Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
Clindamycin Phosphate (UNII: EH6D7113I8) (Clindamycin - UNII:3U02EL437C)
Preferred Pharmaceuticals Inc.
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 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% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes: 60 mL applicator bottle — NDC NDC 68788-7057-6 Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from freezing. Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310 Rev. 09/16 Relabeled By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE SOLUTION PREFERRED PHARMACEUTICALS INC. ---------- CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1% FOR EXTERNAL USE DESCRIPTION Clindamycin Phosphate Topical Solution USP, 1% contains clindamycin phosphate 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, sodium hydroxide and water. The structural formula is represented below: Molecular Formula: C H CIN O PS Molecular Weight: 504.97 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 18 34 2 8 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 U Lue koko asiakirja