EGATEN

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.

EGATEN (triclabendazole) tablet: 250 mg pale red, speckled, capsule shaped, biconvex with “EG ⅁Ǝ” debossed on one side and functionally scored on both sides.

EGATEN is contraindicated in patients with known hypersensitivity to triclabendazole and/or to other benzimidazole derivatives or to any of the excipients in EGATEN.

The reported symptom of overdosage following ingestion of approximately 54 mg/kg of EGATEN (approximately 2.7 times the recommended dose) was nausea. The patient recovered following osmotic diuresis. In the event of overdose, monitor ECG and institute symptomatic treatment.

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

Triclabendazole is a white or almost white, crystalline powder.

EGATEN tablets are 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.

Inactive Ingredients: colloidal silicon dioxide, iron oxide red, lactose monohydrate, maize starch, magnesium stearate, methylhydroxyethylcellulose.

An open label, randomized trial, conducted in Vietnam compared the efficacy of triclabendazole (two 10 mg/kg doses given 12 hours apart with food) to oral artesunate (4 mg/kg, given once daily for 10 days). One hundred patients (age range: 9-74 years) with acute symptomatic fascioliasis were randomized, 50 in each treatment group. At 3 months after treatment, 92% and 76% (difference 16%; 95% CI [1.7, 30.8], p = 0.035) of patients in the triclabendazole and artesunate arms, respectively, reported no clinical symptoms.

The clinical development program of triclabendazole for the treatment of fascioliasis included 6 non-randomized, open label studies performed in Cuba, Bolivia, Peru, Chile, and Iran in a total of 245 adult and pediatric patients with stool-confirmed fascioliasis. All studies were similar in design. The studied triclabendazole doses ranged from 5 mg/kg to 20 mg/kg administered on Days 1-3. Cure was defined as absence of

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).

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

Advise patients that EGATEN 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

Advise patients with a history of prolongation of the QTc interval or a history of symptoms compatible with a long QT interval or with electrolyte imbalance like hypokalemia or when EGATEN is used in patients who receive drugs that are known to prolong the QTc interval or on CYP1A2 inhibitors or have hepatic impairment that their ECGs will need to be monitored

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

For more information on EGATEN, call 1-888-669-6682.

© Novartis

T2022-10

Egaten

(triclabendazole)

250 mg per tablet

NDC 0078-0937-91

Rx only

4 scored tablets

Novartis