MUPIROCIN ointment

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

AvPAK

INN (Tarptautinis Pavadinimas):

MUPIROCIN

Sudėtis:

MUPIROCIN 20 mg in 1 g

Vartojimo būdas:

TOPICAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to: S. aureus and S. pyogenes . This drug is contraindicated in patients with known hypersensitivity to any of the constituents of the product.

Produkto santrauka:

Mupirocin Ointment USP, 2% is available as follows: 60 - 1 Gram Topical Syringe(s) per box (NDC 50268-572-60) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. *Bactroban Nasal® is a registered trademark of GlaxoSmithKline.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

MUPIROCIN- MUPIROCIN OINTMENT
AVPAK
----------
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
trial 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_. Mupirocin inhibits bacterial protein synthesis by
reversibly and specifically binding to
bacterial isoleucyl transfer-RNA (tRNA) synthetase. Due to this unique
mode of action, mupirocin does
not demonstrate cross-resistance with other classes of antimicrobial
agents.
When mupirocin resistance occurs, it results from the production of a
modified isoleucyl-tRNA
synthetase, or the acquisition