Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
MUPIROCIN CALCIUM (UNII: RG38I2P540) (MUPIROCIN - UNII:D0GX863OA5)
Physicians Total Care, Inc.
MUPIROCIN CALCIUM
MUPIROCIN 20 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
BACTROBAN NASAL is indicated for the eradication of nasal colonization with methicillin-resistant S. aureus in adult patients and health care workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of methicillin-resistant S. aureus infection during institutional outbreaks of infections with this pathogen. NOTE: - There are insufficient data at this time to establish that this product is safe and effective as part of an intervention program to prevent autoinfection of high-risk patients from their own nasal colonization with S. aureus . - There are insufficient data at this time to recommend use of BACTROBAN NASAL for general prophylaxis of any infection in any patient population. - Greater than 90% of subjects/patients in clinical trials had eradication of nasal colonization 2 to 4 days after therapy was completed. Approximately 30% recolonization was reported in 1 domestic study within 4 weeks after completion of therapy. These eradication r
BACTROBAN NASAL is supplied in 1.0-gram tubes. NDC 54868-4325-0 (package of 10 single-tube cartons). Store between 20° and 25°C (68° and 77°F); excursions permitted to 15°-30°C (59°-86°F). Do not refrigerate.
New Drug Application
BACTROBAN - MUPIROCIN CALCIUM OINTMENT PHYSICIANS TOTAL CARE, INC. ---------- BACTROBAN NASAL (MUPIROCIN CALCIUM OINTMENT, 2%) FOR INTRANASAL USE ONLY DESCRIPTION BACTROBAN NASAL (mupirocin calcium ointment, 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 NASAL is a white to off-white ointment that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% pure mupirocin free acid) in a soft white ointment base. The inactive ingredients are paraffin and a mixture of glycerin esters (SOFTISAN 649). CLINICAL PHARMACOLOGY PHARMACOKINETICS Following single or repeated intranasal applications of 0.2 gram of BACTROBAN NASAL 3 times daily for 3 days to 5 healthy adult male subjects, no evidence of systemic absorption of mupirocin was demonstrated. The dosage regimen used in this study was for pharmacokinetic characterization only. (See DOSAGE AND ADMINISTRATION for proper clinical dosing information.) In this study, the concentrations of mupirocin in urine and of monic acid in urine and serum were below the limit of determination of the assay for up to 72 hours after the applications. The lowest levels of determination of the assay used were 50 ng/mL of mupirocin in urine, 75 ng/mL of monic acid in urine, and 10 ng/mL of monic acid in serum. Based on the detectable limit of the urine assay for monic acid, one can extrapolate that a mean of 3.3% (range: 1.2 to 5.1%) of the applied dose could be systemically absorbed from the nasal mucosa of ADULTS. Data from a report of a pharmacokinetic study in neonates and premature infants indicate that, un Կարդացեք ամբողջական փաստաթուղթը