Tindamax (tinidazole) Press Releases from Mission Pharmacal

7/31/2007: New Study Finds Tindamax^® To Be Effective, Well-Tolerated Treatment for Bacterial Vaginosis Full Release»
5/24/2007: FDA Approves Tindamax^® for Bacterial Vaginosis First New Oral Treatment for Bacterial Vaginosis in a Decade Full Release»
11/13/2006: Centers for Disease Control and Prevention Recommends Tindamax^® for the Treatment of Trichomoniasis in Latest Sexually Transmitted Disease Guidelines Full Release»
8/17/2006: Mission Pharmacal Submits Supplemental New Drug Application for Tindamax^® (Tinidazole) as Treatment of Bacterial Vaginosis Full Release»
5/9/2006: Most Common Curable STD a Significant Public Health Concern When Untreated, May Contribute to Spread of HIV New Web Resource Launched to Educate on Trichomoniasis Treatment Full Release»
5/8/2006: Mission Pharmacal Completes Phase III Study of Tindamax^® for the Treatment of Bacterial Vaginosis Full Release»
4/20/2006: Mission Pharmacal Acquires Tindamax^®: Treatment for Trichomoniasis, Most Common Non-Viral Sexually Transmitted Disease Potent, Well-Tolerated Therapy Allows Simple One-Day, One-Dose Regimen Full Release»

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