MUPIROCIN 2%- mupirocin ointment

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

DirectRX

Spôsob podávania:

TOPICAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

- Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to: S. aureus and S. pyogenes. 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.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

MUPIROCIN 2%- MUPIROCIN OINTMENT
DIRECTRX
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MUPIROCIN
SPL UNCLASSIFIED SECTION
PRESCRIBING INFORMATION
For Dermatologic Use. Not for Ophthalmic Use.
CLINICAL PHARMACOLOGY SECTION
Application of 14C-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 of, by genetic transfer, a plasmid
mediating a new isoleucyl-tRNA
synthetase. High-level plasmid-mediated resistance (MIC >512 mcg/mL)
has been reported in
increasing numbers of isolates of Staphylococcus aureus and with
higher frequency in coagulase-
negative staphylococci. Mupirocin resistance occurs with greater
frequency in methicillin-resistant
than methicillin-susceptible staphylococci. Because of the occurrence
of mupirocin resistance in
methicillin-resistant Staphylococcus aureus (MRSA), it is appropriate
to test MRSA