Aptiom

Generic Name: eslicarbazepine (Oral route)

es-li-kar-BAZ-e-peen AS-e-tate

Commonly used brand name(s)

In the U.S.

  • Aptiom

Available Dosage Forms:

  • Tablet

Therapeutic Class: Anticonvulsant

Chemical Class: Dibenzazepine Carboxamide

Uses For Aptiom

Eslicarbazepine is used with other medicines to control partial seizures (convulsions) in the treatment of epilepsy.

Eslicarbazepine belongs to a class of medicines called anticonvulsants. It acts in the brain to prevent seizures. However, this medicine cannot cure epilepsy and will only work to control seizures as long as you continue to take it.

Slideshow: Flashback: FDA Drug Approvals 2013

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

Before Using Aptiom

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 eslicarbazepine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of eslicarbazepine have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving eslicarbazepine.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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.

Interactions with Medicines

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 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.

  • Abiraterone Acetate
  • Ado-Trastuzumab Emtansine
  • Alfentanil
  • Alprazolam
  • Amiodarone
  • Amitriptyline
  • Amlodipine
  • Apixaban
  • Aprepitant
  • Aripiprazole
  • Artemether
  • Astemizole
  • Atazanavir
  • Atorvastatin
  • Bedaquiline
  • Boceprevir
  • Bosutinib
  • Brentuximab Vedotin
  • Brinzolamide
  • Bromocriptine
  • Budesonide
  • Buprenorphine
  • Buspirone
  • Cabazitaxel
  • Cabozantinib
  • Carbamazepine
  • Carisoprodol
  • Ceritinib
  • Cilostazol
  • Cisapride
  • Citalopram
  • Clarithromycin
  • Clobazam
  • Clomipramine
  • Clopidogrel
  • Clozapine
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclophosphamide
  • Cyclosporine
  • Dabrafenib
  • Darifenacin
  • Darunavir
  • Dasatinib
  • Delavirdine
  • Dexamethasone
  • Diazepam
  • Dihydroergotamine
  • Docetaxel
  • Doxepin
  • Dronedarone
  • Dutasteride
  • Eletriptan
  • Elvitegravir
  • Enzalutamide
  • Eplerenone
  • Ergotamine
  • Erythromycin
  • Escitalopram
  • Esomeprazole
  • Estradiol
  • Everolimus
  • Felodipine
  • Fentanyl
  • Fluticasone
  • Fosamprenavir
  • Fosphenytoin
  • Halofantrine
  • Haloperidol
  • Hydrocodone
  • Iloperidone
  • Imatinib
  • Indinavir
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Lansoprazole
  • Letrozole
  • Levomilnacipran
  • Lomitapide
  • Lopinavir
  • Losartan
  • Lovastatin
  • Lurasidone
  • Maraviroc
  • Medroxyprogesterone
  • Mefloquine
  • Mephenytoin
  • Meprobamate
  • Methadone
  • Midazolam
  • Mifepristone
  • Mitotane
  • Nateglinide
  • Nelfinavir
  • Nifedipine
  • Nilotinib
  • Nisoldipine
  • Omeprazole
  • Ondansetron
  • Orlistat
  • Ospemifene
  • Oxycodone
  • Paclitaxel
  • Pantoprazole
  • Pazopanib
  • Perampanel
  • Phenobarbital
  • Phenytoin
  • Pimozide
  • Piperaquine
  • Pomalidomide
  • Ponatinib
  • Prednisolone
  • Prednisone
  • Primidone
  • Progesterone
  • Propafenone
  • Propranolol
  • Quetiapine
  • Quinidine
  • Quinine
  • Rabeprazole
  • Ranolazine
  • Regorafenib
  • Rifabutin
  • Rilpivirine
  • Riociguat
  • Ritonavir
  • Roflumilast
  • Rosuvastatin
  • Salmeterol
  • Saquinavir
  • Saxagliptin
  • Sildenafil
  • Siltuximab
  • Simeprevir
  • Simvastatin
  • Sirolimus
  • Sorafenib
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Tamsulosin
  • Telaprevir
  • Telithromycin
  • Temsirolimus
  • Terfenadine
  • Ticagrelor
  • Tipranavir
  • Tolvaptan
  • Trabectedin
  • Tramadol
  • Trazodone
  • Triamcinolone
  • Triazolam
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Verapamil
  • Vilanterol
  • Vilazodone
  • Vincristine Sulfate
  • Vincristine Sulfate Liposome
  • Vinflunine
  • Voriconazole
  • Vortioxetine
  • Warfarin
  • Zaleplon
  • Zileuton
  • Ziprasidone
  • Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Ethinyl Estradiol
  • Levonorgestrel

Interactions with Food/Tobacco/Alcohol

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:

  • Depression, history of or
  • Hyponatremia (low sodium in the blood) or
  • Mental illness, history of—Use with caution. May make these conditions worse.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Aptiom

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.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may crush the tablets or swallow them whole. You may take this medicine with or without food.

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 seizures:
      • Adults—At first, 400 milligrams (mg) once a day. After one week, your doctor may increase your dose to 800 mg once a day. However, the dose is usually not more than 1200 mg once a day.
      • Children—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

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

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.

Precautions While Using Aptiom

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Eslicarbazepine may cause some people to be agitated, irritable, or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, or feeling nervous, restless, or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you notice any of these side effects, tell your doctor right away.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause serious allergic reactions affecting multiple body organs (eg, liver, kidneys). Check with your doctor right away if you have the following symptoms: a fever, dark urine, headache, rash, stomach pain, swollen, painful, or tender lymph glands in neck, armpit, or groin, unusual tiredness, or yellow eyes or skin.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause hyponatremia (low sodium in the blood). Check with your doctor right away if you have confusion, decreased urine output, dizziness, fast or irregular heartbeat, headache, muscle pain or cramps, nausea or vomiting, swelling of face, ankles, or hands, or unusual tiredness or weakness while you are using this medicine.

Eslicarbazepine may cause some people to become dizzy, drowsy, clumsy, tired, or it may cause vision changes. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or not able to see well. If these reactions are especially bothersome, check with your doctor.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not suddenly stop taking this medicine without checking first with your doctor. If you have been instructed to stop taking eslicarbazepine, ask your doctor how to slowly decrease the dose. This will decrease your chance of having more seizures.

Birth control medicines may not work while you are using this medicine. Use another form of birth control to avoid getting pregnant. Other forms include condoms, a diaphragm, contraceptive foam, or jelly.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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.

Aptiom 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:

Less common
  • Confusion
  • decreased urine output
  • dizziness
  • fast or irregular heartbeat
  • fever or chills
  • increased in seizure frequency or severity
  • muscle pain or cramps
  • nausea or vomiting
  • severe thirst
  • shortness of breath
  • swelling of the face, ankles, or hands
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • unusual tiredness or weakness
Incidence not known
  • Abdominal or stomach pain
  • blistering, peeling, or loosening of the skin
  • bloating of the abdomen or stomach
  • changes in behavior
  • discouragement
  • difficulty breathing
  • difficulty swallowing
  • fast heartbeat
  • feeling sad or empty
  • hives, rash, or itching skin
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid, shallow breathing
  • red skin lesions, often with a purple center
  • sores, ulcers, or white spots in the mouth or on the lips
  • thoughts or attempts at killing oneself
  • upper right abdominal or stomach pain
  • yellow eyes or skin

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
  • Blurred vision
  • double vision
  • sensation of spinning or constant movement
  • sleepiness
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Less common
  • Changes in patterns and rhythms of speech
  • heartburn or indigestion
  • irritability
  • loss of interest or pleasure
  • lower back or side pain
  • shakiness and unsteady walk
  • shakiness in the legs, arms, hands, or feet
  • tingling of the hands or feet
  • trembling or shaking of the hands or feet
  • trouble concentrating
  • unusual weight gain or loss

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.

See also: Side effects (in more detail)

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