mupirocin 2 % Topical Ointment

Generic Name: MUPIROCIN
Brand Name: Mupirocin
  • Substance Name(s):
  • MUPIROCIN

WARNINGS

Mupirocin ointment is not for ophthalmic use.

DRUG INTERACTIONS

Drug Interactions The effect of the concurrent application of mupirocin ointment and other drug products has not been studied.

DESCRIPTION

Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 NF and polyethylene glycol 3350 NF. Mupirocin is a naturally occurring antibiotic. The chemical name is ( E)-(2 S,3 R,4 R,5 S)-5-[(2 S,3 S,4 S,5 S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2 H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C 26H 44O 9, and the molecular weight is 500.63. The chemical structure is: ChemStruc

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 in 15 g (NDC 51672-1312-1), 22 g (NDC 51672-1312-0) and 30 g (NDC 51672-1312-2) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

INDICATIONS AND USAGE

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

PEDIATRIC USE

Pediatric Use The safety and effectiveness of mupirocin ointment have been established in the age range of 2 months to 16 years. Use of mupirocin ointment in these age groups is supported by evidence from adequate and well-controlled studies of mupirocin ointment in impetigo in pediatric patients studied as a part of the pivotal clinical trials. (See CLINICAL STUDIES .)

PREGNANCY

Pregnancy Teratogenic effects Pregnancy Category B Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) on a mg/m 2 basis and revealed no evidence of harm to the fetus due to mupirocin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

NUSRING MOTHERS

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when mupirocin ointment is administered to a nursing woman.

INFORMATION FOR PATIENTS

Information for Patients Use this medication only as directed by your healthcare provider. It is for external use only. Avoid contact with the eyes. The medication should be stopped and your healthcare practitioner contacted if irritation, severe itching, or rash occurs. If impetigo has not improved in 3 to 5 days, contact your healthcare practitioner.

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.