ERYTHROMYCIN- erythromycin gel

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

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 supplied as follows: 30 gram tubes - NDC 0168-0216-30      60 gram tubes - NDC 0168-0216-60 STORAGE: NOTE: FLAMMABLE. KEEP AWAY FROM HEAT AND FLAME. Store and dispense in original container. Keep tube tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2216D R03/14 #153

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

ERYTHROMYCIN- ERYTHROMYCIN GEL
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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ERYTHROMYCIN TOPICAL GEL USP, 2%
FOR DERMATOLOGIC USE ONLY.
RX ONLY
NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Erythromycin Topical Gel USP, 2% contains erythromycin 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:
(3_R_*,4_S_*,5_S_*,6_R_*,7_R_*,9_R_*,11_R_*,12_R_*,
13_S_*,14_R_*)-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.
It has the following
structural formula:
Erythromycin is a white or slightly yellow, odorless or practically
odorless, bitter crystalline powder.
Erythromycin is very soluble in very polar 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 base of
alcohol 92% 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 USP, 2% is indicated for the topical
treatme