Bactroban Cream

[mupirocin calcium]

Mupirocin is bactericidal at concentrations achieved by topical application. However, the minimum bactericidal concentration (MBC) against relevant pathogens is generally eight-fold to thirty-fold higher than the minimum inhibitory concentration (MIC). In addition, mupirocin is highly protein bound (> 97%), and the effect of wound secretions on the MICs of mupirocin has not been determined.

Mupirocin has been shown to be active against most strains of Staphylococcus aureus and Streptococcus pyogenes, both in vitro and in clinical studies. (See INDICATIONS AND USAGE section.) The following in vitro data are available, BUT THEIR CLINICAL SIGNIFICANCE IS UNKNOWN. Mupirocin is active against most strains of Staphylococcus epidermidis and Staphylococcus saprophyticus.

CLINICAL STUDIES

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The efficacy of topical Bactroban Cream for the treatment of secondarily infected traumatic skin lesions (e. g., lacerations, sutured wounds and abrasions not more than 10 cm in length or 100 cm 2 in total area) was compared to that of oral cephalexin in two randomized, double-blind, double-dummy clinical trials.

Clinical efficacy rates at follow-up in the per protocol populations (adults and pediatric patients included) were 96.1% for Bactroban Cream (n= 231) and 93.1% for oral cephalexin (n= 219). Pathogen eradication rates at follow-up in the per protocol populations were 100% for both Bactroban Cream and oral cephalexin.

Pediatrics

There were 93 pediatric patients aged 2 weeks to 16 years enrolled per protocol in the secondarily infected skin lesion studies, although only 3 were less than 2 years of age in the Bactroban Cream treated population.

Patients were randomized to either 10 days of topical Bactroban Cream t. i. d. or 10 days of oral cephalexin (250 mg q. i. d. for patients >40 kg or 25 mg/ kg/ day oral suspension in four divided doses for patients . 40 kg). Clinical efficacy at follow-up (7 to 12 days post-therapy) in the per protocol populations was 97.7% (43/ 44) for Bactroban Cream and 93.9% (46/ 49) for cephalexin. Only one adverse event (headache) was thought to be possibly or probably related to drug therapy in the Bactroban Cream intent-to-treat pediatric population of 70 children (1.4%).

HOW SUPPLIED

Bactroban Cream (mupirocin calcium cream), 2% is supplied in 15 gram and 30 gram tubes. NDC 0029-1527-22 (15 gram tube)
NDC 0029-1527-25 (30 gram tube)
Store at or below 25° C (77° F). Do not freeze.
DATE OF ISSUANCE NOV. 2001
©2001, GlaxoSmithKline
All rights reserved.

GlaxoSmithKline Research Triangle Park, NC 27709

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