Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C)
Greenstone LLC
CLINDAMYCIN PHOSPHATE
CLINDAMYCIN 10 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
Clindamycin phosphate topical solution, clindamycin phosphate topical gel and clindamycin phosphate topical 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 topical gel and clindamycin phosphate topical 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 containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes: 30 mL applicator bottle—NDC 59762-3728-1 60 mL applicator bottle—NDC 59762-3728-2 Carton of 60 single-use pledget applicators—NDC 59762-3728-3 Clindamycin phosphate topical gel containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes: 30 gram tube—NDC 59762-3743-1 60 gram tube—NDC 59762-3743-2 Clindamycin phosphate topical lotion containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size: 60 mL plastic squeeze bottle—NDC 59762-3744-1 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing.
New Drug Application Authorized Generic
CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE GEL GREENSTONE LLC ---------- CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION, USP CLINDAMYCIN PHOSPHATE TOPICAL GEL CLINDAMYCIN PHOSPHATE TOPICAL LOTION FOR EXTERNAL USE DESCRIPTION Clindamycin phosphate topical solution and clindamycin phosphate topical lotion contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin phosphate topical gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Each clindamycin phosphate topical solution pledget applicator contains approximately 1 mL of topical solution. 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 water. The gel contains allantoin, carbomer 934P, 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 clindamycin are present in the serum (0–3 ng/mL) and less than 0.2% of the dose is recovered in Olvassa el a teljes dokumentumot