mupirocin MUPIROCIN PROFICIENT RX LP FDA Approved 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 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 500.62. The chemical structure is: Image 1
Generic: MUPIROCIN
Mfr: PROFICIENT RX LP FDA Rx Only
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Substance Mupirocin
Route
TOPICAL
Applications
ANDA065123
Package NDC

Drug Facts

Composition & Profile

Strengths
2 % 22 g
Treats Conditions
Indications And Usage Mupirocin Ointment Usp 2 Is Indicated For The Topical Treatment Of Impetigo Due To S Aureus And S Pyogenes

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0363187261221
UNII
D0GX863OA5
Packaging

HOW SUPPLIED Mupirocin Ointment USP, 2% is available as follows: 22 gram tube (NDC 63187-261-22) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. *Bactroban Nasal® is a registered trademark of GlaxoSmithKline.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL 63187-261-22

Package Descriptions
  • HOW SUPPLIED Mupirocin Ointment USP, 2% is available as follows: 22 gram tube (NDC 63187-261-22) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. *Bactroban Nasal® is a registered trademark of GlaxoSmithKline.
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL 63187-261-22

Overview

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 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 500.62. The chemical structure is: Image 1

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 USP, 2% 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 USP, 2% 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 USP, 2%: 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 USP, 2% have occurred rarely.

Drug Interactions

- The effect of the concurrent application of Mupirocin Ointment USP, 2% and other drug products has not been studied.


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