Aptiom

Generic Name: eslicarbazepine (ES-li-kar-BAZ-e-peen)
Brand Name: Aptiom

Aptiom is used for:

Treating partial-onset seizures. It is used along with other medicines.

Aptiom is an anticonvulsant. Exactly how it works is not known, but it may work by slowing abnormal nerve impulses in the brain.

Do NOT use Aptiom if:

  • you are allergic to any ingredient in Aptiom or to oxcarbazepine
  • you have severe liver problems
  • you are taking oxcarbazepine

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Aptiom:

Some medical conditions may interact with Aptiom. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have kidney or liver problems, thyroid problems, or low blood sodium levels
  • if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Aptiom. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Carbamazepine, oxcarbazepine, phenobarbital, phenytoin, or primidone because they may decrease Aptiom's effectiveness
  • Clobazam, omeprazole, or phenytoin because the risk of their side effects may be increased by Aptiom
  • Hormonal birth control (eg, birth control pills), rosuvastatin, or simvastatin because their effectiveness may be decreased by Aptiom

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aptiom may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aptiom:

Use Aptiom as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Aptiom comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Aptiom refilled.
  • Take Aptiom by mouth with or without food.
  • Aptiom may be swallowed whole or crushed before swallowing.
  • It is important to take all doses on time to keep the level of medicine in your blood constant. Take doses at evenly spaced intervals. Do not skip doses.
  • Taking Aptiom at the same time each day will help you remember to take it.
  • Continue to take Aptiom even if you feel well. Do not miss any doses. Aptiom works best when there is a constant level of it in your body.
  • Do not suddenly stop taking Aptiom without checking with your doctor. Doing so may increase the risk of seizures. If you need to stop taking Aptiom, your doctor will gradually lower your dose. Discuss any questions or concerns with your doctor.
  • If you miss a dose of Aptiom, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aptiom.

Important safety information:

  • Aptiom may cause drowsiness, dizziness, changes in vision, or difficulty with coordination. These effects may be worse if you take it with alcohol or certain medicines. Use Aptiom with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Aptiom; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Patients who take Aptiom may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Aptiom closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes cause death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • A serious and sometimes life-threatening or fatal reaction that may affect your skin or other parts of your body (eg, liver, blood cells) has been reported in patients taking medicines for seizures. A rash may or may not occur with this reaction. Contact your doctor right away if you develop decreased urination; rash; hives; red, swollen, blistered, or peeling skin; swollen glands or lymph nodes; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); unusual bruising or bleeding; severe tiredness or weakness; unusual muscle pain; or symptoms of infection (eg, fever, chills, sore throat).
  • A serious and sometimes fatal side effect called angioedema has been reported with the use of Aptiom. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.
  • Low blood sodium levels may occur from treatment with Aptiom. In severe cases, this can be life-threatening. Call your doctor right away if you have confusion, decreased coordination, fainting, hallucinations, headache, memory problems, mental or mood changes, seizures, sluggishness, trouble concentrating, or weakness.
  • Tell your doctor or dentist that you take Aptiom before you receive any medical or dental care, emergency care, or surgery.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Aptiom. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Lab tests, including liver function and sodium blood levels, may be performed while you use Aptiom. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Aptiom should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Aptiom may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Aptiom while you are pregnant. Aptiom is found in breast milk. Do not breast-feed while taking Aptiom.

Possible side effects of Aptiom:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; headache; nausea; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, eyes, face, lips, throat, or tongue; unusual hoarseness); blood in the urine; chest pain; confusion; decreased coordination; decreased urination; difficult or painful urination; difficulty concentrating or speaking; double or blurred vision, changes in vision, or involuntary eye movement; fever, chills, or persistent sore throat; memory problems or loss; new or worsening mental, mood, or behavior changes (eg, depression, agitation, anxiety, panic attacks, aggressiveness, impulsiveness); new or worsening seizures; painful sores in the mouth or around the eyes; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent muscle pain, weakness, or spasms; shortness of breath; suicidal thoughts or actions; swelling in the arms or legs; swollen glands; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, persistent nausea or vomiting, stomach pain, yellowing of the skin or eyes); tremor; trouble sleeping; trouble walking; unusual bruising or bleeding; unusual tiredness or weakness; unusual weight gain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1- 800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Aptiom:

Store Aptiom at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aptiom out of the reach of children and away from pets.

General information:

  • If you have any questions about Aptiom, please talk with your doctor, pharmacist, or other health care provider.
  • Aptiom is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Aptiom or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Aptiom. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Aptiom. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Aptiom.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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