Flagyl ERCompany: Searle
Approval Status: Approved December 1997
Treatment for: bacterial vaginosis
Areas: Immune System; Pregnancy & Gynecology
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.
Flagyl ER Drug Information
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