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Ciprofloxacin Hydrochloride USP
Description:
Ciprofloxacin is a synthetic, 4-quinolone derivative with bactericidal activity against a wide range of
gram-negative and gram-positive organism.
Flontin® is available as 250mg, 500mg and 750mg film coated tablets and 250mg/5ml dry powder for
suspension as Ciprofloxacin.
Indications:
Flontin® is indicated for the treatment of single or mixed infections caused by two or more susceptible organisms. It may
be used for infections caused by organisms resistant to other antibiotics including aminoglycosides, penicillins and
cephalosporins.
The extensive tissue penetration of ciprofloxacin combined with its enhanced antibacterial activity (including
anti-pseudomonal activity), enables ciprofloxacin to be used alone or in combination with an aminoglycoside or with
beta-Iactam antibiotics for instances when severe neutropenia is present, or with an antibiotic active against anaerobes
where the presence of such organisms are suspected.
Ciprofloxacin is indicated for the treatment of the following infections caused by sensitive bacteria:
- Gastro-intestinal infections e.g. enteric fever, infectious diarrhea.
- Respiratory tract infections: lobar and bronchopneumonia, acute and acute exacerbation of chronic bronchitis, cystic
fibrosis, bronchiectasis empyema.
- Ear, Nose and Throat infections: Otitis media, sinusitis and mastoiditis, especially if due to gram-negative bacteria
(including pseudomonas spp).
- Urinary tract infections: Uncomplicated and complicated urethritis, cystitis, pyelonephritis, prostatitis, epididymitis.
- Skin and Soft tissue infections: Infected ulcers, wound infections, abscesses, celulitis, otitis externa, erysipelas,
infected burns.
- Eye infections: Bacterial conjunctivitis.
- Severe systemic infections: Septicaemia, bacteremia, peritonitis, infections in immunosuppressed patients with
heamatological or solid tumors and in patients in intensive care units with specific problems such as infected burns.
- Infections of the biliary tract: Such as cholangitis, cholecystitis, empyema of the gall bladder.
- Intra-abdominal infections: Peritonitis, intra-abdominal abscesses.
- Bone and Joint infections: Osteomyelitis, septic arthritis.
- Pelvic infections: Salphaingitis, endometritis, inflammatory disease.
- Uncomplicated gonorrhoea.
Microbiology:
Ciprofloxacin is active against both gram-positive and gram-negative bacteria. It is particularly active against
gram-negative bacteria including-Salmonella, Shigella, Campylobacter, Neisseria and Pseudomonas. Ciprofloxacin
has moderate activity against gram-positive bacteria such as Streptococcus Pneumonea & Strep. Faecalis. In vitro
studies have shown that the antibacterial action of ciprofloxacin results by inhibiting the A sub-unit of bacterial DNA
gyrase. This mode of action differs from that of penicillins, cephalosporins, aminoglycosides and teracycline and
therefore, organisms resistant to these antibiotics are often sensitive to ciprofloxacin.
Dosage and administration:
General dosage recommendations: The dosage of ciprofloxacin is determined by the severity and type of infection, the
sensitivity of the causative organism(s) and the age, weight and renal function of patient. The dosage ranges for adults
is 250-750mg twice daily.
Urinary tract infection: 250-500mg every 12 hours for 7-10 days depending on severity of infection and susceptibility.
Cystitis, uncomplicated (in females): 250mg every 12 hours for 3 days.
Lower respiratory tract infections, Skin and soft tissue infections: 500-750mg twice daily for 7-14 days depending on
severity and susceptibility.
Bone and joint infections: 500-750mg twice daily for 4-6 weeks, dependng on severity and susceptibility.
Infectious diarrhea: 500mg every 12 hours for 5-7 days.
Typhoid fever: 500mg every 12 hours for 10 days.
Urethra/cervical gonococcal infection: 500mg as single dose.
Disseminated gonococcal infection: 500mg twice daily to complete 7 days of therapy.
Chancroid: 500mg twice daily for 3 days.
Mild to moderate sinusitis: 500mg every 12 hours for 10 days.
Chronic bacterial prostatitis: 500mg every 12 hours for 28 days
Children:
Oral: 20-30mg/kg/day in 2 divided dosage.
Cystic fibrosis: 20-40mg/kg/day divided every 12 hours.
Contra-Indications:
Ciprofloxacin is contra-indicated in patients who have shown hypersensitivity to ciprofloxacln or other quinolones.
Warning and Preacautions :
Ciprofloxacin should be used with caution in patients with a history of convulsive disorder, CNS disorders and alcoholic
patient. Crystalluria related to the use of ciprofloxacin has been reported patients receiving ciprofloxacin must be well
hydrated and excessive alkalinity of the urine should be avoided.
Drug Interactions:
Concurrent administration of ciprofloxacin with theophylline causes increased levels of theophylline and prolongation
of its half-life elimination, so theophylline shows it adverse effects markedly. If concurrent use cannot be avoided
plasma levels of theophylline must be monitored and dosage adjusted appropriately.
Antacids containing magnesium hydroxide or aluminium hydroxide may interfere with the absorption of ciprofloxacin
resulting in serum and urine levels lower than desired. Iron salts also interfere with ciprofloxacin absorption, so
concomitant uses should be avoided. Prolongation of bleeding time has been reported during concomitant
administration of ciprofloxacin and anticoagulants. Transient increase in serum creatinine have been seen following
concomitant administration of ciprofloxacin and cyclosporin. Therefore serum creatinine level monitoring is advisable.
Information for Patients:
Flontin® tablets should be swallowed whole with an adequate amount of liquid, it may be taken with or without meals.
The preferred time of dosing is two hours after a meal and patient should not take antacids within two hours of dosing.
Use in pregancy and lactation:
Reproduction studies performed mice, rats and rabbits using ciprofloxacin did not revel any evidence of teratogenicity,
impairment of fertility or impairment of pre/post-natal development. However, as with others quinolones, ciprofloxacin
has been shown to cause arthropathy in immature animals and therefore its use during pregnancy is not
recommended. Studies in rat have indicated that ciprofloxacin is secreted in breast milk, administration to nursing
mothers is thus not recommended.
Overdosage:
No informtion on overdosage is available. Routine measures such as gastric lavage should be performed as soon as
possible after ingestion of ciprofloxacin. Serum levels of ciprofloxacin are reduced by dialysis.
Side Effects:
Ciprofloxacln is generally well tolerated. Frequent adverse reactions are GIT disturbances, headache, restlessness,
dizziness, tremor, convulsions, confusion, hallucination, tiredness. Hypersensitivity reactions-skin rashes, pruritus,
photosensitivity, possible systemic reactions including anaphylaxis.
Other possible side effects-transient increase in liver enzymes serum creatinine arthralgia myalgia.
Pharmaceutical precautions:
Store in a cool and dry place, protected from light. keep out of the reach of children.
Supply:
Tablet 250mg in blister Pack of 2x10's
Tablet 500mg in blister pack of 3x10's
Tablet 750mg in blister pack of 2x10's
Dry powder for suspension 250mg/5ml in 60ml bottle
Mirpur, Dhaka, Bangladesh