Metronidazole 1.3% Vaginal Gel

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved April 2014

Specific Treatments:

bacterial vaginosis

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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.