Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Mupirocin Ointment USP, 2% is supplied in 22 g (NDC 63187-151-22) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL - 22 g Tube Carton 63187-151-22
- HOW SUPPLIED Mupirocin Ointment USP, 2% is supplied in 22 g (NDC 63187-151-22) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
- PRINCIPAL DISPLAY PANEL - 22 g Tube Carton 63187-151-22
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 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 26 H 44 O 9 , and the molecular weight is 500.63. The chemical structure is: Chemical Structure
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, 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 mupirocin formulations.
Drug Interactions
The effect of the concurrent application of mupirocin ointment and other drug products has not been studied.
Storage & Handling
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
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