Aptiom

Name: Aptiom

What special precautions should I follow?

Before taking eslicarbazepine,

  • tell your doctor and pharmacist if you are allergic to eslicarbazepine, oxcarbazepine (Oxtellar XR, Trileptal), any other medications, or any of the ingredients in eslicarbazepine tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); hormonal contraceptives (birth control pills, patches, rings, implants, injections, and intrauterine devices); other medications for seizures such as carbamazepine (Carbatrol, Equetro, Epitol, Tegretol, Teril), clobazam (Onfi), oxcarbazepine (Oxtellar XR, Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), or primidone (Mysoline); omeprazole (Prilosec, in Zegerid); simvastatin (Zocor, in Simcor, in Vytorin); and rosuvastatin (Crestor). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had liver or kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you are using hormonal contraceptives, you should know that this type of birth control may not work well when used with eslicarbazepine. You should not use hormonal contraceptives as your only method of birth control while you are taking eslicarbazepine. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking eslicarbazepine, call your doctor.
  • you should know that eslicarbazepine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking eslicarbazepine for the treatment of epilepsy, mental illness, or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as eslicarbazepine to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as eslicarbazepine, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to eslicarbazepine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Aptiom Interactions

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

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.

Commonly used brand name(s)

In the U.S.

  • Aptiom

Available Dosage Forms:

  • Tablet

Therapeutic Class: Anticonvulsant

Chemical Class: Dibenzazepine Carboxamide

What are some other side effects of Aptiom?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Feeling tired or weak.
  • Upset stomach or throwing up.
  • Dizziness.
  • Feeling sleepy.
  • Shakiness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Indications and Usage for Aptiom

Aptiom is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

Aptiom Dosage and Administration

Important Administration Instructions

Instruct patients to administer Aptiom either as whole or as crushed tablets. Instruct patients to take Aptiom either with or without food. The Aptiom dosing regimen depends on age, weight, and renal function.

General Dosing Recommendations

Monotherapy and Adjunctive Therapy

Adult Patients

The recommended initial dosage of Aptiom is 400 mg administered orally once daily. For some patients, treatment may be initiated at 800 mg once daily if the need for seizure reduction outweighs an increased risk of adverse reactions during initiation [see Adverse Reactions (6.1)]. Dosage should be increased in weekly increments of 400 mg to 600 mg, based on clinical response and tolerability, to a recommended maintenance dosage of 800 mg to 1600 mg once daily. For patients on Aptiom monotherapy, the 800 mg once daily maintenance dose should generally be considered in patients who are unable to tolerate a 1200 mg daily dose. For patients on Aptiom adjunctive therapy, the 1600 mg daily dose should generally be considered in patients who did not achieve a satisfactory response with a 1200 mg daily dose.

Pediatric Patients (4 to 17 Years of Age)

In pediatric patients 4 to 17 years of age, the recommended dosing regimen is dependent upon body weight and is administered orally once daily. The recommended initial dosage of Aptiom is shown in Table 1. Dosage should be increased based on clinical response and tolerability, no more frequently than once per week. Titration increments should not exceed those shown in Table 1. The daily maintenance dosage should not exceed the maintenance dosage for each body weight range shown in Table 1.

Table 1: Aptiom Once Daily Dosage Schedule for Pediatric Patients 4 to 17 Years of Age
Body Weight Range Initial and Maximum Titration Increment Dosage (mg/day) Maintenance Dosage (mg/day)
11 to 21 kg 200 400 to 600
22 to 31 kg 300 500 to 800
32 to 38 kg 300 600 to 900
more than
38 kg
400 800 to 1200

Dosage Modifications with Other Antiepileptic Drugs

Some adverse reactions occur more frequently when patients take Aptiom adjunctively with carbamazepine [see Warnings and Precautions (5.6)]. However, carbamazepine reduces the plasma concentration of eslicarbazepine [see Drug Interactions (7.1)]. When Aptiom and carbamazepine are taken concomitantly, the dose of Aptiom or carbamazepine may need to be adjusted based on efficacy and tolerability. For patients taking other enzyme-inducing AEDs (i.e., phenobarbital, phenytoin, and primidone), higher doses of Aptiom may be needed [see Drug Interactions (7.1)].

Aptiom should not be taken as an adjunctive therapy with oxcarbazepine.

Dosage Modifications in Patients with Renal Impairment

In patients with moderate and severe renal impairment (i.e., creatinine clearance < 50 mL/min), the initial, titration, and maintenance dosages should generally be reduced by 50%. Titration and maintenance dosages may be adjusted according to clinical response [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Patients with Hepatic Impairment

Dose adjustments are not required in patients with mild to moderate hepatic impairment. Use of Aptiom in patients with severe hepatic impairment has not been studied, and use in these patients is not recommended [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

Discontinuation of Aptiom

When discontinuing Aptiom, reduce the dosage gradually and avoid abrupt discontinuation in order to minimize the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.7)].

Overdosage

Signs, Symptoms, and Laboratory Findings of Acute Overdose in Humans

Symptoms of overdose are consistent with the known adverse reactions of Aptiom and include hyponatremia (sometimes severe), dizziness, nausea, vomiting, somnolence, euphoria, oral paraesthesia, ataxia, walking difficulties, and diplopia. The maximum dosage studied in open-label adult monotherapy treatment following withdrawal of concomitant AEDs was 2400 mg once daily.

Treatment or Management of Overdose

There is no specific antidote for overdose with Aptiom. Symptomatic and supportive treatment should be administered as appropriate. Removal of the drug by gastric lavage and/or inactivation by administering activated charcoal should be considered.

Standard hemodialysis procedures result in partial clearance of Aptiom. Hemodialysis may be considered based on the patient's clinical state or in patients with significant renal impairment.

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 per day. Your doctor may adjust your dose. However, the dose is usually not more than 1600 mg once per day.
      • Children—Use and dose must be determined by your doctor.

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.

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.

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.

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 Aptiom to anyone under 18 years old.

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