Triclabendazole

What is Triclabendazole?

Triclabendazole (EGATEN) is an anthelmintic used to treat fascioliasis in patients 6 years of age and older.

What are the uses of this medicine?

• This medicine is used to treat fascioliasis in patients 6 years of age and older.
• Fascioliasis is an infectious disease caused by the parasitic flatworms Fasciola hepatica and gigantica, also known as liver flukes.
• The initial infection is characterized by fever, abdominal pain, and increase elevation in liver enzymes.
• Over months to years, the disease may become chronic with occasional pain in the abdomen, jaundice, anemia, and blockage of bile ducts where adult flukes live.
• During this phase, parasite eggs are present in the stool.

How does this medicine work?

• Triclabendazole is an anthelmintic against Fasciola species.
• The mechanism by which triclabendazole exhibits its effect against Fasciola species is not fully elucidated.
• Studies in vitro and/or in infected animals suggest that triclabendazole and its active metabolites (sulfoxide and sulfone) are absorbed by the tegument of the immature and mature worms, leading to a decrease of the resting membrane potential, inhibition of tubulin function as well as protein and enzyme synthesis.
• These metabolic disturbances are associated with inhibition of motility, disruption of the surface as well as ultrastructure that includes inhibition of spermatogenesis and vitelline cells.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to triclabendazole and/or to other benzimidazole derivatives or to any of the excipients in EGATEN.

What drug interactions can this medicine cause?

• No specific clinical drug interaction studies have been conducted for triclabendazole.
• However, in vitro data suggest the potential for increased plasma concentrations of CYP2C19 substrates with concomitant use of triclabendazole.

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

Recommended Dosage

• The recommended dose of EGATEN is 2 doses of 10 mg/kg given 12 hours apart in patients 6 years of age and older.

Administration

• The 250 mg tablets are functionally scored and divisible into two equal halves of 125 mg.
• If the dosage cannot be adjusted exactly, round the dose upwards.
• Take EGATEN orally with food.
• EGATEN tablets can 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 250 mg, functionally scored

This medicine is available in fallowing brand namesː

• EGATEN

What side effects can this medication cause?

The most common side effects of this medicine include:

• abdominal pain
• hyperhidrosis
• nausea
• decreased appetite
• headache
• urticaria
• diarrhea
• vomiting
• musculoskeletal chest pain
• pruritus

What special precautions should I follow?

• This medicine may prolong QT interval.
• Monitor ECG in patients with a history of QT prolongation or who are taking medications which prolong the QT interval.

What to do in case of emergency/overdose?

The reported symptom of overdosage following ingestion of approximately 54 mg/kg of EGATEN (approximately 2.7 times the recommended dose) was nausea.

Management for overdosage

• Management can be done by osmotic diuresis.

Can this medicine be used in pregnancy?

• There are no available data on EGATEN use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness of EGATEN has been established in pediatric patients aged 6 years and older.
• Safety and effectiveness of EGATEN in pediatric patients below the age of 6 years have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• TRICLABENDAZOLE

Inactive ingredients:

• LACTOSE MONOHYDRATE
• STARCH, CORN
• HYMETELLOSE
• MAGNESIUM STEARATE
• SILICON DIOXIDE
• FERRIC OXIDE RED

Who manufactures and distributes this medicine?

• Packager: Novartis Pharmaceuticals Corporation

What should I know about storage and disposal of this medication?

• Store in the original container.
• Store below 30°C (86°F).

• Dailymed label info on Triclabendazole
• FDA Triclabendazole