Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)
Sandoz Inc.
ERYTHROMYCIN
ERYTHROMYCIN 30 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Erythromycin and benzoyl peroxide topical gel USP, 3%;5% is indicated for the topical treatment of acne vulgaris. Erythromycin and benzoyl peroxide topical gel USP, 3%;5% is contraindicated in those individuals who have shown hypersensitivity to any of its components.
TO THE PHARMACIST: IMPORTANT – 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 with supplied spatula until homogeneous in appearance (1 to 1 ½ minutes). Erythromycin and benzoyl peroxide topical gel USP, 3%;5% should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label. NOTE: Prior to reconstitution, store at 20° to 25°C (68° – 77°F). [See USP Controlled Room Temperature]. 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 08540 04275 Rev. 6 04/11
Abbreviated New Drug Application
ERYTHROMYCIN AND BENZOYL PEROXIDE- ERYTHROMYCIN AND BENZOYL PEROXIDE SANDOZ INC. ---------- ERYTHROMYCIN AND BENZOYL PEROXIDE TOPICAL GEL, USP TOPICAL GEL: ERYTHROMYCIN (3%), BENZOYL PEROXIDE (5%) Rx only PLEASE READ COMPLETE COMPOUNDING DIRECTIONS NOTE: TAP VIAL UNTIL ALL POWDER FLOWS FREELY. ADD ROOM TEMPERATURE 70% ETHYL ALCOHOL TO VIAL (TO THE MARK) AND IMMEDIATELY SHAKE/DISSOLVE COMPLETELY. FOR DERMATOLOGICAL USE ONLY – NOT FOR OPHTHALMIC USE Reconstitute Before Dispensing DESCRIPTION Erythromycin and benzoyl peroxide topical gel USP, 3%;5% 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)-ß-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 and benzoyl peroxide topical gel USP, 3%;5% 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: 37 67 13 14 10 4 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, 3%;5% contains, as dispensed, 30 mg (3%) of erythromycin, USP and 50 mg (5%) of benzoyl peroxide, USP in a gel of purified water, USP, alcohol 20%, carbomer homopolymer type C, NF, sodium hydroxide, NF, docusate sodium and fragrance. CLINICAL PHARMA Læs hele dokumentet