Tinidazole

1 INDICATIONS AND USAGE Tinidazole is a nitroimidazole antimicrobial indicated for: Trichomoniasis ( 1.1 ) Giardiasis: in patients age 3 and older ( 1.2 ) Amebiasis: in patients age 3 and older ( 1.3 ) Bacterial Vaginosis: in non-pregnant, adult women ( 1.4 , 8.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of tinidazole tablets and other antibacterial drugs, tinidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.5) 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis . The organism should be identified by appropriate diagnostic procedures.

6 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 ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Edenbridge Pharmaceuticals, LLC at 1-877-381-3336 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

8.1 Pregnancy Risk Summary Available published data from a case-control study and case report with Tinidazole Tablets use in pregnant women are insufficient to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated lower genital tract infections during pregnancy (see Clinical Considerations).

WARNING: POTENTIAL RISK FOR CARCINOGENICITY Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent [see Nonclinical Toxicology (13.1 )]. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole tablets to approved indications only [see Indications and Usage ( 1.1 , 1.2 , 1.3 )]. Avoid chronic use. [see Warnings and Precautions(5.1) ]. 5 WARNINGS AND PRECAUTIONS Seizures and neuropathy have been reported. Discontinue tinidazole tablets if abnormal neurologic signs develop ( 5.1 ) Vaginal candidiasis may develop with tinidazole tablets and require treatment with an antifungal agent ( 5.2 ) Use tinidazole tablets with caution in patients with blood dyscrasias. Tinidazole tablets may produce transient leukopenia and neutropenia ( 5.3 , 7.3 ) 5.1 Potential for genotoxicity and carcinogenicity Carcinogenicity has been seen in mice and rats treated chronically with nitroimidazole derivatives, which are structurally related to tinidazole [see Nonclinical Toxicology (13.1) ]. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. 4 CONTRAINDICATIONS The use of tinidazole is contraindicated: In patients with a previous history of hypersensitivity to tinidazole or other nitroimidazole derivatives. Reported reactions have ranged in severity from urticaria to Stevens-Johnson syndrome [ see Adverse Reactions (6.1 , 6.2) ]. In patients with Cockayne syndrome.