Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
MUPIROCIN CALCIUM (UNII: RG38I2P540) (MUPIROCIN - UNII:D0GX863OA5)
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
MUPIROCIN CALCIUM
MUPIROCIN 21.5 mg in 1 g
PRESCRIPTION DRUG
New Drug Application
BACTROBAN- MUPIROCIN CALCIUM CREAM LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC ---------- 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 Đọc toàn bộ tài liệu