Triclabendazole (oral route)


    Brand Name

    US Brand Name

    Egaten


    Description

    Triclabendazole is used to treat fascioliasis, an infection caused by the liver fluke parasite, Fasciola hepatica.

    Infections with a liver fluke usually occur after eating contaminated water plants, such as watercress or algae, or animals that eat these plants. They travel from your bowels to the bile ducts in the liver where they live and grow. Most patients infected with liver flukes do not show any symptoms, which may cause the infection to last a long time. To prevent getting infected with this parasite, cook your food properly before eating.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Tablet

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of triclabendazole in children younger than 6 years of age. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of triclabendazole in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Bepridil
    • Cisapride
    • Dronedarone
    • Levoketoconazole
    • Mavacamten
    • Mesoridazine
    • Pimozide
    • Piperaquine
    • Saquinavir
    • Sparfloxacin
    • Terfenadine
    • Thioridazine

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Adagrasib
    • Alfuzosin
    • Amiodarone
    • Amisulpride
    • Amitriptyline
    • Anagrelide
    • Apomorphine
    • Aripiprazole
    • Aripiprazole Lauroxil
    • Arsenic Trioxide
    • Asenapine
    • Astemizole
    • Atazanavir
    • Azithromycin
    • Bedaquiline
    • Buprenorphine
    • Buserelin
    • Carbamazepine
    • Ceritinib
    • Chloroquine
    • Chlorpromazine
    • Ciprofloxacin
    • Citalopram
    • Clarithromycin
    • Clofazimine
    • Clomipramine
    • Clothiapine
    • Clozapine
    • Crizotinib
    • Cyclobenzaprine
    • Dabrafenib
    • Dasatinib
    • Degarelix
    • Delamanid
    • Desipramine
    • Deslorelin
    • Deutetrabenazine
    • Dexmedetomidine
    • Disopyramide
    • Dofetilide

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Heart rhythm problems (eg, QT prolongation), history of or
    • Hypokalemia (low potassium in the blood), history of or
    • Liver disease—Use with caution. May make these conditions worse.

    Proper Use

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

    Take this medicine with food.

    Swallow the tablet whole or divide it in half and take it with a glass of water. You may also crush and mix it with applesauce. Take the applesauce mixture within 4 hours.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (tablets):
      • For fascioliasis:
        • Adults and children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 milligrams (mg) per kilogram (kg) of body weight, given 12 hours apart.
        • Children younger than 6 years of age—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Store the tablet in its original container.


    Precautions

    It is very important that your doctor check your or your child's progress at regular visitsto make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

    Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    • Dizziness or lightheadedness
    • feeling of constant movement of self or surroundings
    • sensation of spinning

    Less common

    • Back pain
    • chest pain, discomfort, or tightness
    • cough
    • difficulty breathing
    • fever
    • nausea
    • upper right abdominal or stomach pain
    • vomiting
    • yellow skin or eyes

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Decreased appetite
    • diarrhea
    • headache
    • increased sweating
    • skin rash
    • stomach pain

    Less common

    • Abnormal color of urine
    • back pain
    • constipation
    • difficulty in moving
    • itching
    • joint pain
    • lack or loss of strength
    • muscle pain or stiffness

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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