Tinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole.
Tindamax pink oral tablets contain 250 mg or 500 mg of tinidazole. Inactive ingredients include croscarmellose sodium, FD&C Red 40 lake, FD&C Yellow 6 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized corn starch, titanium dioxide, and triacetin.
How supplied
Tindamax® 250 mg tablets are pink, round, scored tablets, with TM debossed on one side and 250 on the other, supplied in bottles with child-resistant caps as:
NDC 0178-8250-40 Bottle of 40
Tindamax® 500 mg tablets are pink, oval, scored tablets, with TM debossed on one side and 500 on the other, supplied in bottles with child-resistant caps as:
NDC 0178-8500-60 Bottle of 60
NDC 0178-8500-20 Bottle of 20
Professional samples
NDC 0178-8500-02 Bottle of 2
Storage
Store at controlled room temperature 20-25º C (68-77º F); excursions permitted to 15-30º C (59-86º F) [see USP]. Protect contents from light.
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
Health Professional Resources
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:
The Mission Pharmacal family of products
Learn more about innovative therapies including...
CitraNatal®Calcium citrate with vital nutrients for mother and baby » Ferralet® 90The iron therapy with biocomplementary absorption » Urocit®-KKidney stone therapy with wax-matrix delivery for slow, sustained release »
