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CLEOCIN® Vaginal Cream (clindamycin)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

CLEOCIN® Vaginal Cream Quick Finder

INDICATIONS AND USAGE

CLEOCIN Vaginal Cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella...

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DOSAGE AND ADMINISTRATION

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...

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CONTRAINDICATIONS

CLEOCIN Vaginal Cream 2%, is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream. CLEOCIN Vaginal Cream 2%, is also...

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WARNINGS

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Orally and parenterally...

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ADVERSE REACTIONS

Clinical trials

Non-pregnant Women

In clinical trials involving non-pregnant women, 1.8% of...

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OVERDOSAGE

Vaginally applied clindamycin phosphate vaginal cream 2% could be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS.)

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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...

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CLINICAL PHARMACOLOGY

Mechanism of Action

Clindamycin is an antibacterial drug (See

Pharmacokinetics

Following a once a day intravaginal...

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CLINICAL STUDIES

In two clinical studies involving 674 evaluable non-pregnant women with bacterial vaginosis comparing CLEOCIN Vaginal Cream 2% for 3 or 7 days, the clinical cure rates, determined at 1 month posttherapy,...

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HOW SUPPLIED

CLEOCIN Vaginal Cream 2%, (clindamycin phosphate vaginal cream) is supplied as follows:

40 g tube (with 7 disposable applicators)         NDC 0009-3448-01

Store at controlled room temperature 20° to...

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DIRECTIONS FOR USE

Disposable plastic applicators are provided with this package. They are designed to allow proper vaginal administration of the cream.

Remove cap from cream tube. Screw a plastic applicator on the...

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FOR INTRAVAGINAL USE ONLY
NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE

MICROBIOLOGY

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