QTMeds

Drug Database Monograph

EGATEN 250 mg

✓ VERIFIED BY DOCTOR

Active Ingredient: TRICLABENDAZOLE

QTc Interval Status:
prolongation

Clinical Description (Database Summary)

Triclabendazole is an anthelmintic agent used for human fascioliasis that demonstrates dose-dependent prolongation of cardiac repolarization exceeding regulatory thresholds. In an ICH E14 thorough QT crossover study in 45 healthy participants with moxifloxacin positive control, therapeutic dosing (10 mg/kg b.i.d. for 1 day) produced a peak placebo-corrected mean QTcF increase of 9.2 ms (with upper 90% confidence bounds exceeding 10 ms). Supratherapeutic dosing (10 mg/kg b.i.d. for 3 days) led to a marked peak increase of 21.7 ms at 4 hours postdose, coinciding with sulfoxide metabolite peak levels. ECG monitoring is recommended, particularly with prolonged courses or concomitant QT-prolonging drugs.

Scientific Sources / References

https://doi.org/10.1111/cts.13564

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