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Logo BACTROBAN TOPICAL (ointment)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BACTROBAN TOPICAL (ointment)

COMPOSITION:
BACTROBAN TOPICAL ointment contains 2% w/w
mupirocin.

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.6 Topical Antibiotics

PHARMACOLOGICAL ACTION:
Pharmacodynamic properties:
Mupirocin is an antibiotic produced through fermentation of Pseudomonas fluorescens and inhibits bacterial protein synthesis by binding to bacterial isoleucyl t-RNA synthetase.
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:
Mupirocin ointment shows in vivo activity against Staphylococcus aureus (including methicillin-resistant strains), S. epidermidis and beta-haemolytic Streptococcus species.
Pharmacokinetic properties:
1. Absorption
  Mupirocin is poorly absorbed (less than 0,24%) 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.
2. Excretion
  Mupirocin is rapidly eliminated from the body by metabolism to its inactive metabolite monic acid which is excreted mainly by the kidney (90%).

INDICATIONS:
BACTROBAN TOPICAL ointment is indicated for the topical treatment of primary and secondary bacterial skin infections caused by Staphylococcus aureus and other susceptible organisms.
Primary skin infections:
Impetigo, folliculitis, furunculosis and ecthyma.
Secondary infections:
Infected dermatoses e.g., infected eczema. Infected traumatic lesions e.g., abrasions, insect bites, minor (not requiring hospitalisation) wounds and burns.
Prophylaxis:
Mupirocin may be used to avoid bacterial contamination of small wounds, incisions and other clean lesions, and to prevent infection of abrasions and small cuts and wounds.

CONTRA-INDICATIONS:
BACTROBAN TOPICAL ointment is not indicated for the treatment of skin lesions infected with Pseudomonas aeruginosa. BACTROBAN TOPICAL ointment should not be given to patients with a history of hypersensitivity to any of its constituents.

WARNINGS:
The mupirocin ointment formulation is not suitable for:
- ophthalmic use.
- intranasal use.
- 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.
Patients with renal impairment
No restrictions unless the condition being treated could lead to absorption of polyethylene glycol and there is evidence of moderate to severe renal impairment.
Polyethylene glycol can be absorbed from open wounds, burns and damaged skin and is excreted by the kidneys. BACTROBAN TOPICAL 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. The excretion of polyethylene glycol may be impaired and could lead to nephrotoxicity and severe metabolic disturbances.

DOSAGE AND DIRECTIONS FOR USE:
Adults, children and the elderly:
2-3 times a day for up to 10 days, depending on the response.
Hepatic impairment: As above.
Renal Impairment: See "Warnings.

Method of Administration:
A small quantity of mupirocin 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 in the antibacterial activity and potential loss of stability of the mupirocin in the ointment.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
BACTROBAN TOPICAL ointment is well tolerated. Adverse effects localised to the area of application such as burning, stinging, erythema, dryness and itching have been reported very rarely. Cutaneous sensitisation reactions to mupirocin or the ointment base have been reported rarely.
Systemic allergic reactions have been reported in BACTROBAN TOPICAL ointment.
In the rare event of a possible sensitisation reaction or severe local irritation occurring with the use of BACTROBAN TOPICAL ointment, treatment should be discontinued; the product should be rinsed off and appropriate alternative therapy for the infection instituted.
Prolonged or irregular use may result in overgrowth of non-susceptible strains of S. Aureus and other organisms.
The safely in pregnancy and lactation has not been established.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-effects.

IDENTIFICATION:
BACTROBAN TOPICAL ointment is an off-white coloured ointment packed in tubes.

PRESENTATION:
BACTROBAN TOPICAL ointment is available in 10 g, 15 g and 100 g tubes.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
T/20.1.6/75
Zimbabwe: 86/14.1.1/1996 PP

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GlaxoSmithKline South Africa (Pty) Limited
57 Sloane Street
Bryanston
2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
29.09.1988

In-line with MDS-005

GlaxoSmithKline logo

Good Old Printing CT - 021592 3868        P3556/1102

Updated on this site: November 2004
Source: Community Pharmacy

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