BACTROBAN mupirocin calcium cream

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

MUPIROCIN CALCIUM (UNII: RG38I2P540) (MUPIROCIN - UNII:D0GX863OA5)

זמין מ:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (שם בינלאומי):

MUPIROCIN CALCIUM

הרכב:

MUPIROCIN 21.5 mg in 1 g

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

New Drug Application

מאפייני מוצר

BACTROBAN- MUPIROCIN CALCIUM CREAM
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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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