Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)
VersaPharm Incorporated
ERYTHROMYCIN
ERYTHROMYCIN 20 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
Erythromycin Pledgets USP, 2% are indicated for the topical treatment of acne vulgaris. Erythromycin Pledgets USP, 2% are contraindicated in those individuals who have shown hypersensitivity to any of its components.
Erythromycin Pledgets USP, 2% are available in a plastic jar containing 60 pledgets - NDC 61748-202-60. Each pledget is filled to contain 0.8 mL of erythromycin topical solution, 2%. Keep jar tightly closed.
Abbreviated New Drug Application
ERYTHROMYCIN- ERYTHROMYCIN SOLUTION VERSAPHARM INCORPORATED ---------- ERYTHROMYCIN PLEDGETS USP, 2% RX ONLY FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE DESCRIPTION Erythromycin Pledgets USP, 2% contain erythromycin, USP 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: Molecular weight of 733.94 The chemical name for erythromycin is (3R*,4S*,5S*,6R*_,_7_R*_,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. Erythromycin is a white or slightly yellow, crystalline powder, slightly soluble in water, soluble in alcohol, in chloroform, and in ether. It is odorless or practically odorless. It has a pH range between 8.0 and 10.5 in a methanol and water solution prepared by diluting 1 volume of a methanol solution, containing 40 mg per mL, with 19 volumes of water. Each mL of expressible liquid contains 20 mg erythromycin in a base of alcohol (68.5%) (denatured with _tert_-butyl alcohol and denatonium benzoate), propylene glycol and citric acid to adjust pH. Each pledget is filled to contain 0.8 mL of erythromycin topical solution. 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, and 37 67 13 lincomycin, chloramphenicol, and cli Đọc toàn bộ tài liệu