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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


Only Tindamax® is approved to treat both bacterial vaginosis and trichomoniasis (TV).

Clinical Insight

Oral vs vaginal cream therapy: Patient preference for oral dosing is demonstrated to be 84%. More»

Beyond BV

Tindamax® may be prescribed for other infections including: