Aptiom

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

What is Aptiom?

Aptiom (eslicarbazepine) is an anticonvulsant. It works by decreasing nerve impulses that cause seizures and pain.

Aptiom is used together with other medications to treat partial-onset seizures in adults.

Aptiom may also be used for purposes not listed in this medication guide.

Important information

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Slideshow: Flashback: FDA Drug Approvals 2013

Before taking this medicine

You should not use Aptiom if you are allergic to eslicarbazepine or oxcarbazepine.

To make sure Aptiom is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease; or

  • a history of mood problems or suicidal thoughts.

Some people have thoughts about suicide while taking an anticonvulsant. Your doctor will need to check your progress at regular visits while you are taking Aptiom. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category C. Do not start or stop taking Aptiom during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant while taking eslicarbazepine for seizures.

See also: Pregnancy and breastfeeding warnings (in more detail)

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of eslicarbazepine on the baby.

Aptiom can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking Aptiom.

Eslicarbazepine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone under 18 years old without medical advice.

How should I take Aptiom?

Aptiom is usually given once per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food. The Aptiom tablet may be crushed or swallowed whole.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using eslicarbazepine.

Do not stop using this medicine suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Aptiom may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Aptiom side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Aptiom can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Call your doctor right away if you have nausea, lack of energy, confusion, feeling tired or irritable, severe weakness, muscle pain, or increased seizures.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Also call your doctor at once if you have:

  • confusion, vision changes, thinking problems, trouble with walking or coordination;

  • a light-headed feeling, like you might pass out;

  • fever, swollen glands, sore throat, trouble swallowing, flu symptoms;

  • painful mouth sores or sores around your eyes;

  • easy bruising or bleeding, muscle pain or weakness;

  • severe weakness or tired feeling;

  • upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Aptiom side effects may include:

  • dizziness, drowsiness, headache;

  • nausea, vomiting;

  • tremor, feeling shaky; or

  • double vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

dosing information

Usual Adult Dose of Aptiom for Seizures:

Initial dose: 400 mg orally once daily for one week, then increase to 800 mg orally once daily
Maintenance dose: 800 mg orally once daily and some patients may benefit from a maintenance dose of 1200 mg orally once daily (although the 1200 mg dosage is associated with increased adverse reactions)
Maximum dose: 1200 mg orally daily

Comments:
A maximum dose of 1200 mg daily should only be initiated after the patient has tolerated 800 mg daily for at least a week. For some patients, treatment may be initiated at 800 mg once daily if the need for additional seizure reduction outweighs an increased risk of adverse reactions.

Approved indication: As adjunctive treatment of partial-onset seizures

What other drugs will affect Aptiom?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Aptiom, especially:

  • all other seizure medicines you use;

  • omeprazole; or

  • rosuvastatin (Crestor) or simvastatin (Zocor).

This list is not complete. Other drugs may interact with eslicarbazepine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Aptiom.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 2014-01-13, 8:08:57 PM.

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