Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)
SOLA Pharmaceuticals
TOPICAL
PRESCRIPTION DRUG
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: 60 g sealed metal tube (NDC 70512-035-60) Manufactured for: Sola Pharmaceuticals Baton Rouge, LA 70809 Rev. 10/2017
Abbreviated New Drug Application
ERYTHROMYCIN GEL- ERYTHROMYCIN GEL GEL SOLA PHARMACEUTICALS ---------- ERYTHROMYCIN TOPICAL GEL USP, 2% FOR DERMATOLOGICA USE ONLY-NOT FOR OPTHALMIC USE RX ONLY DES CRIPTION 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 Saccharopolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. Chemically, erythromycin is C37H67NO13. . 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% (clear, colorless, gel) contains 20 mg of erythromycin USP in a vehicle consisting of alcohol (92% v/v) 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. INDICATION AND USAGE Erythromycin Topical Ge Lue koko asiakirja