Tindamax (tinidazole) Efficacy and Dosing for Trichomoniasis

Tindamax^® delivers effective treatment in a single dose

Recommended as one of the drugs of choice for treatment of trichomoniasis by the Centers for Disease Control and Prevention (CDC), Tindamax^® has demonstrated cure rates of 92% to 100% in both women and men.

Demonstrated efficacy in clinical trials worldwide

The use of tinidazole (2-g single oral dose) in trichomoniasis has been well documented in 34 published reports from the world literature.

Assessment by culture. In 4 published, blinded, randomized, comparative studies of the 2-g tinidazole single oral dose, efficacy was assessed by culture at time points posttreatment ranging from 1 week to 1 month. Reported cure rates ranged from 92% (37/40) to 100% (65/65) (n=172 total subjects).
Assessment by wet mount. In another group of 4 published, blinded, randomized comparative studies, efficacy was assessed by wet mount between 7-14 days posttreatment. Reported cure rates ranged from 80% (8/10) to 100% (16/16) (n=116 total subjects).

Trichomoniasis cure rates with Tindamax^®

Chart summarizing cure rates following treatment with Tindamax<sup class='reg'>®</sup>. 96% cure rate was achieved with 2-gram stat oral dosing in female patients. 94% cure rate was achieved with 2-gram stat oral dosing in male patients.

* Average of 4 studies with cure rate range of 92%-100% at 1 week to 1 month postdosing.^1-4

** Average of 4 studies with cure rate range of 83%-100%.^5-8

Dosing recommendations for trichomoniasis
Indication	Adults	Children
Trichomoniasis	2 g single dose	n/a
§ CI: confidence interval p-values for both Tindamax^® regimens vs. placebo for therapeutic, clinical and Nugent score cure rates for both 2 and 5 days <0.001

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

O-Prasertsawat P, Jetsawangsri T. Split-dose metronidazole or single-dose tinidazole for the treatment of vaginal trichomoniasis. Sex Transm Dis. 1992 Sep-Oct;19(5):295-7.
Gabriel G, Robertson E, Thin RN. J Int Med Res. 1982;10(2):129-30. J Int Med Res. 1982;10(2):129-30.
Hillström L, Pettersson L, Pálsson E, Sandström SO. Comparison of ornidazole and tinidazole in single-dose treatment of trichomoniasis in women. Br J Vener Dis. 1977 Jun;53(3):193-4.
Aimakhu V. Vaginal trichomoniasis: one stat dose of tinidazole compared with a seven day course of metronidazole. W Afr Med J. 1975 Apr;97-100.
Beric B, Pribicevic V, Djordjevic M, Pavlovic N. Clinical studies on the therapeutic effect of tinidazole ("Fasigyn") during treatment of urogenital trichomonas infections in women and men (with comparative laboratory studies on the effect of metronidazole and tinidazole) Zentralbl Gynakol. 1978;100(24):1594-9.
Massa M, Arias B, Subiabre V, Rojo M. Ensayo terapeutico de la infeccion por Trichomonas vaginalis en el hombre mediate una dosis unica de tinidazol. Bol Chile Parasitol. 1976 Jan-Jun;31(1-2):46-7.
Wallin J, Forsgren A. Tinidazole--a new preparation for T. vaginalis infections. II. Clinical evaluation of treatment with a single oral dose. Br J Vener Dis. 1974 Apr;50(2):148-50.
Fantini E, Leguen J, Kellemberger J, Rubi R. Treatment of trichomoniasis in males with a single dose of a new imidazole derivative. Sem Med. 1974 Jul;46-50.