Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C)
Physicians Total Care, Inc.
CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE 20 mg in 1 g
VAGINAL
PRESCRIPTION DRUG
Clindamycin phosphate vaginal cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). Clindamycin phosphate vaginal cream 2%, can be used to treat non-pregnant women and pregnant women during the second and third trimester. (See CLINICAL STUDIES.) NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vagin
Clindamycin Phosphate Vaginal Cream 2% (clindamycin phosphate vaginal cream) is a white to off-white cream having a slight odor and is supplied as follows: 40 g tube (with 7 disposable applicators) NDC 54868-5307-0 Store at 20° to 25°C (68° to 77° F)[see USP Controlled Room Temperature].
Abbreviated New Drug Application
CLINDAMYCIN PHOSPHATE - CLINDAMYCIN PHOSPHATE CREAM PHYSICIANS TOTAL CARE, INC. ---------- CLINDAMYCIN PHOSPHATE VAGINAL CREAM USP, 2% RX ONLY FOR INTRAVAGINAL USE ONLY NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE DESCRIPTION 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 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). It has a molecular weight of 504.96, and the molecular formula is C H ClN O PS. The structural formula is represented below: Clindamycin phosphate vaginal cream 2%, is a semi-solid, white cream, which contains 2% clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin per gram. The pH of the cream is between 3.0 and 6.0. The cream also contains benzyl alcohol, cetostearyl alcohol, cetyl palmitate, mineral oil, polysorbate 60, propylene glycol, sorbitan monostearate, and stearic acid. Each applicatorful of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate. CLINICAL PHARMACOLOGY Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, 18 34 2 8 administered to 6 healthy female volunteers for 7 days, approximately 5% (range 0.6% to 11%) of the administered dose was absorbed systemically. The peak serum clindamycin concentration observed on the first day averaged 18 ng/mL (range 4 to 47 ng/mL) and on day 7 it averaged 25 ng/mL (range 6 to 61 ng/mL). These peak concentrations were attained approximately 10 hours post-dosing (range 4-24 hours). Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, administered for 7 consecutive days to 5 women with bacterial vaginosis, absorption was slower and less variable than that observed in healthy females. Approximately 5% (range 2% to 8%) of the d Prečítajte si celý dokument