DIQTA 1.0: Drug-Induced QT Prolongation Atlas

TRICLABENDAZOLE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Ambiguous

Severity Score:1.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

WARNINGS AND PRECAUTIONS
QT Prolongation
Transient prolongation of the mean QTc interval was noted on the electrocardiographic recordings in dogs [see Nonclinical Toxicology (13.2)]. Monitor ECG in patients with a history of prolongation of the QTc interval or a history of symptoms compatible with a long QT interval or when EGATEN is used in patients who receive drugs that prolong the QT interval.
PATIENT COUNSELING INFORMATION
QT Prolongation
Advise patients with a history of prolongation of the QTc interval or a history of symptoms compatible with a long QT interval or when EGATEN is used in patients who receive drugs that prolong the QT interval that their ECGs will need to be monitored [see Warnings and Precautions (5.1)].
NONCLINICAL TOXICOLOGY
Animal Toxicology and/or Pharmacology
Dietary administration of triclabendazole at a dose of 39 mg/kg/day (1.1-times the MRHD based on body surface area comparison) was associated with a transient increase in the QT and QTc intervals on weeks 5 and 9 in some dogs in a 13-week study resulting in QT (QTc) intervals of 212-227 (318-338) msec in the 39 mg/kg dose group (adjusted) compared to 190-193 (280-297) msec in controls. At Week 13, no statistically significant differences were noted between the treatment and control groups.
Additionally, when dogs were administered triclabendazole at a single dose of 40 or 100 mg/kg (1.1 or 2.7 times the MRHD based on body surface area comparison), increase in QTc intervals was observed resulting in QTc intervals of 217-247 msec compared to a normal (historical control) of 193-231 msec. However, plasma levels of the sulfone metabolite in dogs (which is thought to mediate QTc prolongation) was about 100-500 times the plasma level of the sulfone metabolite measured in human plasma.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24092

Other ADRs

38381587

Odds Ratio = N/A

Drug Property Information

ATC Code(s):

P02BX04 - triclabendazole

P02BX - Other antitrematodal agents
P02B - ANTITREMATODALS
P02 - ANTHELMINTICS
P - "ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS"

Active Ingredient:TRICLABENDAZOLE

Active Ingredient UNII:4784C8E03O

Drugbank ID:DB12245

PubChem Compound:50248

CTD ID:D000077682

PharmGKB:

CAS Number:68786-66-3

Dosage Form(s):tablet

Route(s) Of Administrator:oral

Daily Dose:

Chemical Structure:

SMILE Code:
CSC1=NC2=C(N1)C=C(Cl)C(OC1=CC=CC(Cl)=C1Cl)=C2

Reference

N/A