Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Mupirocin ointment USP, 2% is supplied in 22 gram tubes. NDC 63187-015-22 (22-gram tube) Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature]. *Bactroban ® Nasal is a registered trademark of GlaxoSmithKline. Manufactured by: Glenmark Generics Ltd. Colvale-Bardez, Goa 403 513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkgenerics.com Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 June 2011 Glenmark logo; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL 63187-015-22
- HOW SUPPLIED Mupirocin ointment USP, 2% is supplied in 22 gram tubes. NDC 63187-015-22 (22-gram tube) Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature]. *Bactroban ® Nasal is a registered trademark of GlaxoSmithKline. Manufactured by: Glenmark Generics Ltd. Colvale-Bardez, Goa 403 513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkgenerics.com Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 June 2011 Glenmark logo
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL 63187-015-22
Overview
Each gram of mupirocin ointment USP, 2% contains 20 mg mupirocin USP 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)-( 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 26 H 44 O 9 , and the molecular weight is 500.63. The chemical structure is: Structure of Mupirocin
Indications & Usage
Mupirocin ointment USP, 2% is indicated for the topical treatment of impetigo due to: S. aureus and S. pyogenes.
Dosage & Administration
A small amount of mupirocin ointment should be applied to the affected area 3 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.
Warnings & Precautions
WARNINGS Mupirocin ointment is not for ophthalmic use.
Contraindications
This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.
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. Systemic reactions to mupirocin ointment have occurred rarely.
Drug Interactions
The effect of the concurrent application of mupirocin ointment and other drug products has not been studied.
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