Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
MUPIROCIN CALCIUM (UNII: RG38I2P540) (MUPIROCIN - UNII:D0GX863OA5)
Physicians Total Care, Inc.
MUPIROCIN CALCIUM
MUPIROCIN CALCIUM 20 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
BACTROBAN CREAM is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of S. aureus and S. pyogenes . BACTROBAN CREAM is contraindicated in patients with known hypersensitivity to any of the constituents of the product.
BACTROBAN CREAM is supplied in 15-gram and 30-gram tubes. NDC 54868-4642-1 (15-gram tube) NDC 54868-4642-0 (30-gram tube) Store at or below 25°C (77°F). Do not freeze. GlaxoSmithKline Research Triangle Park, NC 27709 BACTROBAN CREAM is a registered trademark of GlaxoSmithKline. ©2005, GlaxoSmithKline. All rights reserved. May 2005 BB:L7B Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK 74146
New Drug Application
BACTROBAN - MUPIROCIN CALCIUM CREAM PHYSICIANS TOTAL CARE, INC. ---------- BACTROBAN CREAM® (MUPIROCIN CALCIUM CREAM, 2%) FOR DERMATOLOGIC USE DESCRIPTION BACTROBAN CREAM (mupirocin calcium cream, 2%) contains the dihydrate crystalline calcium hemi-salt of the antibiotic mupirocin. Chemically, it is (α_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, calcium salt (2:1), dihydrate. The molecular formula of mupirocin calcium is (C H O ) Ca•2H O, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium is: BACTROBAN CREAM is a white cream that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% mupirocin free acid) in an oil and water-based emulsion. The inactive ingredients are benzyl alcohol, cetomacrogol 1000, cetyl alcohol, mineral oil, phenoxyethanol, purified water, stearyl alcohol, and xanthan gum. CLINICAL PHARMACOLOGY PHARMACOKINETICS Systemic absorption of mupirocin through intact human skin is minimal. The systemic absorption of mupirocin was studied following application of BACTROBAN CREAM 3 times daily for 5 days to various skin lesions (>10 cm in length or 100 cm in area) in 16 adults (aged 29 to 60 years) and 10 children (aged 3 to 12 years). Some systemic absorption was observed as evidenced by the detection of the metabolite, monic acid, in urine. Data from this study indicated more frequent occurrence of percutaneous absorption in children (90% of patients) compared to adults (44% of patients); however, the observed urinary concentrations in children (0.07 - 1.3 mcg/mL [1 pediatric patient had no detectable level]) are within the observed range (0.08 - 10.03 mcg/mL [9 adults had no detectable level]) in the adult population. In general, the degree of percutaneous absorption following multiple dosing appears to be minimal in adults and children. Any mupirocin reaching the systemic ci Izlasiet visu dokumentu