COMPOSITION :
MUPIBACT OINTMENT
Mupirocin U.S.P 2% w/w
For Dermatologic use
DESCRIPTION :
Each gram of MUPIBACT OINTMENT (mupirocin ointment), 2% contains 20 mg mupirocin in a ointment base. Mupirocin is a naturally occurring antibiotic.
CLINICAL PHARMACOLOGY :
Mupirocin is an antibiotic originally isolated from Pseudomonas fluorescens. It is used topically, and is primarily effective against Gram-positive bacteria. Mupirocin is bacteriostatic at low concentrations and bactericidal at high concentrations. Mechanism
It has a unique mechanism of action, which is selective binding to bacterial isoleucyl-tRNA synthetase, which halts the incorporation of isoleucine into bacterial proteins. Because this mechanism of action is not shared with any other antibiotic, mupirocin has few problems of antibiotic cross-resistance.
INDICATIONS :
MUPIBACT OINTMENT(mupirocin ointment), 2% is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes. MUPIBACT OINTMENT is also effective in surgical wound healing.
DOSAGE AND ADMINISTRATION :
A small amount of MUPIBACT OINTMENT should be applied to the affected area three times daily. The area treated may be covered with gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.
CONTRAINDICATIONS :
This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.
WARNINGS AND PRECAUTIONS :
Warnings :
MUPIBACT OINTMENT is not for ophthalmic use.
Precautions
If a reaction suggesting sensitivity or chemical irritation should occur with the use of MUPIBACT OINTMENT (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.
MUPIBACT OINTMENT is not formulated for use on mucosal surfaces.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals to evaluate carcinogenic potential of mupirocin have not been conducted.
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 mg/m2 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.
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 MUPIBACT OINTMENT is administered to a nursing woman.
Pediatric Use: The safety and effectiveness of Mupirocin have been established in the age range of 2 months to 16 years. Use of MUPIBACT OINTMENT in these age groups is supported by evidence from adequate and well-controlled studies of Mupirocin in impetigo in pediatric patients studied as a part of the pivotal clinical trials.
ADVERSE REACTIONS :
The following local adverse reactions have been reported in connection with the use of MUPIBACT 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.
STORAGE INSTRUCTIONS :
Protect from light. Keep out of reach of children. Do not freeze. Store at temperature below 25°C.
