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5/19/2004

New Antiparasitic Agent Approved

Cheryl A. Thompson

The Food and Drug Administration (FDA) on Monday approved the marketing of the antiparasitic agent tinidazole, a compound related to metronidazole. Presutti Laboratories Inc. will sell the new drug under the brand name Tindamax.

Product director Rhonda Pavicich said the FDA-approved labeling for the drug describes three uses: the treatment of trichomoniasis, giardiasis, and amebiasis. For trichomoniasis and giardiasis, the treatment regimen is a one-time tinidazole dose of 2 g. Amebic dysentery is to be treated with tinidazole 2 g daily for three days, and amebic abscess from amebic hepatitis requires 2 g daily for three to five days.

The contraindications to the use of tinidazole, Pavicich said, are similar to those for metronidazole. Persons with a hypersensitivity to metronidazole or another nitroimidazole derivative must not take tinidazole, she said. The safety of the drug when taken by pregnant women has not been studied, she added.

As with metronidazole, tinidazole users should not consume alcohol. Concomitant use of a nitroimidazole derivative and alcohol can cause abdominal cramps, nausea, vomiting, headaches, and flushing. Whereas the product labeling for brand-name metronidazole states that alcohol should not be consumed for at least one day after the last dose of drug, Pavicich said tinidazole users should wait 72 hours after the last dose.

Compared with metronidazole, the adverse-event profile of tinidazole is "much better" in general, Pavicich said, although bad taste is still a problem.

She said Tindamax will be available in two strengths of film-coated tablets. Initially the 500-mg tablets will be packaged in 20- and 60-count bottles and the 250-mg tablets in 40-count bottles.

"We're hoping to have it in stores by July 1," she said.