BACTROBAN Ointment

Bacterial skin infections, e.g., impetigo, folliculitis and furunculosis.

Dosage

Populations

Adults and Children

BACTROBAN should be applied to the affected area 2-3 times a day for up to 10 days, depending on the response.

The area may be covered with a dressing or occluded if desired.

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.

Hypersensitivity to BACTROBAN or other ointments containing polyethylene glycol and any of its constituents.

Common and uncommon adverse reactions were determined from pooled safety data from a clinical population of 1,573 treated patients encompassing 12 clinical studies. Very rare adverse reactions were primarily determined from post-marketing experience data and therefore refer to reporting rate rather than true frequency.

Skin and subcutaneous tissue disorders:

Common: Burning localized to the area of application.

Uncommon: Itching, erythema, stinging and dryness localized to the area of application. Cutaneous sensitization reactions to mupirocin or the ointment base.

Immune system disorders:

Very rare: Systemic allergic reactions including anaphylaxis, generalized rash, urticaria and angioedema have been reported with BACTROBAN ointment.

None reported.

Fertility

There are no data on the effects of mupirocin on human fertility. Studies in rats showed no effects on fertility.

Pregnancy

Adequate human data on use during pregnancy are not available. Studies in animals do not indicate reproductive toxicity.

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.

In the rare event of a possible sensitization reaction or severe local irritation occurring with the use of the product, treatment should be discontinued, the product should be wiped off and appropriate alternative therapy for the infection 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 or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.

This BACTROBAN ointment formulation is not suitable for

- ophthalmic use,

- intranasal use,

- use in conjunction with cannulae and

- 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.

When BACTROBAN is used on the face care should be taken to avoid the eyes.

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, BACTROBAN should be used with caution if there is evidence of moderate or severe renal impairment.

Mupirocin 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 certain Gram-negative pathogens, such as Haemophillus influenzae.