País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C)
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
CLINDAMYCIN PHOSPHATE
CLINDAMYCIN 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 milliliter is available in the following sizes: 30 mL applicator bottle NDC 0168-0201-30 60 mL applicator bottle NDC 0168-0201-60 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 0168-0202-30 60 gram tube NDC 0168-0202-60 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 0168-0203-60 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 46263755A R01/2020
Abbreviated New Drug Application
CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE GEL E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. REFERENCE LABEL SET ID: D4371159-B58A-40A4-8060-D345843B5468 ---------- 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 MECHANISM OF ACTION The mechanism of action of clindamycin in treating acne vulgaris is unknown. PHARMACOKINETICS 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 cli Leer el documento completo