BACTROBAN- mupirocin calcium cream

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Physicians Total Care, Inc.

INN (Tarptautinis Pavadinimas):

MUPIROCIN CALCIUM

Sudėtis:

MUPIROCIN CALCIUM 20 mg in 1 g

Vartojimo būdas:

TOPICAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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.

Produkto santrauka:

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

Autorizacija statusas:

New Drug Application

Prekės savybės

BACTROBAN - MUPIROCIN CALCIUM CREAM
PHYSICIANS TOTAL CARE, INC.
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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 mupirocin reaching the
systemic ci