CLINDAMYCIN PHOSPHATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International Name):

CLINDAMYCIN PHOSPHATE

Composition:

CLINDAMYCIN 20 mg in 1 g

Administration route:

VAGINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, eg, Trichomonas vagin

Product summary:

Clindamycin Phosphate Vaginal Cream USP, 2% is supplied as follows: 40 g tube (with 7 disposable applicators)    NDC 0168-0277-40 Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE CREAM
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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CLINDAMYCIN PHOSPHATE VAGINAL CREAM USP, 2%
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
MECHANISM OF ACTION
Clindamycin is an antibacterial drug (See MICROBIOLOGY).
18
34
2
8
PHARMACOKINETICS
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).
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
b