EGATEN- triclabendazole tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

TRICLABENDAZOLE (UNII: 4784C8E03O) (TRICLABENDAZOLE - UNII:4784C8E03O)

Disponível em:

Novartis Pharmaceuticals Corporation

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

EGATEN® is indicated for the treatment of fascioliasis in patients 6 years of age and older. EGATEN is contraindicated in patients with known hypersensitivity to triclabendazole and/or to other benzimidazole derivatives or to any of the excipients in EGATEN. 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) . The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Data Animal Data Embryo-fetal developmental toxicity studies revealed no malformations in rats and rabbits at doses up to 200 mg/kg/day and 20 mg/kg/day, respectively (approximately 1.6 times and 0.3 times the MRHD based on body surface area comparison, respectively). The animals were treated orally during organogenesis, starting on Day 6 of the pregnancy until Day 15 in rats and Day 18 in rabbits. Maternal toxicity was noted at doses greater than or equal to 100 mg/kg/day in rats and 10 mg/kg/day in rabbits, which was associated with lower fetus weights and delayed ossification. These findings were considered indicative of delayed physiological growth that was secondary to maternal toxicity. No increase in malformation or other abnormalities was observed at any dose level in either species. 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 is detected in goat milk when administered as a single dose to one lactating animal. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EGATEN and any potential adverse effects on the breastfed infant from EGATEN or from the underlying maternal condition. 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. 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 elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. EGATEN has not been studied in patients with renal impairment. EGATEN has not been studied in patients with hepatic impairment.

Resumo do produto:

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

Status de autorização:

New Drug Application

Características técnicas

EGATEN- TRICLABENDAZOLE TABLET
NOVARTIS PHARMACEUTICALS CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
RECENT MAJOR CHANGES
Warnings and Precautions, QT Prolongation (5.1)
2/2022
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: 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)
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
elevate