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Home » Directories » FDA Approved Drugs » Metronidazole 1.3% Vaginal Gel

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Metronidazole 1.3% Vaginal Gel

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    General Information

    Metronidazole is a nitroimidazole antibiotic medication used particularly for anaerobic bacteria and protozoa.

    Metronidazole 1.3% Vaginal Gel is specifically indicated for the treatment of bacterial vaginosis in non-pregnant women.

    Metronidazole 1.3% is supplied as a vaginal gel for topical administration. Metronidazole vaginal gel 1.3% should be administered once intravaginally at bedtime.

    Clinical Results

    FDA Approval
    The FDA approval of Metronidazole vaginal gel 1.3% was based on a phase III randomized, double-blind, placebo-controlled, multicenter clinical trial. Metronidazole 1.3% was compared to MetroGel-Vagina (metronidazole vaginal gel 0.75%). Results showed that the higher concentration Metronidazole 1.3% was well tolerated and efficacious.

    Side Effects

    Adverse effects associated with the use of Metronidazole vaginal gel 1.3% may include, but are not limited to, the following:

    • vulvovaginal candidiasis
    • headache
    • vulvovaginal pruritus
    • nausea
    • diarrhea
    • dysmenorrhea

    Mechanism of Action

    Metronidazole is a nitroimidazole antibiotic medication used particularly for anaerobic bacteria and protozoa.

    Additional Information

    For additional information regarding Metronidazole 1.3% Vaginal Gel or bacterial vaginosis, please visit the Actavis web page.

    Approval Date: 2014-04-01
    Company Name: Actavis, Inc.
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