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MUPIROCIN OINTMENT USP, 2%

Rx only
For Dermatologic Use

DESCRIPTION

Each gram of mupirocin ointment USP, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350.

Mupirocin is a naturally occurring antibiotic. The chemical name is (E)-(2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid,ester with 9-hydroxynonanoic acid.

The molecular formula of mupirocin is C26H44O9 and the molecular weight is 500.63. The chemical structure is:

CLINICAL PHARMACOLOGY

Application of 14C-labeled mupirocin ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption (<1.1 nanogram mupirocin per milliliter of whole blood). Measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application.

Following intravenous or oral administration, mupirocin is rapidly metabolized. The principal metabolite, monic acid, is eliminated by renal excretion, and demonstrates no antibacterial activity. In a study conducted in seven healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid. The pharmacokinetics of mupirocin has not been studied in individuals with renal insufficiency.

INDICATIONS AND USAGE

Mupirocin ointment, 2% is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes.

CONTRAINDICATIONS

This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.

WARNINGS

Mupirocin ointment is not for ophthalmic use.

PRECAUTIONS

If a reaction suggesting sensitivity or chemical irritation should occur with the use of mupirocin ointment 2%, treatment should be discontinued and appropriate alternative therapy for the infection instituted. As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Mupirocin ointment is not formulated for use on mucosal surfaces. Intranasal use has been associated with isolated reports of stinging and drying.

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, mupirocin 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. A paraffin-based formulation- *Bactroban® Nasal (mupirocin calcium ointment) - is available for intranasal use.

ADVERSE REACTIONS

The following local adverse reactions have been reported in connection with the use of mupirocin ointment : burning, stinging, or pain in 1.5% of patients; itching in 1% of patients; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of patients.

DOSAGE AND ADMINISTRATION

A small amount of mupirocin ointment should be applied to the affected area three times daily. The area treated may be covered with a gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.

CLINICAL STUDIES

The efficacy of topical mupirocin ointment in impetigo was tested in two studies. In the first, patients with impetigo were randomized to receive either mupirocin ointment or vehicle placebo t.i.d. for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric patients included) were 71% for mupirocin ointment (n=49) and 35% for vehicle placebo (n=51). Pathogen eradication rates in the evaluable populations were 94% for mupirocin ointment and 62% for vehicle placebo. There were no side effects reported in the group receiving mupirocin ointment. In the second study, patients with impetigo were randomized to receive either mupirocin ointment t.i.d. or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded study) for 8 days. There was a follow-up visit 1 week after treatment ended.

Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric patients included) were 93% for mupirocin ointment (n=29) and 78.5% for erythromycin (n=28). Pathogen eradication rates in the evaluable patient populations were 100% for both test groups. There were no side effects reported in the mupirocin ointment group.

Pediatrics

There were 91 pediatric patients aged 2 months to 15 years in the first study described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment (n=42) and 36% for vehicle placebo (n=49). In the second study described above, all patients were pediatric except two adults in the group receiving mupirocin ointment. The age range of the pediatric patients was 7 months to 13 years.

The clinical efficacy rate for mupirocin ointment (n=27) was 96%, and for erythromycin it was unchanged (78.5%).

HOW SUPPLIED

Mupirocin Ointment USP, 2% is supplied
      NDC 0168-0352-09       72 x 0.9 gram ( 1/32 Oz) Foilpac®
      NDC 0168-0352-22       22 gram tube

Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

*Bactroban® Nasal is a registered trademark of SmithKline Pharmaceuticals.

E. FOUGERA & CO.
a division of Altana Inc
MELVILLE, NEW YORK 11747

I2352A/IF2352A
R8/05
#122

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