ERYTHROMYCIN gel

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)

Tillgänglig från:

Mylan Pharmaceuticals Inc.

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Erythromycin topical gel is indicated for the topical treatment of acne vulgaris. Erythromycin topical gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Produktsammanfattning:

Erythromycin Topical Gel USP, 2% contains 20 mg of erythromycin, USP per gram. The clear to slightly yellow gel is available as follows: NDC 0378-8212-93 carton containing one 30 g tube NDC 0378-8212-60 carton containing one 60 g tube

Bemyndigande status:

New Drug Application Authorized Generic

Produktens egenskaper

ERYTHROMYCIN- ERYTHROMYCIN GEL
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Erythromycin topical gel USP, 2% contains erythromycin (3R*, 4S*, 5S*,
6R*, 7R*, 9R*, 11R*,
12R*, 13S*,
14R*)-4-[(2,6-Dideoxy-3-_C_-methyl-3-_O_-methyl-α-L-_ribo_-hexopyranosyl)oxy]-14-ethyl-7,
12, 13-trihydroxy-3, 5, 7, 9, 11, 13-hexamethyl-6-[[3, 4,
6,-trideoxy-3-(dimethylamino)-β-D-_xylo_-
hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione), for topical
dermatological use. Erythromycin is
a macrolide antibiotic produced from a strain of
_Saccaropolysporaerythraea _(formerly
_Streptomyces erythreus_). It is a base and readily forms salts with
acids.
Chemically, erythromycin is C
H NO . It has the following structural formula:
Erythromycin has a molecular weight of 733.94. It is a white or
slightly yellow, odorless or
practically odorless, bitter crystalline powder. Erythromycin is very
soluble in very polar organic
solvents such as alcohols, acetone, chloroform, acetonitrile and ethyl
acetate. It is moderately soluble
in less polar solvents such as ether, dichloroethylene and amyl
acetate. It is slightly soluble in nonpolar
solvents such as hexane. It is very poorly soluble in water.
Each gram of erythromycin topical gel USP, 2% contains 20 mg of
erythromycin, USP in a
vehicle consisting of dehydrated alcohol and hydroxypropyl cellulose.
CLINICAL PHARMACOLOGY
The exact mechanism by which erythromycin reduces lesions of acne
vulgaris is not fully
known; however, the effect appears to be due in part to the
antibacterial activity of the drug.
MICROBIOLOGY
Erythromycin acts by inhibition of protein synthesis in susceptible
organisms by reversibly binding
to 50S ribosomal subunits, thereby inhibiting translocation of
aminoacyl transfer-RNA and
inhibiting polypeptide synthesis. Antagonism has been demonstrated _in
vitro _between erythromycin,
lincomycin, chloramphenicol, and clindamycin.
INDICATIONS AND USAGE
Erythromycin topical gel is indicated for the topical treatment of
acne vulgaris.
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CONTRAINDICATIONS
Erythromycin topical