Drug profile
Tinidazole
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Trichomoniasis: a single 2 g oral dose taken with food.
Source: US FDA label for tinidazole (Tindamax), section 'dosage and
administration', retrieved 2026-08-29
- Treat sexual partners with the same dose and at the same time ( 2.3 ) Giardiasis:
Adults: a single 2 g dose taken with food.
Source: US FDA label for tinidazole (Tindamax), section 'dosage and
administration', retrieved 2026-08-29
- Pediatric patients older than three years of age: a single dose of 50 mg/kg (up to
2 g) with food ( 2.4 ) Amebiasis, Intestinal: Adults: 2 g per day for 3 days with
food.
Source: US FDA label for tinidazole (Tindamax), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- Other than for use in the treatment of giardiasis and amebiasis in pediatric
patients older than three years of age, safety and effectiveness of tinidazole in
pediatric patients have not been established. Pediatric Administration: For those
unable to swallow tablets, tinidazole tablets may be crushed in artificial cherry
syrup, to be taken with food [see Dosage and Administration ( 2.2 )].
Source: US FDA label for tinidazole (Tindamax), section 'pediatric use', retrieved
2026-08-29
- Trichomoniasis: a single 2 g oral dose taken with food. Treat sexual partners with
the same dose and at the same time ( 2.3 ) Giardiasis: Adults: a single 2 g dose
taken with food. Pediatric patients older than three years of age: a single dose
of 50 mg/kg (up to 2 g) with food ( 2.4 ) Amebiasis, Intestinal: Adults: 2 g per
day for 3 days with food.
Source: US FDA label for tinidazole (Tindamax), section 'dosage and
administration', retrieved 2026-08-29
- Pediatric patients older than three years of age: a single dose of 50 mg/kg (up to
2 g) with food ( 2.4 ) Amebiasis, Intestinal: Adults: 2 g per day for 3 days with
food.
Source: US FDA label for tinidazole (Tindamax), section 'dosage and
administration', retrieved 2026-08-29
RENAL IMPAIRMENT
- In general, dose selection for an elderly patient should be cautious, reflecting
the greater frequency of decreased hepatic, renal, or cardiac function, and of
concomitant disease or other drug therapy. 8.6 Renal Impairment Because the
pharmacokinetics of tinidazole in patients with severe renal impairment (CrCL < 22
mL/min) are not significantly different from those in healthy subjects, no dose
adjustments are necessary in these patients.
Source: US FDA label for tinidazole (Tindamax), section 'use in specific
populations', retrieved 2026-08-29
HEPATIC IMPAIRMENT
- Patients undergoing hemodialysis: If tinidazole is administered on the same day as
and prior to hemodialysis, it is recommended that an additional dose of tinidazole
equivalent to one-half of the recommended dose be administered after the end of
the hemodialysis [see Clinical Pharmacology ( 12.3 )]. 8.7 Hepatic Impairment
There are no data on tinidazole pharmacokinetics in patients with impaired hepatic
function.
Source: US FDA label for tinidazole (Tindamax), section 'use in specific
populations', retrieved 2026-08-29
PREGNANCY
- Teratogenic effects: Pregnancy Category C The use of tinidazole in pregnant
patients has not been studied.
Source: US FDA label for tinidazole (Tindamax), section 'pregnancy', retrieved
2026-08-29
- Since tinidazole crosses the placental barrier and enters fetal circulation it
should not be administered to pregnant patients in the first trimester.
Source: US FDA label for tinidazole (Tindamax), section 'pregnancy', retrieved
2026-08-29
- Embryo-fetal developmental toxicity studies in pregnant mice indicated no embryo-
fetal toxicity or malformations at the highest dose level of 2,500 mg/kg
(approximately 6.3-fold the highest human therapeutic dose based upon body surface
area conversions).
Source: US FDA label for tinidazole (Tindamax), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING
- Tinidazole is excreted in breast milk in concentrations similar to those seen in
serum.
Source: US FDA label for tinidazole (Tindamax), section 'nursing mothers',
retrieved 2026-08-29
- Tinidazole can be detected in breast milk for up to 72 hours following
administration.
Source: US FDA label for tinidazole (Tindamax), section 'nursing mothers',
retrieved 2026-08-29
- Interruption of breast-feeding is recommended during tinidazole therapy and for 3
days following the last dose.
Source: US FDA label for tinidazole (Tindamax), section 'nursing mothers',
retrieved 2026-08-29