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

Aptiom is used alone or with other medications to treat partial-onset seizures in adults and children who are at least 4 years old.

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

Do not stop using Aptiom suddenly.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using Aptiom.

Call your doctor right away if you have symptoms of low sodium levels in your body such as nausea, confusion, severe weakness, muscle pain, or increased seizures.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

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

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

Do not stop using Aptiom suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Get your prescription refilled before you run out of medicine completely.

Eslicarbazepine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Aptiom.

Store at room temperature away from moisture and heat.

Usual Adult Dose of Aptiom for Epilepsy:

Monotherapy and Adjunctive Therapy:
-Initial dose: 400 mg orally once a day; some patients may be initiated at 800 mg orally once a day if the need for seizure reduction outweighs an increased risk of adverse reactions
-Dose titration: Increase dosage by 400 to 600 mg weekly, based on response and tolerability
-Maintenance dose: 800 to 1600 mg orally once a day; for patients on monotherapy, the 800 mg once daily maintenance dose should be considered in patients who are unable to tolerate a 1200 mg daily dose; for patients on adjunctive therapy, the 1600 mg daily dose should be considered in patients who did not achieve a satisfactory response with a 1200 mg daily dose

Comments:
-This drug may be taken without regard to meals.
-Tablets may be swallowed whole or crushed.

Use: For the treatment of partial-onset seizures as monotherapy or adjunctive therapy

Usual Adult Dose of Aptiom for Seizures:

Monotherapy and Adjunctive Therapy:
-Initial dose: 400 mg orally once a day; some patients may be initiated at 800 mg orally once a day if the need for seizure reduction outweighs an increased risk of adverse reactions
-Dose titration: Increase dosage by 400 to 600 mg weekly, based on response and tolerability
-Maintenance dose: 800 to 1600 mg orally once a day; for patients on monotherapy, the 800 mg once daily maintenance dose should be considered in patients who are unable to tolerate a 1200 mg daily dose; for patients on adjunctive therapy, the 1600 mg daily dose should be considered in patients who did not achieve a satisfactory response with a 1200 mg daily dose

Comments:
-This drug may be taken without regard to meals.
-Tablets may be swallowed whole or crushed.

Use: For the treatment of partial-onset seizures as monotherapy or adjunctive therapy

Usual Pediatric Dose of Aptiom for Epilepsy:

4 to less than 18 years:
Monotherapy and Adjunctive Therapy:
11 to 21 kg:
-Initial dose: 200 mg orally once a day; increase once a week in increments of no more than 200 mg, based on tolerability and response
-Maintenance dose: 400 to 600 mg orally once a day
-Maximum dose: 600 mg orally once a day
22 to 31 kg:
-Initial dose: 300 mg orally once a day; increase once a week in increments of no more than 300 mg, based on tolerability and response
-Maintenance dose: 500 to 800 mg orally once a day
-Maximum dose: 800 mg orally once a day
32 to 38 kg:
-Initial dose: 300 mg orally once a day; increase once a week in increments of no more than 300 mg, based on tolerability and response
-Maintenance dose: 600 to 900 mg orally once a day
-Maximum dose: 900 mg orally once a day
Greater than 38 kg:
-Initial dose: 400 mg orally once a day; increase once a week in increments of no more than 400 mg, based on tolerability and response
-Maintenance dose: 800 to 1200 mg orally once a day
-Maximum dose: 1200 mg orally once a day

Comments:
-This drug may be taken without regard to meals.
-Tablets may be swallowed whole or crushed.

Use: For the treatment of partial-onset seizures in patients 4 years of age and older

Usual Pediatric Dose of Aptiom for Seizures:

4 to less than 18 years:
Monotherapy and Adjunctive Therapy:
11 to 21 kg:
-Initial dose: 200 mg orally once a day; increase once a week in increments of no more than 200 mg, based on tolerability and response
-Maintenance dose: 400 to 600 mg orally once a day
-Maximum dose: 600 mg orally once a day
22 to 31 kg:
-Initial dose: 300 mg orally once a day; increase once a week in increments of no more than 300 mg, based on tolerability and response
-Maintenance dose: 500 to 800 mg orally once a day
-Maximum dose: 800 mg orally once a day
32 to 38 kg:
-Initial dose: 300 mg orally once a day; increase once a week in increments of no more than 300 mg, based on tolerability and response
-Maintenance dose: 600 to 900 mg orally once a day
-Maximum dose: 900 mg orally once a day
Greater than 38 kg:
-Initial dose: 400 mg orally once a day; increase once a week in increments of no more than 400 mg, based on tolerability and response
-Maintenance dose: 800 to 1200 mg orally once a day
-Maximum dose: 1200 mg orally once a day

Comments:
-This drug may be taken without regard to meals.
-Tablets may be swallowed whole or crushed.

Use: For the treatment of partial-onset seizures in patients 4 years of age and older

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 ever had:

• kidney disease;

• liver disease;

• a blood cell disorder; or

• 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.

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 Aptiom for seizures.

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.

Aptiom not approved for use by anyone younger than 18 years old.

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.

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

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

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using eslicarbazepine.

Eslicarbazepine 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, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Also call your doctor at once if you have:

• severe dizziness or drowsiness, vision changes, thinking problems, trouble with walking or coordination;

• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores; or

• liver problems - nausea, loss of appetite, upper stomach pain, dark urine, jaundice (yellowing of the skin or eyes).

Common Aptiom side effects may include:

• dizziness, drowsiness, headache;

• feeling tired;

• nausea, vomiting;

• coordination problems, 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.

Tell your doctor about all your current medicines and any you start or stop using, 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.