Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)
Orit Laboratories LLC
LEVETIRACETAM
LEVETIRACETAM 100 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Levetiracetam Oral Solution, USP is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam oral solution. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Levetiracetam Oral Solution, USP is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam Oral Solution, USP is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. None. Levetiracetam levels may decrease during pregnancy [see Warnings and Precautions (5.9) ] . Pre
Levetiracetam Oral Solution, USP 100 mg/mL is a clear, colorless, grape-flavored liquid. It is supplied in 16 fl. oz. (473 mL) white HDPE bottles (NDC 15955-327-16). 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]. Dispense in a tight, light-resistant container with a child-resistant closure. Dispense accompanying Medication Guide to each patient.
Abbreviated New Drug Application
Orit Laboratories LLC ---------- MEDICATION GUIDE Levetiracetam Oral Solution, USP Read this Medication Guide before you start taking Levetiracetam Oral Solution, USP 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 Oral Solution, USP? Like other antiepileptic drugs, Levetiracetam Oral Solution, USP 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 Oral Solution, USP without first talking to a healthcare provider. • Stopping Levetiracetam Oral Solution, USP 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 Oral Solution, USP? Levetiracetam Oral Solution, USP is a prescription me Perskaitykite visą dokumentą
LEVETIRACETAM - LEVETIRACETAM SOLUTION ORIT LABORATORIES LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVETIRACETAM ORAL SOLUTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVETIRACETAM ORAL SOLUTION, USP. LEVETIRACETAM ORAL SOLUTION, USP INITIAL U.S. APPROVAL: 1999 RECENT MAJOR CHANGES Indications and Usage, Partial Onset Seizures (1.1) [12/2011] Dosage and Administration, Partial Onset Seizures (2.1, 2.2, 2.5) [12/2011] Warnings and Precautions (5.1, 5.3, 5.4, 5.5, 5.7, 5.8, 5.9) [12/2011] INDICATIONS AND USAGE Levetiracetam Oral Solution, USP is an antiepileptic drug indicated for adjunctive therapy in the treatment of: Partial onset seizures in patients 4 years of age and older with epilepsy (1.1) 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_ 4 Years To < 16 Years: 10 mg/kg twice daily, increase in increments of 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 as needed and tolerated in increments of 500 mg twice daily every 2 weeks to a maximum recommended dose of 1500 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 1500 mg twice daily (2.3) _Primary Generalized Tonic-Clonic Seizures_ 6 Years To < 16 Years: 10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily (2.4) Adults Perskaitykite visą dokumentą