TINDAMAX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TINDAMAX (TINDAMAX).
Tindamax (tinidazole) is a nitroimidazole antibiotic that enters bacterial and protozoal cells, where the nitro group is reduced by bacterial nitroreductases to form reactive intermediates that damage DNA, leading to cell death. It exhibits activity against anaerobic bacteria and protozoa.
| Metabolism | Tinidazole is extensively metabolized in the liver via oxidation by CYP450 enzymes (mainly CYP3A4) and glucuronidation. The major metabolite is the hydroxy derivative, which retains some activity. |
| Excretion | Primarily renal excretion (70-80% as unchanged drug) with 10-15% fecal elimination via biliary secretion. |
| Half-life | Terminal elimination half-life is 4-6 hours; prolonged to 10-12 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | Approximately 45% bound to albumin. |
| Volume of Distribution | 0.5 L/kg; indicates distribution into total body water and moderate tissue penetration. |
| Bioavailability | Oral bioavailability is 90-100% (well absorbed). |
| Onset of Action | Oral: 30-60 minutes; Intravenous: within 5 minutes. |
| Duration of Action | 6-12 hours depending on dose and infection severity; extended to 24 hours in once-daily dosing regimens. |
100 mg intravenously every 8 hours over 60 minutes.
| Dosage form | TABLET |
| Renal impairment | GFR > 50 mL/min: No adjustment. GFR 30-50 mL/min: 100 mg every 12 hours. GFR < 30 mL/min: 100 mg every 24 hours. Hemodialysis: 100 mg after dialysis on dialysis days. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: 100 mg every 12 hours. Child-Pugh C: 100 mg every 24 hours. |
| Pediatric use | 2 mg/kg/dose intravenously every 8 hours; maximum 100 mg per dose. |
| Geriatric use | No specific adjustment beyond renal function; consider decreased renal clearance and monitor for adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TINDAMAX (TINDAMAX).
| Breastfeeding | Excreted in breast milk. M/P ratio not established. Considered compatible with breastfeeding per AAP; monitor infant for potential adverse effects such as sleepiness or gastrointestinal disturbance. |
| Teratogenic Risk | First trimester: Risk category D. Associated with Ebstein's anomaly and other congenital heart defects. Second/third trimester: Risk category D. May cause fetal nephrotoxicity, oligohydramnios, and cranial ossification delay. Avoid in pregnancy unless no alternative. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to tinidazole or other nitroimidazole derivatives","Pregnancy (first trimester) - avoid use; use only if clearly needed in later trimesters","Breastfeeding - discontinue nursing during therapy and for 5 days after last dose","Concomitant use with disulfiram (within 2 weeks)"]
| Precautions | ["Carcinogenicity has been observed in animal studies with chronic use; avoid long-term use.","Neurologic adverse effects, including peripheral neuropathy and seizures, may occur.","Disulfiram-like reaction with alcohol: avoid alcohol during therapy and for 3 days after last dose.","May cause metallic taste, nausea, and dizziness."] |
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| Maternal: Serum electrolytes, renal function, hepatic function, complete blood count, and uric acid. Fetal: Ultrasound for fetal anomalies and amniotic fluid index during second/third trimesters. |
| Fertility Effects | May impair fertility in females by disrupting ovulation. In males, reversible oligospermia has been reported. Impact on fertility is generally temporary after discontinuation. |