Tindamax® offers a potent, targeted therapy
Tinidazole is a widely used, highly effective treatment for giardiasis and amebiasis as well as amebic liver abscess, an extraintestinal infection caused by the same organism that causes amebiasis.
Giardiasis
Tinidazole (2-g single dose) use in giardiasis has been documented in 19 published reports from world literature involving both adult and pediatric patients.
- In 8 controlled studies of 619 subjects, 229 were given a 2-g x 1-day (50 mg/kg x 1- day in pediatric patients) oral dose of tinidazole. Reported cure rates for tinidazole ranged from 80% (40/50) to 100% (15/15).
- In 3 of the above trials, the 2-g/1-day dose of tinidazole was compared to 2- or 3-day regimens of varying doses of metronidazole. Reported cure rates for metronidazole ranged from 76% (19/25) to 93% (14/15). Data comparing a single 2-g dose of tinidazole to the commonly recommended 5-7 day dosing for metronidazole are limited.
Intestinal amebiasis
Tinidazole use in intestinal amebiasis has been documented in 26 published reports from world literature.
- Most reports utilized tinidazole 2 g/day x 3 days.
- In 3 of the above trials, the 2-g/1-day dose of tinidazole was compared to 2- or 3-day regimens of varying doses of metronidazole. Reported cure rates for metronidazole ranged from 76% (19/25) to 93% (14/15). Data comparing a single 2-g dose of tinidazole to the commonly recommended 5-7 day dosing for metronidazole are limited.
Amebic liver abscess
Tinidazole use in amebic liver abscess has been documented in 18 published reports from world literature involving over 470 patients.
- Most reports utilized tinidazole 2 g/day x 2-5 days.
- In 7 published, randomized, controlled studies (1 double-blind, 1 single-blind, 5 open-label) using the above dose accompanied by aspiration of the liver abscess when clinically necessary, reported cure rates among 133 subjects ranged from 81% (17/21) to 100% (16/16). Four of these studies utilized at least 3 days of tinidazole.
| Adults | Children > 3 years of age | |
|---|---|---|
| Giardiasis | 2 g single dose | 50 mg/kg single dose (up to 2 g) |
| Amebiasis | 2 g QD × 3 days | 50 mg/kg QD × 3 days (up to 2 g/day) |
| Amebic liver abscess | 2 g QD × 3-5 days | 50 mg/kg QD × 3–5 days (up to 2 g/day) |
Cure rates with Tindamax® in GI-related infections
† 8 randomized, comparative studies.1-7 Cure rates ranged from 80%-100%.
‡ 4 randomized, comparative studies.1,8-10 Cure rates ranged from 86%-93%.
§ 7 randomized, comparative studies;1,11-16 4 studies utilized at least 3 days of tinidazole. Cure rates ranged from 81%-100%.
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
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- Kyrönseppä H, Pettersson T. Treatment of giardiasis: relative efficacy of metronidazole as compared with tinidazole. Scand J Infect Dis. 1981;13(4):311-2.
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- Kundu SC, Sen A, Bhattacherjee TD, Dasgupta DP, Majumdar S, Moorkerjee PK, Mukerjee AB. Comparative evaluation of tinidazole and metronidazole in the treatment of amoebic liver abscess. J Ind Med Assoc. 1977 Sep 16;69(6):127-9.
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- Khokhani RC, Garud AD, Deodhar KP, Sureka SB, Kulkarni M, Damle VB. Comparative study of tinidazole and metronidazole in amoebic liver abscess. Curr Med Res Opin. 1977;5(2):161-3.
- Mathur SN, Itigi A, Krishnaveni, Rai V. Tinidazole and metronidazole in the treatment of amoebic liver abscess. J Int Med Res. 1977;5(6):429-33.
- Simjee AE, Gathiram V, Jackson TF, Khan BF. A comparative trial of metronidazole v. tinidazole in the treatment of amoebic liver abscess. S Afr Med J. 1985 Dec 21;68(13):923-4.
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