate via face mask if available • all cases should be transferred to hospital for observation and treatment. Document details of client management and send this to the hospital with the client • clearly document – the episode in the client’s record including BP, respiratory rate, localised reaction or skin eruptions, respiratory involvement, wheezing or coughing – the drug responsible for the reaction and mark it in the client’s chart. Treatment Name Adrenaline Form Ampoule Strength 1:1000 (1mg/1ml) Recommended dose 0.5mg (0.3-0.5ml) unless under 13 years of age or weighs less than 40 kg (0.01mg/kg to a maximum 0.5mg). Further information refer to Australian Immunisation Handbook. Route of admin Intramuscular Injection Duration Stat Then repeated every five minutes until client condition improves Consumer information May cause headache, restlessness, anxiety and palpitations in the conscious client Management of emergencies Consult MO SECTION 4 2010 3 Note: If adrenaline is given when a strong central pulse is present it may cause reactions such as fear, anxiety, tenseness, restlessness, headache, tremor, weakness, dizziness, pallor, respiratory difficulty and palpitations. Inform the client of these potential side-effects after they have stabilised. Differentiation between Vasovagal episode and Anaphylaxis1 Onset Vasovagal Episode Anaphylaxis Immediate usually within minutes of or during vaccine administration. Usually within 10 minutes of vaccine administration1. Signs and symptoms Skin Generalised pallor, cool, clammy skin Itchy skin, erythema, urticaria or angioedema Respiratory Normal, may be shallow but not laboured Cough, wheeze, stridor or signs of respiratory distress (tachypnoea, cyanosis, costal recession) Cardiovascular Bradycardia, weak/absent peripheral pulse, strong carotid pulse. Hypotension is usually transient and corrects in supine position Tachycardia, weak or absent central pulse. Feel faint, light-headed. Loss of consciousness improves in supine or head down position Sense of severe anxiety and distress. Neurological Hypotension, sustained and no improvement without specific treatment Loss of consciousness, no improvement in supine or head down position. Client education • ensure client is aware of which medication caused their reaction • the client may need to obtain a Medicalert bracelet, so inform them to purchase this from their chemist. Follow-up • 4 all clients with moderate to severe anaphylaxis require follow-up. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Atrophic vaginitis It is normal for the post menopausal female genital tract to undergo atrophy. The appearance may be of a pale epithelium or, where the thin epithelium reveals surface blood vessels, a deeper red colour. No treatment is required if asymptomatic except for Pap smear management. Signs / symptoms • vaginal dryness • dyspareunia • asymptomatic with: – atrophic appearance of genital tract – unsatisfactory pap smear report due to atrophic cellular changes on cytology. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/available): • persistent, recurrent symptoms • no response to treatment • contraindication to treatment • client requests ongoing treatment • immunosuppression e.g. HIV positive client • abnormal findings of significance • findings outside NOs scope of practice. Treatment Indicators Prophylaxis prior to routine pap smear for post menopausal women with: • vaginal discomfort on speculum examination • unsatisfactory pap smear due to atrophic cellular changes on cytology. Regimens • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or MO. SECTION 4 2010 5 • • DTP–SRH endorsed NO may progress if within scope of practice and competence, under the following conditions: – only supply one course of treatment – pap smear or past history indicates treatment with topical oestrogen will improve quality of sample. Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. Name Oestriol (Ovestin) Form Pessaries or cream Strength Pessaries 0.5mg Cream 1mg/1g Recommended dose Pessaries: one pessary (0.5mg) Cream: one applicator (0.5mg) Route of admin Per vagina Frequency/duration Pessaries: one pessary (0.5mg) intravaginally at night for 7 days prior to Pap Smear sampling Cream: one applicator (0.5mg) intravaginally at night for 7 days prior to Pap Smear sampling *Cream or pessary not to be used for 24 hrs prior to performing investigations (for 2-3 weeks TG +AMH). Pregnancy category B1 Poison schedule S4 Emergency management Consult MO Contraindications Oestrogen dependant tumours Undiagnosed vaginal bleeding Thrombophlebitis (or past history) Venous thromboembolism within last two yrs Endometriosis Sensitivity to constituents Pregnancy Porphyria Severe liver dysfunction 6 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Or Name Oestradiol (Vagifem) Form Pessaries Strength 25 microgram Recommended dose Pessaries: one pessary intravaginally at night for 7 days prior to Pap Smear sampling *Pessary not to be used for 24 hrs prior to performing investigations. (for 2 weeks TG +AMH). Route of admin Per vagina Frequency/duration See above Pregnancy category B1 Poison schedule S4 Emergency management Consult MO Contraindications Oestrogen dependant tumours Undiagnosed vaginal bleeding Sensitivity to any constituents Pregnancy Breast carcinoma (known, suspected or history) Acute thrombophlebitis or thromboembolic disorders (or past history associated with previous oestrogen use). Client education • supply written information on use of cream or pessary • advise how to insert cream or pessary and stress the importance of ceasing use prior to attending for pap smear • advise that vaginal preparations may interfere with integrity of condoms • provide MIMS Consumer Medicine Information www.ckn.health.qld.gov.au Contact tracing Refer to History and assessment (section one). Follow-up • not usually required unless there is a problem with pap smear • if the client requires ongoing management of vaginal dryness and other menopausal symptoms refer to a MO or GP. SECTION 4 2010 7 Bacterial vaginosis (BV) Bacterial vaginosis (BV) is a common cause of vaginal discharge in women of childbearing age2. BV results from a decrease in concentration of normal hydrogen-peroxide producing lactobacilli flora and an increase in other vaginal organisms, especially anaerobes such as gardnerella vaginalis2, 3. The absence of inflammation indicates it is vaginosis instead of vaginitis. BV is considered endogenous in origin3. Signs / symptoms4-7 Symptomatic with a minimum of three of the following: • thin, greyish/white, homogenous discharge that adheres to vaginal walls • increased amount of vaginal discharge • malodour or “fishy odour” which is more noticeable during menstruation or after sex • pH of vaginal discharge is alkaline (>4.5) • introital dyspareunia and vulval irritation is usually absent or minimal. Investigations5 - 8 Testing should be performed when a client presents with vaginal discharge. Always examine the cervix and vagina. • speculum examination • take swab from the posterior vaginal wall for M/C/S • wet preparation – mix the vaginal secretion with two drops of normal saline on a microscope slide and examine under 400 x magnification. This allows precise identification of the three major causes of vaginitis. If BV is suspected, look for clue cells • vaginal smear – smear swab from vaginal wall onto a microscope slide, air-dry, heat fix, gram-stain and examine under 1000 x oil-immersion magnification. This allows precise identification of clue cells and absence of lactobacilli • vaginal culture – place swab from vaginal wall into a suitable transport medium (Amie’s or Stuart’s medium with added charcoal) and send for culture testing. Positive culture for gardnerella vaginalis does not necessarily indicate BV as this micro-organism may be present in low numbers as a commensal in many women. • vaginal pH • KOH whiff test positive for volatile amines. In asymptomatic client: • 8 Treatment is not necessary however it is advisable before invasive procedures (i.e. IUD insertion, hysteroscopy or termination of pregnancy) as there is association between bacterial vaginosis and pelvic inflammatory disease. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • Treatment in pregnancy is advisable, as there are reports of association with premature rupture of membranes and ascending infection, although effectiveness of this measure has had variable success in studies to date3. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/available): • persistent symptoms • abdominal or pelvic symptoms e.g. pain or PID • client is pregnant or breastfeeding • contraindication to treatment • immunosuppression e.g. HIV positive client • abnormal findings of significance • findings outside NOs scope of practice. Treatment Regimens • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or MO. • DTP–SRH endorsed NO or may progress if within scope of practice and competence. For all other cases consult a MO or endorsed NP. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. First line regimens39 Name Metronidazole Form Tablet Strength 400mg Recommended dose 400mg Route of admin Oral with food Frequency/duration Twice a day for 5 3, 8, 9 - 77, 10, 11days Pregnancy category B2 Poison schedule S4 SECTION 4 2010 9 Contraindications Pregnancy (first trimester) and lactation (MIMS) Blood dyscrasias Active CNS disease Hypersensitivity to Metronidazole or other imidazole Special precautions Pregnancy category B2 (second and third trimester) Prolonged use Renal or hepatic impairment Alcoholic beverages or drugs containing alcohol may cause flushing, vomiting, tachycardia Adverse Reactions Superinfection G.I. disturbances (e.g. may cause metallic taste in mouth, nausea) Leukopenia and thrombocytopenia Neurological disturbances Sensitivity phenomena Pancreatitis Metallic unpleasant taste Interactions Alcohol (avoid for 24 hrs post treatment) Warfarin Carmustine (BCNU) (chemotherapy drug) Cyclophosphamide Phenytoin, phenobarbitone and other hepatic enzyme inducers Cimetidine and other hepatic enzyme inhibitors Lithium Disulfiram Cyclosporine 5 Fluorouracil Busulfan (cancer chemotherapy drug can cause serious adverse effect if given in combination with Metronidazole 10 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Or Name Clindamycin Phosphate Form Cream Strength 2% Recommended dose 5grams (one full applicator) Route of admin per vagina Frequency/duration One full applicator intravaginally at night for seven nights Pregnancy category A Poison schedule S4 Contraindications Hypersensitivity to Clindamycin, Lincomycin or other components of cream Precautions Systemic absorption, regional enteritis, ulcerative, antibiotic assoc colitis, vaginal intercourse, vaginal products, latex/ rubber contraceptive devices within 72 hours (contains mineral oil), eye contact; pregnancy (first trimester), lactation, children Adverse reactions Superinfection Pseudomembranous colitis Vulval irritation GI and CNS disturbances Rash Interactions Neuromuscular blocking agents (used in anaesthesia) Second line regimens STAT regimens of Metronidazole and Tinidiazole are not recommended as first line treatment option7,12. Evidence demonstrates that cure rates may be lower with STAT regimens. Indications for use are based on history and clinical assessment e.g. issues of compliance with first line regimens. Name Metronidazole Form Tablet Strength 400mg Recommended dose 2grams (5 X 400mg tablets) Route of admin Oral with food Frequency/duration Stat Pregnancy category B2 Poison schedule S4 SECTION 4 2010 11 Contraindications Pregnancy (first trimester) and lactation Blood dyscrasias Active CNS disease Hypersensitivity to Metronidazole or other imidazole Special Precautions Pregnancy Category B2 (second and third trimester) Prolonged use Renal or hepatic impairment Adverse Reactions Superinfection G.I. disturbances (e.g. may cause metallic taste in mouth, nausea) Leukopenia and thrombocytopenia Neurological disturbances Sensitivity phenomena Pancreatitis Interactions Alcohol (avoid for 24 hrs post treatment) Warfarin Carmustine (BCNU) (chemotherapy drug) Cyclophosphamide Phenytoin, phenobarbitone and other hepatic enzyme inducers Cimetidine and other hepatic enzyme inhibitors Lithium Disulfiram Cyclosporine 5 Fluorouracil Busulfan (cancer chemotherapy drug can cause serious adverse effect if given in combination with Metronidazole Or 12 Name Tinidazole Form Tablet Strength 500mg Recommended dose 2gram (4 x 500mg tablets) Route of admin Oral with food QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Frequency/duration Stat Pregnancy category B3 Poison schedule S4 Contraindications Pregnancy (first trimester) and lactation Hypersensitivity to other five Nitrimidazole derivatives Blood dyscrasia History of CNS disease Special precautions Renal impairment Pregnancy (second and third trimester) Children Avoid alcohol for 72 hours after completing dose Adverse reactions Superinfection GI - anorexia, nausea, vomiting, abdominal pain, diarrhoea Neurological disturbances - headache, dizziness, vertigo, Ataxia Rash Leukopenia, neutropenia Sensitivity phenomena Flushing, fever, tiredness Metallic taste Interactions Alcohol Anticoagulants Note: COC user taking a short course (<3 weeks) of antibiotics should be advised to use additional contraceptive protection (i.e. condoms) during treatment and for seven days after antibiotics have been stopped.13 Client education • discuss vulval and vaginal health e.g. no soap or douching • reinforce that BV is not a sexually transmissible infection and that compliance is important • treatment is not necessary if asymptomatic, but it is required before invasive procedures such as IUCD insertion, hysteroscopy or termination of pregnancy • recurrence is common and little is understood about why it recurs. It may be related to sexual activity and menstruation as semen and blood alter the vaginal environment SECTION 4 2010 13 • take Metronidazole with food and avoid alcohol for 24 hours post treatment • take Tinidazole with food and avoid alcohol for 72 hours post treatment • Clindamycin cream contains mineral oil which may weaken latex or rubber such as condoms or vaginal contraceptive diaphragms, therefore use of the contraceptive products is not recommended within 72 hours following treatment with Clindamycin cream 2%. Ingredients can cause burning and irritate eyes. In the event of accidental contact, rinse eye adequately with cool water • client fact-sheet available at www.health.qld.gov.au/sexhealth • provide MIMS Consumer Medicine Information www.ckn.health.qld.gov.au Contact tracing14 There is some evidence of sexual transmission between women who have sex with women, so female partners of women should be contacted and offered treatment48. Male partners do not need to be contact traced or treated Follow-up2 14 • if BV recurs soon after initial treatment, client may require longer course of Metronidazole • if treatment is given during pregnancy to reduce risk of pre-term birth, women should be re-tested 4 – 6 weeks after treatment and retreated if necessary • If symptoms have not resolved consult with MO. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Balanitis and balanoposthitis Balanitis is an inflammation of the glans penis. Balanoposthitis is an inflammation of the foreskin and glans in uncircumcised men. Neither condition is classified an STI and is generally a result of an overgrowth of organisms (fungal or bacterial) which are normally present on the skin of the glans / penis. One of the most common causes is candida albicans and other causes include contact dermatitis and mechanical trauma15, 16. Signs / symptoms17 • rash, inflammation (redness, swelling of skin), pain or irritation • yellow/white pustules or superficial skin erosion • increased smegma • pruritus • preputial oedema and phimosis • inguinal adenopathy. Investigations Lesions (if suspicious refer to MO for review) • swab for HSV PCR (if indicated) • swab for M/C/S (if indicated) • swab for syphilis PCR (if indicated) • measure lesions • skin scraping (if indicated) • additional STI screening as indicated. Serology • syphilis • HIV. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/available): • secondary infection requiring antibiotic treatment • severe phimosis or paraphimosis • symptoms persist for >2 weeks following symptomatic and/or topical management SECTION 4 2010 15 • uncertain diagnosis • contraindication to treatment • immunosuppression e.g. HIV positive • abnormal findings of clinical significance • findings outside NOs scope of practice. Treatment Indicators • clinical findings based on history and examination • branching hyphae and/or budding yeast identified on KOH wet prep • laboratory confirmed diagnosis. For mild symptoms • discuss skin care, hygiene practices and use of non-soap product • use warm water (not hot) for washing • avoid allergens and irritating factors i.e. heat, sweat or hygiene products. For moderate symptoms • candida – refer to Miconazole 2% topical cream regimen • refer to MO if significant or severe inflammation. Regimens for suspected or confirmed candidiasis 16 • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence. For all other cases consult a MO or endorsed NP. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. Name Miconazole nitrate Form Cream Strength 2% Recommended dose Apply to affected area twice daily Route of admin Topical Frequency/duration Twice a day for 2 weeks Pregnancy category A QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Poison schedule S2 Contraindications Sensitivity to any constituents Special precautions Reinfection Diabetes Superinfection Open lesions Adverse reactions Infrequent - irritation, burning, skin rash and maceration. Client education • discuss condition and management including over-the-counter medication • discuss skin care and genital hygiene issues • client fact-sheet available at www.health.qld.gov.au/sexhealth • provide MIMS consumer medication information www.ckn.health.qld.gov.au Contact tracing N/A. Follow-up There is no specific follow-up required. SECTION 4 2010 17 Candidiasis Candida, a yeast that is considered normal flora in the gastrointestinal and genitourinary tracts, has a tendency to overgrow and cause genital symptoms when there is a change or imbalance in normal vaginal acidity due to the use of oral contraceptives, pregnancy, antibiotic use, diabetes mellitus or compromised immune systems. Vulvovaginal candidiasis (VVC) is generally caused by candida albicans and is the most common form of genital mucosal candidiasis7,18. It is not considered an STI, however male partners of women with thrush may become secondarily infected and develop candidal balanitis and female partners may develop candidiasis. Signs / symptoms3, 5 - 7 • vaginal discharge (varying from thick, white ‘cottage-cheese like’ to a thin white homogeneous discharge) • adherent plaques of yeast on vaginal wall • pruritus • genital discomfort, external dysuria, dyspareunia or vaginal soreness • vaginitis, vulvitis or vestibulitis • vaginal pH remains normal (around 4.5) • fissures, vulvar swelling or excoriations. • balanitis • erythema of glans Note: Severe candidiasis can often be confused with genital herpes. Investigations3, 5 - 7 Test clients presenting with abnormal vaginal discharge, vulval erythema or itch. Perform a speculum examination if the vulva is not too painful. Always examine the cervix and vagina in cases of vaginal discharge. Uncomplicated vulvovaginal candidiasis (VVC) Characterised by sporadic or infrequent episodes with mild to moderate symptoms, immunocompetence, likely to be caused by candida albicans. Vaginal 18 • swab from posterior vaginal wall with transport medium (Amie’s or Stuart’s medium with added charcoal) for M/C/S • swab from posterior vaginal wall for wet preparation/gram stain (if available this allows precise identification of spores and pseudo hyphae characteristic of candidiasis) QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • vaginal pH (usually normal below 4) • offer additional STI screening if indicated. Complicated vulvovaginal candidiasis Characterised by recurrent candidiasis >4 times per year, severe VVC, immuno-suppression, debilitation or pregnant client. Vaginal • swab from posterior vaginal wall for M/C/S (to check for candida species). Serology • HIV. Note: • Candida albicans may be detected via vaginal smear or M/C/S, however, a positive culture may not indicate symptomatic infection as it presents in low numbers as part of normal flora in many asymptomatic women • Consider systemic causes of candidiasis in cases of complicated VVC. i.e. people with diabetes mellitus or a compromised immune system are more susceptible to increased skin and mucosal colonisation with candida albicans.19 Additional investigation or referral to a medical officer may be required depending on history and examination e.g. HIV serology, random or fasting BSL and HbA1C. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/available): • persistent, recurrent symptoms • no response to treatment • contraindication to treatment • abdominal pain or pelvic symptoms i.e. pain or PID • client is pregnant • immunosuppression e.g. HIV positive client • abnormal findings of significance • findings outside NOs scope of practice. Note: • However, if Candida is identified and the client’s symptoms have resolved, discuss with client refraining from treatment unless symptoms return. • If candidiasis recurs frequently, consider underlying causes such as diabetes, immunosuppression, HIV infection and antibiotic use. Exclude other recurrent vulval symptoms such as herpes and dermatitis. In most cases, no cause can be found. SECTION 4 2010 19 • Good results are obtained with long-term suppressive anti-fungal therapy, usually with oral fluconazole (category D in pregnancy). Special diets and alternative treatments are generally not effective. Treatment Indicators • symptomatic with yeast spores and hyphae on wet prep and/or gram stained smear • symptomatic with laboratory confirmed diagnosis • In asymptomatic clients, treatment is not necessary.4 Regimens Uncomplicated symptomatic: topical With or without positive wet mount identification of yeast 20 • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence. For all other cases consult an endorsed NP or MO. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. Name Clotrimazole Form Pessary Strength 500mg (this strength not on LAM) Recommended dose 500mg Route of admin Per vagina Frequency/duration One dose only Consumer information Insert at bedtime Emergency management Consult MO Pregnancy category A Poisons schedule S3 Special precautions Not for oral ingestion, ophthalmic use, pregnancy (avoid applicator), lactation Adverse reactions Local irritation, oedema Interactions Latex products QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Or Name Clotrimazole Form Cream Strength 1% (35gram) 100mg Recommended dose 1 x full applicator 100mg Frequency/duration At night for six nights At night for six nights Route of admin Per vagina Consumer information Insert at bedtime Pregnancy category A Poisons schedule S3 Special precautions Not for oral ingestion, ophthalmic use, pregnancy (avoid applicator), lactation Emergency management Consult MO Adverse reactions Local irritation, oedema Interactions Latex products Or Pessaries Or Name Miconazole Nitrate Form Cream Strength 2% (45 gram) Recommended dose 1 x full applicator Route of admin Per vagina Frequency/duration At night for seven nights Consumer information Insert at bedtime Pregnancy category A Poison schedule S3 Emergency management Consult MO Contraindications Known hypersensitivity to Miconazole Nitrate, other imidazole or any ingredient in this product. Special precautions Persistent symptoms, reinfection, diabetes, diaphragms, condoms (rubber damage), pregnancy, lactation, children <12yrs, anticoagulants Adverse reactions Local irritation, burning, pruritus, discharge, headache, pelvic cramping (rarely) Note: If non candida albicans species (i.e. candida glabrata) treatment will need to be altered or duration of therapy increased. Consult with a MO. SECTION 4 2010 21 Uncomplicated symptomatic: oral • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or a MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence. For all other cases consult a MO or endorsed NP. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. Note: Fluconazole oral regimen is not approved as a first line therapy or for ongoing supply. A single dose is indicated and authorised for use if: • extensive vulval irritation is present • topical treatment has failed or caused increased allergic reaction, irritation or hypersensitivity • use of topical therapy is not practical e.g. effects on condom integrity. Name Fluconazole Form Capsule Strength 150mg (this strength is not available on LAM) Recommended dose 150mg Route of admin oral with or without food Frequency/duration one dose (150mg) stat Pregnancy category D Poison schedule S3 Emergency management Consult MO Contraindications Known azole sensitivity Coadministration of fluconazole and cisapride is contraindicated Special precautions Proarrhythmic conditions Renal impairment Sodium/fluid restriction Pregnancy and lactation Children <16 Adverse reactions Common - headache, nausea, abdominal pain, diarrhoea Uncommon - rash, urticaria, dry mouth, dizziness, thirst, insomnia, nervousness, visual changes, polyuria, hot flushes 22 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Interactions Unlikely to be clinically significant with single dose but refer to MO. Sulphonylureas Warfarin Rifamycin Celecoxib Parecoxib Clinically or potentially significant drug interactions have been observed between Fluconazole and the following: Short Acting Benzodiazepines Cisapride Coumarin (type anticoagulants) Cyclosporine Hydrochlorthiazide Oral Hypoglycaemics Phenytoin Rifampicin Rifabutin Tacrolimus Theophylline Drug availability Available on Queensland Health List of Approved Medicines.21 Drug Formulation Dosage regimen Clotrimazole Vaginal cream 1% cream. One applicator full at bedtime for six nights Clotrimazole Vaginal pessary 100mg. Insert one at bedtime for six nights Miconazole Vaginal cream 2%. One applicator full at bedtime for seven nights Fluconazole Capsule 150 mg orally stat Note: 100mg and 50mg capsules available on LAM not indicated – for Candidiasis unless it is severe/ life threatening + amphotericin is contra indicated or not tolerated. SECTION 4 2010 23 Available at most pharmacies (Schedule 3: Pharmacist Only Products). Drug Formulation Regimen Butoconazole (Gynazole) Cream 2%. One applicator full at bedtime once. Not available on LAM Clotrimazole (Canesten, Clozole, Femizole, Chemists own brand, Clofem) Cream 2%. One applicator full at bedtime for three nights Econazole (Pevaryl) Cream/Foaming solution 1%. Apply at bedtime Miconazole Cream 2%. One applicator full at bedtime for seven nights 10%. One applicator full at bedtime once. (this strength not available on LAM) (Resolve) Client education • discuss vulval and vaginal health e.g. no soap or douching • discuss condition and management • advise that vaginal preparations can interfere with integrity of latex products such as condoms and diaphragms (refer to product information) • advise about availability of over-the-counter medications • client fact-sheet available at www.health.qld.gov.au/sexhealth • provide MIMS Consumer Medicine Information www.ckn.health.qld.gov.au Contact tracing14 • male partners of women with candidiasis do not require treatment unless they have signs or symptoms of balanitis • female partners may require treatment48 Follow-up If recurrent episodes or there is no response to treatment. 24 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Cervicitis Signs / symptoms Symptoms of cervicitis do not always accompany cervical infection. Normal appearance of the cervix on examination does not exclude infection and/or abnormality3,21 • intermenstrual or postcoital bleeding • pain during penetrative sex • low abdominal pain • abnormal vaginal discharge • mucopurulent cervical discharge • oedematous, inflamed and friable ectocervix with contact bleeding • sustained cervical bleeding following gentle contact/swabbing.8,22 Investigations Perform investigations based on risk assessment, clinical findings and local policy • • • Vaginal – high vaginal swab for M/C/S – swab for trichomonas PCR (if indicated) – gram stain and wet prep (onsite if available) – pH and whiff test. Endocervical – swab for chlamydia PCR – swab for gonorrhoea M/C/S – swab for trichomonas PCR (If indicated and where available for remote communities) – HSV PCR (endo/ecto) swab if indicated – pap smear +/- thin prep if indicated. Discuss additional STI screening as indicated. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/available): • persistent symptoms after treatment • client is pregnant or breastfeeding SECTION 4 2010 25 • abnormal findings of clinical significance • uncertain diagnosis • contraindication to treatment • immunosuppression e.g. HIV positive client • findings outside NOs usual scope of practice. Treatment Consider syndromic management and empirical treatment for gonorrhoea and chlamydia when: • high prevalence of chlamydia and gonorrhoea in the community • signs of cervicitis or PID • HIV positive client • concerned that client may not return for treatment and follow-up. Syndromically treat HIV positive clients with cervicitis, to reduce risk of cervical HIV shedding and HIV transmission.7 Client education • client fact-sheet available at www.health.qld.gov.au/sexhealth • provide MIMS Consumer Medicine Information www.ckn.health.qld.gov.au Contact tracing Offer STI screening for partners if STI diagnosed. Follow-up Follow-up is at discretion of the clinician. 26 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Chancroid Chancroid is an acute ulcerative disease caused by the bacteria Haemophilus Ducreyi.4,8 It is rare in Australia, but is endemic in places such as South-east Asia, India or Africa. It may be confused with other genital ulcerative disease but should be suspected following sexual contact in an endemic area or with a person from an endemic area. It is transmitted by direct contact with discharge from open lesions during sexual activity. Auto-inoculation to nongenital sites is rare, but can occur. Signs / symptoms7,22, 49 Incubation period is 3 -10 days following sexual exposure. • Lesions commence at the site of inoculation as a tender erythematous papule which becomes pustular, eroded and ulcerates • in males, commonly on the prepuce near the frenulum or in the coronal sulcus. In females, generally at the vaginal entrance and less commonly painless vaginal and cervical ulcers49. • Perianal and extragenital lesions may occur. • ulcers are typically painful and nonindurated with ragged edges. Base may be may be covered with yellow or grey necrotic purulent exudate, ands ulcer frequently bleeds when scraped.49 • associated with painful regional adenitis in about 50% of cases • 10-40% of people with Chancroid have suppurating inguinal lymphadenopathy or “buboes”.49 • constitutional symptoms are usually mild (if present at all) • painful unilateral adenitis. Four criteria for formulating a diagnosis of chancroid • presence of one or more painful ulcers • presence of regional lymphadenopathy • a negative Treponema pallidum evaluation or negative serology at least seven days after the onset of symptoms • negative HSV culture from the ulcer exudate. Investigations Lesion: • GUMP tests – HSV I and II, T. Pallidum, H. Ducreyi, K. Granulomatis • culture in specialised medium for haemophilus ducreyi SECTION 4 2010 27 – collect from base of ulcer or aspirate from bubo – consult MO and laboratory prior to collection. • Offer additional STI screening (including HIV) as indicated by history • Testing for Chancroid should not occur in isolation. A PCR test has been developed which is available from Queensland Health Pathology Services only in the Northern Zone of Queensland as part of the Genital Ulcer Multiplex PCR (GUMP) test. It is likely that a PCR test will replace the need for culture in the future. Diagnosis should only be made by a specialist, based on clinical presentation, history of exposure, and after exclusion of other causes of genital ulcers. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/ available): • Suspected or laboratory confirmed chancroid • no improvement after three days of treatment • no resolution of lymphadenopathy • client is pregnant or breastfeeding • immunosuppression e.g. HIV positive client • abnormal findings of significance. Treatment Indicators • clinical diagnosis is based on history and examination • initiate syndromic management and treat for ulcerative disease as appropriate. Regimens: Symptomatic clients 28 • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence. For all other cases consult a MO or endorsed NP. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Name Azithromycin49 Form Tablet Strength 500mg Recommended dose 1gram (2 x 500mg tablets) Route of admin Oral with or without food Frequency/duration Stat (once only) Pregnancy category B1 Poison schedule S4 Emergency management Consult MO Contraindications Known hypersensitivity to Azithromycin, Erythromycin or any Macrolide antibiotic Special precautions Pneumonia Elderly Prolonged QT interval Renal and hepatic impairment Pregnancy and lactation Children <16 years Adverse reactions Superinfection Angioedema Cholestatic jaundice Raised LFT, AST, ALT Colitis, GI upset Vaginitis Interactions Antacids Colchicine (AMH) Ergot Derivatives Rifabutin Cyclosporine Warfarin Digoxin and drugs that prolong QT interval Note: • COC user taking a short course (<3 weeks) of antibiotics should be advised to use additional contraception (i.e. condoms) during treatment and for seven days after antibiotics have been stopped.13 SECTION 4 2010 29 Or Name Ceftriaxone49 Form Dry powder (vial for injection) Strength 250mg (only available in 500mg, 1g or 2g vials) Recommended dose 250mg Route of admin Intramuscular Injection reconstituted with 2ml 1% Lignocaine solution Frequency/duration Stat (once only) Pregnancy category B1 Poison schedule S4 Emergency management Consult MO Contraindications Allergy to Cephalosporins Major allergy to Penicillin Special precautions Penicillin sensitivity Renal and hepatic impairment Sodium restriction/heart failure (contains 83mg Impaired vitamin K synthesis GI disease (especially colitis) Pregnancy, lactation, Children <12 years, neonates Adverse reactions Hypersensitivity Superinfection Pseudomembranous colitis Hypoprothrombinemia Local reactions Diarrhoea Pancreatitis and gall bladder concretions Interactions Chloramphenicol Observe client for 30 minutes after administration of Ceftriaxone. 30 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Na per gram) Plus for reconstitution of 1g Ceftriaxone powder use. Name Lignocaine Hydrochloride Form Liquid for injection Strength 1% (5ml ampoulel) Recommended dose 3.5ml to be used to reconstitute 1g Ceftriaxone powder Route of admin Intramuscular injection Frequency/duration Stat Pregnancy category A Poison schedule S4 Emergency management Consult with MO Contraindications Local inflammation/sepsis Septicaemia Anticoagulants CNS or spinal cord disease Impaired cardiac conduction, intraventricular block, arrhythmias Hypersensitivity to amide LAS Special precautions High repeated doses - hepatic, renal, cardiac impairment Hypoxia, severe respiratory depression Neurological disorders, epilepsy Elderly, children Pregnancy and lactation Adverse reactions CNS disturbances cardiovascular depression arrhythmias, hypertension Interactions Other local anaesthetics Antiarrhythmics, beta-blockers (especially class 111) Cimetidine phenytoin, other anticonvulsants inhalation anaesthetics skeletal muscle relaxants alcohol SECTION 4 2010 31 Or Ceftriaxone 250mg Powder Vials are not available in some settings and have been substituted with Ceftriaxone Dry Powder 1g vial stock. The regimen using Ceftriaxone Dry Powder is the same Recommended Dose of 250mg Ceftriaxone stat as above. Only the strength in stock has changed to 1g Ceftriaxone Dry Powder. Please follow recommended dose calculation. Name Ceftriaxone Form Dry powder Strength 1gram (0.4ml) Volumes for Dose Calculation 23, 24 1g dry powder (0.4ml) + 1% Lignocaine solution 3.5ml = total volume 3.9ml Recommended dose 250mg (0.98ml) Route of admin Intramuscular Injection Frequency/duration Stat (once only) Pregnancy category B1 Poison schedule S4 Emergency management Consult MO Contraindications Allergy to Cephalosporins Major allergy to Penicillin Pancreatitis and gall bladder concretions Special precautions Penicillin sensitivity Renal and hepatic impairment Impaired vitamin K synthesis GI disease (especially colitis) Pregnancy, lactation, Children <12 years, neonates Adverse reactions Hypersensitivity reactions Superinfection Pseudomembranous colitis Hypoprothrombinemia Local reactions Diarrhoea Pancreatitis and gall bladder concretions Interactions 32 Chloramphenicol QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Observe client for 30 minutes after administration of Ceftriaxone. Plus for reconstitution of 1g Ceftriaxone powder use Name Lignocaine Hydrochloride Form Liquid for injection Strength 1% (5ml ampoule) Recommended dose 3.5ml to be used to reconstitute 1g Ceftriaxone powder Route of admin Intramuscular injection Frequency/duration Stat Pregnancy category A Poison schedule S4 Emergency management Consult with MO Contraindications Local inflammation/sepsis Septicaemia Anticoagulants CNS or spinal cord disease Impaired cardiac conduction, intraventricular block, arrhythmias, hypersensitivity to amide LAS Special precautions High repeated doses - hepatic, renal, cardiac impairment Hypoxia, severe respiratory depression Neurological disorders, epilepsy Elderly, children Pregnancy and lactation Adverse reactions CNS disturbances cardiovascular depression arrhythmias, hypertension Interactions Other local anaesthetics Antiarrhythmics, beta-blockers (especially class 111) cimetidine phenytoin, other anticonvulsants inhalation anaesthetics skeletal muscle relaxants alcohol SECTION 4 2010 33 Or NO consult with a MO prior to supply of Ciprofloxacin • As per the Queensland Hospitals List of Approved Medicines (LAM) Ciprofloxacin is restricted to specialist staff for treatment of serious infections caused by sensitive organisms, on the advice of an Infectious Diseases Physician21 • The Pharmaceutical Benefits Schedule (PBS) restricts use of Ciprofloxacin to treatment of infections due to pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials. • Because of increasing resistance to Ciprofloxacin 500mg orally as a stat dose, this regimen is no longer recommended unless a sensitive gonococcal strain has been identified via laboratory confirmed diagnosis11,12 • Prior to treatment with Ciprofloxacin, consult a MO for a laboratory diagnosis regarding sensitivity to Ciprofloxacin Name Ciprofloxacin Form Tablet Strength 500mg Recommended dose 500mg Route of admin Oral on an empty stomach Frequency/duration Twice a day for three days Pregnancy category B3 Poison schedule S4 Emergency management Consult MO Contraindications Hypersensitivity to other Quinolones including Nalidixic Acid Concurrent administration of ciprofloxacin and ZanaflexTM (US) Special precautions Impaired renal and hepatic function CNS disorders GI disease Pregnancy, lactation Children, neonates Sunlight 34 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Adverse reactions Hypersensitivity Superinfection Pseudomembranous colitis Nausea and diarrhoea Phototoxicity Haemorrhagic cystitis Achilles tendon rupture Interactions Theophylline Anticoagulants Antacids (containing Mg, AL or Ca) Iron supplements Probenecid Sucralfate Theophylline Zinc or iron containing multivitamin Caffeine Cyclosporin Non steroidal anti-inflammatory drugs Metoclopramide Glibenclamide Methotrexate Note: • Choice of treatment depends on local disease and sensitivity patterning • COC users taking a short course (<3 weeks) of antibiotics should be advised to use additional contraception (i.e. condoms) during treatment and for seven days after antibiotics have been stopped13 • Antibody susceptibility may vary according to geographical region of contact • Differentiation of genital ulcerative disease is inaccurate, particularly in areas where more then one causative organism is endemic or prevalent at high rates.24 This is compounded by the presence of HIV infection which may alter clinical manifestations and patterns of GUD occurrence. Recent evidence indicates that HSV 2 is increasing in many populations as the main cause of GUD.24 After detection of GUD (i.e. chancroid, donovanosis, LGV or HSV) it is important to consider additional investigation and treatment based on local sensitivity patterns. SECTION 4 2010 35 Client education • there are only one or two cases notified each year, although no cases have been notified in Queensland since 1993 • when taking Ciprofloxacin or Azithromycin, protect skin from sunlight (especially between 10am – 3pm) as some macrolide antibiotics are associated with increased sensitivity to sunlight • consult a MO if there is a rash, itching, redness or severe sunburn • client fact-sheet available at www.health.qld.gov.au/sexhealth • provide MIMS Consumer Medicine Information www.ckn.health.qld.gov.au Contact tracing14 • contact trace two weeks before ulcer appeared or since arrival from endemic area • partners who had sexual contact with the index case within ten days prior to onset of symptoms should be examined and treated (even if asymptomatic) • offer STI screening to all contacts • empirical/presumptive treatment of all contacts is recommended. Follow-up 36 • three days after treatment and then weekly until resolution. Improvement is expected of substantial ulcer with re-epithelialisation within seven days. Resolution of lymphadenopathy is slower, especially if fluctuant • needle aspiration may be necessary, however avoid incision and drainage • discuss contact tracing outcomes • in the case of treatment failure, consider: – co-infection with another STI (i.e. syphilis or herpes simplex virus) – drug resistance – non-compliance – HIV positive. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Chlamydia Chlamydia is caused by serovar D - K of chlamydia trachomatis, while other serovars are responsible for causing trachoma and lymphogranuloma venereum (LGV). Chlamydia infects the columnar epithelial cells of the urethra, endocervix, fallopian tubes, rectum, oropharynx, epididymis and conjunctiva.3, 21 It is the most common notifiable disease in Australia among young people and the most common cause of urethritis in males and cervicitis in females. Signs / symptoms Female • abnormal vaginal discharge or bleeding (i.e. post coital or IMB) • dysuria • lower abdominal pain, pressure or heaviness • chlamydia cervicitis is indistinguishable from other causes of cervical infection on clinical examination. Signs and symptoms often go unrecognised and include intermenstrual bleeding, post coital bleeding and PV discharge • approximately 10 - 15% of chlamydia cases (in females) are complicated by pelvic infection, resulting in pelvic inflammatory disease (PID). Tubal damage can increase risk of ectopic pregnancy and infertility. Symptoms may include lower abdominal pain and dyspareunia. Male • dysuria • mucoid, watery or mucopurulent discharge and urethral irritation 1 – 3 weeks after exposure • epididymo-orchitis presents as a painful swollen testicle and is occasionally a complication of chlamydia. Both • asymptomatic (most common) • anorectal pain or discharge • Less common indicators include sore throat, eyes, joints or other signs of complicated infection. Investigations Test symptomatic or asymptomatic clients who identify risk behaviour through unprotected sexual intercourse and/or known contacts of chlamydia, gonorrhoea, epididymo-orchitis or pelvic inflammatory disease. If there is history of the client performing unprotected fellatio or being the receptive partner in unprotected anal sex, take swabs from the rectum and pharyngeal sites for PCR. SECTION 4 2010 37 Testing for chlamydia should not occur in isolation, offer additional STI screening as indicated. Pharyngeal • swab for chlamydia PCR. Endocervical • swab for chlamydia PCR. Urethral • first catch urine for chlamydia PCR. Rectal • swab for chlamydia PCR. Note: • first catch urine or self-obtained low vaginal swab for chlamydia PCR is appropriate if unable to do a speculum examination and asymptomatic • if males present with urethral symptoms it is recommended to also take a swab of the urethral discharge for gonorrhoea M/C/S • PCR is not validated for pharyngeal, rectal or low vaginal sites, but is recommended. Positive results should be checked with a supplementary test in the laboratory. • PCR has high specificity and sensitivity when used in high prevalence groups, including those aged 15 - 25 years, symptomatic clients or clients with risk history. Care should be taken in interpreting PCR results in low prevalence populations. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/ available): • symptoms persistent after treatment • intrauterine device in situ • complicated infection (e.g. PID or epididymo-orchitis) • disseminated infection • abnormal findings of significance • contraindication to treatment • client is pregnant or breastfeeding • immunosuppression e.g. HIV positive client • findings outside NOs scope of practice. Treatment 38 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Indicators • diagnosis based on examination findings • laboratory confirmed diagnosis • contacts have tested positive for chlamydia and/or gonorrhoea. Regimens • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or consult a MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence. For all other cases consult a MO or endorsed NP. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. Name Azithromycin Form Tablet Strength 500mg Recommended dose 1gram (2 x 500mg tablets) Route of admin Oral with or without food Frequency/duration Stat (one dose) Pregnancy category B1 Poison schedule S4 Emergency management As for severe allergic reaction - Anaphylaxis Consult MO Contraindications Known hypersensitivity to Azithromycin, Erythromycin or any Macrolide antibiotic Special precautions Pneumonia Elderly Prolonged QT interval Renal and hepatic impairment Pregnancy and lactation Children <16 years SECTION 4 2010 39 Adverse reactions Superinfection Angioedema Cholestatic jaundice Raised LFT, AST, ALT Colitis, GI upset Vaginitis Interactions Antacids Ergot Derivatives Rifabutin Cyclosporine Warfarin Digoxin And drugs that prolong QT interval Or Name Doxycycline Form Capsule or Tablet Strength 100mg Recommended dose 100mg Route of admin Oral with food Frequency/duration Twice a day for 710, 11 – 103 days Pregnancy category D Poison schedule S4 Emergency management As for severe allergic reaction - Anaphylaxis Consult MO Contraindications Pregnancy and lactation Hypersensitivity to any tetracycline Concomitant treatment with oral retinoid Special precautions Don’t take immediately before going to bed Take with food or milk Renal and hepatic impairment Prolonged use Children <8 years 40 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Adverse Reactions Photosensitivity Urticaria Superinfection Pseudomembranous colitis Oesophagitis GI disturbances Tooth discolouration Interactions Acetazolamide Antacids (containing Al, Mg, Ca Bismuth Salts) Anticoagulants Barbiturates Carbamazepine Methoxyflurane (may cause fatal renal toxicity) OCP Penicillin Phenytoin Sodium Bicarbonate Iron Note: • COC user taking a short course (<3 weeks) of antibiotics should be advised to use additional contraception (i.e. condoms) during treatment and for seven days after antibiotics have been stopped.14 • if rectal PCR positive for chlamydia, consider LGV and consult with MO. Client education • client to avoid unprotected sex for a minimum of three days following treatment with Azithromycin or seven days with Doxycycline, and until all contacts are treated • protect skin from sunlight especially between 10am – 3pm and solariums as some Macrolide antibiotics increase sensitivity to sunlight. If there is a rash, itching, redness or severe sunburn consult a MO • Doxycycline to be taken with one full glass of water and client should sit upright for at least 30 minutes after taking medication • client fact-sheet available at www.health.qld.gov.au/sexhealth • provide MIMS Consumer Medicine Information http://ckn.health.qld.gov.au SECTION 4 2010 41 Contact tracing14 Australian guidelines currently state that all contacts for a period of six months prior should be screened and treated. These guidelines are under review (2010). Follow-up 42 • within two weeks to ensure compliance with medication and follow up of partner notification • PCR proof of cure (POC) cannot be reliably undertaken <8 weeks after treatment , and is not recommended • retesting recommended at three months as re-infection is common • refer to a MO if still symptomatic. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Donovanosis 3, 7, 21 Donovanosis is a chronic, progressively destructive genital ulcerative infection caused by the bacteria klebsiella granulomatis. It generally occurs in tropical climates such as Papua New Guinea. Infection in Australia is rare, but is more predominant in the Indigenous populations of northern and central Australia. Signs / symptoms Most commonly affected areas include the penile shaft and glans, vulva and perianal skin. • starts as a papule or subcutaneous nodule which ulcerates • four classical types: • – ulcerogranulomatous – is the most common and may appear as beefy red granulations or painless ulcers with thick, rolled edges – hypertrophic verrucous - like a dry walnut – necrotic destructive - deep and foul smelling – sclerotic or cicatricial - fibrous scar tissue. if regional lymph nodes are involved, it can lead to progressive tissue invasion from the genitals to the groin. Investigations3 Test all clients who present with ulcerated lesions (especially those living in rural and remote areas). When investigating suspected cases, always test for common causes of genital ulceration i.e. herpes and syphilis. Lesions • perform genital ulcer multiplex PCR (GUMP) swab. Use a sterile cotton-tipped swab to swab the centre and edges of the lesion aiming to moisten the swab with ulcer exudate, then place into a dry sterile container. This test is used to detect herpes simplex virus, treponema pallidum, klebsiella granulomatis and haemophilus ducreyi • press slide for Donovan bodies. Clean the lesion with saline, then press a glass slide on the lesion, ensuring that the base and the edges of the lesion are pressed onto the slide. Allow to air-dry. • HSV PCR swab of lesion • punch biopsy of lesion and non-infected tissue (advancing edge) for Donovan bodies should be collected if there is no improvement in lesions after six weeks of treatment • serology • – syphilis – HIV. Discuss additional STI screening with the client. SECTION 4 2010 43 Note: • testing for donovanosis should not occur in isolation • donovanosis is often diagnosed from clinical evidence and on epidemiological grounds. Laboratory confirmation of diagnosis is not required for notification or treatment • the GUMP test is funded for Indigenous clients who have genital lesions, where donovanosis is suspected or the cause is unclear. If a non-Indigenous person is suspected of having donovanosis, reach agreement with the laboratory to process the GUMP specimen. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/ available): • Directly observed therapy (DOT) is recommended • if lesions have not responded to treatment after four weeks • if lesions are not healed after six weeks • contraindication to treatment • client is pregnant or breast feeding • consult a specialist for advice on treating babies born to mothers with donovanosis at time of delivery • immunosuppression e.g. HIV positive client • uncertain diagnosis • abnormal findings of clinical significance • findings outside NOs scope of practice. Notify Queensland Syphilis Register (1800 032 238) on suspicion of donovanosis and prior to commencing treatment, complete GUD notification form and send to Syphilis Register. Treatment Indicators 44 • diagnosis based on examination findings and epidemiological evidence • manage syndromically • treat for donovanosis, syphilis and HSV at time of consultation after • specimens have been collected • laboratory confirmation. You may need to modify treatment as laboratory results become available • contact of partner who has tested positive or is diagnosed symptomatically for donovanosis QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • if there is no improvement in six weeks and neoplasm is suspected, take a punch biopsy of lesion and non-infected tissue (advancing edge). Snip or punch biopsy of donovanosis lesions can usually be taken with minimal discomfort using local anaesthetic. Regimens • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or a MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence. For all other cases consult a MO or endorsed NP. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. Name Azithromycin Form Tablet Strength 500 mg Recommended dose 1 gram (2 x 500mg tablets) Route of admin Oral with or without food Frequency/duration 1 gram per week for four weeks or until lesion healed Pregnancy category B1 Poison schedule S4 Emergency management As for severe allergic reaction – Anaphylaxis Consult MO Contraindications Known hypersensitivity to Azithromycin, Erythromycin or any Macrolide antibiotic Special precautions Pneumonia Elderly Prolonged QT interval Renal and hepatic impairment Pregnancy and lactation Children <16 years SECTION 4 2010 45 Adverse reactions Superinfection Angioedema Cholestatic jaundice Raised LFT, AST, ALT Colitis, GI upset Vaginitis Interactions Antacids Ergot Derivatives Rifabutin Cyclosporine Warfarin Digoxin And drugs that prolong QT interval Plus Name Benzathine Penicillin Bicillin (LA) Form Suspension Strength 900mg / 2.3 ml (1,200,000 units) Recommended dose 1.8 g (2 x 900mg/2ml or 2,400,000 International units) Route of admin IM Frequency/duration Stat (one dose) Pregnancy category A Poison schedule S4 Emergency management As for severe allergic reaction – Anaphylaxis Consult MO Contraindications Previous hypersensitivity to Penicillin Do not inject into or near an artery or nerve Inadvertent intravascular administration can be dangerous Special precautions Anaphylaxis Lactation Jarisch-Herxheimer reaction 46 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Adverse reactions Atrophy Superinfection Pseudo membranous colitis Hypersensitivity Haematological effects Acute interstitial nephritis Neuropathy Nephropathy Interactions Tetracycline Probenecid or Benzathine Benzylpenicillin (Pan Benzathine Penicillin)26, 28 Benzathine Benzylpenicillin (Pan Benzathine Penicillin) and Benzathine Penicillin (Bicillin LA) are the same drug in different presentations. Benzathine Benzylpenicillin (Pan Benzathine Penicillin) is approved for use where Bicillin LA is unavailable. Recommended dose and frequency remains the same as for Benzathine LA but the different product means an increase in required volume and change in preparation process. Name Benzathine Benzylpenicillin (Pan Benzathine Penicillin) Form Powder Strength 900mg (1,200,000 International units) Recommended dose 1.8g Route of admin IM reconstituted with: (2 x 900mg or 2,400,000 International units) 4ml of water for injection27 Administer 4.6ml (1vial) in each buttock. Frequency/duration Stat (one dose) Pregnancy category A Poison schedule S4 Emergency management See allergic reaction/anaphylaxis management Consult MO Contraindications Allergy to Penicillin SECTION 4 2010 47 Special precautions Re-bleed for Syphilis serology at time of treatment for true baseline RPR titre Lactation Anaphylaxis Adverse reactions Atrophy Superinfection Pseudo membranous colitis Hypersensitivity Haematological effects Acute interstitial nephritis Jarisch-Herxheimer reaction Neuropathy Nephropathy Interactions Tetracycline, Probenecid Benzathine Benzylpenicillin (Pan Benzathine Penicillin) injection technique27, 28 To minimise discomfort: • reconstitute each 900mg in minimum 4mls of water for injection • use a 5ml syringe • hold vial vertically and shake until the powder is absorbed • prepare immediately prior to administration • warm the injection by rolling between palms of hands prior to administration. This can help reduce discomfort for the client. Do not heat >50oC • if there is a delay in administration following preparation, rotate syringe vertically prior to administration to ensure powder is mixed. This will reduce obstruction of the needle due to precipitation of the suspension • attach a 21 gauge or 19 gauge needle to the syringe just prior to injecting suspension to prevent blockage of needle • administer in the upper-outer quadrant of the gluteus maximus • give two injections - one in each buttock • apply pressure to the injection site for at least 10 seconds prior to administration. Note: • 48 clinical differentiation of genital ulcerative disease is inaccurate, particularly in areas where more then one causative organism is endemic or prevalent at high rates.25 This QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES is compounded by the presence of HIV infection which may alter clinical manifestations and patterns of GUD occurrence. Recent evidence indicates that HSV 2 is increasing in many populations as the main cause of GUD25. After detection of GUD (i.e. chancroid, donovanosis, LGV or HSV) it is important to consider additional investigation and treatment based on local aetiology and sensitivity patterns. • COC users taking a short course (<3 weeks) of antibiotics should be advised to use additional contraception (i.e. condoms) during treatment and for seven days after antibiotics have been stopped.13 Client education • keep lesions clean and dry • if there is purulent discharge, sitz baths or saline cleansing can relieve discomfort • protect skin from sunlight (especially between 10am – 3pm) as some macrolide antibiotics increase sensitivity to sunlight. If there is a rash, itching, redness or severe sunburn consult a MO • encourage client to refrain from sexual contact until lesions are completely healed and partner(s) are treated • Offer condoms and lube • Offer screening for other STIs • client fact-sheet available at www.health.qld.gov.au/sexhealth • provide MIMS Medication Consumer Information www.ckn.health.qld.gov.au Contact tracing14 Offer all partners who had sexual contact during the period of active lesions and 40 days prior to the onset of symptoms, an STI screening and treat presumptively for donovanosis. Follow-up • this condition is highly stigmatised so ongoing support and counselling is important • review weekly until healed and symptoms resolved • if there is no improvement within six weeks refer to a MO • review in three and six months to ensure there is no evidence of reinfection SECTION 4 2010 49 Dyspareunia Recurrent or persistent genital pain experienced before, during, or after sexual intercourse, penetration or masturbation is classified as dyspareunia. It is situational or generalised in presentation and can be acute or chronic (acquired or lifelong). 1-5 The Diagnostic and Statistical Manual of Mental Disorders fourth edition (DSM IV) classifies dyspareunia as a sexual pain disorder under sexual dysfunction and lists the additional criteria for diagnosis as a recurrent or persistent genital pain associated with sexual intercourse; and a disturbance that causes marked distress or interpersonal difficulties.1,2 Dyspareunia can be related to physical, neurological and complex psychosocial issues.2,3 Predisposing risk factors can include anxiety, depression, history of sexual assault or specifically in females – peri/post menopause and pelvic inflammatory disease.4,5 Identifying when the pain occurs in relation to the stage of a sexual act is helpful in determining the cause.6 Dyspareunia is rare in males. History A detailed history should include assessment of possible physical, neurological and psychological causes as ongoing management, treatment and indication for referral to medical officer is dependant on the suspected cause. Examination and investigations will be guided by the comprehensive history findings. Females A detailed history should include: • sexual, medical, surgical and family history including medication history • specific questions related to pain: – nature (i.e. when and where the pain occurs) – onset (i.e. before, on initial penetration, during or after sexual intercourse, with orgasm or positional) – location (i.e. superficial, at vaginal entrance, vaginal or deeper, single or multiple sites) – duration and severity (i.e. is pain lifelong or acquired, how long does it last?) – frequency (i.e. permanent or intermittent - does the pain occur with every sexual encounter? If not, what is different about the times when no pain is experienced?) – characteristics (i.e. stinging, cutting, burning, pulling or stabbing)7 – radiation (i.e. does pain travel to the perineum, rectum, abdomen etc) – contributing or aggravating factors: >Is it situational or general? >Does it occur with all partners, foreplay and non-penetrative sexual behaviour or with penetration with fingers, sex toys, tampon 50 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES > What makes it better – if anything, is it bad enough to take pain medication, does using lubrication stop the pain? >Are there any aggravating factors: sex, direct pressure, urination, menses, bowel movement, diet, orgasms.8 • treatment – history of previous treatment, did they experience pain with previous vaginal examinations, has any over the counter preparations been used, of anything out of the medicine cupboard at home? • other physical symptoms: vaginal discharge, abnormal bleeding, associated abdominal pains, history of STI • contraception history • sexual function/dysfunction apart from pain • pregnancy and delivery history: • experience of trauma, lacerations or episiotomy • has sex changed since, has the pain begun or changed since birth. • recent body art e.g. genital piercing • skin disorders • bowel or bladder disorders or chronic conditions • trauma, neurological disorders or chronic illness • psychosocial – mood, depression, anxiety, lifestyle and fatigue – altered self esteem or coping skills – sexual abuse – libido – social history – relationships/recent changes9 – impact on partner/relationship – cultural, religious impact, conflict or restrictions. Males A detailed history should include: • sexual, medical, surgical and family history including medication history • specific questions related to pain: – onset [i.e. lifelong, situational, acute vs chronic (>6months), precipitating factors, spontaneous or transient] – location (i.e. deep in the penis, superficial, in the prostate region or in the testes) SECTION 4 2010 51 – duration (i.e. is it with all sex, oral or masturbation. How long does the pain last, how long does it take to resolve completely, and is it at the moment of ejaculation only) – characteristics [i.e. intense (use pain scale), burning, stinging, pulling, cutting, stabbing, sharp, dull or tugging. Is it bad enough to take pain medication? Are there any urinary symptoms? frequency, urgency, dysuria or any blood in semen or urine] – contributing or aggravating factors: > is the pain affected by ejaculation, intercourse, toys (penile enlargers), alcohol, any objects inserted into the urethra or use of drugs that may lead to ‘violent’ sex, > does anything makes the pain better (i.e. does using lubrication stop the pain). – radiation (i.e. does the pain travel to the testes, perineum, rectum, abdomen etc). • treatment (i.e. have any over-the-counter preparations been used or anything out of the medicine cupboard at home) • family history (i.e. pyrones disease or testicular cancer) • sexual function/dysfunction apart from pain (i.e. how bothersome is it) • associated relationship issues • recent surgical history (e.g. vasectomy, pelvic, gastric surgery, penile implants, penile repair or testicular surgery) • recent body art e.g. penile piercing. Signs / symptoms • client experiences recurrent or persistent genital pain before, during or after sexual intercourse, penetration or masturbation • client experiences recurrent or persistent genital pain during or after ejaculation. Diagnosis3,8,9 Females • • Entry pain – vaginismus, vulvodynia, vulvar vestibulodynia (VBY) or vulvovaginitis – vulvovaginal atrophy, vaginal dryness or inadequate lubrication – skin disorders (i.e. eczema, psoriasis, allergies, vulvar dermatoses or drug reactions) – obstetric causes: episiotomy, vulvar varicosities – genital mutilation. Deep pain – 52 infection (i.e. STI, cystitis or pelvic inflammatory disease) QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • – endometriosis – pelvic congestion or adhesions – bowel disorders (i.e. irritable or inflammatory bowel, constipation or proctitis) – ectopic pregnancy. Entry or deep pain – neurologic disorders (i.e. pudendal nerve lesions) – muscular disorders (i.e. pelvic floor hypertonus or fibromyalgia) – anatomic deformities or congenital anomalies (i.e. retroverted uterus, uterine fibroids, bartholin cysts, genital prolapse, intact or imperforate hymen) – post partum, birth trauma, psychological – trauma (including surgery, self inflicted, inflicted), back injury, sports injury, radiation therapy – trauma during sex – genital cancer. • Neuropathic • Psychological. Males4 • • Physical – infection (i.e. phimosis, epididymo-orchitis, prostatitis, urethritis, cystitis, benign protatic hypertrophy (BPH) or balanitis – torsion of the testes – skin disorders (i.e. eczema, psoriasis, dermatitis, allergies or intraurethral lesions)6 – trauma, back injury or sports injury. Trauma including surgery, self inflicted or inflicted – trauma during sex – anatomic deformities (i.e. Peyronie’s disease, tight or scarred foreskin) – genital cancers (i.e. penile or prostate)7 – alcohol and drugs (i.e. recreational, ED drug use especially injectables). Neuropathic – • compression or entrapment of the pudendal nerve. Psychological. SECTION 4 2010 53 Examination Females • Examination should be guided by comprehensive history findings • General examination - include skin, nails, abdomen and extremities • Palpate abdomen for tenderness and guarding • Examine the vulva and perianal region for erythema, lesions, ulcers, rashes, abnormalities, anatomical presentation, scarring or tenderness • Examine vaginal opening and hymenal membrane for erythema and thickening, presence or absence of lesions, anatomical abnormalities, vaginal discharge or vulvar soreness • Palpate vulva and perineum for pain, tenderness, masses or scarring – assess for vestibulodynia by gently parting the labia minora and using a moist cotton-tipped swab to determine whether there is pain with pressure at one or more points around the vestibule. • Vaginal examination - gently slide a single finger into the vagina and depress the levator ani muscles at multiple angles looking for hypertonicity, spasm or tenderness. • Speculum examination (If tolerated) • – observe for anomalies, discharge, fissures, erosions, ulcers and atrophy – examine the vagina for inflammation, discharge, lesions or other abnormalities – assess the cervix for inflammation, oedema, discharge, bleeding and other abnormalities. Bimanual examination (if tolerated and pregnancy test negative) – assess cervix for cervical excitation – assess uterus for size, position and tenderness – assess adnexae for tenderness and masses. Males 54 • General examination – include skin, nails, abdomen and extremities • Genital examination – standing and lying down. Look for scarring (from circumcision or from old piercing), feel for plaques along the shaft, swelling of the glans, prepuce or shaft, and lesions on the skin • Testes – look for symmetry, size, shape, tenderness, heat, skin lesions, and lesions within the scrotum, testes or epididymis • Feel for the vas deferens from the length up to the groin. • Examine the groin for inguinal hernias QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • Standing – check for symmetry (one testes is usually slightly lower than the other), varicosities (varicocele), hernias or abnormal penile curvature (may be difficult to see with a flaccid penis). Note: The goal of physical examination is to localise the pain or discomfort, determine the type and location of any pathology.4,5 In most cases, female dyspareunia requires referral or at minimum, consultation with a MO for ongoing examination and management. Therefore the extent of examination performed by a NO is dependant on their experience, setting and the clinical scenario. Investigations Females- (only if indicated) • Blood pressure • Urinalysis • BHCG urine pregnancy test • Vaginal • • • – high vaginal swab for M/C/S – pH – gram stain, wet prep (onsite if available, self-collected if client prefers) – swab for trichomoniasis PCR. Endocervical (if indicated and tolerated) – swab for chlamydia PCR – swab for gonorrhoea M/C/S. Urethral – first catch urine for chlamydia and gonorrhoea PCR – first catch urine for trichomoniasis PCR – midstream urine (if indicated) Other sexual health screening as indicated by history. Males • STI screen • clinic urinalysis • testicular ultrasound (if intrascrotal, testicular or vas deferens lesions) • penile ultrasound (if plaques or suspected Peyronie’s disease) Note: Referral for ultrasound prior to referral to MO may be indicated in some clinical settings. SECTION 4 2010 55 Management / treatment Females Female sexual dysfunction often involves several aetiologies contributing to the problem.10 Management must be tailored to the sexual issue and take into account underlying physical and psychological factors (including relationship). Conditions that may alter sexual function (e.g. depression, sexual issues related to medication or substance abuse) should also be considered. Medical referral Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/ available): • suspected organic basis to dyspareunia • uncertain diagnosis • persistent symptoms after treatment • ongoing medical management • contraindication to treatment • client is pregnant or breastfeeding • abnormal findings of significance (i.e. in males – varicocele, hernia, penile curvature, intrascrotal, testicular torsion, testicular or vas deferens lesions) • immunosuppression i.e. HIV positive client • findings outside NOs usual scope of practice. For all other cases • Refer to management and treatment of specific condition diagnosed. Note: requirements for referral and medical consultation will depend on history and clinical findings. For example, if an infection related to STI is obvious, offer treatment according to findings and refer to a MO as indicated. If any mental health issues are identified refer the client to a psychologist/counsellor. Consider epididymo-orchitis or testicular torsion with tender / painful testes in younger males. Contact tracing N/A 56 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Epididymo-orchitis Epididymo-orchitis is a common inflammatory infection involving the testes and epididymis. It can be acute, sub-acute or chronic and is commonly caused by the organisms Chlamydia Trachomatis and Neisseria Gonorrhoea3, 28. History of insertive anal intercourse is associated with an increased risk of epididymo-orchitis due to coliform bacteria. Signs / symptoms • swelling of the testicle (usually unilateral) • painful testicle • +/- fever • urethral discharge • dysuria • pain in inguinal region or abdominal flank on affected side • enlarged tender epididymis on affected testicle • erythema of scrotal skin on affected side • some may be asymptomatic. Investigations • temperature and pulse • testicular examination • urethra (examine for discharge) • urethral: – gram stain (if symptomatic) – external swab for gonorrhoea M/C/S and chlamydia PCR or – first catch urine for gonorrhoea and chlamydia PCR if no discharge – mid-stream urine for M/C/S. Management Refer all suspected cases of epididymo-orchitis to MO. Requires immediate medical consultation or referral to Emergency Department: • testicular torsion • acute orchitis SECTION 4 2010 57 • abnormal findings of clinical significance • uncertain diagnosis • contraindication to treatment • no response to treatment or resolution of symptoms following treatment • immunosuppression e.g. HIV positive client • findings outside NOs scope of practice or capacity. Treatment Indicators • • syndromic management should be based on: – clinical diagnosis of STI according to history and examination – presence of signs and symptoms. laboratory confirmed diagnosis. Regimens for suspected STI related cause • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence. For all other cases consult a MO or endorsed NP. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. First line regimens 8, 10, 11, 29 Name Doxycycline Form Capsule or Tablet Strength 100mg Recommended dose 100mg Route of admin Oral with food Frequency/duration Twice a day for 14 days10, 11 Pregnancy category D Poison schedule S4 Emergency management As for severe allergic reaction - Anaphylaxis Consult MO 58 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Contraindications Pregnancy and lactation Hypersensitivity to any tetracycline Concomitant treatment with oral retinoid Special precautions Do not take immediately before going to bed Take with food or milk Renal and hepatic impairment Prolonged use Children <8 years Adverse reactions Photosensitivity Urticaria Superinfection Pseudomembranous colitis Oesophagitis GI disturbances Tooth discolouration Interactions Acetazolamide Antacids (containing Al, Mg, Ca Bismuth Salts) Anticoagulants Barbiturates Carbamazepine Methoxyflurane (may cause fatal renal toxicity) OCP Penicillin Phenytoin Sodium Bicarbonate Iron SECTION 4 2010 59 Plus Name Ceftriaxone Form Powder Strength 250mg Recommended dose 250mg Route of admin Intramuscular injection reconstituted with 2ml Lignocaine 1% solution Frequency/duration Stat Pregnancy category B1 Poison schedule S4 Emergency management Consult MO Contraindications Allergy to Cephalosporins Allergy to Penicillin Special precautions Penicillin sensitivity Renal and hepatic impairment Impaired vitamin K synthesis GI disease (especially colitis) Pregnancy, lactation Children <12 years Neonates Adverse reactions Hypersensitivity Superinfection Pseudomembranous colitis Hypoprothrombinemia Local reactions Diarrhoea Pancreatitis and gall bladder concretions Interactions Chloramphenicol Observe client for 30 minutes after administration of Ceftriaxone. 60 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES And Name Lignocaine hydrochloride Form Liquid for injection Strength 1% (5ml ampoule) Recommended dose 2 ml to be used to reconstitute 250mg Ceftriaxone powder Route of admin Intramuscular injection Frequency/duration Stat Pregnancy category A Poison schedule S4 Emergency management Consult with MO Contraindications Local inflammation/sepsis Septicaemia Anticoagulants CNS or spinal cord disease Impaired cardiac conduction, intraventricular block, arrhythmias Hypersensitivity to amide LAS Special precautions High repeated doses - hepatic, renal, cardiac impairment Hypoxia, sever respiratory depression Neurological disorders, epilepsy Elderly, children Pregnancy and lactation Adverse reactions CNS disturbances cardiovascular depression arrhythmias hypertension Interactions Other local anaesthetics antiarrhythmics, beta-blockers (especially class 111) cimetidine phenytoin, other anticonvulsants inhalation anaesthetics skeletal muscle relaxants alcohol SECTION 4 2010 61 Or Ceftriaxone 250mg powder vials are not available in some settings and have been substituted with Ceftriaxone dry powder 1 gram vial stock. Note: the regimen using Ceftriaxone dry powder is the same recommended dose of 250mg Ceftriaxone stat as above. Only the strength in stock has changed to 1g Ceftriaxone dry powder. Please follow recommended dose calculation. Name Ceftriaxone Form Dry powder Strength 1g (0.4ml) Volumes for Dose Calculation 23, 24 1g Dry powder (0.4ml) + 1% Lignocaine solution 3.5ml = Total volume 3.9ml Recommended dose 250mg (0.98ml) Route of admin Intramuscular Injection Frequency/duration Stat Pregnancy category B1 Poison schedule S4 Emergency management Consult MO Contraindications Allergy to Cephalosporins Allergy to Penicillin Special precautions Penicillin sensitivity Renal and hepatic impairment Impaired vitamin K synthesis GI disease ( especially colitis) Pregnancy, lactation, Children <12 years Neonates Adverse reactions Hypersensitivity reactions Superinfection Pseudomembranous colitis Hypoprothrombinemia Local reactions Diarrhoea Pancreatitis and gall bladder concretions Interactions 62 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Allergy to Cephalosporins or Penicillin Observe client for 30 minutes after administration of Ceftriaxone. And Name Lignocaine hydrochloride Form Liquid for injection Strength 1% (5ml ampoule) Recommended dose 3.5ml to be used to reconstitute 1g Ceftriaxone powder Route of admin Intramuscular injection Frequency/duration Stat Pregnancy category A Poison Schedule S4 Emergency management Consult with MO Contraindications Local inflammation/sepsis Septicaemia Anticoagulants CNS or spinal cord disease Impaired cardiac conduction, intraventricular block, arrhythmias Hypersensitivity to amide LAS Special precautions High repeated doses: Hepatic, renal, cardiac impairment Hypoxia, sever respiratory depression Neurological disorders, epilepsy Elderly, children Pregnancy and lactation Adverse reactions CNS disturbances cardiovascular depression arrhythmias; hypertension Interactions other local anaesthetics Antiarrhythmics, beta-blockers, especially class 111 cimetidine phenytoin, other anticonvulsants inhalation anaesthetics skeletal muscle relaxants alcohol SECTION 4 2010 63 Or NO consult with a MO prior to supply of Ciprofloxacin 64 • According to the Queensland Hospitals List of Approved Medicines (LAM) Ciprofloxacin is restricted to specialist staff for treatment of serious infections caused by sensitive organisms on the advice of an Infectious Diseases Physician 20 • The Pharmaceutical Benefits Schedule (PBS) places further restriction that Ciprofloxacin only to be used in the treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials 20 • Because of increasing resistance to Ciprofloxacin 500mg orally as a stat dose this regimen is no longer recommended unless a sensitive gonococcal strain has been identified via laboratory confirmed diagnosis 10,11 • Prior to commencing treatment regimens using Ciprofloxacin, consult a MO and/or obtain a laboratory confirmed diagnosis with sensitivity to Ciprofloxacin. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Second line regimens30 Name Azithromycin Form Tablet Strength 500mg Recommended dose 1gram (2 X 500mg tablets) Route of admin Oral with or without food Frequency/duration Stat Pregnancy category B1 Poison schedule S4 Emergency management As for severe allergic reaction - Anaphylaxis Consult MO Contraindications Known hypersensitivity to Azithromycin, Erythromycin or any macrolide antibiotic Special precautions Pneumonia Elderly Prolonged QT interval Renal and hepatic impairment Pregnancy and lactation Children < 16 years Adverse reactions Superinfection Angioedema Cholestatic jaundice Raised LFT, AST, ALT Colitis, GI upset Vaginitis Interactions Antacids Ergot Derivatives Rifabutin Cyclosporine Warfarin Digoxin And drugs that prolong QT interval SECTION 4 2010 65 Plus Name Ceftriaxone Form Powder Strength 250mg Recommended Dose 250mg Route of admin Intramuscular Injection reconstituted with 2ml Lignocaine 1% solution Frequency/duration STAT Pregnancy category B1 Poison schedule S4 Emergency management Consult MO Contraindications Allergy to Cephalosporins Allergy to Penicillin Special precautions Penicillin sensitivity Renal and hepatic impairment Impaired vitamin K synthesis GI disease (especially colitis) Pregnancy, lactation Children <12 years Neonates Adverse reactions Hypersensitivity reactions Superinfection Pseudomembranous colitis Hypoprothrombinemia Local reactions Diarrhoea Pancreatitis and gall bladder concretions Interactions Chloramphenicol Observe client for 30 minutes after administration of Ceftriaxone. 66 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES And Name Lignocaine hydrochloride Form Liquid for injection Strength 1% (5ml vial) Recommended dose 2ml to be used to reconstitute 250mg Ceftriaxone powder Route of admin Intramuscular injection Frequency/duration Stat Pregnancy category A Poison schedule S4 Emergency management Consult with MO Contraindications Local inflammation/sepsis Septicaemia Anticoagulants CNS or spinal cord disease Impaired cardiac conduction, intraventricular block, arrhythmias Hypersensitivity to amide LAS Special precautions High repeated doses: Hepatic, renal, cardiac impairment Hypoxia, sever respiratory depression Neurological disorders, epilepsy Elderly, children Pregnancy and lactation Adverse reactions CNS disturbances cardiovascular depression arrhythmias hypertension Interactions Other local anaesthetics Antiarrhythmics, beta-blockers (especially class 111) cimetidine phenytoin, other anticonvulsants inhalation anaesthetics skeletal muscle relaxants alcohol SECTION 4 2010 67 Or Ceftriaxone 250mg powder vials are not available in some settings and have been substituted with Ceftriaxone dry powder 1gram vial stock. Note: The regimen using Ceftriaxone dry powder is the same recommended dose of 250mg Ceftriaxone stat as above, only the strength in stock has changed to 1g Ceftriaxone dry powder. Follow recommended dose calculation. Name Ceftriaxone Form Dry powder Strength 1g (0.4ml) Volumes for Dose Calculation 24, 25 1g Dry powder (0.4ml) + 1% Lignocaine solution 3.5ml = Total volume 3.9ml Recommended dose 250mg (0.98ml) Route of admin Intramuscular injection Frequency/duration Stat (once only) Pregnancy category B1 Poison Schedule S4 Emergency Management Consult MO Contraindications Allergy to Cephalosporins or Penicillin Special precautions Penicillin sensitivity Renal and hepatic impairment Impaired vitamin K synthesis GI disease (especially colitis) Pregnancy, lactation Children <12 years Neonates Adverse reactions Hypersensitivity Superinfection Pseudomembranous colitis Hypoprothrombinemia Local reactions Diarrhoea Pancreatitis and gall bladder concretions Interactions Allergy to cephalosporins or penicillin Observe client for 30 minutes after administration of Ceftriaxone. 68 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Plus Name Lignocaine Hydrochloride Form Liquid for injection Strength 1% (5ml ampoulel) Recommended dose 3.5ml to be used to reconstitute 1g Ceftriaxone powder Route of admin Intramuscular injection Frequency/duration Stat Pregnancy category A Poison schedule S4 Emergency management Consult with MO Contraindications Local inflammation/sepsis Septicaemia Anticoagulants CNS or spinal cord disease Impaired cardiac conduction, intraventricular block, arrhythmias Hypersensitivity to amide LAS Special precautions High repeated doses Hepatic, renal, cardiac impairment Hypoxia, sever respiratory depression Neurological disorders, epilepsy Elderly, children Pregnancy and lactation Adverse reactions CNS disturbances Cardiovascular depression Arrhythmias Hypertension Interactions Other local anaesthetics Antiarrhythmics, beta blockers (especially class 111) Cimetidine Phenytoin, other anticonvulsants Inhalation anaesthetics Skeletal muscle relaxants Alcohol SECTION 4 2010 69 Note: • for clients where compliance with the Doxycycline regimen is an issue, use Ceftriaxone stat plus Azithromycin 1g stat and repeat Azithromycin in seven days. This is not an authorised regimen so refer to a MO prior to administering • treatment should include analgesics for pain relief • treatment of suspected non-STI related epidiymo-orchitis should be based on history and potentially include treatment for coliforms. Ensure MSU for MCS is collected to guide ongoing management29 and refer to a MO. Client education • protect skin from sunlight (especially between 10am – 3pm) and solariums, as some macrolide antibiotics increase sensitivity to sunlight. If there is a rash, itching, redness or severe sunburn consult a MO • Doxycycline to be taken with one full glass of water. Client to be seated upright for at least 30 minutes after taking medication • client fact-sheet available at www.health.qld.gov.au/sexhealth • provide MIMS Consumer Medicine Information www.ckn.health.qld.gov.au Contact tracing If STI diagnosed, sexual partner(s) should also be examined and treated accordingly. Follow-up 70 • review client in three days to ensure resolution of symptoms and response to treatment. If no improvement, consider changing treatment regimen, surgical referral3 or alternate diagnosis (i.e. testicular infarction, abscess formation, mumps, testicular tumour or tuberculous epididymo-orchitis) • recommend retesting for gonorrhoea and chlamydia in three months if confirmed STI related infection, as reinfection is common. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Genital herpes (HSV) Genital herpes is the most common cause of genital ulcer disease. It is caused by herpes simplex virus 1 and 2 (HSV 1 and HSV 2).3 It is a chronic, life-long viral infection7 acquired by skin-to-skin contact during oral or genital sex. It can be acquired from symptomatic or asymptomatic partners. About 70% of genital herpes is caused by HSV 2 and is primarily transmitted by a person unaware of their infective status or during an episode of asymptomatic shedding.7 Perinatal transmission is a rare but serious infection with high morbidity and mortality. Transmission is more likely to occur with vaginal delivery at the time of primary maternal infection. Risk is significantly lower with recurrent HSV lesions or asymptomatic infection at the time of delivery. A female with a history of genital herpes or an infected partner, should notify the medical obstetric team immediately. A vaginal delivery is usual for women with a history of genital herpes, though lesions at the time of delivery would prompt most obstetric teams to perform a caesarean section. Signs / symptoms3 Most HSV infections are asymptomatic. Clinical manifestations depend on the site of viral entry and immunity from previous oral or genital HSV exposure. Manifestations of newly acquired infection may be severe in non-immune clients, while initial infections are less severe in clients with prior exposure. Sexually acquired manifestations include genital ulceration, gingivostomatitis, urethritis, cervicitis and proctitis. It can be difficult to determine whether a client who presents with herpes for the first time has a true ‘first’ infection or whether it is a recurrence of previously unrecognised infection. Multiple, widespread, bilateral lesions, which are at different stages of development and resolution and at sites of direct mucosal infection are usual indicators of first infection. In contrast, recurrent lesions are grouped and localised, unilateral, at identical stages of development and at cutaneous sites along sacral dermatomes. Primary or initial episode • multiple, widespread, painful lesions with associated systemic symptoms • atypical presentation may include skin splits, skin irritation, fissures or single lesions. Recurrent episode • localised unilateral painful lesion(s) • history of recurrent thrush or lesion(s) • atypical presentation can include skin splits, skin irritation or fissures. HSV infections also present asymptomatically as mild or unrecognised infections. The severity of presentation depends on existing immunity from previous oral/genital HSV exposure and the site of infection. Initial infection is less severe in clients with previous exposure to HSV 1. SECTION 4 2010 71 Investigations Test all clients presenting with genital lesions, ulcers, chronic genital skin tears or recurrent candidiasis. Lesions • HSV PCR swab from the lesion(s) Serology • HSV Serology is not recommended for diagnosis,3 as available tests do not necessarily distinguish between HSV 1 and HSV 2 antibodies. Type-specific herpes antibody tests are available but their place in the diagnosis of genital herpes is unclear • HIV • Syphilis. Note: Testing for HSV should not occur in isolation. Consider testing for other genital ulcer diseases and discuss additional STI screening with the client. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/ available): • prescription required for recurrent episodic or suppression therapy, analgesia • symptoms persist while taking antiviral treatment • disseminated infection i.e. meningitis or neurological problems • severe complications i.e. severe pain, secondary infection, urinary retention, tenesmus or atonic bladder • uncertain diagnosis • client is pregnant or breastfeeding • immunosuppression e.g. HIV positive client • abnormal findings of significance • findings outside NOs scope of practice. Treatment Indicators 72 • diagnosis based on clinical examination • laboratory confirmed diagnosis. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Primary or initial episode regimen • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and should refer management to a DTP–SRH endorsed NO, endorsed NP or MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence under the following conditions: • – supply five days of Valaciclovir or Aciclovir for initial episodes – consult MO or authorised endorsed NP if 10 day treatment required – for all other cases consult a MO or endorsed NP. Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. Name Valaciclovir Form Oral Strength 500mg Recommended dose 500mg Route of admin Oral Frequency/duration Twice daily for 5 - 10 days Pregnancy category B3 Poison schedule S4 Emergency management As for severe allergic reaction – Anaphylaxis Consult MO Contraindications Known hypersensitivity to Aciclovir or Valaciclovir Special precautions Renal and hepatic impairment Dehydration Immuno-compromised clients Pregnancy and lactation Children and elderly Adverse reactions Headache, dizziness Nausea, G.I. upset Rash and hypersensitivity Interactions No clinically significant interactions have been identified Note: regimen for primary Herpes treatment is five days.10-11 Duration may be extended to 10 days supply for moderate to severe episodes.3 SECTION 4 2010 73 Or Name Aciclovir Form Oral Strength 200mg Recommended dose 400mg (2 x 200mg tablets) Route of admin Oral Frequency/duration Three times a day for five days3 Pregnancy category B3 Poison schedule S4 Emergency management As for severe allergic reaction – Anaphylaxis Consult MO Contraindications Known hypersensitivity to Aciclovir or Valaciclovir Special precautions Caution in clients with: Underlying neurological abnormalities Significant hypoxia Electrolyte impairment, dehydration Renal and hepatic impairment History of neurological reaction to cytotoxic drugs Receiving Interferon or intrathecal Methotrexate Pregnancy and lactation Children, Elderly Adverse reactions Nausea or vomiting are most frequent adverse effect Less frequent effects (<1%) include diarrhoea, dizziness, anorexia, fatigue, oedema, skin rashes, leg pain, inguinal adenopathy and sore throat Interactions No clinically significant interactions have been identified Probenecid Concurrent use of diuretics in clients aged > 60 yrs Note: Regimen for primary herpes treatment is five days. 10-11 Duration may be extended to 10 days supply for moderate to severe episodes. 3 Both these regimens prevent new lesion formation and rapidly reduce viral shedding, infectivity and risk of autoinfection. Consider pain relief. In severe cases, client may require hospitalisation. 74 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Primary or initial episode for HIV positive client Consult a MO for all immuno-compromised clients before initiating treatment for initial or primary episodes. Episodic therapy for recurrent episodes Initiate therapy at first sign of prodome or early lesions. Name Valaciclovir Form Oral Strength 500 mg Recommended dose 500mg Route of admin Oral Frequency/duration Twice a day for 3 – 5 days Pregnancy category B3 Poison schedule S4 Emergency management Consult MO Contraindications Known hypersensitivity to Aciclovir or Valaciclovir Special precautions Renal and hepatic impairment Dehydration Immuno-compromised clients Pregnancy Lactation Children and elderly Adverse reactions Headache, dizziness Nausea, G.I. upset Rash & hypersensitivity Interactions No clinically significant interactions have been identified Note: Regimen for episodic therapy for recurrent episodes is three days.11-12 Duration may be extended to five days supply for moderate to severe recurrent episodes.4 SECTION 4 2010 75 Or Name Famciclovir Form Tablet Strength 125mg, 250mg or 500mg Recommended dose 1250mg over a two day period Route of admin Oral Frequency/duration 500mg stat Then 250mg every 12 hours for three doses Pregnancy category B1 Poison schedule S4 Emergency management Consult MO Contraindications Known hypersensitivity to Famciclovir and Penciclovir Special precautions Renal Pregnancy Lactation Children <12 years Tablets contain lactose (should not be taken by clients with galactose intolerance, severe lactase deficiency or glucose malabsorption) Driving/operating machinery if experiencing dizziness/ somnolence Adverse reactions Headache, dizziness Nausea, G.I. upset Skin rash Fatigue / somnolence. Interactions No clinically significant interactions have been identified Note: 500mg Famciclovir is not available on the Queensland Health List of Approved Medicines.20 76 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Or Name Aciclovir Form Oral Strength 200mg Recommended dose 400mg (2 x 200mg tablets) Route of admin Oral Frequency/duration Three times daily for 5 -10 days Pregnancy category B3 Poison schedule S4 Emergency management As for severe allergic reaction – Anaphylaxis Consult MO Contraindications Known hypersensitivity to Aciclovir or Valaciclovir Special precautions Caution in clients with: Underlying neurological abnormalities Significant hypoxia Electrolyte impairment, dehydration Renal and hepatic impairment History of neurological reaction to cytotoxic drugs Receiving Interferon or intrathecal Methotrexate Pregnancy and lactation Children and elderly Adverse reactions Nausea, vomiting and headache are common Less frequent (<1%) includes diarrhoea, dizziness, anorexia, fatigue, oedema, skin rashes, leg pain, inguinal adenopathy, medication taste and sore throat Interactions No clinically significant interactions have been identified Probenecid. Concurrent use of diuretics in clients aged over 60 yrs Episodic therapy for HIV positive (recurrent episodes) Consult a MO before initiating treatment for recurrent HSV episodes for all immunocompromised clients. SECTION 4 2010 77 Suppressive therapy for recurrent episodes For moderately severe recurrences occurring every 4 – 5 weeks or less consider initiating the following regimen.3 • DTP-SRH endorsed and Non DTP-SRH endorsed NO are not authorised to administer/ supply this regimen. Refer to a MO for ongoing management and initiation of suppressive therapy. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. Name Famciclovir Form Tablet Strength 250mg Recommended dose 250 mg Route of admin Oral Frequency/duration Twice a day for 3 – 6 months12 Pregnancy category B1 Poison schedule S4 Or 78 Name Valaciclovir Form Oral Strength 500 mg Recommended dose 500mg Route of admin Oral Frequency/duration Once daily for 3 – 6 months Pregnancy category B3 Poison schedule S4 Name Aciclovir Form Oral Strength 200mg Recommended dose 200mg Route of admin Oral Frequency/duration Two times per day for 3 – 6 months12 Pregnancy category B3 Poison schedule S4 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Note: For clients living with HIV, suppressive therapy can be changed to Valaciclovir 500mg orally twice a day12. Consult a HIV specialist for further advice regarding managing HSV in HIV positive clients. Suppressive therapy should be discontinued after six months to assess the need for further courses. Relapse may occur at the end of prophylaxis. There is no evidence that lysine, zinc, vitamins or other non-mainstream remedies are any more effective than placebo in the prevention of recurrences. Pain management Analgesics, ural sachets, salt baths and local application of ice packs may help reduce discomfort. Topical antiseptics such as povidone-iodine may also be of benefit. Topical Xylocaine jelly 2% is a useful adjunct to Valaciclovir or Aciclovir in managing severe first episodes. It should be applied frequently but for no longer than 24 - 36 hours as there is a rare risk of sensitisation. • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and should refer management to a DTP–SRH endorsed NO, endorsed NP or MO –DTP-SRH endorsed NO may progress if within scope of practice and competence. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. SECTION 4 2010 79 Name Xylocaine (lignocaine) Form Gel Strength 2% Recommended dose Apply sparingly to affected area Route of admin Topical Frequency/duration Every 4 - 6 hourly prn Pregnancy category A Poison schedule S2 Emergency management Consult with MO Contraindications Hypersensitivity to local anaesthetic Special precautions absorption from mucous membranes is relatively high, remove excess jelly. prolonged use, high doses, frequent use mucosal trauma Sepsis Epilepsy impaired cardiac conduction impaired hepatic function severe shock severe renal dysfunction elderly, debilitated, children Adverse reactions local reaction CNS excitation depression cardiovascular depression local reactions Interactions other local anaesthetics antiarrhythmics, beta-blockers (especially class 111) cimetidine phenytoin, other anticonvulsants inhalation anaesthetics skeletal muscle relaxants 80 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Client education • use saline baths, topical betadine and oral analgesia to reduce discomfort • encourage rest and fluid intake to avoid dehydration • the client may require a medical certificate • client fact-sheet available at www.health.qld.gov.au/sexhealth • provide MIMS Consumer Medication Information www.ckn.health.qld.gov.au Contact tracing14 No contact tracing is required, Follow-up • follow-up appointment at one week (if indicated) • discuss recurrence and potential for transmission during sub-clinical shedding • offer counselling to client • inform client to abstain from sex during herpes episodes • refer to a MO if extension of medication regimen required or no improvement of symptoms. SECTION 4 2010 81 Genital warts – human papilloma virus (HPV) There are more than 100 genotypes of the human papilloma virus (HPV). More than 30 of these are known to infect the external and internal anogenital area and may present as genital warts7. The most common genotypes causing genital warts are type 6 and 11. High-risk HPV types 16, 18, 31, 33 and 35 are associated with cervical changes, neoplasias7 and other oncogenic anogenital infections3. The majority of anogenital HPV infections are asymptomatic, unrecognised or subclinical in presentation7. Most HPV infections are believed to spontaneously regress but infections can persist32. A persistent infection with high risk HPV types is the most predictive factor in progression to squamous intraepithelial neoplasia7,32. HPV vaccination is designed to help prevent infection with specific HPV genotypes and protect against persistent infection. Genital warts are transmitted by skin-to-skin sexual contact and transmission of HPV can occur regardless of clinical manifestations3. Incubation period is variable and may be prolonged. The existence of infectivity and infection in the absence of symptoms makes interruption of transmission extremely difficult. Transmission rarely occurs perinatally. Signs / symptoms • asymptomatic carriage of the virus, detectable as viral DNA in affected cells • cytological changes not apparent to the naked eye but detectable by histological techniques • cervical, vaginal, vulval, anorectal and penile lesions seen by colposcopy but not apparent macroscopically • recognisable genital warts or condylomata acuminata. Investigations Clients presenting for a sexual health check should be examined for genital warts. Partners of people diagnosed with genital warts should also be encouraged to attend a sexual health check. 82 • clinical diagnosis • discuss additional STI screening • pap smear (if indicated) • biopsy by a MO (if indicated). QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Management Conditions requiring NO to refer to or at minimum consult with an MO or NP (if appropriate/ available): • warts are extensive and potential labour problems are identified • no response to therapy after four ablative treatments • internal warts • abnormal findings of clinical significance or uncertain diagnosis • atypical warts including pigmented, indurated, fixed or ulcerated • client is pregnant or breastfeeding • immunosuppression e.g. HIV positive or transplant client • findings outside NOs scope of practice. Treatment Indicators Diagnosis of anogenital warts is based on direct visual examination of lesion. If in doubt, excise and examine histologically. This should be considered if lesions are atypical, there is ulceration or attachment to underlying structures or there are prompt or frequent recurrences after treatment. Non-wart HPV infection is often diagnosed by the presence of cytological changes on a pap smear. Assessed risk factors for HPV may indicate need for vaccination. Clinic treatment regimen Factors that may influence selection of treatment include size and number of warts, anatomic site of wart, wart morphology, client preference, cost and convenience of treatment, adverse effects and provider experience. • Non DTP-SRH endorsed NOs are authorised to administer this regimen only if clinical competency completed, otherwise refer to a DTP–SRH endorsed NO, endorsed NP or MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence. For all other cases consult an endorsed NP or MO. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. SECTION 4 2010 83 Name Cryotherapy with Liquid Nitrogen Form Liquid Route of admin Cryospray or topically with cotton buds Frequency/duration Once per week until clearance of warts or refer to MO after four weeks for review Or 84 Name Cryotherapy with Nitrous Oxide Form Gas Route of admin Topically with cryogun Frequency/duration Once per week until clearance of warts or refer to MO after four weeks for review • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer to a DTP–SRH endorsed NO, endorsed NP or MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence. For all other cases consult an endorsed NP or MO. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Name Trichloroacetic acid (TCA) 33, 34 Form Solution Strength 90% (4g) Recommended dose Apply with cotton tip applicator or pointed wooden stick to external warts only Route of admin Topically Frequency/duration Once a week until clearance of warts or refer to MO after four weeks for review Pregnancy category No specific data but not contraindicated in pregnancy Poison schedule S6 Emergency management Acute (skin) causes severe burn and blisters immediately wash affected area with plenty of water continuously for at least 15 mins. Remove contaminated clothing and wash before re-use. seek medical review. Acute (eye) causes severe burn and lacrimation immediately irrigate with plenty of water continuously for at least 15 mins. Hold eyelids open. Acute (swallowed - do not induce vomiting) may cause severe pain in abdomen, vomiting, diarrhoea, hoarseness, rapid and shallow respiration, circulatory collapse and low body temperature. Acute (inhalation) may cause irritation of nose/ soft mucous tissue asphyxiation may result from laryngeal oedema inhalation of acid fumes or aspiration of ingested acids may cause pneumonitis. Contraindications internal warts (rectal, urethral, vaginal and cervical). Special precautions apply only to wart tissue. Protect surrounding skin. TCA solutions have low viscosity and can spread rapidly if applied excessively. Adverse Reactions localised skin irritation or ulceration. Interactions Nil Pharmaceutical Precautions store in a cool (<25°), dry place away from source of heat or ignition. SECTION 4 2010 85 This product is not listed on the Queensland Health Standard Drug List or recommended as a treatment option for genital warts according to the Therapeutic Guidelines.10, 11 Or • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer to a DTP-SRH endorsed NO, endorsed NP or MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence. For all other cases consult an endorsed NP or MO. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. Name Podophyllin Form Solution Strength 25% resin in benzoin compound tincture Recommended dose Small amounts applied to external lesion only. Solution to remain for no longer than four to six hours Route of admin Topical Frequency/duration Once per week until warts clear. Refer to a MO after four weeks for review Pregnancy category D: "Do not use with any other podophyllin preparation..." Poison schedule S4 Emergency management If signs of toxicity refer to a MO for management Contraindications Pregnancy and lactation Internal warts (rectal, urethral, vaginal and cervical) Hypersensitivity to any ingredient Diabetes Clients using steroids or with poor blood circulation Do use with any other podophyllin preparation because of possible symptoms of toxicity Do not apply to healthy tissue or friable/bleeding mucosa – protect skin with Vaseline or other barrier prior to application. Do not ingest orally Special precautions Avoid contact with eyes and mucous membranes Not for use on internal warts (urethral, intravaginal, cervical or intrarectal) Application should be limited to reduce toxicity Application should be limited to <0.5 ml of Podophyllin or an area of <5 cm of warts per session 86 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Adverse reactions Local skin reactions (mild to moderate) i.e. localised pain, burning, pruritus or swelling Interactions No human drug interaction data available Pharmaceutical Store below 25oC, do not freeze Precautions Date bottle when open and discard after one month Note: Podophyllin is no longer a commercially available product or listed on the Queensland Health List of Approved Medicines20 as it is a non-standard cytotoxic compound. Studies demonstrate this product to be less effective than cryotherapy, podophyllotoxin or imiquimod. Recommend use of client provided podophyllotoxin preparations or Imiquimod as alternate treatment options.35 - 37 SECTION 4 2010 87 Pain management Apply lignocaine-prilocaine (emla) or xylocaine jelly for pain management prior to application of liquid nitrogen or nitrous oxide via cryotherapy. There are reports of variable efficacy of lignocaine-prilocaine (emla) on genital skin but FDA has approved its use as a topical local anaesthetic for adults on genital mucous membranes and skin.38 Name Lignocaine-prilocaine (emla) Form Cream Strength 5% Recommended dose 1.5g/10cm2 Route of admin Topical Frequency/duration Prior to procedure, apply a thick layer to ano-genital warts for at least 1 hour for maximum effect Pregnancy category A Poison schedule S2 Contraindications Hypersensitivity to prilocaine, lignocaine or other local anaesthetics Congenital or idiopathic methaemoglobinaemia Glucose-6-Phosphate dehydrogenase (G6PD) deficiency Special precautions Traumatized mucosa or non intact skin Atopic dermatitis Genital skin and mucous membranes3 Adverse reactions Mild local irritation Allergic reaction Increased methaemoglobin level Interactions Other local anaesthetics antiarrhythmics (especially class 111) beta-blockers cimetidine phenytoin, other anticonvulsants inhalation anaesthetics skeletal muscle relaxants Sulphonamides 88 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Or Name Xylocaine jelly 2% Form Gel Strength 2% Recommended dose 5 to 10ml Route of admin Topical Frequency/duration Apply 5 -10 minutes prior to cryotherapy Pregnancy category A Poison schedule S2 Contraindications Hypersensitivity to local anaesthetic Special precautions Absorption from mucous membranes is relatively high, remove excess jelly Prolonged use, high doses, frequent use Mucosal trauma Sepsis Epilepsy Impaired cardiac conduction Impaired hepatic function Severe shock Severe renal dysfunction Elderly, debilitated, children Adverse reactions Local reaction CNS excitation depression cardiovascular depression local reactions Interactions Other local anaesthetics antiarrhythmics (especially class 111) beta-blockers cimetidine phenytoin, other anticonvulsants inhalation anaesthetics skeletal muscle relaxants SECTION 4 2010 89 Regimens: client provided treatment 90 • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer to a DTP–SRH endorsed NO, endorsed NP or MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence. For all other cases consult an endorsed NP or MO. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Name Podophyllotoxin Form Liquid in Ethanol and cream base Strength 0.5% solution 0.15% cream Recommended dose Use the minimum amount of solution/cream necessary to cover lesion Minimize application to normal surrounding tissue Allow to dry thoroughly Route of admin Topical. Cutaneous use only Frequency/duration Twice per day for three consecutive days Then Four days with no treatment Repeat weekly cycle of treatment for a maximum of four weeks Pregnancy category D Poison schedule S4 Emergency management Discontinue use if significant irritation occurs. Consult a MO Contraindications Pregnancy "Do not use with any other Podophyllin preparation..." Existing skin infection, irritation or open wounds Hypersensitivity to Podophyllotoxin Internal warts (rectal, urethral, vaginal and cervical) Special precautions Avoid contact with eyes and mucous membranes. To reduce toxicity, applications should be limited. Systemic toxicity risk increased by treatment of large areas with excessive amounts for prolonged periods, treatment of friable, bleeding or recently biopsied warts or inadvertent application to normal skin or mucous membranes. Adverse reactions Local irritation causing tenderness, itching, erythema and superficial epithelial ulceration Interactions Nil Precautions Store at temperatures not exceeding 30oC Or Only commence Imiquimod regimen following consultation with a MO. SECTION 4 2010 91 Name Imiquimod Form Cream Strength 5% (250mg single use sachets) Recommended dose Apply in thin layer to affected areas Rub area until cream is no longer visible Route of admin Topical Frequency/duration Three times per week (e.g. Mon/Wed/ Fri) at night Leave on for 6 - 10 hours Continue until warts clear or for a maximum of 16 weeks Pregnancy category B1 not recommended in pregnancy or lactation Poison schedule S4 Emergency management Persistent overuse of Imiquimod can result in severe local skin reactions (discontinue until skin integrity improves) Oral ingestion can cause nausea, vomiting and headache (see MO for management) Contraindications "Do not use with any other Podophyllin..." Hypersensitivity to any ingredient Pregnancy and lactation Do use with any Podophyllin preparation because of possible symptoms of toxicity Special precautions Not for use internally (i.e. meatal, urethral, cervical, rectal, sub preputial warts) Take care when treating warts at the opening of the vagina or under the foreskin of an uncircumcised penis, due to possible inflammation. Effectiveness in immunocompromised clients or clients with HIV unknown Avoid sexual contact while cream is on skin. May weaken condoms and vaginal diaphragms No occlusive dressings Adverse reactions Local skin reactions (mild to moderate) i.e. Erythema, Erosion, Excoriation, Oedema Uncommon reactions see MIMS full prescribing information 92 Interactions No known interactions Precautions Store below 25oC and do not freeze QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Podophyllin, podophyllotoxin and imiquimod are all contraindicated in pregnancy and lactation. Client education • apply treatment to lesions only, being careful that preparation does not come into contact with healthy skin • Podophyllin – • wash solution off with soapy water within 4 – 6 hours (or immediately if irritation occurs). Podophyllotoxin solution and cream Reinforce the importance of consumer medication information regarding application and frequency: • – be careful that preparation does not come into contact with healthy skin – do not apply to extensive areas – avoid sexual contact while preparation applied. Imiquimod cream Reinforce the importance of consumer medication information regarding application and frequency: – apply cream to wart before bed, then wash off with mild soapy water in the morning – inform the client that erythema may occur due to a pharmacological response of the body’s immune system – if severe reaction occurs discontinue use and return for review. • routine pap smear is required according to the National Cervical Screening Program • information on cervical cancer available www.health.qld.gov.au/phs/wcss • client fact-sheet available www.health.qld.gov.au/sexhealth • provide MIMS consumer medication information www.ckn.health.qld.gov.au Contact tracing • offer current partners examination and screening Follow-up • follow-up clients during and after treatment and treat relapses as original lesions • HPV changes on a pap smear should be managed according to the NHMRC Guidelines on Management of Abnormal Smears 3 • recommend routine pap smears. SECTION 4 2010 93 Gonorrhoea Gonorrhoea is caused by Neisseria Gonorrhoeae, a gram negative diplococcus, which infects the columnar and transitional epithelial cells of the genitourinary tract, rectum, pharynx and conjunctiva.3 Transmitted predominately by sexual contact it can be transmitted by autoinoculation or prenatally. Signs / symptoms Females • dysuria • abnormal vaginal discharge or bleeding (i.e. post coital or IMB) • lower abdominal pain, pressure or heaviness • anorectal pain or discharge. Gonococcal cervicitis is indistinguishable from other causes of cervical infection on clinical examination.3 Most cases are asymptomatic. Coexistent pharyngeal and anorectal infections are common and often asymptomatic. Females can experience rectal infection resulting from anal sex or the posterior spread of infective secretions from the vagina. Approximately 10 -15% of cases of acute gonococcal cervicitis are complicated by pelvic infection. The prevalence of penicillinase producing Neisseria Gonorrhoeae (PPNG) varies within Australia and averages about 5 - 20% of cases. Co-infection with chlamydia is common in cases of gonorrhoea. Males • dysuria • tender, painful or swollen testicles • anorectal pain or discharge. Gonococcal urethritis is often indistinguishable from other causes of urethral infection on clinical examination.3 It usually presents as purulent discharge within a few days of exposure and cases are rarely asymptomatic. Coexistent pharyngeal and anorectal infections are common in men who have sex with men (MSM) and are often asymptomatic. Rectal infection in MSM results from anal intercourse. Some cases of gonorrhoea are complicated by epididymo-orchitis. Co-infection with chlamydia is common in heterosexual men and increasingly common in MSM. Both (Females / males) 94 • may be asymptomatic • less common indicators include sore throat, eyes, joints or other signs of complicated infection. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Investigations Test symptomatic or asymptomatic clients who identify risk behaviours through unprotected sex. Discuss additional STI screening as indicated. • Pharyngeal – • • Endocervical – swab for gonorrhoea PCR – swab for gonorrhoea M/C/S – gram stain (if available). Urethral – gram stain (if symptomatic) – external swab for gonorrhoea M/C/S. or – • swab for gonorrhoea C/S. first catch urine for gonorrhoea PCR if no discharge. Rectal – gram stain if symptomatic – swab for gonorrhoea PCR – swab for gonorrhoea C/S. Females3 • an endocervical swab for gram-stained smear will detect typical gram-negative diplococci in most cases of cervical gonococcal infection. A gram-stained urethral smear may be useful for at risk females with urethral symptoms or who have had a hysterectomy • endocervical swabs for gonococcal culture must be kept at room temperature and promptly transported to a laboratory in an Amie’s or Stuart’s transport medium containing charcoal • perform a first catch urine test by PCR for nucleic acid amplification to identify gonorrhoea or chlamydia in asymptomatic clients or during screening programs • pharyngeal and anorectal swabs for culture (not smears) should be taken if symptoms or sexual history suggest infection at these sites. Gram-stained smears should be taken via proctoscopy if there are symptoms after unprotected anal intercourse. Nucleic acid amplification testing is not validated at these sites. PCR is still the recommended test for chlamydia but positive results should be checked with a supplementary test in the laboratory. SECTION 4 2010 95 Males3 • swab urethral discharge for a gram-stained smear. The swab will confirm diagnosis by demonstrating polymorphs with intracellular and extracellular gram-negative diplococci in most cases of symptomatic gonococcal infection • a swab of urethral discharge for gonococcal culture must be kept at room temperature and sent to a laboratory in an Amie’s or Stuart’s transport medium containing charcoal. Gonococci survive poorly in a plain Stuart’s medium without charcoal. Diagnosis and results of penicillinase testing is available in 24 - 36 hours. • perform a first catch urine test by PCR for nucleic acid amplification to identify gonorrhoea or chlamydia in asymptomatic clients or during screening programs. • pharyngeal and anorectal swabs for culture (not smears) should also be taken by blind sampling MSM, if sexual history suggests infection at these sites. Gram-stained smears should be taken via proctoscopy if there are symptoms or there is history of unprotected receptive anal intercourse with casual partners. Nucleic acid amplification testing is not validated at these sites. PCR is still the recommended test for chlamydia but positive results should be checked with a supplementary test in the laboratory. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/ available): 96 • symptoms persist after treatment • intrauterine device in-situ • complicated infections e.g. PID or epididymo-orchitis • disseminated infection • client is pregnant or breastfeeding • contraindications to treatment • immunosuppression e.g. HIV positive client • abnormal findings of significance • findings outside NOs scope of practice. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Treatment Indicators • diagnosis based on examination findings • GNICDC seen on gram stained smear • laboratory confirmed diagnosis • contact of partner(s) tested positive for gonorrhoea. If Chlamydia has not been ruled out, the client should be treated as per chlamydia regimens in addition to recommended treatment for gonorrhoea. Regimens • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence. For all other cases consult an endorsed NP or MO. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. SECTION 4 2010 97 Name Ceftriaxone Form Powder Strength 250mg Recommended dose 250mg Route of admin Intramuscular injection reconstituted with 2ml Lignocaine 1% solution Frequency/duration Stat (1 dose) Pregnancy category B1 Poison schedule S4 Emergency management Consult MO Contraindications Allergy to Cephalosporins Allergy to Penicillin Special precautions Penicillin sensitivity Renal and hepatic impairment Impaired vitamin K synthesis GI disease ( especially colitis) Pregnancy, lactation, Children <12 years Neonates Adverse reactions Hypersensitivity reactions Superinfection Pseudomembranous colitis Hypoprothrombinemia Local reactions Diarrhoea Pancreatitis and gall bladder concretions Interactions Chloramphenicol Observe client for 30 minutes after administration of Ceftriaxone. Plus 98 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Name Lignocaine hydrochloride Form Liquid for injection Strength 1% (5ml vial) Recommended dose 2ml to be used to reconstitute 250mg Ceftriaxone powder Route of admin Intramuscular injection Frequency/duration Stat Pregnancy category A Poison schedule S4 Emergency management Consult with MO Contraindications Local inflammation/sepsis Septicaemia Anticoagulants CNS or spinal cord disease Impaired cardiac, intraventricular block arrhythmias Hypersensitivity to amide LAS Special precautions High repeated doses - hepatic, renal, cardiac impairment Hypoxia, sever respiratory depression Neurological disorders, epilepsy Elderly and children Pregnancy and lactation Adverse reactions CNS disturbances cardiovascular depression arrhythmias hypertension Interactions Other local anaesthetics Antiarrhythmics (especially class 111) beta-blockers cimetidine phenytoin, other anticonvulsants inhalation anaesthetics skeletal muscle relaxants alcohol SECTION 4 2010 99 Or Ceftriaxone 250mg powder vials are not available in some settings and have been substituted with Ceftriaxone dry powder 1g vial stock. Note: The regimen using Ceftriaxone dry powder is the same recommended dose of 250mg Ceftriaxone stat as above. Only the strength in stock has changed to 1g Ceftriaxone dry powder. Please follow recommended dose calculation. Name Ceftriaxone Form Dry powder Strength 1gram (0.4ml) Volumes for dose calculation52-53 1gram dry powder (0.4ml) + 1% Lignocaine solution 3.5ml = total volume 3.9ml Recommended dose 250mg (0.98ml) Route of admin Intramuscular injection Frequency/duration Stat Pregnancy category B1 Poison schedule S4 Emergency management Consult MO Contraindications Allergy to Cephalosporins Allergy to Penicillin Special precautions Penicillin sensitivity Renal and hepatic impairment Impaired vitamin K synthesis GI disease (especially colitis) Pregnancy and lactation Children <12 years Neonates Adverse reactions Hypersensitivity Superinfection Pseudomembranous colitis Hypoprothrombinemia Local reactions Diarrhoea Pancreatitis and gall bladder concretions Interactions 100 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Allergy to Cephalosporins or Penicillin Observe client for 30 minutes after administration of Ceftriaxone. Plus Name Lignocaine Hydrochloride Form Liquid for injection Strength 1% (5ml vial) Recommended dose 3.5ml to be used to reconstitute 1g Ceftriaxone powder Route of admin Intramuscular injection Frequency/duration Stat Pregnancy category A Poison schedule S4 Emergency management Consult with MO Contraindications Local inflammation/sepsis Septicaemia Anticoagulants CNS or spinal cord disease Impaired cardiac conduction, intraventricular block, arrhythmias Hypersensitivity to amide LAS Special precautions High repeated doses Hepatic, renal, cardiac impairment Hypoxia, sever respiratory depression Neurological disorders, epilepsy Elderly and children Pregnancy and lactation Adverse reactions CNS disturbances cardiovascular depression arrhythmias, hypertension Interactions Other local anaesthetics Antiarrhythmics (especially class 111) Beta-blockers Cimetidine Phenytoin, other anticonvulsants Inhalation anaesthetics Skeletal muscle relaxants Alcohol SECTION 4 2010 101 Or NO consult with a MO prior to supply of Ciprofloxacin • As per the Queensland Hospitals’ List of Approved Medicines Ciprofloxacin is restricted to specialist staff for treatment of serious infections caused by sensitive organisms on the advice of an Infectious Diseases Physician21 • The Pharmaceutical Benefits Schedule (PBS) restricts use of Ciprofloxacin to the treatment of infections proven to be due to pseudomonas aeruginosa or other gramnegative bacteria resistant to other oral antimicrobials21 • Because of increasing resistance to Ciprofloxacin 500mg orally as a stat dose this regimen is no longer recommended unless a sensitive gonococcal strain has been identified via laboratory confirmed diagnosis10,11 • Prior to commencing treatment regimens using Ciprofloxacin, consult a MO and/or obtain a laboratory confirmed diagnosis with sensitivity to Ciprofloxacin. Name Ciprofloxacin Form Tablet Strength 500mg Recommended dose 500mg Route of admin Oral on empty stomach Frequency/duration Stat (one dose) Pregnancy category B3 Poison schedule S4 Emergency management Consult MO Contraindications Hypersensitivity to other Quinolones including Nalidixic Acid Concurrent administration of ciprofloxacin and ZanaflexTM (US) Special precautions Impaired renal and hepatic function CNS disorders GI disease Pregnancy, lactation Children Neonates Sunlight 102 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Adverse reactions Hypersensitivity reactions Superinfection Pseudomembranous colitis Nausea and diarrhoea Phototoxicity Haemorrhagic cystitis Achilles tendon rupture Interactions Theophylline Anticoagulants Antacids Iron supplements Probenecid Sucralfate Theophylline Zinc or iron containing multi-vitamin Caffeine Methotrexate Metoclopramide Glibenclamide Non steroidal anti-inflammatory drugs Cyclosporine Note: Choice of treatment is dependent on local disease and sensitivity patterns COC user taking a short course (<3 weeks) of antibiotics should be advised to use additional contraceptive protection, such as condoms, during treatment and for seven days after stopping antibiotics. Client education • reinforce importance of safe sex until all contacts are treated • client fact-sheet available at www.health.qld.gov.au/sexhealth • provide MIMS Consumer Medication Information www.ckn.health.qld.gov.au Contact tracing14 • Australian guidelines currently state that all contacts for a period of six months prior should be screened and treated. These guidelines are under review (2010). SECTION 4 2010 103 Follow-up • proof of cure - swab for gonorrhoea M/C/S of infected site two weeks after treatment (if symptoms persist). Do not use swab for gonorrhoea PCR for POC, as it will remain positive for up to eight weeks after treatment • follow-up at 7-10 days to ensure symptoms resolved and check partner(s) have been treated • 104 ensure all contacts tested and treated • test of cure cultures are only necessary if there is doubt about sensitivity of the organism (e.g. a drug other than ceftriaxone has been used) or symptoms are persistent • because re-infection with gonorrhoea or chlamydia is common, routine follow-up for screening at three months is recommended. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES HIV and AIDS 39 The human immunodeficiency virus (HIV) is a retrovirus which was discovered by French and American researchers in 1983, and an antibody test for HIV-1 was available the following year. A less common and less virulent virus is HIV-2, found mainly in West Africa, while only isolated cases have been detected in Australia39. The virus causes depletion of CD4 lymphocytes (T4 or T helper cells) and immuno-deficiency by leaving the immune system open to opportunistic infection and tumours such as pneumicystis jiroveci, pneumonia, oesophageal candidiasis, cerebral toxoplasmosis, diarrhoeal diseases, kaposi’s sarcoma and lymphomas. These and many other conditions are known as AIDS (Acquired Immune Deficiency Syndrome)39. Australia’s situation In Australia, HIV is predominantly sexually transmitted and occurs most commonly in homosexually active men39. However, consider the possibility of HIV infection in any person at risk of STIs and in those with a history of injecting drug use. In Australia, most incident cases (>85%) occur in homosexual men, as the virus hasn’t broadly infiltrated injecting drug users or the heterosexual community. Estimates indicate 17,444 Australians were living with HIV by the end of 2008. Over the past few years, incident cases of HIV have risen and this is causing concern. In 2006, 998 HIV infections were diagnosed, an increase of 31% since 2000. The Asia-Pacific region - particularly Papua New Guinea, Cambodia, Thailand and Myanmar - are experiencing high growth rates of HIV. Papua New Guinea, Cambodia, Myanmar and Thailand are experiencing high rates of HIV and there is a significant risk of transmission from Papua New Guinea to Torres Strait Islander and Cape York communities. The HIV virus is present in blood, semen, vaginal fluids and breast milk, and can be transmitted by: • sexual intercourse (vaginal or anal) • injection of blood, or through mucous membranes contaminated with blood or bodily fluids • infection from mother to infant (in utero, perinatally or through breastfeeding). Signs / symptoms HIV disease comprises three phases: acute primary illness, asymptomatic chronic illness and symptomatic chronic illness. Progression from one stage to another is variable. For further detail see HIV Management in Australasia: a guide for clinical care58. History taking Take a comprehensive history to assess risk behaviours for HIV and conduct a physical examination to look for clinical manifestations of immune dysfunction or neuropsychiatric conditions39, 58. Maintain a high index of suspicion because of the varied clinical picture in HIV58. SECTION 4 2010 105 Pre and post test discussion60 Provide pre-test and post-test discussion to a client undergoing HIV antibody testing. Pretest discussion is essential to prepare the client for testing and ensure they understand the benefits, risks and implications of a positive or negative test result. It also enables you to clarify essential information regarding transmission of HIV, safe sex and injecting drug use. This is also the ideal time to discuss the availability of PEP to people in high risk groups. The National HIV Testing Policy, 200660 provides the principles and framework that guide approaches to HIV testing in Queensland. The policy is available from the Department of Health and Ageing website – www.health.gov.au. People may be tested for the following reasons: • sexual health check-up (i.e. occupational screen for sex workers) • signs or symptoms of HIV • named as a contact of STI or HIV • antenatal screening (HIV testing should be offered to all pregnant women) • immigration screen • insurance medical testing • blood bank and tissue donation • occupational or non-occupational exposure to HIV • prior to some employment Serology testing Combined antigen and antibody tests are now more widely available and are performed when an HIV test is requested. These new tests can generally rule out HIV infection after only weeks from the date of infection. Formerly, it used to take up to three months for an antibody to become reactive after infection but the new ‘window period’ from acquiring HIV to test results becoming positive is now less than six weeks Diagnosis If a result is positive, do a repeat HIV antibody test to confirm the original result was correct39. A positive result is confirmed by the Western Blot analysis. Also perform baseline testing for a range of other infections (including STIs), CD4 count, HIV quantitative RNA test (viral load), along with a baseline genotypic resistance assay (now considered routine). The genotypic resistance assay looks for evidence of resistance virus that may have been transmitted to the individual39. It is estimated that 10 -15% of transmissions in Australia involve a resistant virus39. Primary HIV infection Have a high index of suspicion for acute primary HIV infection (PHI) in clients presenting with infectious mononucleosis-like febrile illness and be aware that in the first week of primary 106 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES infection, HIV antibody assays may remain non-reactive. HIV PCR (viral load) tests will be positive - usually at high copy count during PHI but low counts (<10,000 copies per ml) may represent false positive results. Diagnosis depends on careful assessment of risk factors, clinical picture, serial HIV antibody assays and the viral load test. Laboratory indicators may be lowered or raised white cell count, atypical lymphocytes in the blood film and liver transaminitis39. Refer clients suspected of having primary HIV infection (but who have non-reactive HIV antibody assays initially) for specialist review and ensure they are followed up with repeat HIV antibody tests. Early in the course of PHI, the HIV antibody screening test may be negative but the combined antigen and antibody test has a much shorter window period. Special tests such as detection of the p24 antigen and proviral DNA should be discussed with the laboratory and/or an experienced HIV clinician. If clinical suspicion remains, repeat HIV Ag/Ab testing39. Client education for people newly diagnosed with HIV • provide contact details for groups such as Queensland Association of Healthy Communities QAHC (previously the AIDS Council) and Queensland Positive People (QPP). These groups provide information, support, activities and self-empowerment • offer psychological counselling and support to newly diagnosed clients. • Instruct regarding correct use of condoms • client fact sheet available at www.health.qld.gov.au/sexhealth • provide client with booklets/fact-sheets outlining: – natural history and prognosis of HIV – explanation on prevention of transmission and superinfection – health management including complimentary therapies. • recommend vaccination for HAV and HBV • discuss pneumococcal and influenza vaccination • encourage partner(s) testing • discuss need for monitoring • discuss legal obligations, disclosure of positive status and discrimination issues. Assure client that confidentiality will be maintained • obtain consent for release of information relating to previous medical care. Contact tracing14 • discuss informing sexual partner(s) and others at risk of exposure (eg. people who inject drugs), and agree and document method of identifying and notifying contacts(s) SECTION 4 2010 107 • contact(s) will often require counselling • if primary illness confirmed, trace contacts for at least 6 weeks prior to onset • if late HIV infection or infection of unknown origin, contact trace depending on risk and age of index case (may be necessary to trace back to 1980) • offer PEP and STI screening to partner(s) exposed within the last 72 hours • screen all contacts and offer additional STI screening • if client has donated blood or received blood products, contact relevant blood bank. New client assessment When HIV infection is diagnosed, management may be considered under the following headings:58 • Clinical assessment (history and examination) • Assessment of the social context of the infection • Assessment of the psychological impact of the diagnosis • Laboratory evaluation, including the stage of infection, baseline serological testing • Investigation of co-morbidities and co infections • Health maintenance, including prevention of co-morbidities and STIs • Education and support • Risk assessment and prevention • Public health measures – contact tracing This history relates to a new client who may be testing for HIV or already HIV positive and approaching you for treatment (marked *) 108 • reason for presenting and expectations of consultation • date of last negative result and reason for test • date of positive HIV result (include when, where and why tested) * • HIV related illness * • symptoms suggesting immunodeficiency i.e. weight loss, skin rashes, shingles, pneumonia, unexplained diarrhoea, unexplained fever, headache * • health care provider • most recent CD4 and viral load * • lowest CD4 count* • antiretroviral medication and OI prophylaxis medication* • current HIV medication* • assess tolerance and adherence to current medication (including health belief model)* QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • assess pregnancy (if indicated) • date of last sexual health screen • medical (particular attention to cardiac, metabolic, viral hepatitis and renal), surgical and gynaecological history • psychiatric history • diet and exercise • medications • allergies • family history – cardiovascular disease, diabetes • STI symptoms – discharge, rash, itch, pain, ulcers, sores, post coital bleeding, intermenstrual bleeding, rectal bleeding, rectal pain • sexual history – past syphilis and treatment history – past urethritis – past genital ulcer disease. • knowledge/attitudes of safer sex, superinfection and post exposure prophylaxis (PEP) • smoking and alcohol use • recreational drug use (including injecting drugs) • social history i.e. family support, employment, partner(s), social support, financial situation, housing, Medicare status, MSM/gay community affiliation. The following is a guide to required baseline tests58: • HIV Ab (to confirm) • full blood count (FBC) • LFT and U&E • fasting lipids and glucose • syphilis • hepatitis A (total), • HBsAb, HBsAg, HBcAb • HCVC • Toxoplasma IgG • CMV IgG • STI screen – Chlamydia, gonorrhoea, syphilis • Urine ACR SECTION 4 2010 109 • lymphocyte subsets (CD4/CD8 lymphocyte counts) • genotypic resistance assay • HIV PCR RNA (viral load) test • HLAB*5701 • CXR and Mantoux in those potentially exposed to TB • PAP smear (if relevant). Examination • skin – look for seborrheic dermatitis, xeroderma, shingles scar, kaposi’s sarcoma • oropharynx – look for oral candidiasis, oral hairy leukoplakia, gingivitis • lymph nodes – inguinal, cervical and axillary groups • chest/lungs • cardiovascular including peripheral pulses • abdomen – liver and spleen • pelvic (in females) - GU, rectum/anus (probably can be left on initial visit) • neurological - unilateral weakness, visual field defects, peripheral nerves • (reflexes and sensation) • muscular/skeletal • weight, height and BMI • blood pressure • urinalysis. Monitoring People with HIV should attend regular follow-up at 3 - 6 month intervals58 or more frequently if their clinical or immunological condition warrants it. At each visit, assess the person psychologically and reinforce the importance of transmission prevention. Physical examination should look for evidence of immune dysfunction. Arrange haematological, biochemical, viral load and immune function testing. At subsequent visits, repeat testing for full blood count, HIV viral load and CD4/CD8 lymphocyte counts, U & E and liver function tests. Falling CD4 counts and rising viral load (+/the development of signs or symptoms of immunodeficiency) indicate a need for antiretroviral therapy. Women living with HIV are at increased risk of cervical dysplasia and current guidelines recommend annual pap smears after two successive normal smears six months apart. Any abnormalities should be followed up by colposcopy. Clients living with HIV do not necessarily cease to be sexually active and recent guidelines 110 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES recommend regular screening for common STIs such as gonorrhoea, chlamydia, ano-genital herpes and syphilis. Clinicians should discuss responsibilities for preventing transmission of HIV as well as safer sex practices periodically with clients as part of their routine management. Monitoring response to therapy involves resolution of signs and symptoms attributable to HIV prior to initiation of antiretroviral therapy, including monitoring changes in weight. Monitor drug toxicity depending on the antiretroviral agents the client is taking. Refer to HIV Management in Australasia: a guide for clinical care at www.ashm.org.au Clients with progressive disease (suggested by HIV-related symptoms or deteriorating laboratory surrogate markers) or those who have just commenced or altered antiretroviral therapy require more frequent monitoring. Frequency of monitoring in these circumstances should be made in conjunction with an HIV specialist. Monitoring for clients on antiretroviral treatment Monitoring includes clinical assessment and laboratory testing which aims to document efficacy of therapy ( initial fall in plasma HIV RNA and subsequent rise in CD4) and detection of toxicity (clinical and laboratory)58. Assessment should include58 • History – new symptoms, side effects, adherence, psychosocial issues • Examination – weight, BP, body shape changes, peripheral neuropathy, rash • Laboratory – plasma HIV RNA, CD4 count, FBE, liver function tests, electrolytes. Fasting lipids and glucose 6 monthly. • Assessment for co-morbidity – depression, recreational drugs use, STIs • Assessment of toxicity – peripheral neuropathy, cardiovascular risk factors, lipodystrophy Routine monitoring History • symptoms of disease progression e.g. weight loss, fevers, diarrhoea, skin rash • symptoms of drug toxicity • date of last HIV review, viral load and CD4 count • any interactions with health care system: –GP visits • – hospitalisation – sexual health clinics (if appropriate). Ongoing assessment: – sexual and injecting health risk SECTION 4 2010 111 – smoking – recreational drug use including alcohol – diet, activity, social support, mood, sleep, employment, smoking, alcohol and recreational drug use. Examination • signs of disease progression (see initial presentation) • signs of drug toxicity • weight • blood pressure. Available Investigations • full blood count • UE/LFTs • HIV viral load • lymphocyte sub population • pap smear (as indicated) • offer additional screening as indicated or directed by MO – annual – fasting lipids, glucose, urine analysis, HBsAb – sexual health screening. Prevention Current39 112 • Condoms and community health education focussed on at-risk individuals and communities have shown to be effective in prevention of HIV. • Some of the most cost-effective public health initiatives include needle and syringe programs, and methadone and buprenorphine substitution programs. • Post-exposure prophylaxis (PEP) is a combination of two to three antiretroviral agents given within 72 hours of significant exposure to HIV (usually sexual or occupational). The medications are taken for one month and reduce the risk of acquiring HIV. • Prevent mother to child transmission by using antiretrovirals for the mother during pregnancy and for the baby for a short period after birth. Breastfeeding is not recommended in Australia. The overall risk of vertical transmission is 25-20%58. • Early diagnosis of primary HIV infection, counselling of the index client and contact tracing partners is very important. It is estimated that about half of all HIV infections are caused by someone who was recently infected. Counselling the index client in this setting can have benefits in reducing onward transmission. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Future • Vaginal and anal microbicidal agents that can be introduced by the person having sex (without requiring their sexual partner’s permission) are undergoing trials. • Pre-exposure prophylaxis (PREP) – HIV medication taken prior to intercourse may reduce the risk of HIV infection in those at high risk. • Increased emphasis on testing and treatment of chlamydia, gonorrhoea, syphilis and genital herpes – all of which increase the risk of HIV acquisition and transmission. Trials looking at suppressing HSV-2 in order to prevent HIV transmission are underway, but early results appear to be disappointing. Treatment Clients should be treated according to Australian antiretroviral guidelines58 available at www. ashm.org.au. Treatment is usually commenced when the CD4 count drops to 350cells/µl (usual level for a healthy adult is 450-1200 cells/µL). Combination antiviral therapy (cART) is indicated in pregnant women, people with HIV-associated nephropathy or HBV co infection when hepatitis B treatment is indicated58. Antiretroviral treatment during pregnancy is routine and can reduce the mother-to-child transmission rate to <1%. Without antiretroviral treatment or caesarean section the rate is approximately 25%58. Currently available antiretroviral agents are classified as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), entry and fusion inhibitors (FIs), integrase inhibitor and protease inhibitors (PIs). Nucleoside Reverse Transcriptase Inhibitors (NRTIs): • Abacavir (category B3 in pregnancy) • Didanosine (ddI) (category B2 in pregnancy) • Emtricitabine (FTC) (category B1 in pregnancy) • Lamivudine (3TC) (category B3 in pregnancy) • Zidovudine (AZT) (category B3 in pregnancy) Nucleotide Reverse Transcriptase Inhibitors: • Tenofovir (Category B3 in pregnancy) Non Nucleoside Reverse Transcriptase Inhibitors (NNRTIs): • Efavirenz (Category D in pregnancy) • Nevirapine (Category B3 in pregnancy) • Etravirine (Category B1 in pregnancy) Entry Inhibitor • Maraviroc (Category B1 in pregnancy) SECTION 4 2010 113 Fusion Inhibitors (FIs): • Enfuvirtide (Category B2 in pregnancy) Integrase Inhibitor • Raltegravir (Category B3 in pregnancy) Protease Inhibitors (PIs): • Amprenavir (Category B3 in pregnancy) • Atazanavir (Category B2 in pregnancy) • Fosamprenavir (Category B3 in pregnancy) • Indinavir (Category B3 in pregnancy) • Lopinavir (Category B3 in pregnancy) • Ritonavir (Category B3 in pregnancy) • Saquinavir (Category B1 in pregnancy) Co-formulated preparations • Atripla ( Tenofovir / Emtricitabine / Efavirenz) • Combivir (Zidovudine / Lamiviudine) • Kivexa ( Abacavir / Lamivudine) • Truvada ( Tenofovir / Emtricitabine) The gold standard of HIV treatment is triple combination antiretroviral treatment (cART)58. In general, clients receive two nucleoside analogues in combination with either a nonnucleoside reverse transcriptase inhibitor or a (ritonavir-boosted) protease inhibitor. Only clinicians who have completed an HIV prescriber’s course, attend regular professional updates and are experienced in the use of antiretrovirals can prescribe these S100s. Combination antiretroviral therapy (cART) may cause significant side-effects which can limit the client’s ability to take the medication effectively. Some side-effects include: • nausea and diarrhoea • skin rashs • lipoatrophy (loss of fat from limbs and face) • hyperlipidaemia • raised liver transaminases and bilirubin • impaired glucose tolerance and diabetes. Ninety-five percent compliance with cART is essential in order to reduce the risk of resistant virus developing. People with HIV are more likely to also have other issues which can impact their health including depression, mental illness, higher rates of tobacco and alcohol misuse, unemployment and poverty. 114 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Prophylactic therapy against opportunistic infections (OIs) Prophylactic therapy against opportunistic infections in immunocompromised clients is critical in managing the infection58. Consult an HIV specialist for discussion of opportunistic disease prevention. Refer to HIV Management in Australasia: a guide for clinical care (2009) at www.ashm.org.au/publications Administer primary prophylaxis to clients at risk of developing certain opportunistic infections such as Pneumocystis Jiroveci Pneumonia PCP (CD4 < 200/µL, CD4 % <14%, or presence of Oral Candidiasis) or Mycobacterium avium complex disease (CD4 <50/µL)58. However, primary prophylaxis is not recommended for the following opportunistic infections oropharyngeal/oesophageal candidiasis, CMV disease or cryptococcal meningitis. Clients with CD4 counts < 50/µL or non-retinal CMV disease are at risk of CMV retinitis and should have regular HIV specialist ophthalmological review to enable early detection and treatment of CMV retinitis. Educate clients to notice increased ‘floaters’ or changes to visual acuity and advise them to seek medical attention if these occur. Clients who have already experienced opportunistic infection are at risk of recurrent infection until anti-retroviral therapy induced immune reconstitution occurs. These clients should receive secondary prophylaxis and consult with an HIV specialist. Opportunistic infection prophylaxis may cease following antiretroviral therapy induced immune reconstitution. Consult with an HIV specialist regarding cessation of opportunistic infection prophylaxis. All clients who are diagnosed with latent tuberculosis should also be referred to an HIV specialist. Referral of clients with HIV infection Clients with HIV should be managed by clinicians experienced in the management of HIV disease. Optimal models of care involve HIV specialist and general practitioner input. General practitioners with HIV infected clients would benefit from HIV courses offered by the University of Queensland at www.som.uq.edu.au/hivandhcvprojects Post-exposure prophylaxis (PEP) for HIV If exposed to significant risk of HIV infection through: • occupational exposure e.g. deep needle-stick injury • non-occupational exposure e.g. unprotected receptive or insertive anal or vaginal intercourse • injecting drug user e.g. needle sharing with a person known or suspected to have HIV infection Offer administration of combination antiretroviral therapy for one month. This may provide benefit if drugs are commenced within 72 hours of exposure. There is little direct evidence of the effectiveness of PEP, however a substantial body of indirect epidemiological and animal model evidence now exists for the effectiveness of PEP. The Queensland Health Guidelines for Management of Occupational and non-Occupational Exposures to Blood and Body Fluids, 2009 provide detailed advice regarding PEP. SECTION 4 2010 115 Expert information network Advice is provided 24 hours a day, seven days a week by an infectious diseases physician. • Brisbane Princess Alexandra Hospital (07) 3240 2111 Mater Adult Hospital (07) 3840 8111 Royal Brisbane & Women’s Hospital (07) 3636 8111 • Gold Coast Gold Coast Hospital (07) 5571 8211 • Nambour Nambour General Hospital (07) 5470 6600 • Townsville Townsville General Hospital (07) 4796 1111 • Cairns Cairns Base Hospital (07) 4050 6333 People seeking PEP may present at an emergency department or sexual health clinic where starter packs of antiretroviral drugs are available. They will require follow-up within a few days for counselling, risk review, review of side effects and to receive further prescription of anti-retroviral drugs by an accredited HIV prescriber for one month (if appropriate). Counselling for PEP involves exploring the known or suspected risks of HIV infection against the risks and known side effects of one month’s antiretroviral therapy. The risk of HIV transmission through single exposure is determined by: • method of exposure and its estimated risk • risk that the source is HIV positive, if their status is unknown • co-factors associated with the source and exposed individuals. Assess risk • establish reason for requesting PEP • assess client’s potential risk of exposure to HIV by establishing date, time, and type of exposure • explain relevance for further questioning if exposure was percutaneous, significant mucous membrane or non-intact skin. Assess exposure 116 • determine exposure – what, when, where, whom and exact details (including contributory factors) • amount of blood or body fluid involved (including trauma) • first aid measures applied. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Assess exposed person • explore possibility that the exposed person may already be HIV infected • enquire about most recent HIV test results and reason for testing • assess risk exposures since last HIV test and current incident • enquire about illnesses since the last test which may be consistent with acute primary illness • previous post-exposure prophylaxis and history of treatment • evaluation of current STIs i.e. hepatitis B and hepatitis C • pregnancy risk, contraception and lactation (consider emergency contraception) • medical history including illnesses, medication and drug allergies • psychiatric history • drug and alcohol history • knowledge of the source (if unavailable for interview). Assess the source • determine HIV status of the source (if known) • if source status known to be HIV positive: – most recent plasma viral load –ARV treatment history and any documented resistance • – recent HIV resistance genotyping – current or past STI – HBV and HCV status. if HIV status of source unknown: – assess source persons potential risk i.e. IDU, MSM, country of origin – current or past STI – HBV and HCV status. Explain the principles of PEP • explain PEP (including its indications, effectiveness, risks and benefits) • explore client understanding of transmission of HIV, correct misinformation, respond to questions, advise on risk reduction strategies and make appropriate referrals • obtain medical, gynaecological, menstrual, contraceptive, social and sexual history • enquire about other recent STI and discuss STI screening • consider the need for ECP/HBIG SECTION 4 2010 117 • 118 provide information on the following: – window periods for BBVs and STIs – safe sex and injecting practices – mode of action/compliance, potential side effects and follow-up. • assess support networks and coping strategies • inform client how to access further information and support. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Lymphogranuloma venereum (LGV) Lymphogranuloma venereum (LGV) is an invasive genital disease caused by chlamydia trachomatis serovars L1, L2 or L3, which results in complex and severe symptoms including tissue destruction and ulceration. These serovars differ from other chlamydia trachomatis serovars B - K which are known to cause urethritis and cervicitis. LGV is endemic to tropical areas such as the Caribbean, Africa, South America, Central America and Asia. Almost all infections reported in Australia have either been acquired from endemic areas overseas or in men who have sex with men (MSM). There is reported high incidence of concurrent infection with HIV, syphilis, gonorrhoea and hepatitis C. LGV may cause proctitis if the infection is acquired through unprotected anal sex. Transmission is by direct skin-to-skin contact with open lesions, usually occurring through sexual contact. Lesions outside the genital area are rare but oral lesions have been reported. Signs / symptoms Primary stage49, 50 • painless blister, usually three to ten days after sexual contact (sometimes up to 30 days) • ulceration may occur. Secondary stage • systemic symptoms one to six weeks after sexual contact including inguinal lymphadenopathy, fluctuant bubo, necrosis of the lymph nodes and abscess formation • anorectal symptoms include proctitis, pain, discharge, bleeding, tenesmus, constipation, inflammation and acute haemorrhagic proctitis which is usually confined to the distal 10cm of the anorectal canal • fever, nausea and malaise are common. Late or tertiary stage • development of chronic inflammatory lesions and lymphoedema, sinus formation, scarring, strictures and fibrosis of the anogenital tract, lymphatic obstruction, elephantiasis, rectal strictures and fistulae. Investigations • • Lesion – swab for chlamydia PCR – rectal or anal swab for LGV PCR (available from Pathology Queensland – Central Laboratory (RBWH) phone 0437 082 545) – swab for HSV PCR. Rectal – swab for chlamydia PCR SECTION 4 2010 119 • – swab for LGV PCR (indicated if presenting rectal symptoms and/or positive rectal chlamydia) – swab for HSV PCR – swab for syphilis TPPA DNA / PCR. Serology (discuss with a MO or laboratory) – LGV complement fixation test (LGV-CFT). Contact laboratory prior to testing. Titres >1:64 are highly suggestive of LGV in a client with a compatible clinical picture, while titres <1:32 make the diagnosis unlikely. LGV testing should be performed as a secondary test for all confirmed. Chlamydia trachomatis rectal isolates, and for their sexual partner(s). Attempt to isolate the organism from the lesion, the rectal mucosa or by aspiration from the enlarged nodes or bubo. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/ available): • suspected or laboratory confirmed diagnosis LGV • abnormal findings of clinical significance • uncertain diagnosis • contraindication to treatment • no resolution of symptoms following treatment • client is pregnant or breastfeeding • immunosuppression e.g. HIV positive client • findings outside NOs scope of practice. Treatment Indicators • clinical diagnosis based on history and examination • laboratory confirmed diagnosis • contact of partner who has tested positive. Regimens Treatment only to be instigated following consultation with MO. • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or a MO. DTP–SRH endorsed NO or endorsed NP may progress if within scope of practice. For all other cases consult a MO. 120 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Name Doxycycline Form Tablet Strength 100mg Recommended dose 100mg Route of admin Oral Frequency/duration Twice per day for 21 days Pregnancy category D Poison schedule S4 Emergency management As for severe allergic reaction – Anaphylaxis Consult MO Contraindications Pregnancy and lactation Hypersensitivity to Tetracycline Concomitant treatment with oral retinoid Special precautions Do not take immediately before going to bed Take with food or milk Renal and hepatic impairment Prolonged use Children aged <8 years Adverse reactions Photosensitivity Urticaria Superinfection Pseudomembranous colitis Oesophagitis GI disturbances Tooth discolouration SECTION 4 2010 121 Interactions Acetazolamide Antacids (containing Al, Mg, Ca Bismuth Salts) Anticoagulants Barbiturates Carbamazepine Methoxyflurane (may cause fatal renal toxicity) OCP Penicillin Phenytoin Sodium Bicarbonate Iron 122 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Or Name Azithromycin Form Tablet Strength 500mg Recommended dose 1gram Route of admin Oral with or without food Frequency/duration Once a week for three weeks Pregnancy category B1 Poison schedule S4 Emergency management As for severe Allergic reaction - Anaphylaxis Consult MO Contraindications Known hypersensitivity to Azithromycin, Erythromycin or any macrolide antibiotic Special precautions Pneumonia Elderly Prolonged QT interval Renal and hepatic impairment Pregnancy and lactation Children aged <16 years Adverse reactions Superinfection Angioedema Cholestatic jaundice Raised LFT, AST, ALT Colitis GI upset Vaginitis Interactions Antacids Ergot Derivatives Rifabutin Cyclosporine Warfarin Digoxin and drugs that prolong QT interval SECTION 4 2010 123 Or Name Roxithromycin Form Tablet Strength 150mg or 300mg Recommended dose 150mg Or 300mg (2 x 150mg tablets) Route of admin Oral (administer 15 minutes before or three hours after a meal) Frequency/duration 150mg twice per day for 21 days Or 300mg (2 x 150mg tablets) once per day for 21 days Pregnancy category B1 Poison schedule S4 Emergency management As for severe allergic reaction – Anaphylaxis Consult MO Contradictions Known hypersensitivity to Erythromycin or Macrolide antibiotics Severe hepatic impairment Concomitant therapy with vasoconstrictive ergot Alkoids Special precautions Renal and hepatic impairment Prolonged or repeated use Pregnancy/lactation Children aged <16 years Adverse reactions Superinfection Pseudomembranous colitis GI upset Sensitivity phenomena Altered hepatic function Interactions Ergot alkoids Digoxin Warfarin Midazolam Theophylline Disopyramide Cyclosporine 124 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Note: • COC user taking a short course (<3 weeks) of antibiotics should be advised to use additional contraception (i.e. condoms) during treatment and for seven days after antibiotics have been stopped13. • Clinical differentiation of conditions that cause genital ulcerative disease is inaccurate, particularly in areas where more then one causative organism is endemic26. This is further compounded by the presence of HIV infection which may alter clinical manifestations and patterns of GUD occurrence. Recent evidence suggests that HSV 2 is increasing in many populations as the main cause of GUD26. Therefore after detection of GUD (i.e. Chancroid, Donovanosis, LGV or HSV) it is important to consider additional investigations and treatment regimens based on local aetiology and sensitivity patterns. Client education Doxycycline • protect skin from sunlight especially between 10am – 3pm and solariums as some Macrolide antibiotics increase sensitivity to sunlight. If there is a rash, itching, redness or severe sunburn consult a MO • Doxycycline to be taken with one full glass of water and client should sit upright for at least 30 minutes after taking medication. Roxithromycin • administer 15 minutes before or three hours after a meal – client fact-sheet available www.health.qld.gov.au/sexhealth – provide MIMS consumer product information http://ckn.health.qld.gov.au – Safer sex information, condoms and lubricant – Screen for other STIs Contact tracing In suspected and confirmed cases trace all sexual contacts in the previous 30 days and /or since arrival to onset of systems and treat presumptively. Follow-up Follow-up weekly until there is resolution of symptoms. Fibrotic lesions and fistulae may require surgical attention after treatment is completed. Follow-up contact notification, testing and treatment. SECTION 4 2010 125 Molluscum contagiosum Molluscum contagiosum is a common benign skin disease caused by a poxvirus49. Lesions are predominately self-limiting and spontaneously regress in immunocompetent individuals. In the immunocompromised (i.e. people living with HIV), lesions can become extensive and persistent51. Treatment is not essential as there are no significant abnormal complications, however it can be requested for cosmetic reasons. The disease is transmitted by direct skin contact and fomite transfer49. Signs / symptoms49 Lesions • Generally appear 3 – 12 weeks after contact • Flesh coloured, discrete, smooth, firm, dome-shaped papules with central umbilication • most have a 3 – 5mm diameter, however giant papules (>15mm diameter) can occur • In adults, lesions commonly occur on thighs and buttocks • In people with HIV, the infection may be widespread and is common opportunistic infection49 Investigations Clients should be examined for molluscum contagiosum in the ano-genital area. • clinical diagnosis • histology of inner punctum • discuss additional STI screening. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/ available): 126 • large or extensive lesions • atypical presentation • no response to treatment • secondary infection • immunosuppression e.g. HIV positive client • abnormal findings of significance • findings outside NOs scope of practice. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Treatment Indicators Clinical diagnosis is based on examination. Note: Treatment method should be selected after considering size, quantity and anatomic site of lesions, client preference, cost, convenience, side effects and provider experience. Regimens: clinic treatment only • Non DTP-SRH endorsed NOs are authorised to administer this regimen only if clinical competency is completed, otherwise refer management to a DTP–SRH endorsed NO, endorsed NP or a MO. • DTP–SRH endorsed NO may progress if within scope of practice. For all other cases consult a MO or endorsed NP. • Endorsed NP may progress if within scope of practice. For all other cases consult a MO. Name Cryotherapy with Liquid Nitrogen Form Liquid Route of admin Cryospray or topically with Cotton buds Frequency/duration Once a week Or Name Cryotherapy with Nitrous Oxide Form Gas Route of admin Topically with cryotherapy gun Frequency/duration Once a week SECTION 4 2010 127 Or Name Podophyllotoxin Form Liquid in Ethanol and cream base Strength 0.15% cream Recommended dose Use the minimum amount of solution/cream necessary to cover lesion. Minimize application to normal surrounding tissue and allow to dry thoroughly Route of admin Topical Frequency/duration Twice a day for three consecutive days Then four days with no treatment Maximum of four weeks of treatment Pregnancy category D Poison schedule S4 Emergency management Discontinue use if significant irritation occurs and consult a MO Contraindications Pregnancy - Do not use with any other podophyllin preparation Existing skin infection, irritation or open wounds Hypersensitivity to Podophyllotoxin Internal warts (rectal, urethral, vaginal and cervical) Special precautions Avoid contact with eyes and mucous membranes Limit applications to reduce toxicity Systemic toxicity is a risk increased by treatment of large areas with excessive amounts for prolonged periods, treatment of friable, bleeding or recently biopsied warts or inadvertent application to normal skin or mucous membranes Pain relief Application of Lignocaine-Prilocaine (emla) can be used for pain management prior to application of Liquid Nitrogen or Nitrus oxide via Cryotherapy. 128 • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or a MO. • DTP–SRH endorsed NO or endorsed NP may progress if within scope of practice. For all other cases consult a MO. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Name Lignocaine-Prilocaine (emla) Form Cream Strength Lignocaine 2.5% and Prilocaine 2.5% Recommended dose Apply a thick layer to affected area x 1.5 g/10 cm2 Route of admin Topical Frequency/Duration Apply at least 1 hour prior to cryotherapy Pregnancy category A Poison schedule S2 Contraindications Hypersensitivity to prilocaine, lignocaine or other local anaesthetics Congenital or idiopathic methaemoglobinaemia Deficiency in Glucose 6 Phosphate Dehydrogenase Special precautions Traumatized mucosa or non-intact skin Atopic dermatitis Genital skin and mucous membranes Adverse reactions Mild local irritation Allergic reaction Increased methaemoglobin level Interactions Other local anaesthetics Antiarrhythmics (especially class 111) Beta-blockers Cimetidine Phenytoin Other anticonvulsants Inhalation anaesthetics Skeletal muscle relaxants Sulphonamides Lesions are usually self-limiting and treatment is not essential. Treatment options: • Lesions can be de-roofed with a sterile needle and the contents or ‘core’ expressed or removed with very fine forceps. SECTION 4 2010 129 Client education • avoid picking or scratching , waxing or shaving as this may spread the infection • client fact-sheet available www.health.qld.gov.au/sexhealth • provide MIMS consumer product information www.ckn.health.qld.gov.au Contact tracing Not required. Follow-up Ongoing treatment of lesions may be required. 130 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Non gonococcal urethritis (NGU) 7,49 Urethritis can result from a number of infectious and non-infectious causes. Urethritis not cause by neisseria gonorrhoeae is referred to as non-gonococcal urethritis (NGU). NGU is commonly caused by chlamydia trachomatis, and less commonly by neisseria meningitidis, ureaplasma urealyticum, mycoplasma genitalium, trichomonas vaginalis, HSV, adenoviruses and candida species. Signs / symptoms • urethral discharge • dysuria (usually mild) • penile or urethral irritation • testicular pain or swollen scrotum/testes • meatitis. Investigations Testing for NGU should not occur in isolation. Discuss additional STI screening. Urethral • gram stain (onsite if available) • swab for chlamydia PCR • swab for gonorrhoea M/C/S Or • first catch urine for gonorrhoea and chlamydia PCR (if no discharge). Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/available): • symptoms persist following treatment • associated testicular pain • uncertain diagnosis • contraindication to treatment • immunosuppression e.g. HIV positive client • abnormal findings of significance • findings outside NOs usual scope of practice. SECTION 4 2010 131 Treatment Indicators • clinical diagnosis based on examination and history • >5 PMLs / HPF on gram stained smear • laboratory confirmed diagnosis. Regimens • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or a MO. • DTP–SRH endorsed NO may progress if within scope of practice. For all other cases consult an endorsed NP or a MO. • Endorsed NP may progress if within scope of practice. For all other cases consult a MO. · 132 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Name Azithromycin Form Tablet Strength 500mg Recommended dose 1gram (2 x 500mg tablets) Route of admin Oral with or without food Frequency/duration Stat (1dose) Pregnancy category B1 Poison schedule S4 Emergency management As for severe allergic reaction – Anaphylaxis Consult MO Contraindications Known hypersensitivity to Azithromycin, Erythromycin or any macrolide antibiotic Special precautions Pneumonia Elderly Prolonged QT interval Renal and hepatic impairment Pregnancy and lactation Children <16 years Adverse reactions Superinfection Angioedema Cholestatic jaundice Raised LFT, AST, ALT Colitis, GI upset Vaginitis Interactions Antacids Ergot Derivatives Rifabutin Cyclosporine Warfarin Digoxin And drugs that prolong QT interval. SECTION 4 2010 133 Or Name Doxycycline Form Capsule/tablet Strength 100mg Recommended dose 100mg Route of admin Oral with food Frequency/duration Twice a day for 7-10 days11,12 Pregnancy category D Poison schedule S4 Emergency management As for severe allergic reaction – Anaphylaxis Consult MO Contraindications Pregnancy and lactation Hypersensitivity to any Tetracycline Concomitant treatment with oral retinoid Special precautions Do not take immediately before going to bed Take with food or milk Renal and hepatic impairment Prolonged use Children aged <8 years Adverse reactions Photosensitivity Urticaria Superinfection Pseudomembranous colitis Oesophagitis GI disturbances Tooth discolouration 134 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Interactions Acetazolamide Antacids (containing Al, Mg, Ca Bismuth Salts) Anticoagulants Barbiturates Carbamazepine methoxyflurane (may cause fatal renal toxicity) OCP Penicillin Phenytoin Sodium Bicarbonate Iron Note: • COC user taking a short course (<3 weeks) of antibiotics should be advised to use additional contraception (i.e. condoms) during treatment and for seven days after antibiotics have been stopped13. • Duration of treatment with Doxycycline is dependant on the site and severity of infection9. The Australian Medicines Handbook suggests 1- 3 weeks duration according to site and severity on presentation. Consult with a MO if clinical presentation and findings of examination indicate extension beyond the 10 day regimen above. Client education • protect skin from sunlight and solariums as some Macrolide antibiotics increase sensitivity to sunlight. If there is a rash, itching, redness or severe sunburn consult a MO • Doxycycline to be taken with one full glass of water and client should sit upright for at least 30 minutes after taking medication – client to refrain from unsafe sex for a minimum of three days following treatment and until sexual contacts are treated – client fact-sheet available www.health.qld.gov.au/sexhealth – provide MIMS consumer medicine information www.ckn.health.qld.gov.au Contact tracing All contacts should be screened and offered presumptive treatment according to sexual history. SECTION 4 2010 135 Follow-up 136 • proof of cure (POC) not required if treated with DOT Azithromycin or Doxycycline • swab for PCR POC cannot be reliably undertaken <8 weeks after treatment • if symptomatic, review at two weeks to check compliance with treatment and ensure all contacts are tested and treated. Refer to a MO if still symptomatic. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Pelvic inflammatory disease (PID) Pelvic inflammatory disease (PID) is a range of inflammatory disorders of the female upper genital tract which include endometritis, salpingitis, pelvic abscess and pelvic peritonitis8,32. PID is an acute clinical syndrome often associated with ascending infection due to microorganisms such as neisseria gonorrhoeae or chlamydia trachomatis. This can be termed STI associated PID32. Anaerobic bacteria that are considered normal flora of the genitourinary tract (i.e. gardnerella vaginalis, genital mycoplasms (M. hominins, M. genitalium) or enteric gram-negative rods are sometimes associated with PID, as are gynaecological procedures such as surgery, TOP, delivery, intrauterine contraceptive device (IUCD) insertions/removals. The diagnosis will only be made if symptoms are identified by the client and a bimanual examination is done on women at risk. This is especially important in symptomatic women diagnosed with chlamydia or gonorrhoea at screening NOs must refer to or at minimum consult a MO or authorised endorsed NP regarding all suspected or confirmed cases of PID and acute abdominal pain. Signs / symptoms • low grade PID is commonly asymptomatic • fever • nausea and vomiting • pain (abdominal, pelvic, bowel or bladder) • abnormal vaginal bleeding, irregular menstrual cycles • abnormal discharge (urethral, vaginal or rectal) • sexually transmitted infection (STI) • pregnancy • urinary symptoms (e.g. dysuria, frequency) • evidence of intrauterine or other gynaecological instrumentation (e.g. intrauterine contraceptive device insertion). Factors associated with increased risk of PID • young age • multiple partners • presence of bacterial vaginosis • history of STI • vaginal douching • new partner in previous three months SECTION 4 2010 137 • post-partum endometritis • recent history of instrumentation (i.e. TOP, IUCD insertion) • from areas of high STI prevalence. Diagnosis Diagnosis of PID is clinical and based on signs, history and examination. However, it is important to remember that clinical diagnosis for PID is imprecise. All women with suspected PID should have a bimanual examination. When taking history ensure you ask about the following: • last menstrual period (LMP) • sexual activity including recent change of sexual partner(s) and previous STIs • contraceptive usage e.g. recent insertion of intrauterine systems (IUCS) • recent surgical instrumentation e.g. termination of pregnancy (TOP) and/or delivery • urinary symptoms • medication and drug allergies • onset, location, radiation and duration of pain • severity of pain and whether any treatment has been received • characteristics of pain e.g. acute, chronic or intermittent • associated symptoms e.g. nausea, vomiting, anorexia, diarrhoea, bleeding or haematuria • recent use of analgesia, narcotics or antibiotics • time of last bowel movement. PID should be suspected if a sexually active young woman or women at risk of STI especially experiencing all of the following symptoms: • pelvic or lower abdominal pain and/or tenderness of recent onset • dyspareunia • no other illness can be identified • has one or more of the following minimum criteria present on pelvic examination.7 Minimum criteria for suspecting/diagnosing PID 138 • cervical motion tenderness (CMT) with bimanual palpation • adnexal tenderness • uterine tenderness with bi-manual palpation. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Additional criteria The following additional criteria may support the diagnosis. • mucopurulent discharge from external os • elevated temperature (>38.3c) • abnormal vaginal discharge • presence of abundant numbers of WBC on saline wet prep (>10 cells per high field) • confirmed laboratory diagnosis of chlamydia or gonorrhoea • elevated C-reactive protein • elevated ESR. Investigations Urethral • urinalysis and mid stream urine • urine BHCG. Vaginal • high vaginal swab for M/C/S for BV or candidiasis • high vaginal swab for trichomonas PCR • high vaginal swab for wet prep/gram stain (if available) • pH • whiff test. Endocervical • swab for chlamydia PCR • swab for gonorrhoea M/C/S. Other • bi-manual examination (if not pregnant) • examine abdomen for rebound, tenderness and guarding • temperature, pulse and blood pressure • discuss additional STI screening. Note: If the client declines or is unable to complete an STI screen, encourage as a minimum: • self-administered vaginal swab for chlamydia, gonorrhoea and trichomonas PCR or • first catch urine for chlamydia and gonorrhoea PCR. All women of childbearing age presenting with lower abdominal pain should have a urine SECTION 4 2010 139 pregnancy test to exclude ectopic pregnancy. Negative swabs do not preclude a diagnosis of PID. Pelvic ultrasound is usually unhelpful in establishing or excluding a diagnosis of PID. Laparoscopy provides definitive diagnosis but may be difficult to access so diagnosis is based on pelvic examination. Management Conditions requiring NO to refer to or at minimum consult with an MO or NP (if appropriate/ available): • suspected or confirmed diagnosis of PID • acute abdominal pain • surgical emergency e.g. appendicitis • persistent pain and/or symptoms following treatment • inability to tolerate out-patient treatment • recent instrumentation e.g. intrauterine device in-situ or TOP • complicated infection e.g. symptoms of Fitz Hugh Curtis syndrome • pregnancy test is positive • immunosuppression e.g. HIV positive client • abnormal findings of clinical significance • findings outside NOs scope of practice. Note: NOs are recommended to refer all cases of suspected or confirmed PID to an emergency department if a MO is unavailable for immediate consultation. Treatment Indicators • clinical diagnosis based on examination and history • signs and symptoms • laboratory confirmed diagnosis is not required to commence or continue treatment. For mild to moderate PID (out-patient management) • the client should be reassessed at 72 hours • refer for further MO consultation or hospitalisation if there is no substantial improvement within 72 hours. Regimens • 140 Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or a MO. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • DTP–SRH endorsed NO may progress if within scope of practice. For all other cases consult an endorsed NP or a MO. • Endorsed NP may progress if within scope of practice. For all other cases consult a MO. Regimen 1: Azithromycin, Doxycycline plus Metronidazole This regimen may not give adequate cover for gonorrhoea. Name Azithromycin Form Tablet Strength 500mg Recommended dose 1gram Route of admin Oral with or without food Frequency/duration Stat (one dose) Pregnancy category B1 Poison schedule S4 Emergency management As for severe allergic reaction - Anaphylaxis Consult MO Contraindications Known hypersensitivity to Azithromycin, Erythromycin or Macrolide antibiotic Special precautions Pneumonia Elderly Prolonged QT interval Renal and hepatic impairment Pregnancy and lactation Children aged <16 years Adverse reactions Superinfection Angioedema Cholestatic jaundice Raised LFT, AST, ALT Colitis GI upset Interactions Antacids Ergot derivatives Rifabutin Cyclosporine Warfarin Digoxin And drugs that prolong QT interval SECTION 4 2010 141 And 142 Name Doxycycline Form Capsule or Tablet Strength 100mg Recommended dose 100mg Route of admin Oral with food Frequency/duration Twice a day for 14 days11 Pregnancy category D Poison schedule S4 Emergency management As for severe allergic reaction - Anaphylaxis Consult MO Contraindications Pregnancy and lactation Hypersensitivity to any Tetracycline Concomitant treatment with oral retinoid Special precautions Do not take immediately before going to bed Take with food or milk Renal and hepatic impairment Prolonged use Children aged <8 years Adverse reactions Photosensitivity Urticaria Superinfection Pseudomembranous colitis Oesophagitis GI disturbances Tooth discolouration Interactions Acetazolamide Antacids (containing Al, Mg, Ca Bismuth Salts) Anticoagulants Barbiturates Carbamazepine Methoxyflurane (may cause fatal renal toxicity) OCP Penicillin Phenytoin Sodium Bicarbonate, Iron QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES And Name Metronidazole Form Tablet Strength 400mg Recommended dose 400mg Route of admin Oral Frequency/duration Twice a day for 14 days Pregnancy category B2 Poison schedule S4 Contraindications Pregnancy (first trimester) and lactation Blood dyscrasias Active CNS disease Hypersensitivity to Metronidazole or Imidazoles Special precautions Pregnancy and lactation Prolonged use Renal or hepatic impairment Alcoholic beverages and drugs containing alcohol may cause flushing, vomiting, tachycardia Adverse reactions Superinfection G.I disturbances Leukopenia and thrombocytopenia Neurological disturbances Sensitivity phenomena Pancreatitis Metallic/unpleasant taste Interactions Alcohol (avoid for 24 hrs post treatment) Warfarin Carmustine (BCNU) (chemotherapy drug) Cyclophosphamide Phenytoin, phenobarbitone and other hepatic enzyme Inducers Cimetidine and other hepatic enzyme inhibitors Lithium Disulfiram Cyclosporine 5-Fluorouracil Busulfan (cancer chemotherapy drug can cause serious adverse effect if given in combination with Metronidazole SECTION 4 2010 143 Regimen 2: Azithromycin, Doxycycline, Metronidazole plus Ceftriaxone for suspected or proven gonorrhoea and/or in areas with high prevalence of gonorrhoea. NO are required to consult with a MO prior to progressing to Regimen 2. As per Regimen 1: Azithromycin, Doxycycline and Metronidazole, plus Ceftriaxone and Lignocaine Hydrocholoride. Name Ceftriaxone Form Powder Strength 250mg Recommended dose 250mg Route of admin Intramuscular Injection reconstituted with 2ml Lignocaine 1% solution Frequency/duration Stat Pregnancy category B1 Poison schedule S4 Emergency management Consult MO Contraindications Allergy to cephalosporins Allergy to penicillin Special precautions Penicillin sensitivity Renal and hepatic impairment Impaired vitamin K synthesis GI disease Pregnancy, lactation, children aged <12 years, neonates Adverse reactions Hypersensitivity reactions Superinfection Pseudomembranous colitis Hypoprothrombinemia Local reactions Diarrhoea Pancreatitis and gall bladder concretions Interactions 144 Chloramphenicol QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Name Lignocaine hydrochloride Form Liquid for injection Strength 1% (5ml ampoule) Recommended dose 2mls to be used to reconstitute 250mg Ceftriaxone powder Route of admin Intramuscular injection Frequency/duration Stat Pregnancy category A Poison schedule S4 Emergency management Consult with MO Contraindications Local inflammation/sepsis Septicaemia Anticoagulants CNS or spinal cord disease Impaired cardiac conduction Intraventricular block arrhythmias Hypersensitivity to amide LAS Special Precautions High repeated doses Hepatic, renal, cardiac impairment Hypoxia, sever respiratory depression Neurological disorders Epilepsy Elderly, children Pregnancy and lactation Adverse Reactions CNS disturbances Cardiovascular depression Arrhythmias Hypertension Interactions Other local anaesthetics Antiarrhythmics, beta-blockers (especially class 111) Cimetidine Phenytoin Other anticonvulsants Inhalation anaesthetics Skeletal muscle relaxants Alcohol SECTION 4 2010 145 Observe client for 30 minutes after administration of Ceftriaxone. Or Ceftriaxone 250mg powder vials are not available in some settings and have been substituted with Ceftriaxone dry powder 1g vial stock. The regimen using Ceftriaxone dry powder is the same recommended dose of 250mg Ceftriaxone stat as above, only the strength in stock has changed to 1g Ceftriaxone dry powder. Please follow recommended dose calculation. Name Ceftriaxone Form Dry powder Strength 1g (0.4ml) Volumes for Dose Calculation52,53 1g dry powder (0.4ml) + 1% Lignocaine solution 3.5ml = total volume 3.9ml Recommended dose 250mg (0.98ml) Route of admin Intramuscular injection Frequency/duration Stat (once only) Pregnancy category B1 Poison schedule S4 Emergency management Consult MO Contraindications Allergy to Cephalosporins Major allergy to Penicillin Special precautions Penicillin sensitivity Renal and hepatic impairment Impaired vitamin K synthesis GI disease (especially Colitis) Pregnancy, lactation Children aged <12 years Neonates Adverse reactions Hypersensitivity reactions Superinfection Pseudomembranous colitis Hypoprothrombinemia Local reactions Diarrhoea Pancreatitis and gall bladder concretions Interactions Chloramphenicol Observe client for 30 minutes after administration of Ceftriaxone. 146 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Plus Name Lignocaine hydrochloride Form Liquid for injection Strength 1% (5ml vial) Recommended dose 3.5ml to be used to reconstitute 1g Ceftriaxone powder Route of admin Intramuscular injection Frequency/duration Stat Pregnancy category A Poison schedule S4 Emergency management Consult with MO Contraindications Local inflammation/sepsis Septicaemia Anticoagulants CNS or spinal cord disease Impaired cardiac conduction, intraventricular block, Arrhythmias Hypersensitivity to amide LAS Special precautions High repeated doses Hepatic, renal, cardiac impairment Hypoxia Severe respiratory depression Neurological disorders, epilepsy Elderly, children Pregnancy and lactation Adverse Reactions CNS disturbances Cardiovascular depression Arrhythmias Hypertension Interactions Other local anaesthetics Antiarrhythmics Beta-blockers (especially class 111) Cimetidine Phenytoin Other anticonvulsants Inhalation anaesthetics Skeletal muscle relaxants Alcohol SECTION 4 2010 147 Note: • • • • • Treatment regimens should be effective against N. gonorrhoeae, Chlamydia Trachomatis, anaerobes and bacterial vaginosis as endocervical screening does not rule out an upper reproductive tract infection. Evidence suggests that an effective treatment for mild to moderate PID is Ceftriaxone 250mg IMI plus Doxycycline orally 100mg twice daily for 14 days with or without Metronidazole 500mg orally twice daily for 14 days7,54. The decision to administer this regimen with or without Metronidazole is based on clinical judgement of client risk of anaerobic pathogens such as pelvic abscess; proven or suspected trichomonas vaginalis and/or bacterial vaginosis, or history of gynaecological instrumentation in the preceding 2 - 3 weeks. Currently this is not an approved regimen so a NO is required to discuss first with a MO. Recent studies indicate that a regimen of Azithromycin and Ceftriaxone or Doxycycline and Ceftriaxone (doses as above) for PID may be equivalent in efficacy for first-line treatment of mild PID. However, additional research is required before recommendations can be made54. COC user taking a short course (<3 weeks) of antibiotics should be advised to use additional contraception such as condoms, during treatment and for seven days after antibiotics have been stopped. Women with an IUCD insitu should be referred to a MO. Client education • • • • • • no unsafe sex for a minimum of three days following treatment and until all contacts are treated, offer condoms and lubricant reinforce need to complete remaining treatment regimen protect skin from sunlight and solariums as some Macrolide antibiotics increase sensitivity to sunlight. If there is a rash, itching, redness or severe sunburn consult a MO Doxycycline to be taken with one full glass of water and client should sit upright for at least 30 minutes after taking medication client fact-sheet available www.health.qld.gov.au/sexhealth provide MIMS consumer medicine information www.ckn.health.qld.gov.au Contact tracing Contact trace according to requirements of the specific disease or condition diagnosed. Treat all contacts presumptively. Follow-up 148 • review client in 72 hours to ensure symptoms are responding to treatment. If the client remains symptomatic, refer to a MO immediately • review client again at eight days to assess compliance and resolution of symptoms. Repeat bimanual examination if possible. Reinforce need to complete remaining treatment regimen. If there is no improvement NO are required to refer to a MO. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Proctitis Proctitis is indicated by the presence of anal discharge, blood and/or mucous in stools, and pain during defecation. Proctitis caused by sexually transmitted organisms is usually caused by Neisseria Gonorrhoeae or the herpes simplex virus, however Chlamydia trachomatis is increasingly implicated in MSM. Recently, Lymphogranuloma venereum (LGV) has been identified as a cause of acute proctitis in MSM in Australia, Europe and North America. Signs / symptoms • rectal discharge, itch and/or soreness • blood, pus and/or mucus in stools or on underwear • discomfort or bleeding on defecation or in association with anal penetration. The following are possible causes of Proctitis: • Chlamydia Trachomatis • Neisseria Gonorrhoeae • Trichomonas vaginalis • Herpes simplex virus • Human papilloma virus • Treponema Pallidum • Lymphogranuloma venereum • Enteric pathogens/parasites such as Giardia Lamblia, Entamoeba Histolytica, Campylobacter, Shigella • Inflammatory/Irritable Bowel Syndrome • Rectal and/or bowel abnormalities such as malignancy, benign growths or polyps • Diverticular disease • Anal fissure, tear, sinus or fistula • Foreign bodies • Trauma. When taking history be sure to ask about the following: • Sexual, medical and surgical history and for females a gynaecological and menstrual history • blood, pus and/or mucus in stools or on underwear • discomfort/pain or bleeding on defecation • discomfort/pain or bleeding during or after anal intercourse SECTION 4 2010 149 • associated symptoms e.g. tenesmus, pruritus, pain or fever • previous history of STIs and treatment history • recent change of sexual partner or symptomatic partner • recent increase in anal intercourse • recent overseas travel or sexual contact with person from endemic country • use of foreign objects/sex toys for anal penetration • change in bowel motions/habits. Examination • palpate inguinal lymph nodes for enlargement and or tenderness • examine perianal region for colour, discharge, erythema, lesions, ulcers, rashes, excoriation, trauma or abnormalities • perform proctoscopy and examine rectal mucosa for colour changes, appearance, lesions, ulceration, fissures, discharge, inflammation, masses or abnormalities. Investigations Perform investigations based on risk assessment, clinical findings and local policy. • blood pressure, TPR • rectal mucosa swabs for: • 150 – gonorrhoea PCR or culture and sensitivity (C/S) – chlamydia PCR. If positive also perform LGV serotype (PCR). – swab for HSV PCR (if indicated) – swab for Treponemal PCR for syphilis – press slide and GUMP for donovanosis – consider punch biopsy for lesions that are atypical or unresponsive to treatment (particularly in clients with HIV). serology – syphilis – HIV. • if diarrhoea is present take a stool sample for microscopy, culture and sensitivity (M/C/S) • discuss additional STI screening as indicated by history. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/available): • all cases of proctitis Treatment Indicators Diagnosis based on examination findings: • if anoscopy reveals proctitis (pus, friable mucosa or contact bleeding), initiate presumptive treatment for chlamydia and gonorrhoea • proctitis associated with painful ulceration can suggest herpes simplex virus, so presumptive anti-viral treatment should also be given. Laboratory confirmed diagnosis: • if rectal PCR positive for chlamydia, perform LGV testing and consult with a MO. Regimens • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or consult a MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence. For all other cases consult a MO or endorsed NP. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. SECTION 4 2010 151 Name Doxycycline Form Capsule Strength 100mg Recommended dose 100mg Route of admin Oral with food Frequency/duration Twice a day for 10 days Twice a day for 21 days if LGV confirmed 152 Pregnancy category D Poison schedule S4 Emergency management As for severe allergic reaction - Anaphylaxis Consult MO or refer to appropriate emergency services Contraindications Pregnancy and lactation Hypersensitivity to any tetracycline Concomitant treatment with oral retinoid Special precautions Don’t take immediately before going to bed Take with food or milk Renal and hepatic impairment Prolonged use Children <8 years Adverse Reactions Photosensitivity Urticaria Superinfection Pseudomembranous colitis Oesophagitis GI disturbances Tooth discolouration Interactions Acetazolamide Antacids (containing Al, Mg, Ca Bismuth Salts) Anticoagulants Barbiturates Carbamazepine Methoxyflurane (may cause fatal renal toxicity) OCP Penicillin Phenytoin Sodium Bicarbonate Iron QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES And Name Ceftriaxone Form Powder Strength 250mg Recommended dose 250mg Route of admin Intramuscular injection reconstituted with 2ml Lignocaine 1% solution Frequency/duration Stat (1 dose) Pregnancy category B1 Poison schedule S4 Emergency management Consult MO or refer to appropriate emergency services Contraindications Allergy to Cephalosporins Allergy to Penicillin Special precautions Penicillin sensitivity Renal and hepatic impairment Impaired vitamin K synthesis GI disease ( especially colitis) Pregnancy, lactation, Children <12 years Neonates Adverse reactions Hypersensitivity reactions Superinfection Pseudomembranous colitis Hypoprothrombinemia Local reactions Diarrhoea Pancreatitis and gall bladder concretions Interactions Chloramphenicol SECTION 4 2010 153 Plus for reconstitution of 1gram Ceftriaxone powder use 154 Name Lignocaine Hydrochloride Form Liquid for injection Strength 1% (5ml ampoule) Recommended dose 3.5ml to be used to reconstitute 1gram Ceftriaxone powder Route of admin Intramuscular injection Frequency/duration Stat Pregnancy category A Poison schedule S4 Emergency management Consult with MO Contraindications Local inflammation/sepsis Septicaemia Anticoagulants CNS or spinal cord disease Impaired cardiac conduction, intraventricular block, arrhythmias Hypersensitivity to amide LAS Special precautions High repeated doses Hepatic, renal, cardiac impairment Hypoxia, sever respiratory depression Neurological disorders, epilepsy Elderly and children Pregnancy and lactation Adverse reactions CNS disturbances cardiovascular depression arrhythmias, hypertension Interactions Other local anaesthetics Antiarrhythmics (especially class 111) Beta-blockers Cimetidine Phenytoin, other anticonvulsants Inhalation anaesthetics Skeletal muscle relaxants Alcohol QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Or Ceftriaxone 250mg powder vials are not available in some settings and have been substituted with Ceftriaxone dry powder 1gram vial stock. The regimen using Ceftriaxone dry powder is the same recommended dose of 250mg Ceftriaxone stat as above, only the strength in stock has changed to 1g Ceftriaxone dry powder. Please follow recommended dose calculation. Name Ceftriaxone Form Dry powder Strength 1g (0.4ml) Volumes for Dose Calculation52,53 1g dry powder (0.4ml) + 1% Lignocaine solution 3.5ml = total volume 3.9ml Recommended dose 250mg (0.98ml) Route of admin Intramuscular injection Frequency/duration Stat (once only) Pregnancy category B1 Poison schedule S4 Emergency management Consult MO Contraindications Allergy to Cephalosporins Major allergy to Penicillin Special precautions Penicillin sensitivity Renal and hepatic impairment Impaired vitamin K synthesis GI disease (especially Colitis) Pregnancy, lactation Children aged <12 years Neonates Adverse reactions Hypersensitivity reactions Superinfection Pseudomembranous colitis Hypoprothrombinemia Local reactions Diarrhoea Pancreatitis and gall bladder concretions Interactions Chloramphenicol SECTION 4 2010 155 Note: • observe client for 30 minutes after administration of Ceftriaxone • Azithromycin is likely to be a suitable substitute for Doxycycline although this has not been evaluated. • COC user taking a short course (<3 weeks) of antibiotics should be advised to use additional contraception (i.e. condoms) during treatment and for seven days after antibiotics have been stopped.13 • if rectal PCR positive for chlamydia, consider LGV and consult with a MO. If associated with painful ulceration add presumptive treatment for HSV. Name Valaciclovir Form Oral Strength 500mg Recommended dose 500mg Route of admin Oral Frequency/duration Twice daily for 5 – 10 days12 Pregnancy category B3 Poison schedule S4 Emergency management As for severe allergic reaction – Anaphylaxis Consult MO or refer to appropriate emergency services Contraindications Known hypersensitivity to Aciclovir or Valaciclovir Special precautions Renal and hepatic impairment Dehydration Immuno-compromised clients Pregnancy and lactation Children, the elderly Adverse reactions Headache, dizziness Nausea, G.I. upset Rash and hypersensitivity Interactions 156 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES No clinically significant interactions have been identified Or Name Aciclovir Form Oral Strength 200mg Recommended dose 200mg Route of admin Oral Frequency/duration One tablet 5 times daily for 10 days12 Pregnancy category B3 Poison schedule S4 Emergency management As for severe allergic reaction – Anaphylaxis Consult MO or refer to appropriate emergency services Contraindications Known hypersensitivity to Aciclovir or Valaciclovir Special precautions Caution in clients with: Underlying neurological abnormalities Significant hypoxia Electrolyte impairment, dehydration Renal and hepatic impairment History of neurological reaction to cytotoxic drugs Receiving Interferon or intrathecal Methotrexate Pregnancy and lactation Children, the elderly Adverse reactions Nausea or vomiting are most frequent adverse effect Less frequent effects (<1%) include diarrhoea, leg pain, dizziness, anorexia, fatigue, oedema, skin rashes, inguinal adenopathy, medication taste and sore throat Interactions No clinically significant interactions have been identified Probenecid Concurrent use of diuretics in clients aged > 60 yrs Note: regimen for primary herpes treatment is five days, though duration may be extended to a 10 day supply for moderate to severe episodes. SECTION 4 2010 157 Or Name Famciclovir Form Tablet Strength 125mg, 250mg or 500mg Recommended dose 1250mg over a two day period12 Route of admin Oral Frequency/duration 500mg stat Then 250mg every 12 hours for three doses Pregnancy category B1 Poison schedule S4 Emergency management Consult MO or refer to appropriate emergency services Contraindications Known hypersensitivity to Famciclovir and Penciclovir Special precautions Renal Pregnancy Lactation Children <12 years Tablets contain lactose (should not be taken by clients with galactose intolerance, severe lactase deficiency or glucose malabsorption) Driving/operating machinery if experiencing dizziness/ somnolence Adverse reactions Headache, dizziness Nausea, G.I. upset Skin rash Fatigue / somnolence. Interactions No clinically significant interactions have been identified Note: 500mg Famciclovir is not available on the Queensland Health List of Approved Medicines.21 Client education • 158 avoid unprotected sex until all contacts are treated and for a minimum of three days following treatment with Azithromycin or seven days following treatment with Doxycycline QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • protect skin from sunlight and solariums as some Macrolide antibiotics increase sensitivity to sunlight. If there is a rash, itching, redness or severe sunburn consult a MO • Doxycycline to be taken with one full glass of water and client should sit upright for at least 30 minutes after taking medication • client fact-sheet available at www.health.qld.gov.au/sexhealth • provide MIMS Consumer Medicine Information www.ckn.health.qld.gov.au Contact tracing Contact trace according to requirements of the specific disease or condition diagnosed. Refer to History and assessment (section one). Follow-up Review the client within four days, to assess resolution of symptoms: • refer to a MO if still symptomatic. If diagnosis confirmed with chlamydia: • follow-up within two weeks to ensure compliance with medication • follow-up not required if asymptomatic and treatment of DOT Azithromycin or Doxycycline completed • PCR POC cannot be reliably undertaken <8 weeks after treatment • re-testing recommended at three months as re-infection is common. If diagnosis confirmed with gonorrhoea: • follow-up at 7-10 days to ensure symptoms resolved and check partner(s) have been treated • proof of cure - swab for gonorrhoea M/C/S of infected site two weeks after treatment if symptoms persist. Do not use swab for gonorrhoea PCR for POC, as it will remain positive for up to eight weeks after treatment • re-testing recommended at three months as re-infection is common. SECTION 4 2010 159 Pubic lice Pubic lice or pedicular pubis is caused by an infestation of pthirus pubis which usually attach to hairs in the pubic and perianal regions49. They may also appear on thighs, axilla, axillae, eye lashes and eyebrows49. Transmitted by intimate contact (including sexual contact), public lice it can be transmitted by sharing personal articles such as hairbrushes, combs, towels or clothing49. Signs / symptoms • skin irritation • visible louse/eggs • blue-grey macules (maculae coeruleae) induced by the bite of the louse • brown/red faecal droppings in the pubic hair or underwear • secondary bacterial skin infection. Investigations • visualisation of lice/eggs on examination or under light magnification • discuss additional STI screening. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/available): • secondary skin infection or irritation • uncertain diagnosis • client is pregnant or breastfeeding • contraindication to treatment • immunosuppression e.g. HIV positive client • abnormal findings of clinical significance • findings outside NOs scope of practice. Treatment Indicators 160 • clinical diagnosis based on history and examination • contact with pubic lice. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Regimens • Non DTP-SRH endorsed NOs are authorised to administer this regimen if clinical competency is completed. If not deemed competent, refer management to a DTP–SRH endorsed NO, endorsed NP or consult a MO or endorsed NP. • DTP–SRH endorsed NO may progress if within scope of practice. For all other cases consult an endorsed NP or a MO. • Endorsed NP may progress if within scope of practice. For all other cases consult a MO. Name Permethrin Form Cream/lotion/cream rinse Strength Cream / Lotion 5% Cream rinse 1% Recommended dose Two applications 7 – 10 days apart Route of admin Topical Frequency/duration Cream/Lotion Apply to entire body from neck down, especially between skin folds Leave for 8 - 24 hours before washing off Repeat in 7-10 days if necessary Cream rinse Apply liberally to dry hair, massage into hair base. Leave for 20 mins before washing off, comb hair with fine tooth comb Repeat in 7-10 days if necessary Pregnancy category B2 Poison schedule Cream rinse with conditioner: unscheduled Dermal cream: unscheduled Scabies treatment lotion: unscheduled Emergency management Discontinue use if irritation occurs If contact with eyes rinse immediately with water Consult MO Contraindications Known hypersensitivity to Permethrin or other ingredients in the product Special precautions Avoid eyes and mucous membranes Existing skin infection or open wounds Use with caution during pregnancy/breastfeeding Children aged 6 mths - 2 yrs (medical supervision) Elderly SECTION 4 2010 161 Adverse reactions Uncommon Localised burning, irritation or tingling sensation Interactions No known interactions Recommended that treatment of eczematous skin conditions with corticosteroid creams is withheld prior to treatment, as they may worsen the infection Client education • Do not bathe in hot water prior to applying Permethrin. Apply Permethrin to clean, cool skin. • lice/eggs can be removed with a fine toothed comb • underwear, pyjamas, bath towels and bed linen should be washed in hot water or dry cleaned. Expose mattress, blankets and doonas to sunlight for several hours. It is unnecessary to fumigate living areas • if there is an infestation of the eyelashes, do not apply Permethrin. Instead, apply petroleum jelly to eyelashes twice daily for 7-10 days • provide MIMS consumer medication information www.ckn.health.qld.gov.au Contact tracing • treat any partner(s) from within the last month • close non-sexual contacts such as household members may also need treatment. Follow-up 162 • not necessary • clients should be re-examined 1-2 weeks after treatment if still symptomatic. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Scabies Scabies is caused by Sarcoptes scabiei49. Transmission is predominately through close body contact but it can also spread by sharing clothes or bed linen. Signs / symptoms • papular and eczematous lesions49 with a history of itching which is typically worse at night • scabietic lesions or “burrows” may be visible as a greyish, fine, linear rash or ridge • the mite may be visible in the burrow as a raised white oval with dark pigmentation anteriorly • secondary bacterial infection • ‘Norwegian scabies’ or ‘crusted scabies’ – infestation from a high quantity of mites. Is more likely in an immunosuppressed or institutionalised client – present as thick crusts affecting areas such as the feet and scalp – extremely infectious. Investigations Definitive diagnosis is made by microscopic identification of mites or their eggs from skin scrapings at the site of burrows. Offer STI screening. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/ available): • ‘Norwegian scabies’ or ‘crusted scabies’ are suspected • abnormal findings of clinical significance • uncertain diagnosis • secondary skin infections or irritations • no response after second treatment • contraindication to treatment • client is pregnant or breastfeeding • immunosuppression e.g. HIV positive client • findings outside NOs scope of practice. SECTION 4 2010 163 Treatment Indicators • clinical diagnosis based on history and examination • definitive microscopic identification of mite • known contact of scabies. Regimens • Non DTP-SRH endorsed NOs are authorised to administer this regimen if clinical competence is completed. If not deemed competent, refer management to a DTP–SRH endorsed NO, endorsed NP or a MO. • DTP–SRH endorsed NO may progress if within scope of practice. For all other cases consult an endorsed NP or a MO. • Endorsed NP may progress if within scope of practice. For all other cases consult a MO. Name Permethrin Form Cream/lotion Strength 5% Recommended dose Approximate amount for each application for adults is 30g (1 tube) – some may require a repeat, but not more than 60g (2 tubes) in one application Route of admin Topical Frequency/duration Once a week for two weeks Apply to entire body from neck down, especially between skin folds Leave on for 8 – 24 hours before washing off Pregnancy category Dermal cream: category B2 Scabies treatment: category B2 Poison schedule Dermal cream: unscheduled Lotion: unscheduled Emergency management Discontinue use if irritation occurs If contact with eyes, rinse immediately with water Consult MO Contraindications 164 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Known hypersensitivity to Permethrin or other ingredients in the product Special precautions Avoid eyes and mucous membranes Existing skin infection or open wounds Use with caution during pregnancy and breastfeeding Children aged 6mths - 2yrs (need medical supervision) Elderly Adverse reactions Uncommon Localised burning, irritation or tingling sensation Burning sensation of higher incidence with symptomatic HIV infection Interactions No known interactions Treatment of eczematous skin conditions with corticosteroid creams should be withheld, as they may worsen the infection Client education • avoid contact with eyes and mucous membranes • apply to clean, cool, dry skin, and do not use on broken or infected skin • pay attention to webs of the fingers and toes • do not wash hands after application or wash off lotion for 8-12 hours • pruritus and skin irritation may persist for several weeks after adequate therapy. In severe cases, systemic antipruritics or topical steroids may be necessary to alleviate symptoms • underwear, pyjamas, bath towels and bed linen should be washed in hot water or dry cleaned. Expose mattress and doonas to UV light for 48 – 72 hours or spray with insect repellent • client fact-sheet available www.health.qld.gov.au/sexhealth • provide MIMS consumer medication information www.ckn.health.qld.gov.au Contact tracing • sexual partners and household contacts should be treated at the same time even if asymptomatic • clients and staff in institutional settings such as nursing homes will require treatment. Follow-up • there is no consensus or evidence regarding follow-up • evidence of new burrows and/or secondary skin infections is an indicator for further treatment. SECTION 4 2010 165 Syphilis Syphilis is caused by the bacterium Treponema pallidum49. T. pallidum is a member of the spirochaetaceae family which is responsible for Yaws (T. Pertenue) and Pinta (T. Carareum). Syphilis can be categorised into congenital infection and acquired infection. Congenital infection is acquired through transplacental infection or during delivery. Acquired infection is acquired by direct contact with infectious exudate from associated skin lesions (chancre) and mucous membranes during sexual contact. Transmission may occur within the injecting drug user population. Acquired infection can be divided into two further categories: • Early infection of <2 years (which includes primary, secondary and early latent infection) • Late syphilis of >2 years duration (which includes late clinical stage such as tertiary or late latent infection). Signs / symptoms Primary syphilis The infecting organism disseminates through the body during this time. • 10 - 90 days incubation (three weeks on average) • skin lesions (chancres): – painless ulceration – typically presents as a single painless lesion with raised border and indurated clean base – atypical presentations and/or multiple lesions can occur due to co-infection with HIV, secondary infection or application of topical medication – may occur at extra-genital point of treponemal inoculation i.e. fingers, nipples or lips – painless regional lymphadenopathy may be present. Secondary syphilis Signs and symptoms may appear and regress at intervals over a two year period. • Cutaneous or mucosal rash49 • chancres may still be evident in secondary syphilis • flu-like illness • skin lesions • 166 – bilaterally symmetrical, seldom itchy and generally dry – macular, papular, follicular or pustular. cutaneous and mucosal lesions QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES – snail track ulcers – mucous patches – wart-like lesions (condylomata lata). • generalised lymphadenopathy • loss of eyelashes and outer-third of eyebrows • sometimes alopecia or ‘moth-eaten’ appearance beginning at the occipital scalp • systemic dissemination • manifestation of neurological involvement (more common in HIV infected clients). Latency After the secondary stage there is typically a long period of latency during which the only finding is positive syphilis serology. This interval may be shorter in those who are HIV positive. Tertiary syphilis Tertiary syphilis is rare but should be excluded in anyone presenting with neurological signs who has positive syphilis serology and no history of treatment. Management should always be in consultation with a specialist MO. Testing Testing should occur in the following circumstances: • known contact of syphilis • genital ulceration • presence of other STI • identified risk through unprotected intercourse including oro-genital • symptoms characteristic of second or latent syphilis • sexual health check and routine antenatal testing. Investigations Testing for syphilis should not occur in isolation. Screen for all STIs and if syphilis is suspected contact the Syphilis Register on 1800 032 238 for advice. Serology • syphilis • HBV • HIV. SECTION 4 2010 167 Lesion • dark ground microscopy (if available) • treponemal PCR swab (if available). Discuss with MO and laboratory prior to collection. Serology Most syphilis is diagnosed on the basis of serology. In approximately 75% of cases of primary chancres, serology is positive at the time of presentation. However, negative serology in a client with a genital ulcer does not exclude syphilis. Dark-field microscopy and PCR testing can be used if available. Non-specific (non-treponemal) tests (RPR and VDRL) usually become reactive six weeks after infection. RPR is the most common test to assess disease activity and monitor response to treatment. In early syphilis, there will be a four-fold (2 titre) drop in the RPR titre over 6 - 12 months following adequate treatment. Even without treatment, the RPR titre gradually declines over many years. Specific treponemal tests (EIA, TPPA and FTA-ABS) remain positive ‘for life’ in most cases, regardless of treatment. Some of these tests e.g. FTA - may detect infection at an earlier stage than RPR. RPR plus a specific treponemal test is typically used for screening purposes to detect infections where the RPR may have become negative over time. Specific tests cannot be used for monitoring the efficacy of treatment. Dark-field microscopy This allows demonstration of spirochaetes from primary chancres or mucous membrane lesions of secondary syphilis. The lesion is cleaned with saline, squeezed gently, and a drop of expressed exudate is placed into a drop of saline on a glass slide. If dark-field microscopy is immediately available, motile treponemes can be seen directly in the wet preparation. If dark-field microscopy is not available, allow the sample to dry, then send the slide to a laboratory for detection of treponemes by an immunofluorescent technique (however this test is not commonly available in Australia). Check with your local laboratory to confirm whether dark-field microscopy is available. PCR testing for Treponema pallidum PCR testing of a swab taken from a genital ulcer or mucous membrane lesion has good sensitivity and specificity. In Queensland Health laboratories, this test will only be performed if it is accompanied by a blood specimen for syphilis serology. In the Northern Zone, the test is performed as part of a multiplex PCR test for GUMP. Management Contact the Syphilis Register on 1800 032 238 Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/available): • 168 suspected or laboratory confirmed diagnosis QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • suspected long standing untreated syphilis, tertiary syphilis or neurosyphilis • suspected treatment failure • systemic illness • client is pregnant or breastfeeding • contraindication to treatment e.g. allergy to penicillin • immunosuppression e.g. HIV positive client • abnormal findings of significance e.g. neurological involvement • uncertain diagnosis • findings outside NOs scope of practice. Treatment Indicators • suspected primary or secondary syphilis • laboratory confirmed diagnosis • contact with infectious Syphilis. Regimens Prior to initiation of treatment: • contact the Syphilis Register on 1800 032 238 • consult with a MO • perform systemic physical assessment including neurological examination • repeat syphilis serology before administering initial dose for true baseline RPR. Note: • treatment influenced by infection duration i.e. early or late syphilis • if a MO is unavailable for consultation prior to initiation of treatment (e.g. isolated remote practice) ensure internal procedures are in place to support scope of practice. Regimen 1: Syphilis proven to be <2 years duration (Including primary and secondary syphilis) • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or consult a MO. • DTP–SRH endorsed NO may progress if within scope of practice and competence. For all other cases consult an endorsed NP or MO. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. SECTION 4 2010 169 Name Benzathine Penicillin (Bicillin LA) Form Suspension Strength 900mg / 2.3 ml (1,200,000 International units) Recommended dose 1.8g (2 x 900mg /2.3ml or 2,400,000 International units) Route of admin IMI Frequency/duration Stat (once only) Pregnancy category A Poison schedule Schedule 4 Emergency management See allergic reaction/anaphylaxis management Consult MO Contraindications Allergy to Penicillin Do not inject into or near artery or nerve Beware of inadvertent intravascular administration Special precautions Repeat Syphilis serology at time of treatment for true baseline RPR titre Anaphylaxis Asthma Lactation Jarisch-Herxheimer reaction Adverse reactions Atrophy Superinfection Pseudo membranous colitis Hypersensitivity Haematological effects Acute interstitial nephritis Jarisch Herxheimer reaction Neuropathy Nephropathy Interactions Tetracycline Probenecid If there is a supply shortage of Benzathine Penicillin (Bicillin LA) an approved substitute is Benzathine Benzylpenicillin (Pan Benzathine Penicillin). Recommended dose and frequency remains the same (see preparation guidelines below). 170 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Or Name Procaine Penicillin Form Suspension Strength 1.5gram pre-filled syringe Recommended dose 1gram Route of admin IMI Frequency/duration Daily for 10 days Pregnancy category A Poison schedule S4 Emergency management See allergic reaction/Anaphylaxis management Consult MO Contraindications Allergy to Penicillin or Procaine Special precautions Repeat for syphilis serology at time of treatment for true baseline RPR titre Do not inject into or near blood vessel or nerve Super-infection and pseudomembranous colitis Adverse reactions GI upsets Rashes Urticaria Pain at injection site Extreme anxiety, hallucinations, disorientation Tachycardia Jarisch Herxheimer reaction Interactions Tetracycline Probenecid SECTION 4 2010 171 Regimen 2: Syphilis of >2 years or unknown duration • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or a MO. • DTP–SRH endorsed NO may progress if within scope of practice. For all other cases consult an endorsed NP or MO. • Endorsed NP may progress if within scope of practice. For all other cases consult a MO. Name Benzathine Penicillin (Bicillin LA) Form Suspension Strength 900mg / 2.3ml (1,200,000 International units) Recommended dose 1.8g (2 x 900mg / 2.3ml or 2,400,000 International units) Route of admin IMI Frequency/duration Once a week for three weeks Pregnancy category A Poison schedule Schedule 4 Emergency management See allergic reaction/Anaphylaxis management Consult MO Contraindications Allergy to Penicillin Do not inject into or near an artery or nerve Beware of danger due to inadvertent intravascular administration Special precautions Re-bleed for Syphilis serology at time of treatment for true baseline RPR titre Adverse reactions Atrophy Superinfection Pseudo membranous colitis Hypersensitivity Haematological effects Acute interstitial nephritis Jarisch Herxheimer reaction Neuropathy Nephropathy Interactions Tetracycline Probenecid 172 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Benzathine Benzylpenicillin (Pan Benzathine Penicillin) Benzathine Benzylpenicillin (Pan Benzathine Penicillin) and Benzathine Penicillin (Bicillin LA) is the same drug in a different form. Benzathine Benzylpenicillin (Pan Benzathine Penicillin) is an approved substitute for Benzathine Penicillin (Bicillin LA) when Bicillin LA is unavailable. The recommended dose and frequency remain the same as per Benzathine Penicillin but with an increase in required volume and change in preparation. Name Benzathine Benzylpenicillin (Pan Benzathine Penicillin) Form Powder Strength 900mg (1,200,000 International units) Recommended dose 1.8g (2 x 900mg or 2,400,000 International units) Route of admin IMI reconstituted with: 4ml of water for injection Administer 4.6ml (one vial) in each buttock. Frequency/duration As per Benzathine Penicillin (Bicillin LA), based on duration of infection Pregnancy category A Poison schedule S4 Emergency management See allergic reaction/Anaphylaxis management Consult MO Contraindications Allergy to Penicillin Special precautions Re-bleed for Syphilis serology at time of treatment for true baseline RPR titre Lactation Anaphylaxis Adverse reactions Atrophy Superinfection Pseudo membranous colitis Hypersensitivity Haematological effects Acute interstitial nephritis Jarisch Herxheimer reaction Neuropathy Nephropathy Interactions Tetracycline Probenecid SECTION 4 2010 173 Benzathine Benzylpenicillin (Pan Benzathine Penicillin) injection To minimise discomfort: • reconstitute each 900mg in a minimum of 4mls of water • use a 5ml syringe • hold the vial vertically and mix well until powder is absorbed • prepare immediately prior to administration • prior to administration, warm injection (do not heat above +50oC) by rolling syringe between palm of hands, as this may reduce discomfort for the client • if there is delay in administration following preparation, ensure syringe is rotated vertically prior to administration so it mixes adequately. This will reduce obstruction of the needle due to precipitation of the suspension • attach a 19 gauge or 21 gauge needle for injection to the syringe just prior to injecting suspension, to prevent blockage of needle • administer in the upper/outer quadrant of the gluteus maximus and apply pressure to the injection site at for at least ten seconds prior to administration • give two injections (one in each buttock). Jarisch-Herxheimer reaction Approximately 30% of people treated for primary syphilis and 60% of people treated for secondary syphilis have a reaction characterised by chills, fever, arthralgias, headaches and transiently increased prominence of lesions49. The Jarisch-Herxheimer reaction is due to the release of treponemal constituents and usually occurs within 24 hours of starting treatment. Advise the client that this may occur and that it can cause signs and symptoms to temporarily exacerbate. Signs / symptoms of Jarisch-Herxheimer reaction • prodromal phase with aches and pains (<4 hours) • rigor or chill (4 - 8 hours) • flush with temperature peak and hypotension (8 hours) • falling temperature, back to normal (lasting up to 12 hours) • fever, sweats, shivering, muscle/joint pains, sore throat or headache • sudden worsening of local lesion (i.e. chancre or rash) • fast pulse or feeling faint (postural hypotension). Jarisch-Herxheimer reaction can cause premature labour in some women and fetal distress during the second half of pregnancy. Management • 174 advise client in advance of possible reaction(s) QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • manage with rest and fluids • aspirin or paracetamol - two tablets four hourly (as required). Do not exceed four doses (eight tablets) in 24 hours. Aspirin should not be given during pregnancy Note: COC users taking a short course (<3 weeks) of antibiotics should be advised to use additional contraception such as condoms, during treatment and for seven days after antibiotics have been stopped Penicillin remains the preferred treatment for all stages of syphilis. Serology should be repeated at the time of initial treatment as this will provide a baseline RPR for monitoring response to treatment. Treatment of early syphilis in clients allergic to penicillin This includes clients who have a documented cutaneous reaction or history of hypersensitivity to Penicillin. Use Doxycycline 100 mg twice daily for 14 days. Doxycycline should not be used in pregnancy (category D in pregnancy). Consideration could be given to desensitisation in those who are Penicillin allergic (especially in pregnancy). Erythromycin should not be used during pregnancy as it may not prevent congenital syphilis. Pregnant clients who are allergic to Penicillin pose difficult problems. If Penicillin desensitisation is not possible, the remaining treatment options are Azithromycin or Ceftriaxone. However, the baby will always require additional treatment and careful follow-up if a non-penicillin treatment is used during pregnancy. Penicillin allergic clients should be managed in consultation with an experienced infectious disease or sexual health clinician. Late latent syphilis (>2 years duration) People with late latent syphilis are not sexually infectious. Vertical transmission can still occur even though it’s less likely more than two years after initial infection. The principal goal of treatment is to prevent late complications. Lumbar puncture in late latent syphilis T. Pallidum invades the CNS in 25% of clients with syphilis (irrespective of HIV status). Infection is effectively cleared in about 75% of these clients, while the remaining 25% harbour organisms in their CNS which can lead to symptomatic neurological disease in late syphilis. Symptomatic neurosyphilis in secondary or late syphilis is a rare occurrence, probably due to widespread use of antibiotics for other reasons. Lumbar puncture is not necessary in secondary or latent syphilis unless there is clinical evidence of neurological involvement. Seek specialist advice if in doubt. All clients with positive syphilis serology who have neurological symptoms or signs of late syphilis should undergo lumbar puncture and CSF examination. There is no comprehensive test to diagnose neurosyphilis, so all test results should be SECTION 4 2010 175 interpreted together and correlated with clinical findings. The VDRL-CSF is a standard serological test for syphilis in CSF. When reactive in the absence of significant contamination of CSF with blood, it is considered diagnostic of neurosyphilis. However, the VDRL-CSF may be non-reactive in clients with neurosyphilis. CSF FTA-ABS is less specific but highly sensitive, and if negative, neurosyphilis is usually excluded. The CSF leucocyte count is usually elevated (>5 WBC/mm3) with protein raised and glucose reduced. Seek specialist advice in the management of symptomatic late syphilis and neurosyphilis. Treating neurosyphilis Seek specialist advice. Recommended treatment is Benzyl Penicillin 1.8grams IV (depending on body weight), four hourly for 15 days. Pregnancy and congenital syphilis If a client has history of adequate treatment for syphilis with serological follow-up, and reinfection is unlikely, avoid re-treatment and serological examination of the infant. In areas of high prevalence, it may be necessary to screen for syphilis in pregnancy. Testing should occur during presentation at the third trimester and time of delivery. Vertical transmission of syphilis in untreated women is possible but tends to decrease in probability over time. Pregnant women should be treated with Penicillin at the same dosage for non-pregnant women at a similar stage of infection. Seek specialist advice about females allergic to Penicillin. Tetracyclines should not be used in pregnancy and Erythromycin does not reliably treat an infected foetus. Contact the Queensland Syphilis Register on 1800 032 238 if a pregnant woman has positive syphilis serology. Treatment is adequate if: • completed before 29 weeks • there is a documented four-fold (two titre) drop in RPR before or at time of delivery. A baby is at high risk if: • the mother has primary or secondary syphilis genital sores at time of delivery • the mother was treated with a drug other than Penicillin or treatment was inadequate • treatment of mother was within four weeks of delivery • the mother’s RPR is greater than or equal to 1:64, or is not falling • examination of the baby shows signs of congenital syphilis • the mother’s RPR at delivery shows inadequately treated or previously undiagnosed syphilis. Any high risk baby needs a lumbar puncture and CSF examination for white cells, protein and VDRL. If CSF examination is abnormal: Benzyl Penicillin 50 mg/kg IM or IV daily in two divided doses for ten days, or Procaine Penicillin 50 mg/kg IM daily for ten days. 176 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES If CSF examination is normal: • the baby needs single dose treatment at birth. In the following circumstances, the baby is at low risk and requires only a single dose treatment of Benzathine Penicillin (Bicillin LA) 50 mg/kg IM at birth. • the mother had no syphilis serology performed during pregnancy but there is moderate - high prevalence of syphilis in her community (e.g. remote Indigenous community). The mother should have an RPR performed at the earliest opportunity to ensure the baby is not at high risk • the mother was treated for syphilis with Penicillin during pregnancy, treatment was completed before 36 weeks with an adequate response • the baby needed a lumbar puncture but the result is normal. The baby needs no investigation or treatment if: • the mother had all antenatal and pregnancy bloods taken and all syphilis antibody screens EIA or TPPA or FTA-ABS and RPR are non-reactive • the RPR during pregnancy and just prior to pregnancy are stable low titres • the mother has a documented record of past treatment. If in doubt consult a paediatrician or infectious disease clinician. A useful reference is the Australian Society of Infectious Diseases and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Phone (02) 9256 5475 or email [email protected] Follow-up for babies The mother needs follow-up in all cases where she may have had syphilis during pregnancy. Babies fall into four groups for follow-up: • high risk with abnormal CSF - repeat RPR and lumbar puncture at six months and review by paediatrician • high risk with normal CSF but confirmed Congenital Syphilis - RPR at six months and review by paediatrician • high risk with normal CSF and no signs of Congenital Syphilis - follow-up the mother only • low risk or no treatment needed - follow-up mother only. Client education • reinforce compliance with treatment • inform clients of childbearing age that treatment and follow-up is important • sexual contact should be avoided until primary chancre healed • client fact-sheet available www.health.qld.gov.au/sexhealth • provide MIMS consumer medication information www.ckn.health.qld.gov.au SECTION 4 2010 177 Contact tracing • contract trace according to sexual history and stage of infection • for primary syphilis • • – notify sexual contacts within the past three months – on-the-spot presumptive treatment using Early Syphilis Regimen (Regimen 1) is recommended for all sexual contacts of primary syphilis. for secondary/early latent syphilis – partner notification can extend up to two years, as sexual transmission may occur during the first two years of infection – on-the-spot presumptive treatment using Early Syphilis Regimen (Regimen 1) is recommended for all sexual contacts of secondary syphilis. in late latent infection, if exposure >12 months prior and contact has positive serology, treat with Regimen 2. Patients with late latent syphilis do not normally transmit the infection. The Queensland Syphilis Register The Queensland Syphilis Register is a state-wide database containing serology and treatment history of people who have positive syphilis serology recorded in accordance with requirements of the Public Heath Act 2005. Enhanced surveillance is conducted for all notifications. Contact 1800 032 238 to request details on serology and past treatment to aid client management. Follow-up4 • follow-up serology is based on presentation, stage of infection and history • primary and secondary stage syphilis: – repeat serology at three, six and 12 months – discuss results of follow-up serology with a MO – • after adequate treatment of early syphilis, a four-fold (two titre) drop in RPR titre should occur over 6 -12 months. Quantitative RPR or VDRL tests should be taken at six, 12 and 24 months following treatment. If at six months the RPR has fallen by at least two titres and is 1:16 or less, further follow-up may not be necessary unless reinfection is likely • re-treatment should be considered if signs/symptoms persist or recur, if there is a sustained four-fold increase in the titre of RPR or VDRL or if the initial RPR or VDRL titre fails to show a four-fold decrease within 12 months • consider reinfection or treatment failure and refer to a MO if: – 178 after adequate treatment of early syphilis, a four-fold (two titre) drop in RPR titre should occur over 6 - 12 months. persistent or recurrent symptoms QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES – increase in RPR titre – failure of RPR to show a four-fold (2 titre) decrease over 6 -12 months. • in cases of treatment failure, consult a doctor and consider the possibility of immunosuppression before proceeding to lumbar puncture • follow-up serology is especially important for those clients treated with antibiotics other than Penicillin. Consider risk of potential reinfection during follow-up period. SECTION 4 2010 179 Tinea cruris Tinea cruris is a superficial fungal infection of the groin and adjacent skin caused by dermatophytes which cause the skin to become red and itchy. Common etiologic agents for tinea cruris are trichophyton rubrum and epidermophyton floccosum, while trichophyton mentagrophytes and trichophyton verrucosum are also known to be involved55. Infection is more common in men than women and frequently occurs in young men in association with tinea infection of the feet32 (known as tinea pedis). Tinea cruris can be spread by close contact, fomites and autoinoculation and is common in hot or humid climates or associated with wearing tight-fitting or wet clothing/underwear55. Signs / symptoms • macular erythematous scaling, itchy red rash in groin extending to inner thighs, and may include buttocks, lower back and abdomen • edges are sharply demarked with a prominent annular rim • rash may have central clearance with satellite lesions • pustules of fungal folliculitis • autoinoculation from feet can sometimes occur. Investigations • skin scraping (for onsite KOH wet preparation) • swab of area for M/C/S (if indicated) • exclude other causes of rash • discuss additional STI screening. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/ available): 180 • abnormal or atypical presentation • uncertain diagnosis • clients with severe tinea cruris or suspected inflammatory component • immunosuppression e.g. HIV positive client • abnormal findings of significance • findings outside NOs scope of practice. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Treatment Indicators • clinical findings based on history and examination • branching hyphae and/or budding yeast identified on KOH wet preparation • laboratory confirmed diagnosis. Regimens • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or a MO. • DTP–SRH endorsed NO may progress if within scope of practice. For all other cases consult an endorsed NP or a MO. • Endorsed NP may progress if within scope of practice. For all other cases consult a MO. Name Miconazole nitrate Form Cream Strength 2% Recommended dose Apply thin layer to affected area Route of admin Topical Frequency/duration Twice a day for one month Continue uninterrupted treatment until lesions completely healed Pregnancy category A Poison schedule S2 Contraindications Sensitivity to any constituents Special precautions Reinfection Diabetes Superinfection Open Lesions Adverse reactions Irritation, burning, skin rash and maceration Client education • discuss condition, management and pre-disposing factors • discuss skin care and genital hygiene • client fact-sheet available www.health.qld.gov.au/sexhealth • provide MIMS consumer medication information www.ckn.health.qld.gov.au SECTION 4 2010 181 Contact tracing Not required. Follow-up If there is no resolution of condition. 182 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Trichomoniasis Trichomoniasis is caused by the motile flagellated protozoan Trichomonas Vaginalis7, 32. Infection can result in vaginitis and urethritis in females and urethritis in males. Infection is relatively uncommon in urban Australian settings, but is prevalent in Indigenous populations of Australia and countries such as Africa, Asia, and Latin America. Transmission is predominately through sexual contact but perinatal transmission can also occur. Co-infection with other STIs is common. Signs / symptoms Female Symptoms can persist for years. About 10 - 50 % of females can remain asymptomatic. • vaginal discharge – copious greenish/yellow which is sometimes frothy – ‘fishy odour’ which is more noticeable during menstruation or after sexual intercourse – wet prep reveals trichomonads. • Vaginitis or vulvitis • vulval irritation • cervicitis (strawberry cervix) • dysuria • dyspareunia • sometimes minimal or no symptoms. Male Infection is usually asymptomatic and short-lived in comparison to female infection (i.e. months as opposed to years). • dysuria • urethral discharge (usually scant or moderate, rarely copious or purulent) • urethral irritation • urinary frequency • prostatitis (rare) • balanoposthitis (rare). SECTION 4 2010 183 Investigations There is no reliable test available for males. Females presenting with persistent, offensive and irritating vaginal discharge should be tested. This should be a routine part of any sexual health check in high prevalence areas such as remote Indigenous communities. It is sometimes picked up by an incidental finding on a pap smear. Ensure that women with a vaginal discharge have a vaginal and cervical examination. Vaginal • swab for M/C/S • swab for PCR • urine for PCR • wet preparation (onsite if available) • pH • whiff test. For microscopy (wet preparation) and culture, transport using Amie’s or Stuart’s medium with added charcoal. • take high vaginal swab for wet prep and culture • treat contacts of females with trichomonas or contacts of males with urethral symptoms (in the absence of gonorrhoea or chlamydia) empirically for trichomonas • trichomonads may be seen on a pap smear, however there is a significant • rate of false positives. Confirm diagnosis by microscopy and culture of vaginal discharge • PCR test for trichomonas is only available through Queensland Health Pathology Service on specimens from remote communities. Transport a high vaginal swab in a dry sterile container at room temperature for PCR testing. Theoretically, when validated, the PCR test should also allow reliable testing of first catch urine specimens for Trichomonas Vaginalis in males and females. • if trichomonas is diagnosed, a full STI assessment is recommended. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/ available): 184 • signs of erythrasma, psoriasis, eczema or allergy • unresolved symptoms following treatment • relapse or reinfection • uncertain diagnosis • client is pregnant or breastfeeding QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • contraindication of treatment • immunosuppression e.g. HIV positive client • abnormal findings of significance • findings outside NOs scope of practice. Treatment Indicators • laboratory confirmed diagnosis or positive on-site microscopy • clinical findings based on history and examination in endemic populations • contact of partner who tested positive for trichomoniasis. Recurrent symptoms may be due to reinfection, relapse and presence of resistant trichomonas vaginalis or presence of Candida colonisation which frequently occurs after treatment with Metronidazole. Regimens • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or a MO. • DTP–SRH endorsed NO may progress if within scope of practice. For all other cases consult an endorsed NP or MO. • Endorsed NP may progress if within scope of practice. For all other cases consult a MO. Name Metronidazole Form Tablet Strength 400mg Recommended dose 2grams or 400mg (for continuing infection) Route of admin Oral take with food Frequency/duration 2grams stat (5 x 400mg tablets) or 400mg tablet twice daily for five days9 Pregnancy category B2 Poison schedule S4 Emergency management Consult MO and/or Anaphylaxis management SECTION 4 2010 185 Contraindications Pregnancy (first trimester) Blood dyscrasias Active CNS disease Hypersensitivity to Metronidazole or other Imidazole Special precautions Pregnancy and lactation in second and third trimester (Category B2) Prolonged use Renal or hepatic impairment Alcoholic beverages and drugs containing alcohol may cause flushing, vomiting or tachycardia Adverse reactions Super-infection G.I disturbances Leukopenia and Thrombocytopenia Neurological disturbances Sensitivity phenomena Pancreatitis Metallic, unpleasant taste Interactions Alcohol (avoid for 24hrs post treatment) Warfarin Carmustine (BCNU) (chemotherapy drug) Cyclophosphamide Phenytoin, phenobarbitone and other hepatic enzymeinducers Cimetidine and other hepatic enzyme-inhibitors Lithium Disulfiram Cyclosporine 5 Fluorouracil Busulfan (cancer chemotherapy drug can cause serious adverse effects if given in combination with Metronidazole) Continuing infection is generally caused by re-infection or non-compliance with treatment. If treatment failure is suspected, use the longer course treatment regimen or consider possible resistance to Metronidazole. 186 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Or Name Tinidazole Form Tablet Strength 500mg Recommended dose 2grams (4 x 500mg tablets) Route of admin Oral with food Frequency/duration Stat Pregnancy category B3 Poison schedule S4 Emergency management Severe allergic reaction management Anaphylaxis Consult MO Contraindications Pregnancy (first trimester) Hypersensitivity to other 5-Nitrimidazole derivatives Blood dyscrasia History of CNS disease Lactation Special precautions Renal impairment Pregnancy (second and third trimester) - refer to MO Children Avoid alcohol for 72 hours after completing dose Adverse reactions Superinfection GI Anorexia Nausea or vomiting Abdominal pain Diarrhoea Neurological (i.e. headache, dizziness, Vertigo, Ataxia) Rash Leukopenia Neutropenia Sensitivity phenomena Flushing, fever, tiredness Metallic, unpleasant taste Interactions Alcohol Anticoagulants SECTION 4 2010 187 COC user taking a short course (<3 weeks) of antibiotics should be advised to use additional contraception (i.e. condoms) during treatment and for seven days after antibiotics have been stopped. Client education • client fact-sheet available www.health.qld.gov.au/sexhealth • provide MIMS consumer medication information www.ckn.health.qld.gov.au Contact tracing14 Current partners evaluated and treated presumptively Follow-up If client remains symptomatic. 188 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Urinary tract infection (UTI) Acute uncomplicated urinary tract infections (UTI) are usually caused by a single microorganism with the commonest pathogen being Escherichia Coli32. Less common causes include: • gram negative organisms i.e. pseudomonas • gram negative bacilli i.e. enterobacter, klebsiella or proteus • gram positive cocci i.e. staphylococcus, streptococcus or enterococcus. UTI is common during pregnancy and has been associated with increased risk of pyelonephritis, premature delivery and fetal mortality56. Group B streptococcus (GBS) is a frequent cause of asymptomatic bacteriuria, urinary tract infection in pregnant women, clients with diabetes or clients with weaker immune systems. Uncomplicated UTIs are unusual in healthy young men32. Signs / symptoms • urinary frequency or urgency • dysuria • hematuria • offensive smelling urine • nocturia • suprapubic discomfort or lower abdominal pain • mild back pain • incontinence • abnormal urinalysis • – reveals nitrites, blood or protein and more than 1+ leucocytes – +/- past history of pathology confirmation of E Coli. other important medical history – past history of urological surgery – diabetes – immunosuppression e.g. HIV positive client – urinary incontinence – drug treatments or radiotherapy – pregnancy. SECTION 4 2010 189 Investigations • temperature, blood pressure and pulse • urinalysis • mid stream urine for M/C/S (as indicated) • first catch urine for chlamydia, gonorrhoea and trichomonas PCR • (as indicated) • perform bimanual examination to exclude mild to moderate PID • palpate abdomen for suprapubic, loin pain and bladder distension. Note: Empricial treatment with antibiotics is recommended in otherwise healthy females presenting with symptoms/signs of uncomplicated lower UTI. In females with symptoms of vaginal itch or discharge, explore alternative diagnoses and consider pelvic examination prior to treatment. Urinalysis and MSU • urinalysis via dipstick is recommended for diagnosis of bacteria in females with limited urinary symptoms. Empirical treatment is still indicated if symptomatic with negative urinalysis • some evidence suggests MSU for M/C/S is not necessary for uncomplicated UTI in nonpregnant females, prior to initiating empirical treatment • MSU for M/C/S is recommended if: – unresponsive to syndromic management of uncomplicated UTI – symptoms return 2 - 4 weeks post syndromic treatment – history of syndromic treatment of uncomplicated UTI without MSU – recurrent UTI and suspicion of upper urinary tract involvement – the client is pregnant. Management Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/ available): 190 • suspected or confirmed UTI (in males) • history of syndromic treatment of uncomplicated UTI without MSU • persistent symptoms after treatment • recurrent or complicated infection • client is pregnant or breastfeeding • contraindication to treatment QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • immunosuppression e.g. HIV positive client • abnormal findings of significance • findings outside NOs scope of practice. Treatment Indicators Uncomplicated UTI in non-pregnant, immuno-competent women suspected or confirmed by: • clinical findings based on history and examination • laboratory confirmed diagnosis. May need to modify treatment when MSU results are available. Regimens • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH endorsed NO, endorsed NP or a MO. • DTP–SRH endorsed NO may progress if within scope of practice. For all other cases consult an endorsed NP or a MO. • Endorsed NP may progress if within scope of practice. For all other cases consult a MO. SECTION 4 2010 191 Name Trimethoprim Form Strength Recommended dose Route of admin Frequency/duration Tablet 300mg 300mg Oral Women: 300mg at night for three days11,56 or Men: 300mg at night for 14 days11 Consult MO for suspected or confirmed UTI in men B3 S4 Pregnancy category Poison schedule Emergency management Contraindications Special precautions Adverse reactions Interactions 192 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES As for severe allergic reaction - Anaphylaxis Consult MO Hypersensitivity to Trimethoprim Severe renal and hepatic impairment Severe haematological disorders Megaloblastic anaemia due to folate deficiency/ lactation Renal and hepatic impairment Prolonged use Blood dyscrasias Folate deficiency Pregnancy Elderly Children aged <6 years Superinfection Rash, pruritus, exfoliative dermatitis GI disturbances Haematological changes and fever Phenytoin Anticoagulants Pyrimethamine Dapsone Warfarin Digoxin Procainamide Zidovudine Zalcitabine Lamivudine Rifampicin Cyclosporin Diuretics Methotrexate ACE Inhibitors Potassium supplements Or Consult a MO prior to supply and/or administration of Nitrofurantoin regimen if there is history or clinical symptoms of renal impairment. Avoid use of Nitrofurantoin in cases of moderate to severe renal impairment, as inadequate urinary concentrations are achieved resulting in toxic concentrations in the plasma9. Name Nitrofurantoin Form Capsule Strength 50mg or 100mg Recommended dose 50mg Route of admin Orally (taken with food or milk) Frequency/duration Non-pregnant women: 50mg four times daily for five days11,12 or Men: 50mg four times daily for 14 days11 Consult MO for suspected or confirmed UTI in men Pregnancy category A Poison schedule S4 Emergency management As for severe allergic reaction - Anaphylaxis Consult MO Contraindications Acidifying alkalinising drugs Anuria Oliguria Severe renal impairment Furan derivative hypersensitivity Pregnancy (during labour and delivery or when labour imminent) Infant aged <1mth Special precautions Renal impairment acidosis Anaemia Diabetes Mellitus Electrolyte imbalance Vitamin B deficiency Debilitating disease History of asthma Young males G 6 PD deficiency Prolonged use (monitor liver and renal function, pulmonary condition) Pregnancy (category A - only applies to short-term therapy) Lactation SECTION 4 2010 193 Adverse Reactions GI upset Pseudomembranous colitis Polyneuropathy Haematological disturbances including haemolytic anaemia Hypersensitivity reactions (i.e. pulmonary, rash, dermatological, lupus-like syndrome, Anaphylaxis) Hepatotoxicity Brown discolouration of urine Interactions Acidifying alkalinising drugs Phenobarbitone Uricosuric drugs i.e. Probenecid, Sulfinpyrazone Antacids Note: • Nitrofurantoin is not recommended if there is history or signs of renal impairment. Treatment is less effective and carries an increased risk of toxicity because of impaired excretion of the drug9,11. Care should be taken with Nitrofurantoin in Indigenous populations due to high incidence of renal impairment57. • Single dose therapy with Nitrofurantoin is not recommended for use as it is not as reliable in preventing relapse as multi-dose therapy10,11. • COC users taking a short course (<3 weeks) of antibiotics should be • advised to use additional contraception such as condoms, during treatment and for seven days after antibiotics are stopped13. • Using intravaginal oestrogen can help reduce recurrent UTI in post menopausal women11. Client education 194 • if condition improves throughout treatment still ensure the full-course of antibiotics is completed • increase water intake (minimum two litres per day) and reduce intake bladder irritants such as caffeine • promote correct posture for voiding to empty bladder • use urinary alkalinisers to help reduce dysuria, however they are not recommended when Nitrofurantoin regimen is supplied • Nitrofurantoin may stain soft-gel contact lenses • take medication with food or liquid to minimise GI disturbance • sexual intercourse can contribute to recurrent UTI. Studies have shown that voiding after sexual intercourse does not reduce incidence or prevent UTI56 • refer to MO for discussion regarding ongoing preventative management if experiencing three or more UTIs per year QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • discuss non-antimicrobial strategies • randomised trials indicate drinking 200 - 750mls of cranberry or lingonberry juice daily or taking cranberry concentrate tablets can reduce symptomatic recurrent UTI by 10 - 20%56 • client fact-sheet available www.health.qld.gov.au/sexhealth • provide MIMS consumer medicine information www.ckn.health.qld.gov.au Contact tracing Not required. Follow-up • review in seven days if symptoms are not resolved • if resistant organism, repeat mid stream urine for M/C/S or urinalysis post completion of therapy • refer to MO if still symptomatic or UTI reoccurs after treatment. First discuss with a MO as further investigations may be needed prior to referral e.g. renal function test and ultrasound • review MSU results and sensitivities of any bacterial growth to determine additional follow-up requirements • routine follow-up is not indicated56. SECTION 4 2010 195 Vaccination - Hepatitis A (HAV) Hepatitis A is an acute infection of the liver caused by the hepatitis A virus (HAV)1. HAV is a picornavirus [33] that is now classified as a hepatovirus1. HAV is transmitted by the faecal-oral route by either person-to-person contact or through contaminated food or water. The incubation period for hepatitis A is 15 to 50 days and it is able to survive on hands and in the environment for considerable periods of time. It is important to remember for purposes of infectivity and prevention that HAV can be excreted in faeces for up to 2 weeks prior to onset of illness and for approximately 1 week after presentation of illness1. The majority of infections are sub clinical and self limiting (especially in children) and complications are rare. HAV does not result in chronic infection or chronic liver disease7. HAV is endemic at high prevalence rates in many developing countries with majority of the community infected at a young age1. In developed countries risk factors include: travel to a high prevalence country, institutional settings such as child care centres, MSM, IDU and occasional outbreaks related to poor hygiene, food handling and contaminated water.1, 32 Vaccination against HAV should be offered to all clients assessed to be at risk factors of infection and tested negative HAV Total Ab. Management • check protocols and availability of equipment and drugs necessary for management of anaphylaxis prior to each vaccination1 • advise the client of risks and benefits of vaccination and preventable diseases1 • perform a pre-vaccination assessment1 • obtain client consent and advise that explicit verbal consent is required prior to subsequent vaccinations regardless of whether written consent has been previously recorded. Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/ available): • prescription for HAV or combined HBV/HAV vaccine is required • contraindication to vaccine • immunosuppression e.g. HIV positive client • abnormal findings of significance • findings outside NOs scope of practice. Treatment Regimens • 196 Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH, immunisation endorsed NO, endorsed NP or a MO. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES • DTP–SRH endorsed NO and immunisation endorsed NOs may progress if within scope of practice and competence. For all other cases consult an endorsed NP or MO. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. Hepatitis A vaccine is not currently listed in the List of Approved Medicines20, but is an approved vaccine for administration by an appropriately endorsed nurse. Name Havrix 1440 (formaldehyde inactivated Hepatitis A virus) Age >16years1 Form Liquid Strength 1440 ELISA units Recommended dose 1.0ml Route of admin IMI deltoid Frequency/duration 2 dose schedule at 0 month and repeat at 6 - 12 months Pregnancy category B2 Poison schedule S4 Emergency management See adverse reactions Consult MO Contraindications Vaccine should not be administered to any client with a previous anaphylactic reaction to any of the vaccine components or a previous dose of Hepatitis A vaccine Severe febrile illness Never administer vaccine intravenously Special precautions Pregnancy, breast feeding Thrombocytopenia or bleeding disorder Elderly Impaired immune responsiveness e.g. HIV positive Post exposure prophylaxis Adverse reactions Mild local events of a short duration Local soreness at injection site Induration, redness and swelling Headache Malaise/fatigue or fever Anorexia and nausea are common Rare reactions: Guillain-Barre Syndrome and Autoimmune Haemolytic Anaemia Anaphylactic reactions Convulsions (See full product information for less common reactions) Interactions Hepatitis A immune serum globulin SECTION 4 2010 197 Pregnancy Pregnancy is not a contraindication to hepatitis A vaccination in clients for who it would otherwise be indicated.13 Transport storage and handling1,40,42 • transport vaccine according to National Vaccine Storage Guidelines • store in vaccine refrigerator at 20 - 80C • Do not freeze vaccine. Client education • provide personal record card containing details of vaccination(s) • provide date for next vaccination • clients should remain onsite for observation for at least 15 minutes following vaccination as most life threatening events begin within 10 minutes of vaccination • client fact-sheet available www.health.qld.gov.au/sexhealth • provide MIMS Consumer Medication Information www.ckn.health.qld.gov.au Contact tracing14 • not applicable unless client has acute hepatitis A • if acute hepatitis A notify Public Health Unit – refer to MO for management – high priority contact tracing of sexual partners, domestic contacts, close social contacts and food handlers is recommended for up to 50 days from onset of symptoms Note: A combined Hepatitis A and B vaccine is available. Refer to MO if indicated or requested. Follow-up Not applicable. 198 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Vaccination - Hepatitis B (HBV) Hepatitis B infection is caused by the hepatitis B virus (HBV), a virus that contains a partially double stranded DNA1, 32. HBV has an outer surface envelope that contains hepatitis B surface antigen (HBsAg) and a core containing hepatis B core antigen (HBcAg). HBcAg is not detected in the blood but excess HBsAg circulates in the blood and is used in HBV screening and detection of infectivity. HBeAg is also produced by HBV and excreted into the blood. Presence of HBeAg in serum along with HBsAg indicates an acute infection or ongoing increased infectivity. Hepatitis B surface antibodies (HBsAb) are produce in response to HBsAg and indicate immunity due to past infection or vaccination. HBV prevalence rates varieties across the world and within some countries1, 32. It is important to understand prevalence rates when screening and offering vaccination in order to ensure appropriate pre test information. HBV is transmitted perinatally and in early childhood from close contact in developing countries with high prevalence. But in developed countries such as Australia the main mode of transmission is from adult exposure to infectious blood or body fluids (semen, vaginal secretions) by sexual contact or percutaneous routes (e.g. injecting drug use)1, 7. Vaccination against HBV should be offered to the following: • anyone assessed to be at risk of HBV • anyone with HBsAb <10u/L with history of no prior completion of vaccination schedule1 • opportunities vaccination for all clients of sexual health services • SIW and their partners • Household and sexual contacts of people who live with acute and chronic HBV as well as • members of families who have migrated from high prevalence countries • Men who have sex with men and their contacts • IDU and their contacts • Persons with chronic liver disease and/or HCV • Haemodialysis clients, HIV-positive clients and other immunosuppressed clients • Health-care workers • Recipients of blood/blood products, persons who have sustained a needle stick injury, sexual • assault victims, and persons from areas of endemic Hepatitis B infection7 • Other at risk groups as outlined in NHMRC (Current Version) The Australian Immunisation Handbook Management • check protocols and availability of equipment and drugs necessary for management of anaphylaxis before each vaccination1 as per The Australian Immunisation Handbook and DTP-SRH SECTION 4 2010 199 • advise the client of risks and benefits of vaccination and preventable diseases as per The Australian Immunisation Handbook1 and refer to the handbook for further detailed advice re immunosuppression, scheduling, etc. • perform a pre-vaccination assessment1 • obtain client consent and advise that explicit verbal consent is required prior to subsequent vaccinations regardless of whether written consent has been previously recorded. Conditions requiring NO to refer to or at minimum consult with a MO or NP (if appropriate/ available): • prescription for HBV or combined HBV/HAV vaccine is required • contraindication to vaccination • immunosuppression e.g. HIV positive client • abnormal findings of significance • findings outside NOs scope of practice. Treatment Regimens 200 • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer management to a DTP–SRH, immunisation endorsed NO, endorsed NP or a MO. • DTP–SRH endorsed NO and immunisation endorsed NOs may progress if within scope of practice and competence. For all other cases consult an endorsed NP or MO. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Name HB Vax ll (Adult) (Recombinant DNA Hepatitis B vaccine) Age Adult (over 20 years of age) Form Suspension Strength 10 microgram in 1.0ml Recommended dose 3 x 10 microgram /1.0ml Route of admin Intramuscular injection Frequency/duration 3 Dose Schedule: Stat, 1month, 6 months Pregnancy category B2 Poison schedule S4 Emergency management See adverse reactions/emergency conditions - Anaphylaxis Contraindications Vaccine should not be administered to any client with a previous anaphylactic reaction to any of the vaccine components or a previous dose of Hepatitis B vaccine. Consult MO Severe febrile illness >38.50C (postpone administration) Special precautions Never administer Hepatitis B vaccine intravenously Do not administer in the gluteal region or intradermally/ subcutaneously since these routes may not result in optimum immune response Impaired immune responsiveness in those receiving immunosuppressive therapy Severely compromised cardiopulmonary status Coagulation disorder Adverse reactions Common: Soreness at injection site, induration, erythema, swelling, fatigue, headache, fever (usually low grade), nausea, dizziness, myalgia and arthralgia Rare: Anaphylaxis, demyelinating disease, Guillain-Barre Syndrome and Arthritis Interactions Inter-changeability of vaccines. Although switching brands is not recommended, in cases where the brand of the vaccine used for previous doses is not known, any brand may be used as there is no reason to believe that use of a different brand will compromise immunogenicity or safety Do not mix in the same syringe with other vaccines No data available. SECTION 4 2010 201 Or Name HB Vax II (paediatric) (Recombinant DNA Hepatitis B vaccine) Age Children and young adults aged up to 20yrs Form Suspension Strength 5 microgram in 0.5ml Recommended dose 3 x 5 microgram/0.5ml regimen Route of admin Intramuscular injection. For administration to a child, refer to ‘Standard Techniques’ in NHMRC (current version) - The Australian Immunisation Handbook Frequency/duration 3 dose schedule: Stat, 1mth, 6mths Pregnancy category B2 Poison schedule S4 Emergency management See allergic reactions/emergency conditions - Anaphylaxis Consult MO Or Name Engerix B (adult) (Recombinant DNA Hepatitis B vaccine) Age Adult (over 20 years of age) Form Suspension Strength 20 microgram in 1ml Recommended dose 3 x 20 microgram /1ml regime Route of administration Intramuscular injection Frequency/duration 3 dose schedule: Stat, 1mth, 6mths Pregnancy category B2 Poison schedule S4 Emergency management See allergic reactions/emergency conditions- Anaphylaxis Consult MO 202 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Or Name Engerix B (Paediatric) (Recombinant DNA Hepatitis B vaccine) Age Children and young adults aged up to 20yrs Form Suspension Strength Paediatric 10 microgram in 0.5ml Recommended dose 3 x 10 microgram in 0.5ml Route of admin Intramuscular injection Frequency/duration 3 dose schedule: Stat, 1month, 6 months Pregnancy category B2 Poison schedule S4 Emergency management Anaphylaxis Consult MO Alternate two-dose regimens for adolescents (aged 11 – 15 yrs)1 Research indicates that adolescents (aged 11 - 15) vaccinated with HB Vax II 10 microgram (adult formula) in a two-dose regimen of 0 and 4 - 6 months, develop similar antibody protection as those vaccinated with the standard three-dose paediatric regimen. Refer to NHMRC (current version) - The Australian Immunisation Handbook for further information on hepatitis B Alternate 2-dose regimen and hepatitis B catch-up vaccines. Accelerated schedule1 In circumstances where rapid protection is required (e.g. vaccination of travellers) there are two available regimens: • Engerix B (adult) 20mg per ml can be administered in an accelerated schedule of 0, 7 and 21 days with a booster at 12 months • Engerix B (adult) 20mg per ml at 0, 1, 2 and 12 months. Pregnancy1 Pregnancy is not a contraindication to hepatitis B vaccination in clients for who it would otherwise be indicated. 1 Transport, storage and handling1,40,42 • store in vaccine refrigerator at 20 - 80C • do not freeze vaccine. SECTION 4 2010 203 Client education • provide personal record card containing details of vaccination(s) • provide date for next vaccination • clients should remain onsite for observation for at least 15 minutes following vaccination as most life threatening events begin within 10 minutes of vaccination • client fact-sheet available www.health.qld.gov.au/sexhealth • provide MIMS Consumer Medication Information www.ckn.health.qld.gov.au Contact tracing14 • not required unless client has acute hepatitis B • if acute hepatitis B – refer to MO for management – high priority contact tracing of sexual partners, domestic contacts and people who inject drugs is recommended for up to 180 days prior to index case developing symptoms. If index is asymptomatic, trace according to history. Follow-up Post vaccination serological testing (HbsAb) is recommended at four weeks after the third dose of hepatitis B. This is for high risk clients: 204 • at significant occupational risk • at risk of severe or complicated disease, either immunocompromised or with pre-existing liver disease not related to hepatitis B • in whom a poor response to hepatitis B vaccination is expected e.g. immunocompromised clients with HIV infection or chronic renal failure • who are persistent non-responders. They should be informed about the need for hepatitis B immunoglobulin to be administered within 72 hours of parenteral exposure to HBV or 14 days of sexual exposure.1,43 - 46 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Vaccination – HPV There are more than 100 genotypes of Human papilloma virus (HPV) with more than 30 that are known to infect the external and internal anogenital area and may present as genital warts7. The most common genotype that cause genital warts on the skin are Type 6 and 11, high risk HPV types (16, 18, 31, 33, 35) are strongly associated with cervical changes, neoplasias7 and other oncogenic anogenital infections. Majority of anogenital HPV infections are asymptomatic, unrecognised or subclinical in presentation7. The majority of HPV infections are believed to spontaneously regress but infections can persist32. A persistent infection with high risk HPV types is the most predictive factor in progression to squamous intraepithelial neoplasia7, 32. HPV vaccination is designed to help prevent infection with specific HPV genotypes and protect against persistent infection. Offer vaccination for: • risk of HPV infection • prevention of cervical, vulvar, vaginal cancer, precancerous or dysplastic lesions, genital warts, infection caused by HPV types 6, 11, 16, 18 in females 9-26 yrs and prevention of infection caused by HPV types 6, 11, 16, 18 in males 9-15 yrs. Note: • pre-vaccination HPV screening is not recommended • vaccination for HPV should not occur in isolation. Discuss pap smear and additional STI screening with client. National HPV Vaccination Program39 The Australian Government is funding the Human Papillomavirus (HPV) vaccine Gardasil® to girls aged 12 and 13 years, through a school-based program, on an ongoing basis as part of the National Immunisation Program. Note: • HPV vaccine is registered for males aged 9 - 15 years, however it is not funded for males under the National HPV Vaccination Program39 • HPV vaccine is not approved for use in females aged < 9 and is registered but not funded for women > 26 years or males aged < 9 or > 15 years. Regimens • Non DTP-SRH endorsed NOs are not authorised to administer this regimen and must refer to a DTP–SRH or immunisation endorsed NO, endorsed NP or MO. • DTP–SRH or immunisation endorsed NO may progress if within scope of practice and competence. For all other cases consult an endorsed NP or MO. • Endorsed NP may progress if within scope of practice and competence. For all other cases consult a MO. SECTION 4 2010 205 Name Human papillomavirus quadrivalent (types 6, 11, 16, 18) recombinant vaccine - Gardasil® Age 9 – 26 years (female only) Form Suspension Strength 120 micrograms / 0.5 ml Recommended dose 0.5ml Route of admin Intramuscular injection Administer in deltoid region of upper arm or higher anterolateral area of thigh 206 Frequency/duration 3 dose schedule: 0, 2 month, 6 months Pregnancy category B2 Poison schedule S4 Emergency management See allergic reactions/emergency conditions- Anaphylaxis (consult MO) Contraindications Hypersensitivity to active substances or any components of the vaccine (including yeast, aluminium phosphate, sodium chloride, L-histidine, polysorbate and sodium borate) Hypersensitivity after previous Gardasil doses Severe febrile illness >38.50C (postpone administration) IV administration Moderate to sever febrile illness Pregnancy Elderly Special precautions Non-HPV related genital ulcer disease/infection Disease caused by non-vaccine HPV types Continue routine cervical screening, detection, removal of lesions after vaccine Current, recent febrile illness Impaired immune responsiveness e.g. genetic defect, immunosuppressive, HIV Thrombocytopenia, coagulation disorders Pregnancy Children <9 yrs Adverse reactions Injection site reaction Fever Bronchospasm (very rare) Interactions Immunosuppressants e.g. systemic corticosteroids, antimetabolites, alkylating agents, cytotoxics QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES Observe client for at least 15 minutes after vaccination. Missed or late doses • Quadrivalent HPV vaccine has shown to be effective if all three doses are administered within 12 months • if three doses cannot be completed within 12 months it is not recommended to restart the course • missed doses should be administered as soon as possible.39 Accelerated dose If a shorter vaccination schedule is necessary: • administer the second dose at least one month after the first dose • administer the third dose at least three months after the second dose. Booster doses • protective immunity demonstrated for five years • no indication currently for boosters.39 Pregnancy • do not administer Quadrivalent HPV during pregnancy, however it can be administered to clients who are lactating40 - 41 Interaction with hepatitis B vaccine • Quadrivalent HPV vaccine can be administered concurrently with hepatitis B (recombinant) vaccine12, 40 • immune response and safety profile equivalent to vaccine administered separately. Transport, storage and handling41 - 42 • transport and store in accordance with the National Vaccine Storage Guidelines • store in vaccine refrigerator at 20 - 80C. • do not freeze vaccine. The National Human Papillomavirus (HPV) Vaccination Program Register The Australian Government has developed a national HPV register which collects confidential data to evaluate the impact of the HPV vaccination program against cervical cancer rates, issues reminders to complete vaccination course, issues certificate of completion and provides a mechanism to contact recipients if a booster is required at a later date. Vaccinated females aged 18 - 26 years are not required to provide their details, but can elect to have their details included in the HPV register. Information is collected on a consent form at time of vaccination, then forwarded to the HPV register. SECTION 4 2010 207 Visit www.hpvregister.org.au for more information about the National Human Papillomavirus (HPV) Vaccination Program Register or phone 1800 478 734. Client education • clients should remain on site for observation for at least 15 minutes following vaccination • provide personal record card containing details of vaccination(s) and date of next vaccination • reinforce importance of completing vaccination regimen • provide details of available recall systems to improve immunisation rates • advise about the HPV register, which is designed to monitor and evaluate the impact of HPV vaccination on cervical cancer rates www.access.health. qld.gov.au/hid/InfectionsandParasites/ImmunisationandVaccination/ nationalHumanPapillomavirusHpvVaccinationProgramRegister_ap.asp • obtain informed consent from the client to include their details on the HPV Register. A Medicare card number is required for registration. Contact tracing • Not applicable. Follow-up 208 • follow-up clients during and after treatment and treat relapses as original lesions • HPV changes on a pap smear should be managed according to the NHMRC Guidelines on Management of Abnormal Smears 4 • recommend routine pap smears. QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES References 1. NHMRC (current version) The Australian Immunisation Handbook 2. J.D Sobel, R.L. Barbieri and V.A. Barss, 2008 Bacterial Vaginosis 3. Queensland Health, CD Branch, 2006 Queensland Management Guidelines for the Detection and Treatment of Sexually Transmissible Diseases and Genital Infections 4. J Ross and C Ison, 2006 Sexually Transmitted Infections: UK national screening and testing guidelines for sexually transmitted infections. BMJ, (Supp 4) 5. Journal of Internal medicine, P Carr, et al., 2005 “Shotgun” Versus Sequential testing: Cost Effectiveness of Diagnostic Strategies for Vaginitis (20:p793-799) 6. Anderson, M., K. Klink, and A. Cohrssen Evaluation of Vaginal Complaints. JAMA, 2004. 291(11): p. p1368-1379. 7. Centres for Disease Control and Prevention, 2006 Sexually Transmitted Diseases Treatment Guidelines - Morbidity and Mortality Weekly Report (Volume 55: no RR-11) 8. Australian Medicines Handbook Editorial Advisory Board, Jan 2007 Australian Medicines Handbook (electronic version) 9.Australian Medicines Handbook Editorial Advisory Board, Australian Medicines Handbook (electronic version) - current edition 10.Queensland Health, QHEPS Clinicians Knowledge Network site, 2006 Therapeutic Guidelines Limited, Antibiotics 11.Antibiotic Expert Group Therapeutic Guidelines: Antibiotics, Therapeutic Guidelines Limited: Melbourne, Editor. Current eTG Version, 12.MIMS, 2009 13. MIMS Annual/On-line 14. Sexual Health and Family Planning Australia, Ashfield, Contraception: An Australian Clinical Practice Handbook (2nd edition) 15.Australasian Society for HIV Medicine, 2006 Australasian Contact Tracing Manual (3rd Edition) 16. RoyalAdelaide Hospital, 2007 Sexually Transmissible Disease Service (website) 17. eMedicine, 2007 Balanoposthitis Editor, Osipov, V.O 18. British Association for Sexual Health and HIV, 2008 UK National Guideline on the Management of Balanitis 19.Kauffman, C.A., K.A. Marr, and A.R. Thorner, 2007 Overview of Candida infections 20.Weintrob, A.C., et al., 2006 Susceptibility to infections in persons with diabetes mellitus SECTION 4 2010 209 21Queensland Health, Clinical and Statewide Services Division (CaSS), 1 February 2010 List of Approved Medicines (LAM) 22Control of Communicable Disease Manual (19th Edition), 2008 D. Heymann 23Department of Health (WA), C.D.C.D.H.P. Group, 2006 Guidelines for Managing Sexually Transmitted Infections 24. British Association for Sexual Health and HIV, 2007 National Guideline for the Management of Chancroid. Clinical Effectiveness Group (Association for Genitourinary Medicine and the Medical Society for the Study of Venereal Diseases). (cited) http://www.bashh.org/guidelines.asp#guides. 25Royal Children’s Hospital Melbourne, 2002 Paediatric Pharmacopoeia (13th edition- p52) Mayne Pharma, 2006 Ceftriaxone Product Information (Version 3.0) 26. World Health Organisation, 2003 Guidelines for the Management of Sexually transmitted Infections 27.CARPA, 2006 Protocol for alternate use of pan benzathine Penicillin where Bicillin LA is not available 28.Public Health Agency of Canada, 17 May 2005 Protocol for the Preparation of Benzathine Penicillin 29.Eyre, R.C., M.P. O’Leary, and D.M. Rind, 2007 Evaluation of the acute scrotum in adults 30.IP Communication Melbourne, 2005 Penile, epididymal, and testicular conditions in Sexual Health Medicine Aitken, S., D. Russell, D. Bradford, and C. Fairley, Editors. 31.Queensland Health & Royal Flying Doctor Service (Queensland), 2007 Primary Clinical Care Manual (4th Edition) 32.IP Communication, 2005 Sexual Health Medicine Russell, D., Bradford. D., and Fairley, C. 33.Micromedex Healthcare series, 2006 DRUGEX Trichloroacetic Acid Thomson 34.The eMedicine Clinical Knowledge Base, 2008 Condyloma Acuminatum Higgins, R.V 35. British Association for Sexual Health and HIV, 2007 United Kingdom National Guideline on the Management of Anogenital Warts. Clinical Effectiveness Group (British Association for Sexual Health and HIV) 36.International Journal of STD and AIDS, 2007 Comparison of the effectiveness of commonly used clinic based treatments for external genital warts. 18(6): p365 - 368 Sherrard, J. and L. Riddell 37.Dermatology online Journal, 2006. An evidence-based review of medical and surgical treatments of genital warts. 12(3): p5 Scheinfeld, N. and D.S. Lehman 38.Micromedex Healthcare series, 2007 210 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES DRUGEX Lidocaine/Prilocaine Thomson 39.Sexual Health Society of Victoria National Management Guidelines for Sexually Transmissible Infections 40.Australian Government, updated August 2009 The National HPV Vaccine Program http://www.health.gov.au/internet/standby/publishing.nsf/Content/home 41.Australian Family Physician, 2007 HPV vaccination: A paradigm shift in public health, 36(3): p106-111 May, J 42.National Centre for Immunisation Research and Surveillance (NCIRS), updated September 2006 Human Papilloma Vaccines for Australians: Information for GPS and Immunisation Providers 43.Commonwealth Australia, 2005 National Vaccine Storage Guidelines: Strive for 5 (Immunise Australia Program) www.health.gov.au/internet/immunise/publishing.nsf/Content/provider-store 44.British Association of Sexual Health and HIV Clinical Effectiveness Group, 2005 United Kingdom National Guideline on the Management of the Viral Hepatitides A, B & C BASHH Clinical Effectiveness Guidelines 45.Royal Adelaide Hospital, 2005 Diagnosis and Management of STDs (including HIV infection) 46.World Health Organisation, Department of Communicable Disease Surveillance and Response, 2002 Hepatitis B 47.Queensland Health, 2006 Queensland Health Policy for Hepatitis B Immunisation 48.Australian Family Physician, 2009, 38 (6), 388-393) Lesbian and bisexual women’s sexual health McNair, R. 49.McGraw, New York, 2008 Sexually Transmitted Diseases (4th edition) Holmes K.K, Sparling P.F, Mardh P.A, Lemon S.M, Stamm W.E, Piot P. & Wasserheit J.N 50.Sexual Health, 2006 Lymphogranuloma Venereum in Australia. Sims, I. et al 51Sexually Transmitted Infections (2nd Ed.), 2000 McMillan, A. and Scott, G.R. 52.Mayne-Pharma, 2006 Ceftriaxone Product Information, version 3.0 53.Paediatric Pharmocopoeia, (13th Ed), 2002, p. 52 Royal Children’s Hospital Melbourne 54.Treatment of pelvic inflammatory disease, 2008 Hynes, N.A 55.Tinea Cruris, eMedicine, December 2009 Wiederkehr, M. and Schwartz, R.A. 56.BMJ, 2006. 332, 94-97 Urinary tract infections in women: diagnosis and management in primary care. 57.eMJA, 2002. 176 (11), 515-516 Kidney disease: Are you at risk? Cass, A. SECTION 4 2010 211 58.HIV management in Australasia: a guide for clinical care. Australasian Society of HIV Medicine, 2009 59.HIV, viral hepatitis and STIs: a guide for primary care. Australasian Society of HIV Medicine, 2008 60.National HIV Testing Policy 2006 Department of Health and Ageing 212 QUEENSLAND SEXUAL HEALTH CLINICAL MANAGEMENT GUIDELINES
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