BACTROBAN
Mupirocin
Presentation
Bactroban Ointment 2% contains 20mg mupirocin per gram in a bland water soluble ointment base consisting of polyethylene glycol 400 and polyethylene glycol 3350 (polyethylene glycol ointment NF).
Clinical Particulars
Therapeutic Indications
Bactroban Ointment is indicated for the topical treatment of the following primary and secondary skin infections due to susceptible pathogens: primary pyodermas such as impetigo, folliculitis, furunculosis, ecthyma; secondary infected dermatoses such as eczema, psoriasis, atopic dermatitis, herpes, epidermolysis bullosa, icthyosis, and infected traumatic lesions such as ulcers, minor burns, cuts, abrasions, lacerations, wounds, biopsy sites, surgical incisions and insect bites.
Prophylactically, Bactroban Ointment may be used to prevent bacterial contamination in minor burns, biopsy sites, incisions and other clean lesions. For abrasions, minor cuts and wounds the prophylatic use of Bactroban may prevent the development of infection and permit wound healing.
Posology and Method of Administration
A small amount of Bactroban Ointment should be applied to the affected area three times daily. The area treated may be covered with a gauze dressing if required.
Contraindications
Bactroban ointment should not be given to patients with a history of hypersensitivity to any of its constituents.
Special Warnings and Special Precautions for Use
Patients with renal impairment
Elderly patients: No restrictions unless the condition being treated could lead to absorption of polyethylene glycol and there is evidence of moderate or severe renal impairment.
This mupirocin ointment formulation is not suitable for:
- ophthalmic use
- intranasal use (in neonates or infants)
- use in conjunction with cannulae
- at the site of central venous cannulation
Avoid contact with eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed.
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.
In the rare event of a possible sensitisation reaction or severe local irritation occurring with the use of mupirocin ointment, treatment should be discontinued, the product should be rinsed off and appropriate alternative therapy for the infection instituted.
As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms.
Interaction with Other Medicaments and Other Forms of Interaction
No drug interactions have been reported.
Pregnancy and Lactation
Pregnancy:
Adequate human data on use during pregnancy are not available. However, animal studies have not identified any risk to pregnancy or embryo-foetal development.
Lactation
Adequate human and animal data on use during lactation are not available. If a cracked nipple is to be treated, it should be thoroughly washed prior to breast feeding.
Effect on Ability to Drive and Use Machines
No adverse effects on the ability to drive or operate machinery have been observed.
Undesirable Effects
Bactroban ointment is well tolerated. The following side effects have been reported very rarely: itching, burning, erythema, stinging and dryness localised to the area of application. Cutaneous sensitisation reactions to mupirocin or the ointment base have been reported rarely. Systemic allergic reactions have been reported with Bactroban ointment
Overdose
Not applicable.
Pharmacological Properties
Pharmacodynamic Properties
General Properties
Mupirocin is a novel antibiotic produced through fermentation of Pseudomonas fluorescens. Mupirocin inhibits isoleucyl transfer-RNA synthetase, thereby arresting bacterial protein synthesis.
Due to this particular mode of action and its unique chemical structure, mupirocin does not show any cross-resistance with other clinically available antibiotics.
Mupirocin shows little risk of selection of resistant bacteria if used as prescribed.
Mupirocin has bacteriostatic properties at minimum inhibitory concentrations and bactericidal properties at the higher concentrations reached when applied locally.
Following intravenous or oral administration, mupirocin is rapidly metabolised to the inactive monic acid.
Activity
Bactroban ointment shows in vivo activity against Staphylococcus aureus (including methicillin-resistant strains), S. epidermidis and beta-haemolytic Streptococcus species.
The in vitro spectrum of activity includes the following bacteria:
Aerobic Gram-positive
- Staphylococcus aureus
(including beta-lactamase producing strains and methicillin resistant strains)
- Staphylococcus epidermidis
- Other coagulase negative Staphylococci (including methicillin resistant strains)
- Streptococcus
species
Anaerobic Gram-negative:
- Haemophilus influenzae
- Neisseria gonorrheae
- Neisseria meningitidis
- Branhamella catarrhalis
- Pasteurella multocida
- Proteus mirabilis
- Proteus vulgaris
- Enterobacter cloacae
- Enterobacter aerogenes
- Citrobacter freundii
- Bordetella pertussis
Susceptibility
- Staphylococcus aureus*
- Staphylococcus epidermidis*
- Coagulase-negative staphylococci*
- Streptococcus species*
- Haemophilus influenzae
- Neisseria gonorrhoeae
- Neisseria meningitidis
- Moraxella catarrhalis
- Pasteurella multocida
* Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications.
Insusceptible
- Corynebacterium
species
- Enterobacteriaceae
- Gram negative non-fermenting rods
- Micrococcus
species
- Anaerobes
Cross-resistance
Mupirocin does not demonstrate cross-resistance with any other known antimicrobial.
Resistance mechanisms
Low-level resistance in staphylococci (MICs 8-256 mcg/ml) has been shown to be due to changes in the native isoleucyl tRNA synthetase enzyme. High-level resistance in staphylococci (MICs 512 mcg/ml) 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 into the bacterial cell.
Pharmacokinetic Properties
Absorption
Mupirocin is poorly absorbed through intact human skin. However, if it is absorbed (e.g. through broken/diseased skin) or it is given systemically, it is metabolised to the microbiologically inactive metabolite monic acid and rapidly excreted.
Excretion
Mupirocin is rapidly eliminated from the body by metabolism to its inactive metabolite monic acid which is excreted mainly by the kidney (90%).
Preclinical Safety Data
No further information of relevance.
Pharmaceutical Particulars
Incompatibilies
None reported.
Shelf Life
Two years when stored below 25°C (77°F).
Special precautions for storage
Bactroban ointment may be stored at room temperature (below 25°C or 77°F) up to the expiry date.
Package Quantities
Bactroban Ointment 2% is supplied in 15g tubes.
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