Clindamycin Phosphate
Clindamycin Phosphate Prescribing Information
Clindamycin phosphate vaginal cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as
In two clinical studies involving 674 evaluable non-pregnant women with bacterial vaginosis comparing Clindamycin phosphate vaginal cream 2% for 3 or 7 days, the clinical cure rates, determined at 1 month posttherapy, ranged from 72% to 81% for the 3-day treatment and 84% to 86% for the 7-day treatment.
Clindamycin Phosphate Vaginal Cream 2% 3 Day | Clindamycin Phosphate Vaginal Cream 2% 7 Day | ||||
|---|---|---|---|---|---|
US Study | 94/131 | 72% | 110/128 | 86% | |
European Study | 161/199 | 81% | 181/216 | 84% | |
In a clinical study involving 249 evaluable pregnant patients in the second and third trimester treated for 7 days, the clinical cure rate, determined at 1 month posttherapy, was 60% (77/129) in the clindamycin arm and 9% (11/120) for the vehicle arm. The determination of clinical cure was based on the absence of a "fishy" amine odor when the vaginal discharge was mixed with a 10% KOH solution and the absence of clue cells on microscopic examination.
Other pathogens commonly associated with vulvovaginitis, eg,
The recommended dose is one applicatorful of clindamycin phosphate vaginal cream 2%, (5 grams containing approximately 100 mg of clindamycin phosphate) intravaginally, preferably at bedtime, for 3 or 7 consecutive days in non-pregnant patients and for 7 consecutive days in pregnant patients. (See
In two clinical studies involving 674 evaluable non-pregnant women with bacterial vaginosis comparing Clindamycin phosphate vaginal cream 2% for 3 or 7 days, the clinical cure rates, determined at 1 month posttherapy, ranged from 72% to 81% for the 3-day treatment and 84% to 86% for the 7-day treatment.
Clindamycin Phosphate Vaginal Cream 2% 3 Day | Clindamycin Phosphate Vaginal Cream 2% 7 Day | ||||
|---|---|---|---|---|---|
US Study | 94/131 | 72% | 110/128 | 86% | |
European Study | 161/199 | 81% | 181/216 | 84% | |
In a clinical study involving 249 evaluable pregnant patients in the second and third trimester treated for 7 days, the clinical cure rate, determined at 1 month posttherapy, was 60% (77/129) in the clindamycin arm and 9% (11/120) for the vehicle arm. The determination of clinical cure was based on the absence of a "fishy" amine odor when the vaginal discharge was mixed with a 10% KOH solution and the absence of clue cells on microscopic examination.
Clindamycin phosphate vaginal cream 2%, is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream. Clindamycin phosphate vaginal cream 2%, is also contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.
In clinical trials involving non-pregnant women, 1.8% of 600 patients who received treatment with clindamycin phosphate vaginal cream 2% for 3 days and 2.7% of 1325 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events. Medical events judged to be related, probably related, possibly related, or of unknown relationship to vaginally administered clindamycin phosphate vaginal cream 2%, were reported for 20.7% of the patients receiving treatment for 3 days and 21.3% of the patients receiving treatment for 7 days. Events occurring in ≥1% of patients receiving clindamycin phosphate vaginal cream 2% are shown in Table 1.
Clindamycin Phosphate Vaginal Cream | ||
|---|---|---|
Event | 3 Day n=600 | 7 Day n=1325 |
Urogenital | ||
Vaginal moniliasis | 7.7 | 10.4 |
Vulvovaginitis | 6.0 | 4.4 |
Vulvovaginal disorder | 3.2 | 5.3 |
Trichomonal vaginitis | 0 | 1.3 |
Body as a Whole | ||
Moniliasis (body) | 1.3 | 0.2 |
Other events occurring in <1% of the clindamycin vaginal cream 2% groups include:
Systemic clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
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-
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, mixed fatty acid esters, mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, and stearic acid.
Each applicatorful of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate.