Bactroban Cream - Side Effects & Drug Interactions

mupirocin calcium

• Bactroban Cream - Drug Description
• Bactroban Cream - Warnings & Precautions
• Bactroban Cream - Clinical Pharmacology
• Bactroban Cream - Overdosage & Contraindications
• Bactroban Cream - Indications & Dosage

ADVERSE REACTIONS

In two randomized, double-blind, double-dummy trials, 339 patients were treated with topical Bactroban Cream plus oral placebo. Adverse events thought to be possibly or probably drug-related occurred in 28 (8.3%) patients. The incidence of those events that were reported in at least 1% of patients enrolled in these trials were: headache (1.7%), rash and nausea (1.1% each).

Other adverse events thought to be possibly or probably drug-related which occurred in less than 1% of patients were:

abdominal pain,

burning at application site,

cellulitis,

dermatitis,

dizziness,

pruritus,

secondary wound infection,

ulcerative stomatitis.

In a supportive study in the treatment of secondarily infected eczema, 82 patients were treated with Bactroban Cream. The incidence of adverse events thought to be possibly or probably drug-related was as follows:

nausea (4.9%),

headache and burning at application site (3.6% each),

pruritus (2.4%)

and one report each of abdominal pain, bleeding secondary to eczema, pain secondary to eczema, hives, dry skin and rash.

Drug Interactions

The effect of the concurrent application of topical mupirocin calcium cream and other topical products has not been studied.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential of mupirocin calcium have not been conducted.

Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for mutagenicity: rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.

Fertility studies were performed in rats with mupirocin administered subcutaneously at doses up to 49 times a human topical dose of 1 gram/ day (approximately 20 mg mupirocin per day) on a mg/ m 2 basis and revealed no evidence of impaired fertility from mupirocin sodium.