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, 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 chemical structure is: C 26 H 44 O 9 M.W. 500.63 Structural formula for mupirocin ointment USP
Generic: MUPIROCIN
Mfr: PROFICIENT RX LP FDA Rx Only
FunFoxMeds box
Substance Mupirocin
Route
TOPICAL
Applications
ANDA065085
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 BOX
All Product Codes
UNII
D0GX863OA5
Packaging

HOW SUPPLIED Mupirocin Ointment USP, 2% is supplied in 22 gram tubes (NDC 63187-525-22). Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature].; Package/Label Display Panel Mupirocin Ointment USP 2% 22 Grams Carton Text NDC 63187-525-22 MUPIROCIN OINTMENT, USP 2% Rx only For Dermatologic Use Only. Not For Ophthalmic Use. 22 GRAMS 63187-525-22

Package Descriptions
  • HOW SUPPLIED Mupirocin Ointment USP, 2% is supplied in 22 gram tubes (NDC 63187-525-22). Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature].
  • Package/Label Display Panel Mupirocin Ointment USP 2% 22 Grams Carton Text NDC 63187-525-22 MUPIROCIN OINTMENT, USP 2% Rx only For Dermatologic Use Only. Not For Ophthalmic Use. 22 GRAMS 63187-525-22

Overview

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 )-(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 chemical structure is: C 26 H 44 O 9 M.W. 500.63 Structural formula for mupirocin ointment USP

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 Avoid contact with the eyes. In case of accidental contact, rinse well with water. In the event of sensitization or severe local irritation from mupirocin ointment, usage should be discontinued. Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including mupirocin ointment, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin- producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
Contraindications

This drug is contraindicated in patients with known hypersensitivity to any of the constituents of the product.

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 subjects; itching in 1% of subjects; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of subjects. Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of mupirocin.

Drug Interactions

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


Similar Drugs

Related medications based on brand, generic name, substance, active ingredients.

View all similar drugs →