For the treatment of trichomoniasis caused by <i>T. vaginalis</i> in both female and male patients. Also for the treatment of giardiasis caused by <i>G. duodenalis</i> in both adults and pediatric patients older than three years of age and for the treatment of intestinal amebiasis and amebic liver abscess caused by <i>E. histolytica</i> in both adults and pediatric patients older than three years of age.
Tinidazole is an antiprotozoal agent. The nitro group of tinidazole is reduced by cell extracts of <i>Trichomonas</i>. The free nitro radical generated as a result of this reduction may be responsible for the antiprotozoal activity. The mechanism by which tinidazole exhibits activity against <i>Giardia</i> and <i>Entamoeba</i> species is not known.
There are no reported overdoses with tinidazole in humans. In acute studies with mice and rats, the LD 50 for mice was generally > 3,600 mg/kg for oral administration and was > 2,300 mg/kg for intraperitoneal administration. In rats, the LD 50 was > 2,000 mg/kg for both oral and intraperitoneal administration.
Rapidly and completely absorbed under fasting conditions. Administration with food results in a delay in T<sub>max</sub> of approximately 2 hours and a decline in C<sub>max</sub> of approximately 10% and an AUC of 901.6 &plusmn; 126.5 mcg hr/mL.
Elimination half-life is 13.2 &plusmn; 1.4 hours. Plasma half-life is 12 to 14 hours.
Tinidazole crosses the placental barrier and is secreted in breast milk. Tinidazole is excreted by the liver and the kidneys. Tinidazole is excreted in the urine mainly as unchanged drug (approximately 20-25% of the administered dose). Approximately 12% of the drug is excreted in the feces.
* 50 L