देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)
DIRECT RX
LEVETIRACETAM
LEVETIRACETAM 500 mg
ORAL
PRESCRIPTION DRUG
1.1 Partial Onset Seizures Levetiracetam tablets USP are 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 tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures Levetiracetam tablets USP are 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 gener
Levetiracetam tablets USP, 250 mg are blue coloured, oblong-shaped, biconvex, film-coated tablets, debossed with "L" and "U" on either side of the breakline on one side and "X01" on the other side. They are supplied as follows: NDC 68180-112-09 Bottles of 90's NDC 68180-112-16 Bottles of 120's NDC 68180-112-02 Bottles of 500's Levetiracetam tablets USP, 500 mg are yellow coloured, oblong-shaped, biconvex, film-coated tablets, debossed with "L" and "U" on either side of the breakline on one side and "X02" on the other side. They are supplied as follows: NDC 68180-113-09 Bottles of 90's NDC 68180-113-16 Bottles of 120's NDC 68180-113-02 Bottles of 500's Levetiracetam tablets USP, 750 mg are orange coloured, oblong-shaped, biconvex, film-coated tablets, debossed with "L" and "U" on either side of the breakline on one side and "X03" on the other side. They are supplied as follows: NDC 68180-114-09 Bottles of 90's NDC 68180-114-16 Bottles of 120's NDC 68180-114-02 Bottles of 500's Levetiracetam tablets USP, 1000 mg are white to off-white coloured, oblong-shaped, biconvex, film-coated tablets, debossed with "L" and "U" on either side of the breakline on one side and "X04" on the other side. They are supplied as follows: NDC 68180-115-07 Bottles of 60's NDC 68180-115-02 Bottles of 500's 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 child-resistant closure along with medication guide provided separately.
Abbreviated New Drug Application
LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED DIRECT RX ---------- SPL MEDGUIDE SECTION MEDICATION GUIDE LEVETIRACETAM TABLETS USP 250 mg, 500 mg, 750 mg and 1000 mg Rx only Read this Medication Guide before you start taking levetiracetam 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 tablets? 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 tablets without first talking to a healthcare provider. Stopping levetiracetam 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 levetiracetam tablets? Levetiracetam tablets are a prescription medicine taken by mouth that is used with other med पूरा दस्तावेज़ पढ़ें
LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED DIRECT RX ---------- LEVETIRACETAM INDICATIONS & USAGE SECTION 1.1 Partial Onset Seizures Levetiracetam tablets USP are 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 tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures Levetiracetam tablets USP are 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. DOSAGE & ADMINISTRATION SECTION 2.1 Important Administration Instructions Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function. Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg. Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed. 2.2 Partial Onset Seizures Adults 16 Years and Older In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see CLINICAL STUDIES ( 14.1)], a consistent increase in response with increased dose has no पूरा दस्तावेज़ पढ़ें