Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C)
Physicians Total Care, Inc.
CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE 10 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate Lotion are indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS. ) Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate Lotion are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
Clindamycin Phosphate Topical Solution, USP 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes: 30 mL applicator bottle NDC 54868-2875-1 60 mL applicator bottle NDC 54868-2875-0 Clindamycin Phosphate Gel, USP 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes: 30 gram tube NDC 54868-4654-1 60 gram tube NDC 54868-4654-0 Clindamycin Phosphate Lotion (Clindamycin Phosphate Topical Suspension, USP 1%) containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size: 60 mL bottle NDC 54868-4806-0 Store at 20°-25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from freezing. Keep all liquid dosage forms in containers tightly closed. November 2007 E. FOUGERA & CO. A division of Nycomed US Inc. MELVILLE, NEW YORK 11747 IFI201A Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
CLINDAMYCIN PHOSPHATE - CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE - CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE - CLINDAMYCIN PHOSPHATE GEL PHYSICIANS TOTAL CARE, INC. ---------- CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1%, CLINDAMYCIN PHOSPHATE GEL USP, 1%, CLINDAMYCIN PHOSPHATE LOTION (CLINDAMYCIN PHOSPHATE TOPICAL SUSPENSION USP, 1%) RX ONLY FOR EXTERNAL USE DESCRIPTION Clindamycin Phosphate Topical Solution and Clindamycin Phosphate Lotion (Clindamycin Phosphate Topical Suspension USP, 1%) contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin Phosphate Gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, and purified water. The gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water. The structural formula is represented below: The chemical name for clindamycin phosphate is: Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-_trans_-4- propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-_threo_-α-D-_galacto_-octopyranoside 2-(dihydrogen phosphate). CLINICAL PHARMACOLOGY Although clindamycin phosphate is inactive _in vitro_, rapid _in vivo_ hydrolysis converts this compound to the antibacterially active clindamycin. Cross resistance has been demonstrated between clindamycin and lincomycin. Antagonism has been demonstrated between clindamycin and erythromycin. Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 1 Прочитать полный документ