Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)
Perrigo New York Inc
PRESCRIPTION DRUG
Erythromycin-Benzoyl Peroxide Topical Gel is indicated for the topical treatment of acne vulgaris. Erythromycin-Benzoyl Peroxide Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.
How Supplied and Compounding Directions: 23.3 grams (as dispensed) 02 20 grams 0.8 grams 3 mL 46.6 grams (as dispensed) 86 40 grams 1.6 grams 6 mL Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycin . Add this solution to gel and stir until homogeneous in appearance (1 to 1½ minutes). Erythromycin-Benzoyl Peroxide Topical Gel should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label. NOTE: Prior to reconstitution, store at room temperature between 15° and 30°C (59° – 86°F). After reconstitution, store under refrigeration between 2° and 8°C (36° – 46°F). Do not freeze. Keep tightly closed. Keep out of the reach of children. Rx Only
New Drug Application Authorized Generic
ERYTHROMYCIN-BENZOYL PEROXIDE- ERYTHROMYCIN AND BENZOYL PEROXIDE PERRIGO NEW YORK INC ---------- ERYTHROMYCIN-BENZOYL PEROXIDE TOPICAL GEL TOPICAL GEL: ERYTHROMYCIN (3%), BENZOYL PEROXIDE (5%) FOR DERMATOLOGICAL USE ONLY – NOT FOR OPHTHALMIC USE RECONSTITUTE BEFORE DISPENSING DESCRIPTION Erythromycin-Benzoyl Peroxide Topical Gel contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 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 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 of approximately 1 mg/mL in water and is soluble in alcohol at 25°C. Erythromycin-Benzoyl Peroxide Topical Gel 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-Benzoyl Peroxide Topical Gel contains, as dispensed, 30 mg (3%) of erythromycin and 50 mg (5%) of benzoyl peroxide in a base of purified water USP, Carbomer Homopolymer Type C, alcohol 20%, sodium hydroxide NF, docusate sodium and fragrance. 37 67 13 14 10 4 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 desquamative effect which may also c Olvassa el a teljes dokumentumot