Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
levetiracetam (UNII: 44YRR34555) (levetiracetam - UNII:44YRR34555)
Atlantic Biologicals Corps.
levetiracetam
levetiracetam 100 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Levetiracetam oral solution 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 oral solution 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 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 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 ]
NDC:17856-0241-1 in a CUP of 10 SOLUTIONS NDC:17856-0241-5 in a CUP of 5 SOLUTIONS Levetiracetam Oral Solution 100 mg/mL is a clear, colorless, grape-flavored liquid. It is supplied in 16 fl. oz. (473 mL) white HDPE bottles. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]; excursions permitted to 15°-30°C (59°-86°F). Dispense accompanying Medication Guide to each patient.
Abbreviated New Drug Application
LEVETIRACETAM- LEVETIRACETAM SOLUTION Atlantic Biologicals Corps. ---------- MEDICATION GUIDE Levetiracetam Oral Solution Read this Medication Guide before you start taking levetiracetam oral solution 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? Like other antiepileptic drugs, levetiracetam oral solution 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 without first talking to a healthcare provider. • Stopping levetiracetam oral solution 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? Levetiracetam oral solution is a prescriptio Прочитать полный документ
LEVETIRACETAM- LEVETIRACETAM SOLUTION ATLANTIC BIOLOGICALS CORPS. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVETIRACETAM ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM ORAL SOLUTION INITIAL U.S. APPROVAL: 1999 INDICATIONS AND USAGE Levetiracetam oral solution 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 • • _Partial Onset Seizures_ • • _Myoclonic Seizures In Adults and Pediatric Patients 12 Years And Older_ • _Primary Generalized Tonic-Clonic Seizures_ • • _Adult Patients with Impaired Renal Function_ • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS •Psychiatric Symptoms: 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•Somnolence and Fatigue: Monitor patients for these symptoms and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam ( ) 5.3•Withdrawal Seizures: Levetiracetam must be gradually withdrawn ( ) 5.6 ADVERSE REACTIONS Most common adverse reactions (incidence in levetiracetam-treated patients is ≥ 5% more than in placebo-treated patients) include: Use the oral solution for pediatric patients with body weight ≤ 20 kg ( ). 2.1 For pediatric patients, use weight-based dosing for the ora Прочитать полный документ