Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)
NuCare Pharmaceuticals, Inc.
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.
Erythromycin Topical Solution, USP 2% is supplied as follows: 60 mL bottle with applicator NDC 68071-1799-6 bottles of 60 Store in a dry place at temperatures between 15 ° –25 ° C (59 ° –77 ° F) [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED
Abbreviated New Drug Application
ERYTHROMYCIN- ERYTHROMYCIN SOLUTION NUCARE PHARMACEUTICALS, INC. ---------- ERYTHROMYCIN TOPICAL SOLUTION, USP 2% FOR TOPICAL USE ONLY NOT FOR USE IN EYES RX ONLY DESCRIPTION Erythromycin Topical Solution, USP 2% contains erythromycin ((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), 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 C H NO . It has the following structural formula: Erythromycin has the molecular weight of 733.94. It is a white or slightly yellow, crystalline powder and it is slightly soluble in water; soluble in alcohol, in chloroform and in ether. Each mL of Erythromycin Topical Solution, USP 2% contains 20 milligrams of erythromycin in a base of alcohol, USP (66.0%) and propylene glycol, USP. 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. 37 67 13 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, USP 2% is indicated for the topical treatment of acne vulgaris. CONTRAINDICATIONS Erythromycin Topical Solution, USP 2% is contraindicated in those individuals who have shown hypersensitivity to any of its components. WARNINGS PSEUDOMEMBRANOUS COLITIS Läs hela dokumentet