Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
Clindamycin Phosphate (UNII: EH6D7113I8) (Clindamycin - UNII:3U02EL437C)
Actavis Pharma, Inc.
Clindamycin Phosphate
Clindamycin 10 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
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 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. Safety and effectiveness in pediatric patients under the age of 12 have not been established. Clinical studies for clindamycin phosphate topical solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
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 bottles – NDC 0472-0987-91 60 mL applicator bottles – NDC 0472-0987-92 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from freezing. Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. 11/2017 8-0321ACT6
Abbreviated New Drug Application
CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE SOLUTION ACTAVIS PHARMA, INC. ---------- CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION, USP 1% RX ONLY FOR EXTERNAL USE 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. Sodium hydroxide or hydrochloric acid may be added to adjust pH. 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. INDICATIO Прочитајте комплетан документ