Kraj: Stany Zjednoczone
Język: angielski
Źródło: 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 mL
TOPICAL
PRESCRIPTION DRUG
Erythromycin Topical Solution is indicated for the topical treatment of acne vulgaris. Erythromycin Topical Solution is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Erythromycin Topical Solution USP, 2% is supplied as follows: 60 mL bottle with applicator NDC 0168-0215-60 Store in a dry place at temperatures between 15° - 25°C (59° - 77°F)[See USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2215F/IF2215H R12/11 #85
Abbreviated New Drug Application
ERYTHROMYCIN- ERYTHROMYCIN SOLUTION E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. ---------- ERYTHROMYCIN TOPICAL SOLUTION USP 2% FOR TOPICAL USE ONLY. NOT FOR USE IN EYES. RX ONLY DESCRIPTION: Erythromycin Topical Solution contains erythromycin for topical dermatologic 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: (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 crystalline powder that is very soluble in water, freely soluble in alcohols, acetone, chloroform, acetonitrile, ethyl acetate, and moderately soluble in ether, ethylene dichloride and amyl acetate. Each mL of Erythromycin Topical Solution USP 2% contains 20 mg of erythromycin base in a vehicle consisting of alcohol (71.5%), and propylene glycol. It may contain citric acid to adjust pH. 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 50 S 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 Solution is indicated for the topical treatment of acne vulgaris. CONTRAINDICATIONS: Erythromycin Topical Solution is contraindicated in those individuals who have shown hy Przeczytaj cały dokument