Version May 2024
Fascioliasis: Oral: 10 mg/kg every 12 hours for 2 doses (the 250 mg tablets are scored and divisible into two equal halves of 125 mg; if the dosage cannot be adjusted exactly, round the dose upwards).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Triclabendazole: Pediatric drug information")
Fascioliasis: Children ≥6 years and Adolescents: Oral: 10 mg/kg/dose every 12 hours for 2 doses. Note: Round dose up to the nearest half (125 mg) or whole tablet (250 mg).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Children ≥6 years and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
Children ≥6 years and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Central nervous system: Headache (14%)
Dermatologic: Hyperhidrosis (25%), urticaria (11%)
Gastrointestinal: Abdominal pain (93%), decreased appetite (18%), nausea (18%)
1% to 10%:
Dermatologic: Pruritus (4%)
Gastrointestinal: Diarrhea (7%), vomiting (7%)
Hepatic: Increased serum bilirubin (7%), increased serum aspartate aminotransferase (5%), increased serum alkaline phosphatase (4%), increased serum alanine aminotransferase (3%)
Neuromuscular & skeletal: Musculoskeletal chest pain (4%)
Frequency not defined: Hepatic: Increased liver enzymes
Hypersensitivity to triclabendazole, other benzimidazole derivatives, or to any component of the formulation
Concerns related to adverse effects:
• Hepatic toxicity: Transient increases in liver enzymes and total bilirubin have been reported in patients receiving triclabendazole.
• QTc prolongation: QTc interval prolongation may occur. Monitor ECG in patients with a history of known or suspected QTc prolongation; electrolyte disturbances (eg, hypokalemia); risk factors for increased exposure to triclabendazole and/or metabolites (eg, hepatic impairment, CYP1A2 inhibitors); or when used with concomitant QTc-prolonging drugs.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Egaten: 250 mg [scored; contains corn starch]
No
Tablets (Egaten Oral)
250 mg (per each): $0.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Egaten is only available via the Egaten Free Goods Program. Distribution is provided by AllCare Plus Pharmacy. Additional information may be obtained by contacting AllCare Plus Pharmacy at (888) 774-7327.
Oral: Administer with food. Tablets may 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.
Oral: Administer with food and water; tablet may be swallowed whole, divided in half, or crushed and sprinkled over a small amount of applesauce; administer within 4 hours; round dose up to the nearest whole or half tablet
Fascioliasis: Treatment of fascioliasis in patients ≥6 years of age
Substrate of CYP1A2 (minor), CYP2C19 (minor), CYP2C9 (minor), CYP2D6 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Food increases triclabendazole and sulfoxide metabolite AUC and Cmax 2 and 3-fold, respectively. Management: Take with food.
Adverse events were not observed in animal reproduction studies.
Information related to the use of triclabendazole in pregnancy is limited (Alatoom 2008).
It is not known if triclabendazole is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Monitor ECG in patients with a history of known or suspected QT prolongation, electrolyte disturbances (eg, hypokalemia), risk factors for increased exposure to triclabendazole and/or metabolites (eg, hepatic impairment, CYP1A2 inhibitors), or when used with concomitant QTc-prolonging drugs.
Triclabendazole is an anthelmintic against Fasciola species. In vitro data suggest that triclabendazole and its active metabolites are absorbed by the tegument of the immature and mature worms, leading to a decrease of the resting membrane potential, inhibition of motility, disruption of the surface as well as ultrastructure that include inhibition of spermatogenesis and vitelline cells.
Absorption: Increased absorption with food (Lecaillon 1998)
Distribution: Vd: ~1 L/kg
Protein binding: Triclabendazole: 96.7%; Sulfoxide metabolite: 98.4%; Sulfone metabolite: 98.8% in human plasma
Metabolism: Primarily metabolized by CYP1A2 (~64%) into its active sulfoxide metabolite and to a lesser extent by CYP2C9, CYP2C19, CYP2D6, CYP3A, and FMO. Sulfoxide metabolite is further metabolized primarily by CYP2C9 to the active sulfone metabolite.
Half-life elimination: Triclabendazole: 8 hours; Sulfoxide metabolite: 14 hours; Sulfone metabolite: 11 hours
Time to peak: Tmax 3.0 ± 0.4 hours (El-Tantawy 2007)
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