MUPIROCIN ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Quality Care Products LLC

INN (International Name):

MUPIROCIN

Composition:

MUPIROCIN 20 mg in 1 g

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 49999-644-22) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. *Bactroban Nasal® is a registered trademark of GlaxoSmithKline.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MUPIROCIN- MUPIROCIN OINTMENT
QUALITY CARE PRODUCTS LLC
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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
_Pseudomonasfluorescens_. Mupirocin inhibits bacterial protein
synthesis by reversibly and
specifically binding to bacterial isoleucyl transfer-RNA (tRNA)
synthetase. Due to this
26
44
9
14
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 sy