levetiracetam 500 MG Oral Tablet
1 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 ) 1.1 Partial-Onset Seizures Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy 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. 1.3 Primary Generalized Tonic-Clonic Seizures 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.
Mylan Pharmaceuticals Inc.
OVAL WHITE M 615
M 615 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
LEVETIRACETAM Tablets, USP are available containing 500 mg, 750 mg or 1000 mg of
LEVETIRACETAM, USP. The 500 mg tablets are white, film-coated, modified capsule-shaped, scored tablets debossed with M to the left of the score and 615 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5615-78 bottles of 120 tablets NDC 0378-5615-05 bottles of 500 tablets The 750 mg tablets are white, film-coated, modified capsule-shaped, scored tablets debossed with M to the left of the score and 617 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5617-78 bottles of 120 tablets NDC 0378-5617-05 bottles of 500 tablets The 1000 mg tablets are white, film-coated, modified capsule-shaped, scored tablets debossed with M to the left of the score and 619 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5619-91 bottles of 60 tablets 16.2 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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