Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C)
Preferred Pharmaceuticals Inc.
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 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 68788-7040-6 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing. Fougera PHARMACEUTICALS INC. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. MELVILLE, NEW YORK 11747 46206122A/46206123A R03/18 Relabeled By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE LOTION PREFERRED PHARMACEUTICALS 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%) contain 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 974P, 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 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are p Leggi il documento completo