Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
clindamycin phosphate (UNII: EH6D7113I8) (clindamycin - UNII:3U02EL437C)
PharmaDerm, A division of Nycomed US Inc.
clindamycin phosphate
clindamycin phosphate 10 mg in 1 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
CLINDAMAX LOTION- CLINDAMYCIN PHOSPHATE SUSPENSION PHARMADERM, A DIVISION OF NYCOMED US INC. ---------- CLINDAMAX LOTION (CLINDAMYCIN PHOSPHATE TOPICAL SUSPENSION USP 1%) RX ONLY FOR EXTERNAL USE ONLY DESCRIPTION ClindaMax Lotion (clindamycin phosphate topical suspension 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 topical 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 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 read_full_document