Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)
Renaissance Pharma, 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 available as follows: 30 g sealed metal tube (NDC 40085-315 -30) 60 g sealed metal tube (NDC 40085-315 -60)
New Drug Application Authorized Generic
ERYTHROMYCIN- ERYTHROMYCIN GEL RENAISSANCE PHARMA, INC. ---------- ERYTHROMYCIN TOPICAL GEL 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 _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 37 67 13 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 Eryth Preberite celoten dokument