Bactroban

Ointment: Mupirocin (free acid).
Nasal ointment: Mupirocin calcium.

Ointment: Excipients/Inactive Ingredients: Polyethylene glycol 400, Polyethylene glycol 3350.
Nasal ointment: Mupirocin calcium equivalent to 2% w/w mupirocin free acid in a white soft paraffin based ointment.
Excipients/Inactive Ingredients: White soft paraffin, Softisan.

Ointment: Bacterial skin infections, e.g. impetigo, folliculitis and furunculosis.
Nasal ointment: Elimination of nasal carriage of staphylococci, including methicillin-resistant Staphylococcus aureus (MRSA).

Ointment: 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.
Method of Administration: For topical administration.
A small quantity of Bactroban 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.
Nasal ointment: Adults (including the elderly/renally impaired/hepatically impaired) and Children: Apply a small quantity of Bactroban Nasal Ointment, about the size of a match head (approximately 30 mg of ointment), to each nostril two to three times a day for at least 5 days.
Method of Administration: Use a cotton tipped applicator. After application, the nostrils should be closed by pressing the sides of the nose together several times.
Nasal carriage should normally be clear within three to five days of treatment.
Dosage should not exceed ten days.
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.

Ointment: Symptoms and signs: There is currently limited experience with overdosage 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 centre, where available.
Nasal ointment: The toxicity of mupirocin is very low. In the event of accidental ingestion of the nasal ointment, symptomatic treatment should be given.

Ointment: Hypersensitivity to mupirocin or any of the constituents of the preparations (see Description).
This formulation is not suitable for ophthalmic or intranasal use.
Nasal ointment: Hypersensitivity to mupirocin or any of the excipients.

Should a possible sensitisation reaction or severe local irritation occur with the use of Bactroban, treatment should be discontinued, the product should be washed off/wiped away 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 diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
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/observed.
Ointment: Bactroban Ointment is not suitable for: ophthalmic use, intranasal use (in neonates or infants), use in conjunction with cannulae, and at the site of central venous cannulation.
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 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.

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 Bactroban in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on its use during pregnancy, Bactroban should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.
Breast-feeding: There is no information on the excretion of Bactroban in milk.
Ointment: 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.
Very rare adverse reactions were primarily determined from post-marketing experience data and therefore refer to reporting rate rather than true frequency.
Ointment: Common and uncommon adverse reactions were determined from pooled safety data from a clinical trial population of 1573 treated patients encompassing 12 clinical studies.
Immune system disorders: Very rare: Systemic allergic reactions including anaphylaxis, generalized rash, urticaria and angioedema have been reported with Bactroban 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.
Nasal ointment: Uncommon adverse reactions were determined from pooled safety data from a clinical trial population of 422 treated patients encompassing 12 clinical studies.
Immune system disorders: Very rare: Cutaneous hypersensitivity reactions.
Respiratory, thoracic and mediastinal disorders: Uncommon: Nasal mucosa reactions.

No drug interactions have been identified.

Instructions for use and handling: Any product remaining at the end of treatment should be discarded. Wash the hands after application.
Incompatibilities: None reported.

Topical Antibiotics

D06AX09 - mupirocin ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases.
R01AX06 - mupirocin ; Belongs to the class of other nasal preparations for topical use.

A