국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C)
Preferred Pharmaceuticals Inc.
CLINDAMYCIN PHOSPHATE
CLINDAMYCIN 10 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
Rx Only Clindamycin Phosphate Topical Solution USP, 1% is 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 USP, 1% is 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% is available as follows: 60 mL applicator bottle (NDC 68788-6959-6)
Abbreviated New Drug Application
CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE SOLUTION PREFERRED PHARMACEUTICALS INC. ---------- CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1% FOR EXTERNAL USE RX ONLY DESCRIPTION Clindamycin Phosphate Topical Solution USP, 1% contains clindamycin phosphate USP at a concentration equivalent to 10 mg clindamycin per milliliter. 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, purified water, and sodium hydroxide (to adjust the pH to between 4.0 - 7.0). 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 present in the serum (0–3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin. Clindamycin activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones after application of clindamycin phosphate topical solution for 4 weeks was 597 mcg/g of comedonal material (range 0–1490). Clindamycin _in vitro _inhibits all _Propionibacterium acnes _cultures tested (MICs 0.4 mcg/mL). Free fatty acids on the skin surface have been decreased from approximately 14% to 2% following application of clindamycin. INDICATIONS AND USAGE 전체 문서 읽기