Triclabendazole (Oral)

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

Infections with a liver fluke usually happen after eating contaminated water plants, like watercress or algae, or animals that eat these plants. They move from your intestines to the bile ducts in the liver where they live and grow. Most patients with liver fluke infections do not show any symptoms, which can make the infection 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.

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

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

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

In deciding to use a medicine, you and your doctor will need to consider the risks of taking the medicine against the benefits it may provide. For this medicine, keep the following points in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies to determine how triclabendazole affects children younger than 6 years old. Its safety and effectiveness in this age group have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of triclabendazole. However, older patients are more likely to have liver, kidney, or heart issues due to aging, which may require careful monitoring and possible dose adjustments for those taking this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the possible benefits against the potential risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if interactions could happen. In these situations, your doctor may change the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are significant and may not include all possible interactions.

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
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or the frequency of one or both medicines.

• Adagrasib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buprenorphine
• Buserelin
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Enoxacin
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Fluvoxamine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Interferon Alfa-2b
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mexiletine
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nafarelin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Obeticholic Acid
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Peginterferon Alfa-2a
• Pentamidine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Risperidone
• Ritonavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tolterodine
• Toremifene
• Trazodone
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zotepine
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works for you. Be sure to tell your doctor about any other medical conditions you have, especially:

• Heart rhythm problems (e.g., QT prolongation), history of or
• Hypokalemia (low potassium in the blood), history of or
• Liver disease—Use with caution. This may worsen these conditions.

Along with its needed effects, Triclabendazole (Oral) 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.

In the U.S.

• Egaten

Available Dosage Forms:

• Tablet

Therapeutic Class: Anthelmintic

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.