País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
MUPIROCIN (UNII: D0GX863OA5) (MUPIROCIN - UNII:D0GX863OA5)
Quality Care Products LLC
MUPIROCIN
MUPIROCIN 20 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to: S. aureus and S. pyogenes . This drug is contraindicated in patients with known hypersensitivity to any of the constituents of the product.
Mupirocin Ointment USP, 2% is available as follows: 22 g tube (NDC 49999-644-22) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. *Bactroban Nasal® is a registered trademark of GlaxoSmithKline.
Abbreviated New Drug Application
MUPIROCIN- MUPIROCIN OINTMENT QUALITY CARE PRODUCTS LLC ---------- MUPIROCIN OINTMENT USP, 2% For Dermatologic Use RX ONLY DESCRIPTION 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 H O and the molecular weight is 500.62. The chemical structure is: CLINICAL PHARMACOLOGY Application of C-labeled mupirocin ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption (<1.1 nanogram mupirocin per milliliter of whole blood). Measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application. Following intravenous or oral administration, mupirocin is rapidly metabolized. The principal metabolite, monic acid, is eliminated by renal excretion, and demonstrates no antibacterial activity. In a trial conducted in 7 healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid. The pharmacokinetics of mupirocin has not been studied in individuals with renal insufficiency. MICROBIOLOGY - Mupirocin is an antibacterial agent produced by fermentation using the organism _Pseudomonasfluorescens_. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA (tRNA) synthetase. Due to this 26 44 9 14 unique mode of action, mupirocin does not demonstrate cross-resistance with other classes of antimicrobial agents. When mupirocin resistance occurs, it results from the production of a modified isoleucyl-tRNA sy Llegiu el document complet