Triclabendazole
Generic Name: triclabendazole
Brand Names:
Egaten
11 DESCRIPTION EGATEN (triclabendazole) tablet is an orally administered anthelmintic for immediate release. Triclabendazole is designated chemically as benzimidazole derivative, 6-chloro-5-(2, 3-dichlorophenoxy)-2-(methylthio)-1H-benzimidazole (triclabendazole). The molecular formula for triclabendazole is C 14 H 9 Cl 3 N 2 OS and the molecular weight is 359.65 g/mol. The chemical structure of triclabendazole is shown below: Triclabendazole is a white or almost white, crystalline powder.
Overview
11 DESCRIPTION EGATEN (triclabendazole) tablet is an orally administered anthelmintic for immediate release. Triclabendazole is designated chemically as benzimidazole derivative, 6-chloro-5-(2, 3-dichlorophenoxy)-2-(methylthio)-1H-benzimidazole (triclabendazole). The molecular formula for triclabendazole is C 14 H 9 Cl 3 N 2 OS and the molecular weight is 359.65 g/mol. The chemical structure of triclabendazole is shown below: Triclabendazole is a white or almost white, crystalline powder.
Uses
1 INDICATIONS AND USAGE EGATEN ® is indicated for the treatment of fascioliasis in patients 6 years of age and older. EGATEN ® tablet is an anthelmintic indicated for the treatment of fascioliasis in patients 6 years of age and older.
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dose of EGATEN is 2 doses of 10 mg/kg given 12 hours apart in patients 6 years of age and older. 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. The recommended dose of EGATEN is 2 doses of 10 mg/kg given 12 hours apart in patients 6 years of age and older. ( 2 ) Take orally with food. ( 2 ) Swallow tablets whole or divide in half and take with water, or crush and administer with applesauce.
Side Effects
6 ADVERSE REACTIONS 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.
Interactions
7 DRUG INTERACTIONS CYP2C19 Substrates : Re-check the plasma concentration of concomitantly administered CYP2C19 substrates after cessation of EGATEN therapy, if the plasma concentrations of the CYP2C19 substrates are elevated during administration of EGATEN. ( 7.1 ) 7.1 Effect of EGATEN on CYP2C19 Substrates 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 [see Clinical Pharmacology (12.3)] . The potential elevation in concentrations of concomitantly used CYP2C19 substrates is expected to be transient based on the short elimination half-life and short treatment duration of triclabendazole.
Warnings
5 WARNINGS AND PRECAUTIONS QT Prolongation : Prolongs QTc interval. Monitor electrocardiogram (ECG) in patients with a history of QTc prolongation or with electrolyte imbalance like hypokalemia or who are taking medications which prolong the QTc interval, or on CYP1A2 inhibitors, or have hepatic impairment. ( 5.1 ) 5.1 QT Prolongation EGATEN prolongs the QTc interval [see Clinical Pharmacology (12.2)] . The magnitude of QTc prolongation can increase with increasing treatment duration of EGATEN. Administration of EGATEN concurrently with CYP1A2 inhibitors and use in patients with hepatic impairment may result in increased exposures of triclabendazole and/or its metabolites, and, therefore, may increase the risk for QT prolongation. 4 CONTRAINDICATIONS EGATEN is contraindicated in patients with known hypersensitivity to triclabendazole and/or to other benzimidazole derivatives or to any of the excipients in EGATEN. Patients with known hypersensitivity to triclabendazole, other benzimidazole derivatives or any of the excipients in EGATEN. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary 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. 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 (see Data) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied EGATEN (triclabendazole) tablets are supplied as pale red, speckled, capsule shaped, biconvex tablets with “EG ⅁Ǝ” debossed on one side and functionally scored on both sides. Each tablet contains 250 mg of triclabendazole. EGATEN (triclabendazole) tablets are available as: Blister packs of 4 tablets (NDC 0078-0937-91).
Frequently Asked Questions
What is Triclabendazole used for?▼
1 INDICATIONS AND USAGE EGATEN ® is indicated for the treatment of fascioliasis in patients 6 years of age and older. EGATEN ® tablet is an anthelmintic indicated for the treatment of fascioliasis in patients 6 years of age and older.
What are the side effects of Triclabendazole?▼
6 ADVERSE REACTIONS 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.
Can I take Triclabendazole during pregnancy?▼
8.1 Pregnancy Risk Summary 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. 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 (see Data) .
What are the important warnings for Triclabendazole?▼
5 WARNINGS AND PRECAUTIONS QT Prolongation : Prolongs QTc interval. Monitor electrocardiogram (ECG) in patients with a history of QTc prolongation or with electrolyte imbalance like hypokalemia or who are taking medications which prolong the QTc interval, or on CYP1A2 inhibitors, or have hepatic impairment. ( 5.1 ) 5.1 QT Prolongation EGATEN prolongs the QTc interval [see Clinical Pharmacology (12.2)] . The magnitude of QTc prolongation can increase with increasing treatment duration of EGATEN. Administration of EGATEN concurrently with CYP1A2 inhibitors and use in patients with hepatic impairment may result in increased exposures of triclabendazole and/or its metabolites, and, therefore, may increase the risk for QT prolongation. 4 CONTRAINDICATIONS EGATEN is contraindicated in patients with known hypersensitivity to triclabendazole and/or to other benzimidazole derivatives or to any of the excipients in EGATEN. Patients with known hypersensitivity to triclabendazole, other benzimidazole derivatives or any of the excipients in EGATEN. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.