Information for Health Professionals: Tindamax (tinidazole)

Think twice, prescribe once with Tindamax^®

An effective therapy that reduces the risks of vaginal candidiasis

The first new oral therapy approved for bacterial vaginosis (BV) in a decade, Tindamax^® protects lactobacilli while targeting BV pathogens—and has a low incidence of secondary vaginal candidiasis (4.7%).

One treatment for bacterial vaginosis (BV) and trichomoniasis (TV)

Studies show that many patients with TV are also positive for BV.^1-5 Tindamax^® is the only medication approved as both an antibacterial agent for BV and antiprotozoal treatment for TV.⁶

Convenient dosing with a favorable side effect profile

Tindamax^® offers a shorter and more convenient treatment for bacterial vaginosis than the current standard of care. A second-generation nitroimidazole, it is well tolerated with a low incidence of GI adverse effects.⁶

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

Krieger J, Tam M, Stevens C et al. Diagnosis of trichomoniasis, comparison of conventional wet-mount examination with cytologic studies, cultures, and monoclonal antibody staining of direct specimens. JAMA. 1988;259:1223-1227.
Hillier SL, Krohn MA, Nugent RP, Gibbs RS. Characteristics of three vaginal flora patterns assessed by gram stain among pregnant women. Vaginal Infections and Prematurity Study Group. Am J Obstet Gynecol. 1992 Mar;166(3):938-44.
Dan M, Sobel JD. Trichomoniasis as seen in a chronic vaginitis clinic. Infect Dis Obstet Gynecol. 1996;4(2):77-84.
Heine RP, McGregor JA, Patterson E, Draper D, French J, Jones W. Trichomonas vaginalis: Diagnosis and Clinical Characteristics in Pregnancy. Infect Dis Obstet Gynecol. 1994;1(5):228-34.
Demirezen S, Korkmaz E, Beksaç MS. Association between trichomoniasis and bacterial vaginosis: examination of 600 cervicovaginal smears. Cent Eur J Public Health. 2005 Jun;13(2):96-8.
Data on file. Mission Pharmacal Company.