ERYTHROMYCIN gel

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Aidarex Pharmaceuticals LLC

INN (International Name):

ERYTHROMYCIN

Sammensætning:

ERYTHROMYCIN 20 mg in 1 g

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Erythromycin Topical Gel USP, 2% is indicated for the topical treatment of acne vulgaris. Erythromycin Topical Gel USP, 2% is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Produkt oversigt:

Erythromycin Topical Gel USP, 2% is available as follows: 60 g sealed metal tube (NDC 53217-0021 -01)

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

ERYTHROMYCIN- ERYTHROMYCIN GEL
AIDAREX PHARMACEUTICALS LLC
----------
ERYTHROMYCIN TOPICAL GEL USP, 2%
FOR DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC USE
_RX ONLY_
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 _Saccaropolyspora
erythraea_ (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,
37
67
13
chloramphenicol, and clindamycin.
INDICATIONS AND USAGE
Erythromycin Topical G