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Triclabendazole

Medically reviewed by Drugs.com. Last updated on Sep 18, 2020.

Pronunciation

(try KLUH bend uh zole)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Egaten: 250 mg [scored; contains corn starch]

Brand Names: U.S.

  • Egaten

Pharmacologic Category

  • Anthelmintic

Pharmacology

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.

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

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).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

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).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

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

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>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.

Monitoring Parameters

Monitor ECG in patients with a history of known or suspected QT prolongation or when used with concomitant QTc-prolonging drugs.

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

What is this drug used for?

• It is used to treat a certain parasite infection (fascioliasis).

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Abdominal pain

• Diarrhea

• Nausea

• Vomiting

• Lack of appetite

• Sweating a lot

• Dizziness

• Headache

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Shortness of breath

• Fast heartbeat

• Abnormal heartbeat

• Passing out

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.