Keppra XR levetiracetam
Refer to the “Also Known As” section to reference different products that include the same medication as Keppra XR.
Brand Name: Keppra XR
Generic Name: LEVETIRACETAM
Drug Type: HUMAN PRESCRIPTION DRUG
Dosage Form: TABLET, FILM COATED, EXTENDED RELEASE
Packager: UCB, Inc.
Data Current As Of: 2021-02-11
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
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)].
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
Smyrna, GA 30080
KEPPRA XR is a registered trademark of the UCB Group of companies
© 2020, UCB, Inc., Smyrna, GA 30080
All rights reserved.
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:
| Do not stop KEPPRA XR without first talking to a healthcare provider .
| How can I watch for early symptoms of suicidal thoughts and actions?
|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:
|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?
|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:
|The most common side effects seen in people who take KEPPRA XR include:|
|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?
|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.|
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).|