Triclabendazole: Uses & Side Effects

Dosage and Administration

General

Triclabendazole is available in the
following dosage form(s) and strength(s):

Tablets: 250 mg, functionally scored.1

Dosage

It is essential
that the manufacturer’s labeling be consulted for more detailed information
on dosage and administration of this drug. Dosage summary:

Pediatric Patients

The recommended dosage of triclabendazole
in pediatric patients 6 years of age and older is 2 doses of 10 mg/kg given 12
hours apart.

Take orally with food.

Swallow tablets whole or divide in half and
take with water, or crush and administer with applesauce.

If the dosage cannot be adjusted exactly,
round dose upwards.

Adults

The recommended dosage of triclabendazole
in adults is 2 doses of 10 mg/kg given 12 hours apart.

Take orally with food.

Swallow tablets whole or divide in half and
take with water, or crush and administer with applesauce.

If the dosage cannot be adjusted exactly,
round dose upwards.

Cautions

Contraindications

Patients with known hypersensitivity to
triclabendazole, other benzimidazole derivatives or any of the excipients in
triclabendazole.

Warnings/Precautions

QT Prolongation

Transient prolongation of the mean QTc
interval was noted on the electrocardiographic recordings in dogs. 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 triclabendazole
is used in patients who receive drugs that prolong the QT interval.

Specific Populations

Pregnancy

Risk Summary: There are no available data on triclabendazole use in pregnant women
to inform a drug-associated risk of major birth defects, miscarriage or adverse
maternal or fetal outcomes. Reproductive studies in animals (rat and rabbits)
have not shown a risk of increased fetal abnormalities with exposure to
triclabendazole during organogenesis at doses approximately 0.3 to 1.6 times
the maximum recommended human dose (MRHD) of 20 mg/kg based on body surface
area comparison.

The estimated background risk of major
birth defects and miscarriage for the indicated population are unknown. All
pregnancies have a background risk of birth defect, loss, or other adverse
outcomes. In the U.S. general population, the estimated background risk of
major birth defects and miscarriage in clinically recognized pregnancies is
2–4% and 15–20%, respectively.

Animal Data:
Embryo-fetal developmental toxicity studies revealed no malformations in rats and
rabbits at doses up to 200 mg/kg/day and 20 mg/kg/day, respectively
(approximately 1.6 times and 0.3 times the MRHD based on body surface area
comparison, respectively). The animals were treated orally during
organogenesis, starting on day 6 of the pregnancy until day 15 in rats and day
18 in rabbits. Maternal toxicity was noted at doses greater than or equal to
100 mg/kg per day in rats and 10 mg/kg per day in rabbits, which was associated
with lower fetus weights and delayed ossification. These findings were
considered indicative of delayed physiological growth that was secondary to
maternal toxicity. No increase in malformation or other abnormalities was
observed at any dose level in either species.

Lactation

There are no data on the presence of
triclabendazole in human milk, the effects on the breastfed infant, or the
effects on milk production. Published animal data indicate that triclabendazole
is detected in goat milk when administered as a single dose to one lactating
animal. When a drug is present in animal milk, it is likely that the drug will
be present in human milk. The developmental and health benefits of
breastfeeding should be considered along with the mother’s clinical need for
triclabendazole and any potential adverse effects on the breastfed infant from
triclabendazole or from the underlying maternal condition.

Pediatric Use

Safety and effectiveness of triclabendazole
has been established in pediatric patients aged 6 years and older.

Safety and effectiveness of triclabendazole
in pediatric patients below the age of 6 years have not been established.

Geriatric Use

Clinical studies of triclabendazole did not
include sufficient numbers of patients aged 65 and over to determine whether
the elderly respond differently from younger patients. In general, dose
selection for an elderly patient should be cautious, reflecting the greater
frequency of decreased hepatic, renal, or cardiac function, and of concomitant
disease or other drug therapy.

Renal Impairment

Triclabendazole has not been studied in
patients with renal impairment.

Hepatic Impairment

Triclabendazole has not been studied in
patients with hepatic impairment.1

Common Adverse Effects

Most common adverse reactions (greater than
2%) with triclabendazole 20 mg/kg dose are abdominal pain, hyperhidrosis,
nausea, decreased appetite, headache, urticaria, diarrhea, vomiting,
musculoskeletal chest pain, and pruritus.

Interactions

Specific Drugs

It is essential
that the manufacturer’s labeling be consulted for more detailed information
on interactions with this drug, including possible dosage adjustments.
Interaction highlights:

CYP2C19 Substrates: Re-check the plasma concentration of concomitantly administered CYP2C19
substrates after cessation of triclabendazole therapy, if the plasma
concentrations of the CYP2C19 substrates are elevated during administration of
triclabendazole.

Advice to Patients

Important Administration Instructions

Advise patients that triclabendazole should
be taken orally with food. The 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.

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 triclabendazole is used in patients who receive
drugs that prolong the QT interval that their ECGs will need to be monitored.

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

Keyword: triclabendazole.

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