Drug Catalog - Product Detail
MUPIROCIN OINT 2% 22GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0180-22 | GLENMARK PHARMACEUTICALS | 22 | 2% | OINTMENT |
PACKAGE FILES
Generic Name
MUPIROCIN
Substance Name
MUPIROCIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA090480
Description
11 DESCRIPTION Mupirocin Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin, USP. 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-3,4dihydroxy-β-methyl-2 H -pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin, USP is C 26 H 44 O 9 , and the molecular weight is 500.6 g/mol. The structural formula of mupirocin, USP is: Figure 1. Structure of Mupirocin, USP Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin, USP in a water-miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Each gram of Mupirocin Ointment USP contains 20 mg mupirocin, USP in a water-miscible ointment base. Mupirocin Ointment USP, 2% is supplied in 22-gram tubes. NDC 68788-8534-2 22-gram tube (1 tube per carton) Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Mupirocin ointment is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes). Mupirocin ointment is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • For Topical Use Only. • Apply a small amount of mupirocin ointment, with a cotton swab or gauze pad, to the affected area 3 times daily for up to 10 days. • Cover the treated area with gauze dressing if desired. • Re-evaluate patients not showing a clinical response within 3 to 5 days. • Mupirocin ointment is not for intranasal, ophthalmic, or other mucosal use [see Warnings and Precautions ( 5.2 , 5.6 )] . • Do not apply mupirocin ointment concurrently with any other lotions, creams, or ointments [see Clinical Pharmacology ( 12.3 )]. • For Topical Use Only. ( 2 ) • Apply a small amount of mupirocin ointment, with a cotton swab or gauze pad, to the affected area 3 times daily for up to 10 days. ( 2 ) • Re-evaluate patients not showing a clinical response within 3 to 5 days. ( 2 ) • Not for intranasal, ophthalmic, or other mucosal use. ( 2 )