BACTROBANTM CREAM GlaxoSmithKline Mupirocin calcium Warnings and Precautions For intranasal use, a separate presentation, QUALITATIVE AND QUANTITATIVE BACTROBAN nasal ointment, is available. COMPOSITION Mupirocin calcium equivalent to 2% w/w mupirocin Avoid contact with the eyes. In the rare event of a possible sensitisation reaction free acid. or severe local irritation occurring with the use of PHARMACEUTICAL FORM BACTROBAN cream, treatment should be discontinWhite cream for topical administration in a multi-use ued, the product should be washed off and appropritube. ate alternative therapy for the infection instituted. As with other antibacterial products, prolonged use CLINICAL PARTICULARS may result in overgrowth of non-susceptible organisms. Indications BACTROBAN cream is indicated for the topical Interactions treatment of secondarily infected traumatic lesions No drug interactions have been identified. such as small lacerations, sutured wounds or abraPregnancy and Lactation sions. Use in pregnancy: Dosage and Administration Adequate human data on use during pregnancy Dosage are not available. However, animal studies have not Adults/children/elderly identified any risk to pregnancy or embryo-foetal Three times a day for up to 10 days, depending on development. the response. Mupirocin should only be used in pregnancy when Hepatic impairment: No dosage adjustment is nec- the potential benefits outweigh the potential risks essary. associated with treatment. Renal impairment: No dosage adjustment is necesUse in lactation: sary. Adequate human and animal data on use during lacMethod of administration tation are not available. A small quantity of cream should be applied to the If a cracked nipple is to be treated, it should be thoraffected area with a piece of clean cotton wool or oughly washed prior to breast feeding. gauze swab. Effects on Ability to Drive and Use Machines The treated area may be covered by a dressing. No adverse effects on the ability to drive or operate Do not mix with other preparations as there is a risk machinery have been identified. of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the mupi- Adverse Reactions rocin in the cream. The following convention has been used for the classification of frequency: Contraindications BACTROBAN cream should not be given to patients common: >1/100 and <1/10 with a history of hypersensitivity to any of its constit- Skin and subcutaneous tissue disorders: uents. Common: Cutaneous hypersensitivity reactions Overdose Not applicable. broken/diseased skin. However, clinical trials have shown that when given systemically, it is metabolised to the microbiologically inactive metabolite PHARMACOLOGICAL PROPERTIES monic acid and rapidly excreted. Pharmacodynamics Mupirocin is rapidly eliminated from the body by Pharmacodynamic properties metabolism to its inactive metabolite monic acid Mupirocin is a novel antibiotic produced through ferwhich is rapidly excreted by the kidney. mentation by Pseudomonas fluorescens. Mupirocin inhibits isoleucyl transfer-RNA synthetase, thereby Pre-clinical Safety Data arresting bacterial protein synthesis. Due to this par- No further information of relevance. ticular mode of action and its unique chemical strucPHARMACEUTICAL PARTICULARS ture, mupirocin does not show any cross-resistance List of Excipients with other clinically available antibiotics. Xanthan gum Mupirocin shows little risk of selection of bacterial Liquid paraffin resistance if used as prescribed. Cetomacrogol 1000 Mupirocin has bacteriostatic properties at minimum Stearyl alcohol inhibitory concentrations and bactericidal properties Cetyl alcohol at the higher concentrations reached when applied Phenoxyethanol locally. Benzyl alcohol Mupirocin is a topical antibacterial agent showing in Purified water vivo activity against Staphylococcus aureus (including methicillin-resistant strains), S. epidermidis and Incompatibilities beta-haemolytic Streptococcus species. None identified. The in vitro spectrum of activity includes the follow- Shelf Life ing bacteria: The expiry date is indicated on the packaging. Aerobic Gram-positive: Staphylococcus aureus (including beta-lactamaseproducing strains and methicillin resistant strains). Staphylococcus epidermidis (including beta-lactamase-producing and methicillin-resistant strains) Other coagulase-negative staphylococci (including methicillin-resistant strains). Streptococcus species Special Precautions for Storage BACTROBAN cream may be stored at room temperature (below 25oC) up to the expiry date. Do not freeze. Nature and Contents of Container Squeezable aluminium tubes with a screw cap containing 15 g. Instructions for Use/Handling No special instructions. Any product remaining at the end of treatment should be discarded. Not all presentations are available in every country. Version number: MDS03/IPI02 Date of issue: 02 June 2004 Pharmacokinetics Systemic absorption of mupirocin through intact BACTROBAN is a trademark of: human skin is low although it may occur through the GlaxoSmithKline group of companies Aerobic Gram-negative: Haemophilus influenzae Neisseria gonorrhoeae Neisseria meningitidis Moraxella catarrhalis Pasteurella multocida BACTROBAN OINTMENT GlaxoSmithKline Mupirocin free acid not available. There is, therefore, inadequate evidence of safety to recommend the use of BACTROBAN durQUALITATIVE AND QUANTITATIVE ing pregnancy. COMPOSITION 2% w/w mupirocin free acid in a white, translucent, However, studies in experimental animals have shown mupirocin to be without teratogenic effects. water soluble, polyethylene glycol base. Adequate human and animal data on use during lacPHARMACEUTICAL FORM tation are not available. Ointment. Effects on Ability to Drive and Use Machines CLINICAL PARTICULARS No adverse effects on the ability to drive and use Indications machines have been observed. Bacterial skin infections, e.g. impetigo, folliculitis and Adverse Reactions furunculosis. Clinical trials data Dosage and Administration Skin and subcutaneous tissue disorders: Adults and Children: Burning localised to the area of application. BACTROBAN should be applied to the affected Itching, erythema, stinging and dryness localised to area up to three times daily, for up to 10 days. The the area of application. area may be covered with a dressing or occluded if Cutaneous sensitisation reactions to mupirocin or desired. the ointment base. Contraindications Post-marketing experience Hypersensitivity to BACTROBAN or other ointments containing polyethylene glycol and any of its constit- Immune system disorders: Systemic allergic reactions have been reported with uents. BACTROBAN ointment. Warnings and Precautions This BACTROBAN formulation is not suitable for Overdose ophthalmic or intra-nasal use. When BACTROBAN Not applicable. is used on the face care should be taken to avoid PHARMACOLOGICAL PROPERTIES the eyes. Polyethylene glycol can be absorbed from Pharmacodynamics open wounds and damaged skin and is excreted by BACTROBAN is a topical antibacterial agent, active the kidneys. against those organisms responsible for the majority In common with other polyethylene glycol-based of skin infections, e.g. Staphylococcus aureus, includointments, BACTROBAN should be used with cau- ing methicillin-resistant strains, other staphylococci tion if there is evidence of moderate or severe renal and streptococci. It is also active against certain Gramimpairment. negative pathogens, such as Haemophilus influenzae. Interactions Pharmacokinetics None reported. Absorption Pregnancy and Lactation BACTROBAN penetrates intact human skin but the Adequate human data on use during pregnancy are rate of systemic absorption appears to be low. Excretion Systemically absorbed BACTROBAN is rapidly metabolised to the inactive metabolite monic acid and quickly excreted by the kidneys. PHARMACEUTICAL PARTICULARS List of Excipients Polyethylene glycol Incompatibilities None reported. Shelf Life The expiry date is indicated on the packaging. Special Precautions for Storage Store below 25oC. Nature and Contents of Container As registered locally. Instructions for Use/Handling Any ointment remaining at the end of the treatment should be discarded. Version number: MDS006/IPI02 Date of issue: 26 February 2004 BACTROBAN is a trademark of: the GlaxoSmithKline group of companies. BACTROBAN NASAL GlaxoSmithKline Mupirocin calcium Interactions None reported. QUALITATIVE AND QUANTITATIVE COMPOSITION Pregnancy and Lactation Mupirocin calcium equivalent to 2% w/w mupirocin Adequate human data on use during pregnancy free acid in a white soft paraffin based ointment. are not available. However, animal studies have not identified any risk to pregnancy or embryo-foetal PHARMACEUTICAL FORM development. Nasal ointment: Adequate human and animal data on use during lacCLINICAL PARTICULARS tation are not available Indications Effects on Ability to Drive and Use Machines Elimination of nasal carriage of staphylococci, No adverse effects on the ability to drive or use including methicillin resistant Staphylococcus auremachinery have been observed. us (MRSA). For the treatment of bacterial skin infections Adverse Reactions Clinical trials data BACTROBAN ointment should be used. See package leaflet for this BACTROBAN formula- Nasal mucosa reactions have been reported tion or contact the manufacturer for details. Post marketing data Dosage and Administration Adults and Children: BACTROBAN nasal ointment should be applied to the anterior nares two to three times a day, as follows: A small amount of ointment, about the size of a match head is squeezed on the little finger. The ointment is applied to the inside of one nostril. This is repeated for the other nostril. The nostrils are closed by pressing the sides of the nose together. This spreads the ointment throughout the nares. A swab may be used to carefully apply the ointment to infants or patients who are very ill. Nasal carriage should normally clear within 3-5 days of commencing treatment. Contraindications Hypersensitivity to any of its constituents. Cutaneous hypersensitivity reactions Overdose Not applicable. PHARMACOLOGICAL PROPERTIES Pharmacodynamics BACTROBAN is a novel antibiotic, both in chemical structure and mode of action, available only for topical use. BACTROBAN is active against those organisms responsible for the majority of skin infections, e.g. Staphylococcus aureus, including methicillin-resistant strains, other staphylococci and streptococci. It is also active against certain Gram-negative pathogens, such as Haemophilus influenzae. PHARMACEUTICAL PARTICULARS List of Excipients White soft paraffin Softisan Warnings and Precautions As with all topical preparations care should be taken Incompatibilities to avoid contact with the eyes. None reported. Shelf Life The expiry date is indicated on the packaging. Special Precautions for Storage Store below 25oC. Nature and Contents of Container As registered locally. Instructions for Use/Handling Any ointment remaining at the end of the treatment should be discarded. Version number: GDS012/IPI03 Date of issue: 09 February 2006 BACTROBAN is a trademark of: the GlaxoSmithKline group of companies
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