Elepsia XR

Elepsia XR is a prescription medication used to treats partial onset seizures. Elepsia XR belongs to a group of drugs called anticonvulsants, which may work by decreasing abnormal excitement in the brain.

This medication comes as an extended release tablet and is usually taken once a day. 

Take Elepsia XR tablets whole. Do not split or cut Elepsia XR tablets.

Common side effects of Elepsia XR include feeling tired and irritability. Since Elepsia XR can make you feel tired, do not drive or operate heavy machinery until you know how Elepsia XR affects you.

Elepsia XR is a prescription medicine taken by mouth that is used with other medicines to treat partial onset seizures in patients 12 years of age or older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take Elepsia XR exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. 

The recommended starting dose of Elepsia XR tablets, for the treatment of partial onset seizures in patients ≥ 12 years of age with epilepsy, is 1000 mg once daily. The dosage may be adjusted in increments of 1000 mg every 2 weeks, to a maximum recommended dose of 3000 mg once daily.

Your doctor may change your dose changes based on how your kidney works. 

Like other antiepileptic drugs, Elepsia XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.

Call your doctor right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your doctor between visits as needed, especially if you are worried about symptoms.

Do not stop Elepsia XR without first talking to your doctor.

• Stopping Elepsia XR suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Call your healthcare provider right away if you have any of these symptoms:

• mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. A few people may develop psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs) and unusual behavior.
• extreme sleepiness, tiredness, and weakness
• problems with muscle coordination (problems walking and moving)
• a skin rash. Serious skin rashes can happen after you start taking Elepsia XR. There is no way to tell if a mild rash will become a serious reaction.

Elepsia XR may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how Elepsia XR will affect you.

The most common side effects seen in people who take Elepsia XR include:

• nausea
• influenza
• nasopharyngitis
• somnolence
• dizziness
• irritability

These side effects can happen at any time, but occur more often within the first 4 weeks of treatment.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

No Elepsia XR drug interactions have been identified. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Tell your doctor if you are pregnant or planning to become pregnant. 

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. You and your doctor will have to decide if you should take Elepsia XR while you are pregnant.

If you become pregnant while taking Elepsia XR, talk to your doctor about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. You can also enroll in the UCB AED Pregnancy Registry by calling 1-888-537-7734. The purpose of these registries is to collect information about the safety of Elepsia XR and other antiepileptic medicine during pregnancy.

Tell your doctor if you are breastfeeding or planning to breastfeed. Elepsia XR can pass into your milk and may harm your baby. You and your healthcare provider should discuss whether you should take Elepsia XR or breast-feed; you should not do both.