Bactroban^® (Mupirocin 2% Ointment and Cream)

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SIDE EFFECTS, SAFETY AND RISKS

Mupirocin is well tolerated when applied topically. However side effects do occasionally happen. Reported side effects include:

Topical cream:

• Headache
• Upper respiratory tract infection
• Nausea
• Pain
• Diarrhea
• Pharyngitis

Topical ointment:

• burning, stinging or pain
• Itching
• Erythema
• Dryness.

[Compendium of Pharmaceuticals and Specialties, 36th Ed. Ottawa: Canadian Pharmacists’ Association (2001).]

Precautions and Contraindications

1. Prolonged use of topical mupirocin may result in overgrowth of nonsusceptible organisms, including fungi.
2. Pending further accumulation of safety data, the manufacturer cautions against use of mupirocin ointment in burn patients, particularly those with extensive burns, since potentially toxic amounts of polyethylene glycol contained in the vehicle may be absorbed percutaneously in such patients. The manufacturer further cautions that it should not be applied to the eye or mucous membranes.
3. Patients receiving topical mupirocin therapy should be advised to contact their clinician if any sign of a local adverse reaction occurs, such as irritation, severe pruritus or rash, or if improvement is not evident within 3-5 days of therapy.

Precautions to consider

Open wounds

Polyethylene glycol can be absorbed from open wounds and damaged skin, and is excreted by the kidneys. Do not use if absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate to severe renal impairment..

[Drug Information for the Health Care Professional, USP DI Volume I, 21st Ed. Micromedex (2001).]

Prophylaxis

There are insufficient data at this time to recommend mupirocin nasal for general prophylaxis of any infection in any patient population or to establish that this product is safe and effective as part of an intervention program to prevent autoinfection of high-risk patients from their own nasal colonization.

[Drug Information for the Health Care Professional, USP DI Volume I, 21st Ed. Micromedex (2001).]

Sensitivity Reaction / Superinfection

If a reaction suggesting sensitivity or chemical irritation occurs, discontinue treatment and institute appropriate alternative therapy.

Prolonged use of antibiotics may result in overgrowth of nonsusceptible organisms, including fungi.

Pregnancy / Reproduction

Fertility – Adequate and well-controlled studies in humans have not been done. However, studies in rats and rabbits given oral, SC and IM doses of up to 100 times the human topical dose have not demonstrated that mupirocin causes impaired fertility.

Pregnancy – Adequate and well-controlled studies in humans have not been done. However, studies in rats and rabbits given oral, SC and IM doses of up to 100 times the human topical dose have not demonstrated that mupirocin causes adverse effects in the fetus. FDA Pregnancy category B.

[Drug Information for the Health Care Professional, USP DI Volume I, 19th Ed. Micromedex (1999).]

Paediatrics / Geriatrics

Pediatrics - The safety and effectiveness of mupirocin cream have not been established in children < 3 months of age. The safety and effectiveness of mupirocin ointment have not been established in children < 2 months of age.

[Drug Information for the Health Care Professional, USP DI Volume I, 21st Ed. Micromedex (2001).]

Geriatrics - In two studies using mupirocin cream vs. placebo, 30 patients >65 years of age were treated and no overall difference in safety was observed.

[Clin Infect Dis. 2003 Dec 1; 37(11):1467-74]

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