Jane S. Ricciuti, RPh, MS


July 13, 2004

In This Article

Anti-infective Agents

(tinidazole) Tablets

Manufacturer: Presutti Laboratories, Inc.,

Drug Approval Classification: Original New Drug Application (Approval Date: 5/17/04)

Indication: Tindamax (tinidazole) oral tablets are indicated for the treatment of:

  • Trichomoniasis caused by T vaginalis in both female and male patients. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent reinfection.

  • Giardiasis caused by G duodenalis (also termed G lamblia) in both adults and pediatric patients older than three years of age.

  • Amebiasis caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cyst passage.

Dosing: It is recommended that tinidazole be taken with food to minimize the incidence of epigastric discomfort and other gastrointestinal side effects. Food does not affect the oral bioavailability of tinidazole.

Dosage is based on indicated treatment:

  • Trichomoniasis: In both females and males, a single 2 g oral dose. Since trichomoniasis is a sexually transmitted disease, sexual partners should be treated with the same dose and at the same time.

  • Giardiasis: In adults, a single 2 g dose. In pediatric patients older than three years of age, a single dose of 50 mg/kg (up to 2 g).

  • Amebiasis:

    • Intestinal: In adults, a 2-g dose per day for 3 days. In pediatric patients older than 3 years of age, 50 mg/kg/day (up to 2 g per day) for 3 days.

    • Amebic liver abscess: In adults, a 2 g dose per day for 3-5 days. In pediatric patients older than three years of age, 50 mg/kg/day (up to 2 g per day) for 3-5 days.

Clinical Summary: Tinidazole is an antiprotozoal agent in the nitroimidazole class similar to metronidazole. The labeling for tinidazole includes a black box warning to call attention to the risk of carcinogenicity that has been seen in mice and rats treated chronically with metronidazole. No data have been reported for tinidazole.

Tinidazole demonstrates activity both in vitro and in clinical infections against the following protozoa:

  • Trichomonas vaginalis

  • Giardia duodenalis (also termed G lamblia)

  • Entamoeba histolytica

Adverse Effects: More than 3600 patients have been treated with a single 2-g dose in clinical trials. Adverse effects were reported by 11% of patients. In the multiday-dosing clinical trials, adverse events were reported by 13.8% of patients. Adverse events were generally mild and self-limiting. The incidence of gastrointestinal adverse events was greater than that observed in other categories, including metallic taste, nausea, and anorexia.

Pharmacokinetics: A 2-g oral tinidazole pharmacokinetic study resulted in a mean peak plasma concentration (Cmax) of 47.7 (± 7.5) micrograms/mL with a mean time to peak concentration (Tmax) of 1.6 (± 0.7) hours and a mean area under the plasma concentration-time curve (AUC) of 901.6 (± 126.5) micrograms hr/mL at 72 hours. Tinidazole is distributed into virtually all tissues and body fluids and also crosses the blood-brain barrier. The apparent volume of distribution is about 50 liters. Plasma protein binding of tinidazole is 12%. Tinidazole crosses the placental barrier and is secreted in breast milk. The plasma half-life is 12-14 hours.

Tinidazole, like metronidazole, is significantly metabolized in humans prior to excretion. Tinidazole is partly metabolized by oxidation, hydroxylation and conjugation. Tinidazole is biotransformed mainly by CYP3A4. In an in vitro metabolic drug interaction study, tinidazole concentrations of up to 75 micrograms/mL did not inhibit the enzyme activities of CYP1A2, CYP2B6, CYP2C9, CYP2D6, CYP2E1 and CYP3A4.


Tindamax (tinidazole) Tablets Labeling


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