MUPIROCIN ointment

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

H.J. Harkins Company, Inc.

INN (Διεθνής Όνομα):

MUPIROCIN

Σύνθεση:

MUPIROCIN 20 mg in 1 g

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Mupirocin Ointment USP, 2% is available as follows: 22 gram tube (NDC 45802-112 -22) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. *Bactroban Nasal® is a registered trademark of GlaxoSmithKline. MADE IN ISRAEL MANUFACTURED BY PERRIGO, YERUHAM 80500, ISRAEL Repacked by: H.J. Harkins Company, Inc. Nipomo, CA 93444 Rev: 11/11

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

MUPIROCIN - MUPIROCIN OINTMENT
H.J. HARKINS COMPANY, INC.
----------
MUPIROCIN OINTMENT USP, 2%
For Dermatologic Use
_RX ONLY_
DESCRIPTION
Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a
bland water miscible ointment
base (polyethylene glycol ointment, NF) 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 molecular
formula of mupirocin is C
H O
and the molecular weight is 500.62. The chemical structure is:
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 7 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