国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
ERYTHROMYCIN
ERYTHROMYCIN 20 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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.
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
Abbreviated New Drug Application
ERYTHROMYCIN- ERYTHROMYCIN GEL E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. ---------- 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 完全なドキュメントを読む