Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)
Lyne Laboratories, Inc.
ERYTHROMYCIN
ERYTHROMYCIN 30 mg in 1 g
PRESCRIPTION DRUG
Abbreviated New Drug Application
ERYTHROMYCIN AND BENZOYL PEROXIDE- ERYTHROMYCIN AND BENZOYL PEROXIDE GEL LYNE LABORATORIES, INC. ---------- ERYTHROMYCIN AND BENZOYL PEROXIDE TOPICAL GEL USP Topical Gel: erythromycin (3%), benzoyl peroxide (5%) For Dermatological Use Only – Not for Ophthalmic Use Reconstitute Before Dispensing DESCRIPTION Erythromycin and Benzoyl Peroxide Topical Gel USP contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-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)-β-D- _xylo_-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione]. 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 (C H NO ). It has the following structural formula: Erythromycin has the molecular weight of 733.94. It is a white crystalline powder and has a solubility 37 67 13 of approximately 1 mg/mL in water and is soluble in alcohol at 25˚C. Erythromycin and Benzoyl Peroxide Topical Gel USP also contains benzoyl peroxide for topical use. Benzoyl peroxide is an antibacterial and keratolytic agent. Chemically, benzoyl peroxide is (C H O ). It has the following structural formula: Benzoyl peroxide has the molecular weight of 242.23. It is a white granular powder and is sparingly soluble in water and alcohol and soluble in acetone, chloroform and ether. Each gram of Erythromycin and Benzoyl Peroxide Topical Gel USP contains, as dispensed, 30 mg (3%) of erythromycin and 50 mg (5%) of benzoyl peroxide in a base of purified water USP, carbomer 940 NF, ethyl alcohol 20%, sodium hydroxide NF, docusate sodium and fragrance. 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. Benzoyl peroxide has a keratolytic and de Прочетете целия документ