PRE AND POST SX POUCH- mupirocin 2%, dimethicone 5%, chlorhexidine gluconate 4% kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Terrain Pharmaceuticals

INN (International Name):

CHLORHEXIDINE GLUCONATE

Composition:

CHLORHEXIDINE GLUCONATE 4 g in 100 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Mupirocin Ointment USP, 2% is available as follows: 22 g 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.

Authorization status:

unapproved drug other

Summary of Product characteristics

PRE AND POST SX POUCH- MUPIROCIN 2%, DIMETHICONE 5%, CHLORHEXIDINE
GLUCONATE 4%
TERRAIN PHARMACEUTICALS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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PRE & POST SX POUCH
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.
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44
9
14
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)
synth