Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)
Par Pharmaceutical Inc.
LEVETIRACETAM
LEVETIRACETAM 500 mg
ORAL
PRESCRIPTION DRUG
Levetiracetam extended-release tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients ≥16 years of age with epilepsy. ( 1) None Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. In animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. Levetiracetam extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses ≥350 mg/kg/day (approximately equivalent to the maximum recommended human dose of 3000 mg [MRHD] on a mg/m 2 basis) and with increased pup mortality and offspring behavioral alterations at a dose of 1800 mg/kg/day (6 times the MRHD
Levetiracetam extended-release tablets 500 mg are white to off-white, capsule shaped, biconvex tablets, debossed with “P” on one side and “204” on the other. They are supplied in white HDPE bottles containing 60 tablets (NDC 49884-204-02) and 500 tablets (NDC 49884-204-05). Levetiracetam extended-release tablets 750 mg are white to off-white, capsule shaped, biconvex tablets, debossed with “P” on one side and “205” on the other. They are supplied in white HDPE bottles containing 60 tablets (NDC 49884-205-02) and 500 tablets (NDC 49884-205-05). Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure Levetiracetam extended-release tablets 500 mg are white to off-white, capsule shaped, biconvex tablets, debossed with “P” on one side and “204” on the other. They are supplied in white HDPE bottles containing 60 tablets (NDC 49884-204-02) and 500 tablets (NDC 49884-204-05). Levetiracetam extended-release tablets 750 mg are white to off-white, capsule shaped, biconvex tablets, debossed with “P” on one side and “205” on the other. They are supplied in white HDPE bottles containing 60 tablets (NDC 49884-205-02) and 500 tablets (NDC 49884-205-05).
Abbreviated New Drug Application
LEVETIRACETAM- LEVETIRACETAM TABLET, EXTENDED RELEASE Par Pharmaceutical Inc. ---------- LEVETIRACETAM EXTENDED-RELEASE TABLETS 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 is levetiraceta Đọc toàn bộ tài liệu
LEVETIRACETAM- LEVETIRACETAM TABLET, EXTENDED RELEASE PAR PHARMACEUTICAL INC. ---------- 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 INITIAL U.S. APPROVAL: 1999 RECENT MAJOR CHANGES Warnings and Precautions ( 5) [04/2009] Patient Counseling Information ( 17) [04/2009] INDICATIONS AND USAGE Levetiracetam extended-release tablet is an antiepileptic drug indicated for adjunctive therapy in the treatment of partial onset seizures in patients ≥16 years of age with epilepsy ( 1) DOSAGE AND ADMINISTRATION Treatment should be initiated with a dose of 1000 mg once daily. The daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended daily dose of 3000 mg ( 2). See full prescribing information for use in patients with impaired renal function ( 2.1). DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS • • USE IN SPECIFIC POPULATIONS • • SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE. REVISED: 12/2014 500 mg white to off-white, film-coated extended-release tablet (3) 750 mg white to off-white, film-coated extended-release tablet (3) None (4) SUICIDAL BEHAVIOR AND IDEATION. (5.1) NEUROPSYCHIATRIC ADVERSE REACTIONS: Levetiracetam extended-release tablets causes somnolence, dizziness, and behavioral abnormalities. The adverse reactions that may be seen in patients receiving levetiracetam extended- release tablets are expected to be similar to those seen in patients receiving immediate-release levetiracetam tablets. (5.2) In controlled trials of immediate-release levetiracetam tablets in patients experiencing partial onset seizures, immediate-release levetiracetam causes somnolence and fatigue, coordination difficulties, and behavioral abnormalities (e.g., psychotic sympto Đọc toàn bộ tài liệu