Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)
Padagis Israel Pharmaceuticals Ltd
ERYTHROMYCIN
ERYTHROMYCIN 20 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
Erythromycin Topical Solution USP, 2% is indicated for the topical treatment of acne vulgaris. Erythromycin Topical Solution USP, 2% is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Abbreviated New Drug Application
ERYTHROMYCIN- ERYTHROMYCIN SOLUTION PADAGIS ISRAEL PHARMACEUTICALS LTD ---------- ERYTHROMYCIN TOPICAL SOLUTION USP, 2% FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE RX ONLY DESCRIPTION Erythromycin Topical Solution USP, 2% 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-_0_-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)-ß-D-_xylo_- hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. It has the following structural formula: Molecular Formula: C H NO Molecular Weight: 733.94 Erythromycin is a white or slightly yellow crystalline powder that is slightly 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 (66%), citric acid, and propylene glycol. 37 67 13 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 Solution USP, 2% is indicated for the topical treatment of acne vulgaris. CONTRAINDICATIONS Erythromycin Topical Solution USP, 2% is contraindicated in Lesen Sie das vollständige Dokument