EGATEN (triclabendazole) tablets are supplied as pale red, speckled, capsule shaped, biconvex tablets, with imprint "EG EG" 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).
Storage
Store in the original container. Store below 30�C (86�F). These highlights do not include all the information needed to use EGATEN safely and effectively. See full prescribing information for EGATEN.
EGATEN� (triclabendazole) tablets, for oral use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
EGATEN� tablet is an anthelmintic indicated for the treatment of fascioliasis in patients 6 years of age and older. (1)
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. (2)
Take orally with food. (2)
Swallow tablets whole or divide in half and take with water, or crush and administer with applesauce. (2)
If the dosage cannot be adjusted exactly, round dose upwards. (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 250 mg, functionally scored. (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to triclabendazole, other benzimidazole derivatives or any of the excipients in EGATEN. (4)
WARNINGS AND PRECAUTIONS
QT Prolongation: May prolong QT interval. Monitor ECG in patients with a history of QT prolongation or who are taking medications which prolong the QT interval. (5.1)
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.
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)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 9/2019 Fascioliasis
Egaten (triclabendazole) is a benzimidazole anthelmintic indicated for the treatment of fascioliasis, a neglected tropical disease (NTD) caused by liver flukes Fasciola hepatica and Fasciola gigantica.
