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:

Physicians Total Care, Inc.

INN (International Name):

CLINDAMYCIN PHOSPHATE

Composition:

CLINDAMYCIN PHOSPHATE 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, e.g., Trichomonas vagin

Product summary:

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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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