Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)
China Resources Saike Pharmaceutical Co., Ltd.
LEVETIRACETAM
LEVETIRACETAM 500 mg
ORAL
PRESCRIPTION DRUG
Levetiracetam tablets are indicated for the treatment of partial-onset in patients 1month of age and older. Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. Levetiracetam 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, during pregnancy. Encourage women who are taking levetiracetam during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy regis
Levetiracetam tablets USP, 500 mg are yellow, oval-shaped, scored, film-coated tablets engraved with "500 MG" on one side. They are supplied in white HDPE bottles as follows: NDC 43489-122-09 bottles of 120 tablets NDC 43489-122-05 bottles of 1,000 tablets Levetiracetam tablets USP, 1,000 mg are white, oval-shaped, scored, film-coated tablets engraved with "1000 MG" on one side. They are supplied in white HDPE bottles as follows: NDC 43489-124-08 bottles of 60 tablets NDC 43489-124-03 bottles of 500 tablets Levetiracetam Tablets USP, 500 mg and 1,000 mg are functionally scored. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
China Resources Saike Pharmaceutical Co., Ltd. ---------- MEDICATION GUIDE LEVETIRACETAM TABLETS, USP (lee-va-tye-RA-se-tam) Read this Medication Guide before you start taking levetiracetam 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? Like other antiepileptic drugs, levetiracetam 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 without first talking to a healthcare provider. • Stopping levetiracetam 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 levetiracetam? Levetiracetam tablets are a prescription medicine taken by mouth that is used to treat partial-onset seizures in people 1 Прочетете целия документ
LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED CHINA RESOURCES SAIKE PHARMACEUTICAL CO., LTD. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVETIRACETAM TABLETS, USP, SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVETIRACETAM TABLETS, USP. LEVETIRACETAM TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1999 RECENT MAJOR CHANGES Indications and Usage( 1.1) 10/2019 Dosage and Administration( 2.2, 2.6) 10/2019 INDICATIONS AND USAGE Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) DOSAGE AND ADMINISTRATION Use the oral solution for pediatric patients with body weight ≤ 20 kg ( 2.1). For pediatric patients, use weight-based dosing for the oral solution with a calibrated measuring device (not a household teaspoon or tablespoon) ( 2.1) Partial Onset Seizures (monotherapy or adjunctive therapy) 1 Month to < 6 Months: 7 mg/kg twice daily, increase by 7 mg/kg twice daily every 2 weeks to recommended dose of 21 mg/kg twice daily ( 2.2) 6 Months to < 4 Years: 10 mg/kg twice daily, increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 25 mg/kg twice daily ( 2.2) 4 Years to < 16 Years: 10 mg/kg twice daily, increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily ( 2.2) Adults 16 Years and Older: 500 mg twice daily, increase by 500 mg twice daily every 2 weeks to a recommended dose of 1,500 mg twice daily ( 2.2) Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1,500 mg twice daily ( 2.3) Primary Generalized Tonic-Clon Прочетете целия документ