Each gram of ointment contains: Mupirocin BP 20 mg (2% w/w).
Excipients/Inactive Ingredients: Polyethylene glycol 3350 and polyethylene glycol 400.
Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use. ATC code: D06AX09.
Pharmacology: Pharmacodynamics: Murocin contains mupirocin which is a novel antibiotic produced through fermentation by Pseudomonas fluorescens. Mupirocin inhibits isoleucyl transfer-RNA synthetase, thereby arresting bacterial protein synthesis.
Mupirocin has bacteriostatic properties at minimum inhibitory concentrations and bactericidal properties at the higher concentrations reached when applied locally.
Mechanism of Resistance: Low-level resistance in staphylococci is thought to result from point mutations within the usual staphylococcal chromosomal gene (ileS) for the target isoleucyl tRNA synthetase enzyme. High-level resistance in staphylococci has been shown to be due to a distinct, plasmid encoded isoleucyl tRNA synthetase enzyme.
Intrinsic resistance in Gram negative organisms such as the Enterobacteriaceae could be due to poor penetration of the outer membrane of the Gram negative bacterial cell wall.
Due to its particular mode of action, and its unique chemical structure, mupirocin does not show any cross-resistance with other clinically available antibiotics.
Microbiological Susceptibility: The prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infection is questionable.
Commonly susceptible species: Staphylococcus aureus*; Streptococcus pyogenes*; Streptococcus pyogenes*; Streptococcus spp. (βhaemolytic, other than S. pyogenes).
Species for which acquired resistance may be a problem: Staphylococcus spp., coagulase negative.
Inherently resistant organisms: Corynebacterium spp.; Micrococcus spp.
* Activity has been satisfactorily demonstrated in clinical studies.
Pharmacokinetics: After topical application of Mupirocin ointment, Mupirocin is only very minimally absorbed systemically and that which is absorbed is rapidly metabolised to the antimicrobially inactive metabolite, monic acid. Penetration of Mupirocin into the deeper epidermal and dermal layers of the skin is enhanced in traumatised skin and under occlusive dressings.
Elderly patients: No restrictions unless there is evidence of moderate or severe renal impairment. (See Precautions.)
Murocin is a topical antibacterial agent, 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 Gram-negative organisms such as Escherichia coli and Haemophilus influenzae. Murocin is used for skin infections, e.g. impetigo, folliculitis, furunculosis.
Dosage: Adults (including elderly/hepatically impaired) and children: Two to three times a day for up to ten days, depending on the response.
Renally impaired: See Precautions.
Route of administration: Topical.
Method of administration: A small quantity of ointment should be applied to cover the affected area. The treated area may be covered by a dressing.
Any product remaining at the end of treatment should be discarded.
Do not mix with other preparations as there is a risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the Mupirocin in the ointment.
Symptoms: There is currently limited experience with over dosage of mupirocin.
Treatment: There is no specific treatment for an overdose of mupirocin. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary. Further management should be as clinically indicated or as recommended by the national poisons center, where available.
Hypersensitivity to the active substance or to any of the excipients.
Murocin is not suitable for ophthalmic or intranasal use.
Should a possible sensitisation reaction or severe local irritation occur with the use of Mupirocin ointment?
Treatment should be discontinued, the product should be washed off and appropriate therapy instituted.
As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. Although this is less likely to occur with topically applied mupirocin, if prolonged or significant diarrhea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
Renal impairment: Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol based ointments, mupirocin ointment should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment.
Mupirocin ointment is not suitable for: Ophthalmic use; Intranasal use; Use in conjunction with cannulae; At the site of central venous cannulation.
Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed.
Effects on Ability to Drive and Use Machines: No adverse effects on the ability to drive or operate machinery have been identified.
Fertility: There are no data on the effects of Mupirocin on human fertility. Studies in rats showed no effects on fertility.
Pregnancy: Reproduction studies on Mupirocin in animals have revealed no evidence of harm to the foetus, as there is no clinical experience on its use during pregnancy, Mupirocin should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.
Lactation: There is no information on the excretion of Mupirocin in milk. If a cracked nipple is to be treated, it should be thoroughly washed prior to breast feeding.
Adverse reactions are listed as follows by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), including isolated reports.
Immune system disorders: Very rare: Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema have been reported with Mupirocin ointment.
Skin and subcutaneous tissue disorders: Common: Burning localised to the area of application.
Uncommon: Itching, erythema, stinging and dryness localised to the area of application. Cutaneous sensitisation reactions to Mupirocin or the ointment base.
Adverse Drug Reactions: Inform doctors about unexpected reactions after using drugs.
No drug interactions have been identified.
Store in dry place, temperature below 30°C. Protect from direct sunlight. Do not freeze.
Shelf-Life: 24 months.
D06AX09 - mupirocin ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases.
Oint 2% (white or almost white) x 5 g x 1's, 15 g x 1's.
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