Tindamax (tinidazole) Drug Facts and Product Information

Tindamax^® (tinidazole), a second-generation nitroimidazole, is an antiprotozoal drug which is used to treat certain types of parasitic infections, including the sexually transmitted disease trichomoniasis, also known as "trich." Tindamax^® is also indicated to treat the intestinal parasitic infections giardiasis and amebiasis, as well as amebic liver infections.

When approved by the FDA in May 2004, Tindamax^® marked the first advancement in the treatment of trichomoniasis in over 40 years. Additionally, the recently approved supplemental indication for the treatment of bacterial vaginosis (BV) makes Tindamax^® the first oral therapy approved for this condition in a decade.

Compared to the current standard of care:

Tindamax^® has a long serum half-life (12-14 hours v. 6-7 hours).
Tindamax^® has an excellent safety profile and a low incidence of gastrointestinal side effects.
Additionally, increased lipid solubility of Tindamax^® results in more efficient tissue absorption.

Bacterial vaginosis (BV)

Clinical trial data show once-daily Tindamax^® to be significantly superior to placebo in treating BV, and as well-tolerated and safe as compared to placebo.
Unlike intravaginal treatments such as creams or gels, Tindamax^® treats the entire reproductive tract systematically, including the upper tract, where BV has been shown to migrate.
Administered as one gram (two tablets) once daily for five days or two grams (four tablets) once daily for two days, Tindamax^® provides a shorter and more convenient oral treatment for bacterial vaginosis than the current standard of care.

Trichomoniasis

Tindamax^® is recommended as one of the drugs of choice for the treatment of trichomoniasis by the Centers for Disease Control and Prevention (CDC).¹
In over 30 clinical studies of trichomoniasis, Tindamax^® has demonstrated cure rates of 92 to 100 percent in both women and men.
Tindamax^® effectively treats trichomoniasis in one dose, while sparing protective vaginal lactobacilli.

Giardiasis (giardia)

Tindamax^® is recommended as one of the drugs of choice for the treatment of giardiasis by the Centers for Disease Control and Prevention (CDC).²
Tindamax^® is the only single-dose oral therapy approved to treat giardiasis.
Single-dose Tindamax^® for giardiasis has demonstrated cure rates of 80 to 100 percent

Important Safety Information

WARNING: POTENTIAL RISK FOR CARCINOGENICITY

Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Its use should be reserved for the conditions described in INDICATIONS AND USAGE.

Contraindications

Prior history of hypersensitivity to tinidazole or other nitroimidazole derivatives
First trimester of pregnancy
Nursing mothers, unless breast-feeding is interrupted during tinidazole therapy and for 3 days following the last dose

Warnings and Precautions

Seizures and neuropathy have been reported. Discontinue Tindamax if abnormal neurologic signs develop
Vaginal candidiasis may develop with Tindamax and require treatment with an antifungal agent
Use Tindamax with caution in patients with blood dyscrasias. Tindamax may produce transient leukopenia and neutropenia

Adverse Reactions

Most common adverse reactions for a single 2 g dose of tinidazole (incidence >1%) are metallic/bitter taste, nausea, weakness/fatigue/malaise, dyspepsia/cramps/epigastric discomfort, vomiting, anorexia, headache, dizziness and constipation. To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal Company at 1-800-298-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

This material is intended to provide basic information. Patients should discuss all medical advice, diagnosis, and treatment with their healthcare provider.

Please see full Prescribing Information

The Centers for Disease Control and Prevention: Sexually Transmitted Diseases Treatment Guidelines, 2006. Available at http://www.cdc.gov/std/treatment/2006/toc.htm. Accessed January 30, 2007.
The Centers for Disease Control and Prevention: Health Guide for International Travelers, 2005-2006. Available at http://www2.ncid.cdc.gov/travel/yb/utils/ybGet.asp?section=dis&obj=giardiasis.htm. Accessed January 31, 2007.