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Triclabendazole (Egaten)

Trade Name : EGATEN

Novartis Pharmaceuticals Corporation

TABLET

Strength 250 mg/1

TRICLABENDAZOLE

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Triclabendazole (Egaten) which is also known as EGATEN and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 250 mg/1 per ml. Read more

Triclabendazole (Egaten) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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.
  • 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. ()
  • 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. ()
  • EGATEN (triclabendazole) tablet: 250 mg pale red, speckled, capsule shaped, biconvex with imprint of u201cEG EGu201d on one side and functionally scored on both sides.
  • Tablets: 250 mg, functionally scored. ()
  • 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. ()
  • 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 EGATEN is used in patients who receive drugs that prolong the QT interval.
  • QT Prolongation:
  • 5.1
  • 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. ()
  • 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 . 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.
  • For those CYP2C19 substrate drugs that require therapeutic monitoring of systemic drug exposures, if the plasma concentrations of the CYP2C19 substrates are elevated during administration of triclabendazole, re-check the plasma concentration of the CYP2C19 substrates after cessation of triclabendazole therapy.
  • 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. ()ntttttttt
  • No data
  • 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.
  • 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 CHClNOS 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.
  • EGATEN tablets are pale red, speckled, capsule shaped, biconvex tablets, with imprint u201cEG EGu201d 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.
  • No data
  • No data
  • 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 eggs in the stool based on the Kato-Katz method at Day 60 in patients who were positive at baseline. Across these studies, there was a finding of a dose response. Specifically, the Day 60 cure rate was highest (95.5%; 95% CI [77%, 100%]) for the 20 mg/kg dose, which was given in 2 divided doses, followed by cure rates of 88% (95% CI [64%, 99%]), 80% (95% CI [73%, 86%]), and 50% (95% CI [27%, 73%]) in the 15 mg/kg, 10 mg/kg, and 5 mg/kg dose groups, respectively. The 5 mg/kg, 10 mg/kg, and 15 mg/kg dosing regimens are not approved . These rates were significantly higher than that estimated from patients receiving an inadequate, non-triclabendazole treatment in a separate study (22%; 95% CI [9.8, 38.2]).
  • How Supplied
  • EGATEN (triclabendazole) tablets are supplied as pale red, speckled, capsule shaped, biconvex tablets, with imprint u201cEG EGu201d 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 30u00b0C (86u00b0F).
  • Important Administration Instructions
  • 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 .
  • 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 EGATEN is used in patients who receive drugs that prolong the QT interval 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.
  • u00a9 Novartis
  • T2019-100
  • PRINCIPAL DISPLAY PANEL
  • Egatenn
  • (triclabendazole)Tablets
  • 250 mg
  • NDC 0078-0937-91
  • Rx only
  • 4 scored tablets
  • Novartis

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