MUPIROCIN ointment

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

MUPIROCIN (UNII: D0GX863OA5) (MUPIROCIN - UNII:D0GX863OA5)

متاح من:

Rebel Distributors Corp

INN (الاسم الدولي):

MUPIROCIN

تركيب:

MUPIROCIN 20 mg in 1 g

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Mupirocin ointment 2% is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes . This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.

ملخص المنتج:

Mupirocin Ointment USP, 2% is supplied in 22 gram tubes. Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. *Bactroban® Nasal is a registered trademark of SmithKline Beecham Pharmaceuticals. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. F 3/2005 Repackaged by: REBEL DISTRIBUTORS COPR Thousand Oaks, CA 91320

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

MUPIROCIN- MUPIROCIN OINTMENT
REBEL DISTRIBUTORS CORP
----------
MUPIROCIN OINTMENT USP, 2%
1010
FOR DERMATOLOGIC USE
DESCRIPTION
Each gram of Mupirocin Ointment 2% contains 20 mg mupirocin in a bland
water miscible ointment base
(polyethylene glycol ointment, N.F.) consisting of polyethylene glycol
400 and polyethylene glycol
3350. Mupirocin is a naturally occurring antibiotic. The chemical name
is (_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. The chemical
structure is:
C
H O M.W. 500.63
CLINICAL PHARMACOLOGY
Application of
C-labeled mupirocin ointment to the lower arm of normal male subjects
followed by
occlusion for 24 hours showed no measurable systemic absorption (< 1.1
nanogram mupirocin per
milliliter of whole blood). Measurable radioactivity was present in
the stratum corneum of these
subjects 72 hours after application.
Following intravenous or oral administration, mupirocin is rapidly
metabolized. The principal
metabolite, monic acid, is eliminated by renal excretion, and
demonstrates no antibacterial activity. In a
study conducted in seven healthy adult male subjects, the elimination
half-life after intravenous
administration of mupirocin was 20 to 40 minutes for mupirocin and 30
to 80 minutes for monic acid.
The pharmacokinetics of mupirocin has not been studied in individuals
with renal insufficiency.
MICROBIOLOGY
Mupirocin is an antibacterial agent produced by fermentation using the
organism _Pseudomonas_
_fluorescens. _It is active against a wide range of gram-positive
bacteria including methicillin-resistant
_Staphylococcus aureus _(MRSA). It is also active against certain
gram-negative bacteria. Mupirocin
inhibits bacterial protein synthesis by reversibly and specifically
binding to bacterial isoleucyl transfer-
RNA synthetase. Due to this unique mode of action, mupirocin
demonstrates no _in vitro_ cross-resistance
with other classes of antimicrobial agents