MINTEZOL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MINTEZOL (MINTEZOL).
Thiabendazole inhibits the mitochondrial fumarate reductase system in susceptible helminths, disrupting energy metabolism.
| Metabolism | Extensively metabolized in the liver via hydroxylation, primarily by cytochrome P450 enzymes, with subsequent glucuronidation. |
| Excretion | Renal: 90% within 24 hours (5% unchanged, 85% as metabolites). Fecal: <10%. |
| Half-life | Terminal elimination half-life: 2-8 hours (mean 4 hours). Hepatic impairment prolongs; dose adjustment recommended. |
| Protein binding | 93% bound to plasma proteins (mainly albumin). |
| Volume of Distribution | 2-4 L/kg; extensively distributed into tissues including brain, liver, and muscles. |
| Bioavailability | Oral: >90% (well absorbed from GI tract). |
| Onset of Action | Oral: 1-2 hours for anthelmintic effect. |
| Duration of Action | Single dose maintains therapeutic levels for 12-24 hours. Repeat dosing often required for complete cure. |
50 mg/kg/day orally in 2-3 divided doses, maximum 3 g/day, for 2-3 days.
| Dosage form | SUSPENSION |
| Renal impairment | No specific guidelines; use caution in severe renal impairment (CrCl <10 mL/min) with potential for increased toxicity; consider dose reduction or extended interval. |
| Liver impairment | Contraindicated in Child-Pugh class C; for Child-Pugh A and B, use with caution and monitor for adverse effects, no specific dose reduction guidelines. |
| Pediatric use | 50 mg/kg/day orally in 2 divided doses, maximum 3 g/day, for 2-3 days (age >1 year); not recommended for children <1 year. |
| Geriatric use | No specific dose adjustment; use lowest effective dose due to increased risk of CNS and gastrointestinal side effects; monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MINTEZOL (MINTEZOL).
| Breastfeeding | Excreted into breast milk in small amounts; M/P ratio unknown. Potential for adverse effects in nursing infants (e.g., nausea, vomiting). Weigh benefits against risks; consider alternative anthelmintics with better safety profiles (e.g., albendazole). |
| Teratogenic Risk | FDA Pregnancy Category C. First trimester: avoid use; associated with increased risk of congenital anomalies (cranial, skeletal) in animal studies. Second and third trimesters: use only if clearly needed; potential risk of fetal bradycardia and CNS depression. Limited human data, but risk-benefit assessment required. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to thiabendazole or any component of the formulation; patients with hepatic disease; concurrent administration with drugs known to cause hepatotoxicity.
| Precautions | May cause serious hepatic injury including cholestatic jaundice and hepatic necrosis; monitor liver function tests. Associated with severe skin reactions (Stevens-Johnson syndrome, erythema multiforme). Avoid in patients with hepatic disease. May cause CNS effects such as dizziness and seizures. Use with caution in renal impairment. |
Loading safety data…
| Fetal Monitoring | Monitor maternal hepatic function (LFTs) and renal function. Fetal monitoring: assess heart rate for bradycardia during prolonged therapy. Consider ultrasound for fetal growth and anatomy if first-trimester exposure. |
| Fertility Effects | No specific human data on fertility impairment. Animal studies have shown no adverse effects on fertility at clinically relevant doses. Theoretical risk of hormonal disruption due to SHBG binding, but clinical significance unknown. |