Perampanel

What it is used for

Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older 1.1 Partial-Onset Seizures Perampanel tablets are indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older.

1.2 Primary Generalized Tonic-Clonic Seizures Perampanel tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.

The most important thing to know

1. Perampanel tablets may cause mental (psychiatric) problems, including: new or worse aggressive behavior (including homicidal behavior), hostility, anger, anxiety, or irritability being suspicious or distrustful (believing things that are not true) seeing objects or hearing things that are not there confusion difficulty with memory other unusual or extreme changes in behavior or mood Tell your healthcare provider right away if you have any new or worsening mental problems while taking perampanel.

2. Like other antiepileptic drugs, perampanel tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempt 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 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. 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 healthcare provider between visits as needed, especially if you are worried about symptoms. Do not stop perampanel tablets without first talking with a healthcare provider. Stopping perampanel tablets suddenly can cause serious problems. Stopping perampanel tablets suddenly can cause you to have seizures more often.

What are perampanel tablets? Perampanel tablets are a prescription medicine used: to treat partial-onset seizures with or without secondarily generalized seizures in people with epilepsy who are 4 years of age and older with other medicines to treat primary generalized tonic-clonic seizures in people with epilepsy who are 12 years of age and older Perampanel tablets are a controlled substance (CIII) because it can be abused or lead to drug dependence.

Keep your perampanel tablets in a safe place to protect it from theft. Never give your perampanel tablets to anyone else because it may harm them. Selling or giving away this medicine is against the law. It is not known if perampanel tablets are safe and effective for partial onset seizures in children under 4 years of age or for primary generalized tonic-clonic seizures in patients under 12 years of age.

Before taking perampanel tablets, tell your healthcare provider about all of your medical conditions, including if you: have or have had depression, mood problems, aggressive or hostile behavior (for example, homicidal behavior), suicidal thoughts or behavior, or other psychiatric problems have liver or kidney problems drink alcohol have abused prescription medicines, street drugs, or alcohol in the past are pregnant or plan to become pregnant.

It is not known if perampanel will harm your unborn baby. If you become pregnant while taking perampanel tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334 or go to http://www.aedpregnancyregistry.org.

The purpose of this registry is to collect information about the safety of perampanel and other antiepileptic medicine during pregnancy. are breastfeeding or plan to breastfeed. It is not known if perampanel passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take perampanel tablets.

You and your healthcare provider should decide if you will take perampanel or breastfeed. You should not do both. Tell your healthcare provide

How to take it

Take perampanel tablets exactly as your healthcare provider tells you. Your healthcare provider will tell you how much perampanel to take and when to take it. Perampanel is usually taken 1 time a day at bedtime. Your healthcare provider may change the dose. Do not change the dose without talking to your healthcare provider.

Talk to your healthcare provider about what to do if you miss more than 1 dose of perampanel. If you take too much perampanel, call your local Poison Control Center or go to the nearest hospital emergency room right away.

Side effects, and when to stop

Perampanel may cause other serious side effects, including: Dizziness, vertigo (sense of spinning), and problems walking normally. You may have problems walking normally if you are unsteady because you feel dizzy. These symptoms can increase when the dose of perampanel is increased. Your risk of feeling dizzy and having problems walking normally may be higher if you are elderly.

Sleepiness and tiredness. See " What should I avoid while taking perampanel tablets? " Increased risk of falls. Taking perampanel can increase your chance of falling. These falls can cause serious injuries. Your risk of falling may be higher if you are elderly. A serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells.

This allergic reaction can be life-threatening and can cause death. Call your healthcare provider right away if you have: a skin rash, hives fever or swollen glands that do not go away swelling of your face shortness of breath, swelling of the legs, yellowing of the skin or whites of the eyes, or dark urine. The most common side effects of perampanel include: dizziness nausea and vomiting headache sleepiness weight gain bruising tiredness vertigo (sense of spinning) abdominal pain irritability problems walking normally anxiety falls problems with muscle coordination These are not all of the possible side effects of perampanel.

For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What to avoid

Do not drive, operate heavy machinery, or do other dangerous activities until you know how perampanel affects you. Perampanel tablets may make you dizzy, sleepy, or tired. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking perampanel until you talk to your healthcare provider. Perampanel tablets taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

Perampanel tablets when taken with alcohol may also make your mood worse, increase anger, confusion, and depression.

Storing it

Store perampanel tablets at room temperature between 68°F to 77°F (20°C to 25°C). Replace the cap tightly after opening. Keep perampanel tablets and all medicines out of the reach of children.