Levetiracetam 1000 MG Oral Tablet
1 INDICATIONS AND USAGE Levetiracetam tablets are indicated for adjunctive therapy in the treatment of: Partial onset seizures in patients one month 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) 1.1 Partial Onset Seizures Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam tablets 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 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.
Amneal Pharmaceuticals LLC
OVAL WHITE OL 1000
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
LEVETIRACETAM tablets, USP, 250 mg, are supplied as blue, oblong-shaped, scored, film-coated tablets debossed with “OL” and “250” on one side. They are supplied in white HDPE bottles and are available as follows: Bottles of 120: NDC 65162-528-16
LEVETIRACETAM tablets, USP, 500 mg, are supplied as yellow, oblong-shaped, scored, film-coated tablets debossed with “OL” and “500”on one side. They are supplied in white HDPE bottles and are available as follows: Bottles of 120: NDC 65162-529-16
LEVETIRACETAM tablets, USP, 750 mg, are supplied as dark pink, oblong-shaped, scored, film-coated tablets debossed with “OL” and “750” on one side. They are supplied in white HDPE bottles and are available as follows: Bottles of 120: NDC 65162-538-16
LEVETIRACETAM tablets, USP, 1,000 mg, are supplied as white, oblong-shaped, scored, film-coated tablets debossed with “OL” and “1000” on one side. They are supplied in white HDPE bottles and are available as follows: Bottles of 60: NDC 65162-539-06 16.2 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 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.
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