triclabendazole (Rx)

Brand and Other Names:Egaten
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 250mg

Fascioliasis

Indicated for treatment of fascioliasis

10 mg/kg PO x2 doses administered 12 hr apart

Tablets are scored and divisible into two equal halves of 125 mg

If dosage cannot be adjusted exactly, round dose upwards

Dosage Modifications

Renal or hepatic impairment: Not studied

Dosage Forms & Strengths

tablet

  • 250mg

Fascioliasis

Indicated for treatment of fascioliasis in patients ≥6 years

<6 years: Safety and efficacy not established

≥6 years

  • 10 mg/kg PO x2 doses administered 12 hr apart
  • Tablets are scored and divisible into two equal halves of 125 mg
  • If dosage cannot be adjusted exactly, round dose upwards

Dosage Modifications

Renal or hepatic impairment: Not studied

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Interactions

Interaction Checker

and triclabendazole

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    Contraindicated

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            Adverse Effects

            >10%

            10 mg/kg total

            • Abdominal pain (56%)
            • Hyperhidrosis (23%)

            20 mg/kg total in 2 divided doses

            • Abdominal pain (93%)
            • Hyperhidrosis (25%)
            • Nausea (18%)
            • Decreased appetite (18%)
            • Headache (14%)
            • Urticaria (11%)

            1-10% (10 mg/kg total)

            Vertigo (9%)

            Nausea (8%)

            Urticaria (7%)

            Vomiting (6%)

            Headache (6%)

            Dyspnea (5%)

            Pruritus (4%)

            Asthenia (4%)

            Musculoskeletal chest pain (4%)

            Cough (4%)

            Decreased appetite (3%)

            Chest pain (3%)

            Pyrexia (2%)

            Jaundice (2%)

            Chest discomfort (2%)

            1-10% (20 mg/kg total in 2 divided doses)

            Vomiting (7%)

            Diarrhea (7%)

            Elevated bilirubin (6.8%)

            Elevated AST (4.5%)

            Elevated ALP (4.2%)

            Pruritus (4%)

            Musculoskeletal chest pain (4%)

            Elevated ALT (3%)

            Postmarketing Reports

            Resistance to triclabendazole reported outside the United States

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            Warnings

            Contraindications

            Hypersensitivity to triclabendazole and/or to other benzimidazole derivatives or to any of the excipients

            Cautions

            Transient QT prolongation noted; monitor ECG in patients with a history of QT prolongation or when used in patients who receive drugs that prolong the QT interval

            Drug interactions overview

            • In vitro data suggest coadministration of triclabendazole and CYP2C19 substrates may increase plasma concentrations of CYP2C19 substrates; potential elevated concentrations of CYP2C19 substrates is expected to be transient based on the short elimination half-life and short treatment duration of triclabendazole
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            Pregnancy & Lactation

            Pregnancy

            There are no available data on use in pregnant women to inform a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

            Lactation

            There are no data on presence in human milk, effects on the breastfed infant, or 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

            Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Mechanism of action is not fully elucidated

            Studies in vitro and/or in infected animals suggest that triclabendazole and its active metabolites (sulfoxide and sulfone) are absorbed by the tegument of the immature and mature worms of Fasciola hepatica and Fasciola gigantica, leading to a decrease of the resting membrane potential, inhibition of tubulin function as well as protein and enzyme synthesis

            Absorption

            Peak plasma concentration: 1.16 micromol/L (triclabendazole); 38.6 micromol/L (sulfoxide); 2.29 micromol/L (sulfone)

            Peak plasma time: 3-4 hr AUC: 5.72 micromol⋅hr/L (triclabendazole); 386 micromol⋅hr/L (sulfoxide); 30.5 micromol⋅hr/L (sulfone)

            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 and to a lesser extent by CYP1A1, CYP1A2, CYP1B1, CYP2C19, CYP2D6, and CYP3A4

            Elimination

            Half-life: 8 hr (triclabendazole); 14 hr (sulfoxide); 11 hr (sulfone)

            No excretion data on humans

            Excretion (in animals): Feces (90% [sulfoxide and sulfone metabolite]); urine (<10%)

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            Administration

            Oral Administration

            Administer with food

            Swallow tablet (whole or divided in half) with water

            Alternatively, may be crushed and mixed with applesauce (stable up to 4 hr)

            Storage

            Tablets: Store in original container at <30°C (86°F)

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.