Country: United States
Language: English
Source: NLM (National Library of Medicine)
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)
BluePoint Laboratories
LEVETIRACETAM
LEVETIRACETAM 500 mg
ORAL
PRESCRIPTION DRUG
Levetiracetam extended-release tablet is indicated for the treatment of partial-onset seizures in patients 12 years of age and older. Levetiracetam extended-release tablet is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4)] Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including levetiracetam extended-release tablets, during pregnancy. Encourage women who are taking levetiracetam extended-release tablets during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary Prolonged experience with levetiracetam tablets in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy regi
Levetiracetam Extended-release Tablets USP, 500 mg are white to off white, oblong-shaped, biconvex, film coated tablets, imprinted 'L008' (in black ink) on one side and plain on the other side. They are supplied in white HDPE bottles containing 60 tablets (NDC 68001-113-06). Levetiracetam Extended-release Tablets USP, 750 mg are white to off white, oblong-shaped, biconvex, film coated tablets, imprinted 'L009' (in black ink) on one side and plain on the other side. They are supplied in white HDPE bottles containing 60 tablets (NDC 68001-114-06). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure.
Abbreviated New Drug Application
BluePoint Laboratories ---------- MEDICATION GUIDE LEVETIRACETAM (LEE-ve-tye-RA-se-tam) EXTENDED-RELEASE TABLETS USP, for oral use Rx Only Read this Medication Guide before you start taking levetiracetam extended-release tablets 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 levetiracetam extended-release tablets? Like other antiepileptic drugs, levetiracetam extended-release tablets 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 levetiracetam extended-release tablets without first talking to a healthcare provider. • Stopping levetiracetam extended-release tablets 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 are leve Read the complete document
LEVETIRACETAM- LEVETIRACETAM TABLET, EXTENDED RELEASE BLUEPOINT LABORATORIES ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVETIRACETAM EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVETIRACETAM EXTENDED-RELEASE TABLETS. LEVETIRACETAM EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1999 INDICATIONS AND USAGE Levetiracetam extended-release tablet is indicated for the treatment of partial-onset seizures in patients 12 years of age and older ( 1) DOSAGE AND ADMINISTRATION Initiate treatment with a dose of 1000 mg once daily; increase by 1000 mg every 2 weeks to a maximum recommended dose of 3000 mg once daily ( 2) See full prescribing information for use in patients with impaired renal function ( 2.1) DOSAGE FORMS AND STRENGTHS 500 mg white, film-coated extended-release tablet ( 3) 750 mg white, film-coated extended-release tablet ( 3) CONTRAINDICATIONS Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred ( 4, 5.4) WARNINGS AND PRECAUTIONS Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms ( 5.1) Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior ( 5.2) Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam extended-release tablets ( 5.3) Serious Dermatological Reactions: Discontinue levetiracetam extended-release tablets at the first sign of rash unless clearly not drug related ( 5.5) Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination. Advise patients to not drive or operate machinery until they have gained experience on levetiracetam extended-release tablets ( 5.6) Withdrawal Seizures: levetiracetam extended- Read the complete document