Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Egaten: 250 mg [scored; contains corn starch]
Pharmacology
Mechanism of Action
Triclabendazole is an anthelmintic against Fasciola species. In vitro data suggest that triclabendazole and its active metabolites are absorbed by the tegument of the immature and mature worms, leading to a decrease of the resting membrane potential, inhibition of motility, disruption of the surface as well as ultrastructure that include inhibition of spermatogenesis and vitelline cells.
Pharmacokinetics/Pharmacodynamics
Absorption
Increased absorption with food (Lecaillon 1998)
Distribution
Vd: ~1 L/kg
Metabolism
Primarily metabolized by CYP1A2 (~64%) into its active sulfoxide metabolite and to a lesser extent by CYP2C9, CYP2C19, CYP2D6, CYP3A, and FMO. Sulfoxide metabolite is further metabolized primarily by CYP2C9 to the active sulfone metabolite.
Time to Peak
Tmax: 3.0 ± 0.4 hours (El-Tantawy 2007)
Half-Life Elimination
Triclabendazole: 8 hours; Sulfoxide metabolite: 14 hours; Sulfone metabolite: 11 hours
Protein Binding
Triclabendazole: 96.7%; Sulfoxide metabolite: 98.4%; Sulfone metabolite: 98.8% in human plasma
Use: Labeled Indications
Fascioliasis: Treatment of fascioliasis in patients ≥6 years of age
Contraindications
Hypersensitivity to triclabendazole, other benzimidazole derivatives, or to any component of the formulation
Dosage and Administration
Dosing: Adult
Fascioliasis: Oral: 10 mg/kg every 12 hours for 2 doses (the 250 mg tablets are scored and divisible into two equal halves of 125 mg; if the dosage cannot be adjusted exactly, round the dose upwards).
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Fascioliasis: Children ≥6 years and Adolescents: Oral: 10 mg/kg/dose every 12 hours for 2 doses. Note: Round dose up to the nearest half (125 mg) or whole tablet (250 mg).
Administration
Oral: Administer with food. Tablets may be swallowed whole or divided in half and taken with water or crushed and administered with applesauce. The crushed tablet mixed with applesauce is stable for up to 4 hours.
Storage
Store below 30°C (86°F) in the original container.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
>10%:
Central nervous system: Headache (14%)
Dermatologic: Hyperhidrosis (25%), urticaria (11%)
Gastrointestinal: Abdominal pain (93%), decreased appetite (18%), nausea (18%)
1% to 10%:
Dermatologic: Pruritus (4%)
Gastrointestinal: Diarrhea (7%), vomiting (7%)
Hepatic: Increased serum bilirubin (7%), increased serum aspartate aminotransferase (5%), increased serum alkaline phosphatase (4%), increased serum alanine aminotransferase (3%)
Neuromuscular & skeletal: Musculoskeletal chest pain (4%)
Frequency not defined: Hepatic: Increased liver enzymes
Warnings/Precautions
Concerns related to adverse effects:
- Hepatic toxicity: Transient increases in liver enzymes and total bilirubin have been reported in patients receiving triclabendazole.
- QTc Prolongation: Transient QTc interval prolongation has been observed in animals; monitor ECG in patients with a history of known or suspected QTc prolongation or when used with concomitant QTc-prolonging drugs.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Monitoring Parameters
Monitor ECG in patients with a history of known or suspected QT prolongation or when used with concomitant QTc-prolonging drugs.
Pregnancy
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies.
Information related to the use of triclabendazole in pregnancy is limited (Alatoom 2008).
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience abdominal pain, diarrhea, nausea, vomiting, lack of appetite, sweating a lot, dizziness, or headache. Have patient report immediately to prescriber shortness of breath, fast heartbeat, abnormal heartbeat, or passing out (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
