EGATEN Tablet (2020)

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Συγγραφείς

Novartis Pharmaceuticals Corporation

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1. Indications and Usage

EGATEN is indicated for the treatment of fascioliasis in patients 6 years of age and older.

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. ...

3. Dosage Forms and Strengths

EGATEN (triclabendazole) tablet: 250 mg pale red, speckled, capsule shaped, biconvex with imprint of EG EG on one side and functionally scored on both sides.

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.

5. Warnings and Precautions

5.1 QT Prolongation Transient prolongation of the mean QTc interval was noted on the electrocardiographic recordings in dogs [see Nonclinical Toxicology (13.2)]. Monitor ECG in patients with a ...

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 ...

6.2. Postmarketing Experience

Resistance to triclabendazole has been reported outside the United States [see Microbiology (12.4)].

7. Drug Interactions

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 ...

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 ...

8.2. Lactation

Risk Summary 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 ...

8.4. Pediatric Use

Safety and effectiveness of EGATEN has been established in pediatric patients aged 6 years and older. Safety and effectiveness of EGATEN in pediatric patients below the age of 6 years have not been established. ...

8.5. Geriatric Use

Clinical studies of EGATEN 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 ...

8.6. Renal Impairment

EGATEN has not been studied in patients with renal impairment.

8.7. Hepatic Impairment

EGATEN has not been studied in patients with hepatic impairment.

10. Overdosage

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. ...

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 ...

12.1. Mechanism of Action

Triclabendazole is an anthelmintic against Fasciola species [see Microbiology (12.4)].

12.2. Pharmacodynamics

Triclabendazole exposure-response relationships and the time course of pharmacodynamics response are unknown.

12.3. Pharmacokinetics

After oral administration of a single dose of 10 mg/kg triclabendazole with a 560-kcal meal to patients with fascioliasis, mean peak plasma concentrations (Cmax) for triclabendazole, the sulfoxide ...

12.4. Microbiology

Mechanism of Action The mechanism by which triclabendazole exhibits its effect against Fasciola species is not fully elucidated. Studies in vitro and/or in infected animals suggest that triclabendazole ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenesis No genotoxic potential was noted for triclabendazole tested in a battery of 6 genotoxicity in vitro and in vivo assays which include a bacterial reverse mutation assay, chromosome aberration ...

13.2. Animal Toxicology and/or Pharmacology

Dietary administration of triclabendazole at a dose of 39 mg/kg/day (1.1-times the MRHD based on body surface area comparison) was associated with a transient increase in the QT and QTc intervals on weeks ...

14. Clinical Studies

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). ...

16.1. How Supplied

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 ...

16.2. Storage and Handling

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

17. Patient Counseling Information

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 ...