Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)
Padagis Israel Pharmaceuticals Ltd
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 45802-966 -94) 60 g sealed metal tube (NDC 45802-966 -96)
Abbreviated New Drug Application
ERYTHROMYCIN- ERYTHROMYCIN GEL PADAGIS ISRAEL PHARMACEUTICALS LTD ---------- 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 37 67 13 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 Topic Belgenin tamamını okuyun