Brand Names: Aptiom (ap tee’ om)
Eslicarbazepine acetate (ES li Kar BAZ e peen) has been approved by the FDA to treat focal onset seizures in patients 4 years of age and older.
Your epilepsy treatment should always be discussed with your healthcare provider before use. Based on their judgment and knowledge, a drug may be prescribed for other epilepsy types not included in the indications. For more information, please see the prescribing information.
Eslicarbazepine acetate is available as a tablet, which can be taken either whole or crushed and with or without food.
If you are allergic to eslicarbazepine acetate, carbamazepine, or oxcarbazepine, or any of the inactive ingredients, then you should not take it.
If you are currently taking oxcarbazepine, you should not take eslicarbazepine acetate because they have not been studied together.
If you have kidney problems, taking eslicarbazepine acetate requires caution. Talk with your healthcare provider to see if you will need a dosing adjustment.
Other considerations may influence whether you should take eslicarbazepine acetate. Tell your healthcare provider if you:
Do not stop taking eslicarbazepine acetate suddenly unless directed to do so by your healthcare provider.
As with all antiseizure medications, eslicarbazepine acetate should be withdrawn gradually to minimize the risk of causing or worsening seizures or status epilepticus. You should not stop using eslicarbazepine acetate suddenly unless your healthcare provider tells you to stop the medicine because of a serious side effect.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking eslicarbazepine acetate with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you take: oxcarbazepine, carbamazepine, simvastatin, omeprazole, clobazam, phenobarbital, phenytoin, birth control medicine, rosuvastatin, or primidone.
At this time, there is not enough evidence regarding developmental risks associated with the use of eslicarbazepine acetate in pregnant people. In animal studies, there were instances of developmental issues at clinically relevant doses. However, having a seizure during pregnancy could harm both the pregnant individual and the baby. Tell your healthcare provider right away if you become pregnant. Do not start or stop taking seizure medication during pregnancy without your healthcare provider’s advice.
If you become pregnant while taking eslicarbazepine acetate, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiseizure medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
Eslicarbazepine acetate is present in breast milk. It is unknown if there are effects on the breastfed infant, or if eslicarbazepine acetate impacts milk production. Talk to your healthcare provider about the risks. Your healthcare provider will consider the developmental and health benefits of breastfeeding along with your need for eslicarbazepine acetate and the potential effect on the infant from eslicarbazepine acetate or from your epilepsy.
Eslicarbazepine acetate may decrease the effectiveness of hormonal contraceptives, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using eslicarbazepine acetate, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.
The effect of eslicarbazepine acetate on fertility in humans is unknown. There is some evidence in animal studies to suggest impairment of fertility.
Eslicarbazepine acetate is approved by the FDA because it is safe and effective for most people who take it. However, there are risks associated with all medicines. Some side effects caused by eslicarbazepine acetate can be very serious, and even life-threatening. It is important to be informed about these serious reactions and to be aware of their symptoms.
The most common side effects that were reported in studies of eslicarbazepine acetate are dizziness, sleepiness, tremor, back pain, headache, nausea, vomiting, rash, diarrhea, blurred or double vision, tiredness, fever, insomnia, lack of coordination, dry mouth, abdominal pain, stuffy nose, infections (including seasonal influenza), and sore throat.
Studies have found that people who take antiseizure medications including eslicarbazepine acetate may have suicidal thoughts or behaviors, which occur in approximately 1 in 500 patients. If you experience any thoughts or impulses to hurt yourself, you should contact your HCP immediately.
Eslicarbazepine acetate may cause life-threatening rashes including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). While not all rashes are serious, there is no way to predict which ones will become life-threatening. Call your healthcare provider at the first sign of any rash, so they can decide if you should continue taking eslicarbazepine acetate. Tell your healthcare provider right away if you have a skin rash, blistering or peeling of your skin, hives, or painful sores in your mouth or around your eyes.
Factors that may increase the risk of getting a serious skin rash when taking eslicarbazepine acetate have not been identified.
Rare but life-threatening reactions involving the immune system or multi-organ hypersensitivity, which can cause serious blood or liver problems have been reported with eslicarbazepine acetate use. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you experience: swelling of your face, eyes, lips, or tongue; trouble swallowing or breathing; hives; fever, swollen glands, or sore throat that do not go away or come and go; yellowing of your skin or eyes; unusual bruising or bleeding; severe fatigue or weakness; severe muscle pain; or frequent infections or infections that do not go away.
Eslicarbazepine acetate may cause the level of sodium in your blood to be low (hyponatremia). Symptoms of low blood sodium include nausea, tiredness, lack of energy, irritability, confusion, muscle weakness or muscle spasms, and more frequent or more severe seizures. Certain other drugs can also cause low sodium in your blood. Be sure to tell your healthcare provider about all the other medicines that you are taking.
Rare cases of anaphylaxis (allergic reaction) and angioedema (e.g., swelling of the throat, head, and neck) have been reported when taking eslicarbazepine acetate. If you develop any of these reactions after taking eslicarbazepine acetate then the drug should be discontinued.
Eslicarbazepine acetate may cause problems that can affect your nervous system. Symptoms of nervous system problems include dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, and vision problems.
Do not drive, operate heavy machinery, or do dangerous activities until you know how eslicarbazepine acetate affects you, as it may slow your thinking and motor skills.