Keppra XR levetiracetam

Get an overview of KEPPRA XR (levetiracetam tablet, film coated, extended release), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Keppra XR can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Keppra XR.

Drug Basics

Brand Name: Keppra XR

Generic Name: LEVETIRACETAM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED, EXTENDED RELEASE

Packager: UCB, Inc.

Data Current As Of: 2021-02-11

Indications and Usage (1) 10/2019
Dosage and Administration (2.1, 2.3) 10/2019

Indications & Usage

KEPPRA XR® is indicated for the treatment of partial-onset seizures in patients 12 years of age and older.

KEPPRA XR is indicated for the treatment of partial-onset seizures in patients 12 years of age and older (1)

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Psychiatric Reactions and Changes in Behavior

Advise patients that KEPPRA XR may cause changes in behavior (e.g. irritability and aggression). In addition, patients should be advised that they may experience changes in behavior that have been seen with other formulations of KEPPRA, which include agitation, anger, anxiety, apathy, depression, hostility, and psychotic symptoms [see Warnings and Precautions (5.1)].

Suicidal Behavior and Ideation

Counsel patients, their caregivers, and/or families that antiepileptic drugs (AEDs), including KEPPRA XR, may increase the risk of suicidal thoughts and behavior and advise patients to be alert for the emergence or worsening of symptoms of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or thoughts about self-harm. Advise patients, their caregivers, and/or families to immediately report behaviors of concern to a healthcare provider [see Warnings and Precautions (5.2)].

Effects on Driving or Operating Machinery

Inform patients that KEPPRA XR may cause dizziness and somnolence. Inform patients not to drive or operate machinery until they have gained sufficient experience on KEPPRA XR to gauge whether it adversely affects their ability to drive or operate machinery [see Warnings and Precautions (5.3)].

Anaphylaxis and Angioedema

Advise patients to discontinue KEPPRA XR and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.4)].

Dermatological Adverse Reactions

Advise patients that serious dermatological adverse reactions have occurred in patients treated with levetiracetam and instruct them to call their physician immediately if a rash develops [see Warnings and Precautions (5.5)].

Dosing and Administration

Patients should be instructed to only take KEPPRA XR once daily and to swallow the tablets whole. They should not be chewed, broken, or crushed.

Inform patients that they should not be concerned if they occasionally notice something that looks like swollen pieces of the original tablet in their stool.

Withdrawal of KEPPRA

Advise patients and caregivers not to discontinue use of KEPPRA XR without consulting with their healthcare provider. KEPPRA XR should normally be gradually withdrawn to reduce the potential of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.7)].

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during KEPPRA therapy. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant [see Use in Specific Populations (8.1)].

KEPPRA XR manufactured for
UCB, Inc.
Smyrna, GA 30080

KEPPRA XR is a registered trademark of the UCB Group of companies
© 2020, UCB, Inc., Smyrna, GA 30080
All rights reserved.

MEDICATION GUIDE
KEPPRA XR® (KEPP-ruh XR) (levetiracetam)
extended-release tablets, for oral use
    This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 10/2020    
Read this Medication Guide before you start taking KEPPRA XR and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about KEPPRA XR?
Like other antiepileptic drugs, KEPPRA XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.
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
  • 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
Do not stop KEPPRA XR without first talking to a healthcare provider .
  • Stopping KEPPRA 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.
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.
What is KEPPRA XR?
KEPPRA XR is a prescription medicine taken by mouth that is used to treat partial-onset seizures in people 12 years of age and older.
It is not known if KEPPRA XR is safe or effective in people under 12 years of age.
Before taking your medicine, make sure you have received the correct medicine. Compare the name above with the name on your bottle and the appearance of your medicine with the description of KEPPRA XR provided below. Tell your pharmacist immediately if you think you have been given the wrong medicine.
Who should not take KEPPRA XR? Do not take KEPPRA XR if you are allergic to levetiracetam.
What should I tell my healthcare provider before starting KEPPRA XR?
Before taking KEPPRA XR, tell your healthcare provider about all of your medical conditions, including if you:
  • have or have had depression, mood problems or suicidal thoughts or behavior.
  • have kidney problems.
  • are pregnant or planning to become pregnant. It is not known if KEPPRA XR will harm your unborn baby. You and your healthcare provider will have to decide if you should take KEPPRA XR while you are pregnant. If you become pregnant while taking KEPPRA XR, 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 KEPPRA XR and other antiepileptic medicine during pregnancy.
  • are breastfeeding or plan to breastfeed. KEPPRA XR can pass into your breast milk. It is not known if the KEPPRA XR that passes into your breast milk can harm your baby. Talk to your doctor about the best way to feed your baby while you receive KEPPRA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. Do not start a new medicine without first talking with your healthcare provider.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
How should I take KEPPRA XR?
  • Take KEPPRA XR exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much KEPPRA XR to take and when to take it. KEPPRA XR is usually taken 1 time each day.
  • Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
  • Take KEPPRA XR with or without food.
  • Swallow the tablets whole. Do not chew, break, or crush tablets.
  • The inactive part of KEPPRA XR tablets may not dissolve after all the medicine has been released in your body. You may sometimes notice something in your bowel movement that looks like swollen pieces of the original tablet. This is normal.
  • If you take too much KEPPRA XR, call your local Poison Control Center or go to the nearest emergency room right away.
What should I avoid while taking KEPPRA XR?
Do not drive, operate machinery or do other dangerous activities until you know how KEPPRA XR affects you. KEPPRA XR may make you dizzy or sleepy.
What are the possible side effects of KEPPRA XR?
KEPPRA XR can cause serious side effects including:
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 get 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.
  • allergic reactions such as swelling of the face, lips, eyes, tongue, and throat, trouble swallowing or breathing, and hives.
  • a skin rash. Serious skin rashes can happen after you start taking KEPPRA XR. There is no way to tell if a mild rash will become a serious reaction.
  • problems with muscle coordination (problems walking and moving).
The most common side effects seen in people who take KEPPRA XR include:
  • sleepiness
  • irritability
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of KEPPRA XR. 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.
How should I store KEPPRA XR?
  • Store KEPPRA XR at room temperature, between 59°F to 86°F (15°C to 30°C) away from heat and light.
  • Keep KEPPRA XR and all medicines out of the reach of children.
General information about the safe and effective use of KEPPRA XR.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use KEPPRA XR for a condition for which it was not prescribed. Do not give KEPPRA XR to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about KEPPRA XR that is written for health professionals.
What are the ingredients in KEPPRA XR?
Keppra XR tablet active ingredient: levetiracetam
Inactive ingredients: colloidal anhydrous silica, hypromellose, magnesium stearate, polyethylene glycol 6000, polyvinyl alcohol-partially hydrolyzed, titanium dioxide (E171), Macrogol/PEG3350, and talc. The imprinting ink contains shellac, FD&C Red #40, n-butyl alcohol, propylene glycol, titanium dioxide, ethanol, and methanol. KEPPRA XR does not contain lactose or gluten.
Distributed by
UCB, Inc.
Smyrna, GA 30080
KEPPRA XR is a registered trademark of the UCB Group of companies
© 2020, UCB, Inc., Smyrna, GA 30080
All rights reserved.
For more information, go to www.keppraxr.com or call 1- (844) 599-CARE (2273).
This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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