MUPIROCIN ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Atlantic Biologicals Corps

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: and . S. aureus S. pyogenes This drug is contraindicated in patients with known hypersensitivity to any of the constituents of the product.

Product summary:

NDC:17856-0112-1 in a SYRINGE of 1 OINTMENTS

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MUPIROCIN- MUPIROCIN OINTMENT
ATLANTIC BIOLOGICALS CORPS
----------
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 ( )-(2 ,3 ,4 ,5 )-5-[(2 ,3 ,4 ,5 )-
2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2
-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. _ESRRSSSSSH_
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 . 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. _Pseudomonasfluorescens_
When mupirocin resistance occurs, it results from the production of a
modified isoleucyl-tRNA
synthetase, or the acquisitio