Tindamax (tinidazole) Has a Significantly Lower Side Effect Rate

Excellent tolerability plus low incidence of GI side effects

Tindamax^® is a second-generation nitroimidazole. While chemically related to metronidazole, it has a more favorable pharmacokinetic profile, longer plasma half-life, and significantly reduced incidence of side effects.

Pharmacokinetic profile: plasma half-life¹

Chart illustrating the plasma half-life of tinidazole (12-14 hours) vs metronidazole (6-8 hours).

Figure 1

In bacterial vaginosis

In a large-scale study of tinidazole for treatment of bacterial vaginosis, both oral dosing options (2 g × 2 days and 1 g × 5 days) provided effective therapy with a low incidence of nausea and other GI side effects typically associated with metronidazole therapy.²

Tolerability comparison: Tindamax^® vs placebo
Side effect profile	Tinidazole 1 g qd for 5 days	Tinidazole 2 g qd for 2 days	Placebo	Total
Number of participants	77	78	80	235
Any gastrointestinal symptom(s)	19 (24.7)	25 (32.1)	18 (22.5)	62 (26.0)
Dysgeusia (bad or metallic taste in mouth)	20 (26.0)^*	31 (39.7)^*	4 (5.0)	55 (23.4)
Headache	9 (11.7)	14 (17.9)	13 (16.3)	36 (15.3)
Nausea	8 (10.4)	14 (17.9)†	6 (7.5)	28 (11.9)
Abdominal discomfort	7 (9.1)	4 (5.1)	6 (7.5)	17 (7.2)
Vulvovaginal discomfort	7 (9.1)	7 (9.0)	2 (2.5)	16 (6.8)
Genital pruritus (female)	6 (7.8)	5 (6.4)	2 (2.5)	13 (5.5)
Fatigue	1 (1.3)	4 (5.1)	6 (7.5)	11 (4.7)
Dizziness	4 (5.2)	4 (5.1)	1 (1.3)	9 (3.8)
Vaginal discharge	2 (2.6)	3 (3.8)	3 (3.8)	8 (3.4)
Urine abnormality	3 (3.9)	4 (5.1)	1 (1.3)	8 (3.4)
Stomach discomfort	2 (2.6)	3 (3.8)	2 (2.5)	7 (3.0)
Vaginal candidiasis	4 (5.2)	2 (2.6)	1 (1.3)	7 (3.0)
Diarrhea	1 (1.3)	2 (2.6)	2 (2.5)	5 (2.1)
Vaginal odor	1 (1.3)	1 (1.3)	3 (3.8)	5 (2.1)
Adverse events reported in more than 2% of participants, tinidazole treatment of bacterial vaginosis, intent-to-treat population² Data are n (%). A patient was counted, at most, once per preferred term, system organ class, or any event. * P<0.001 compared with placebo. † P<0.5 compared with placebo.				Table 1

In trichomoniasis

Tinidazole also demonstrated excellent tolerability during a study evaluating 2-g × 1-day dosing for trichomoniasis³ and was found to be a "potent and well-tolerated option" vs metronidazole in another TV treatment study.⁴

Incidence of GI adverse events: Pooled data from 3 comparative studies^3,5,6

Chart summarizing GI adverse events. Results represent pooled data from 3 studies comparing single-dose 2 g tinidazole vs 2 g metronidazole in patients with trichomoniasis. Nausea, vomiting, and diarrhea were common events reported in all 3 studies. Other events included anorexia, bitter taste, abdominal pain, giddiness, general weakness, constipation, pressure over stomach, pruritus, vertigo, and dark urine.

Figure 2

Simplify dosing and reduce complications

With the convenience of oral treatment, short dosing schedules, and reduced complications from secondary vaginal candidiasis, Tindamax^® offers a simple, effective solution to treating bacterial vaginosis and trichomoniasis as well as GI infections.

Research shows that patients prefer oral therapy vs vaginal creams in the treatment of BV¹
Compared to metronidazole, Tindamax^® therapy requires fewer than half the doses required for effective BV treatment²
Tindamax^® targets infection-causing pathogens while sparing protective lactobacilli; this results in a lower risk of secondary vaginal candidiasis, a treatment complication that can increase patient return rates

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

Data on file. Mission Pharmacal Company.
Livengood CH 3rd, Ferris DG, Wiesenfeld HC, Hillier SL, Soper DE, Nyirjesy P, Marrazzo J, Chatwani A, Fine P, Sobel J, Taylor SN, Wood L, Kanalas JJ. Effectiveness of two tinidazole regimens in treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):302-9.
Manorama HT, Shenoy DR. Single-dose oral treatment of vaginal trichomoniasis with tinidazole and metronidazole. J Int Med Res. 1978;6(1):46-9.
Nanda N, Michel RG, Kurdgelashvili G, Wendel KA. Trichomoniasis and its treatment. Expert Rev Anti Infect Ther. 2006 Feb;4(1):125-35.
Anjaeyulu R, Gupte SA, Desai DB. Single-dose treatment of trichomonal vaginitis: a comparison of tinidazole and metronidazole. J Int Med Res. 1977;5(6):438-41.
Weidenbach A, Leix H. Treatment of trichomonal vaginitis with a single dose of tinidazole. Curr Med Res Opin. 1974;2(3):147-52.