CLINDAMYCIN PHOSPHATE- clindamycin phosphate cream

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C)

Verfügbar ab:

Preferred Pharmaceuticals, Inc.

Verabreichungsweg:

VAGINAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Clindamycin phosphate vaginal cream USP, 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 USP, 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, eg, Trichomo

Produktbesonderheiten:

Clindamycin Phosphate Vaginal Cream USP, 2% is supplied as follows: 40 g tube (with 7 disposable applicators) - 68788-9841-0 Store at 20° to 25°C (68° to 77° F)[see USP Controlled Room Temperature]. Protect from freezing.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE CREAM
PREFERRED PHARMACEUTICALS, 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 USP, 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, stearic acid and
purified water.
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%,
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 to 24
hours).
18
34
2
8
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%