Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Immunology | Obstetrics/Gynecology (Women’s Health)
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved December 1997
Treatment Area: bacterial vaginosis
Flagyl ER, a new, once-daily, oral drug delivery system
containing 750 mg of metronidazole, has been approved for marketing
by the FDA. Flagyl ER is an extended release formulation of the
anti-infective agent, metronidazole. It is the first and only
once-a-day oral medication approved for the treatment of bacterial
vaginosis (BV), the most frequent form of vaginal inflammation in
the U.S. With a recommended dosing regimen of one tablet taken
orally daily for seven days, Flagyl ER offers an extended release
system to ensure 24-hour therapeutic coverage.
In controlled comparison studies against vaginal cream, Flagyl
ER restored the pH and normal vaginal flora earlier than the
comparator vaginal cream by one month post-therapy. The quality of
life evaluation in these studies, using data from a general health
questionnaire known as the SF-36, showed there was no statistical
difference in tolerability between the new, systemic Flagyl ER and
a vaginal cream.
Because metronidazole crosses the placental barrier and enters
the fetal circulation rapidly, it should not be administered to
pregnant patients during the first trimester.