lamotrigine 50 MG Disintegrating Oral Tablet
1 INDICATIONS AND USAGE Lamotrigine orally disintegrating tablets are indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic seizures. generalized seizures of Lennox-Gastaut syndrome. ( 1.1 ) Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. ( 1.1 ) Bipolar disorder : Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. ( 1.2 ) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established. 1.1 Epilepsy Adjunctive Therapy Lamotrigine orally disintegrating tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. Monotherapy Lamotrigine orally disintegrating tablets are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.2 Bipolar Disorder Lamotrigine orally disintegrating tablets are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Clinical Studies (14.2) ] . Limitations of Use Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
Amneal Pharmaceuticals of New York LLC
ROUND WHITE IX527
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16 HOW SUPPLIED/STORAGE AND HANDLING
LAMOTRIGINE Orally Disintegrating Tablets, USP 25 mg, off-white to white circular tablets debossed with “IX526” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 0115-9939-01 50 mg, off-white to white circular tablets debossed with “IX527” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 0115-9940-01 100 mg, off-white to white circular tablets debossed with “IX528” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 0115-9941-01 200 mg, off-white to white circular tablets debossed with “IX529” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 0115-9942-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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