lamotrigine 25 MG Chewable Tablet
1 INDICATIONS AND USAGE Lamotrigine is 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 AED. ( 1.1 ) Bipolar disorder in patients aged 18 years and older: 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 ) 1.1 Epilepsy Adjunctive Therapy: Lamotrigine is 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 is 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 is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults (aged 18 years and older) treated for acute mood episodes with standard therapy. The effectiveness of lamotrigine in the acute treatment of mood episodes has not been established. The effectiveness of lamotrigine as maintenance treatment was established in 2 placebo-controlled trials in patients with bipolar I disorder as defined by DSM-IV [see Clinical Studies (14.2) ] . The physician who elects to prescribe lamotrigine for periods extending beyond 16 weeks should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Taro Pharmaceuticals U.S.A., Inc.
ROUND WHITE L25 T
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lamotrigine 5 MG Chewable Tablet
Taro Pharmaceuticals U.S.A., Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Lamotrigine Tablets (Chewable, Dispersible), 5 mg: white, oval tablets, engraved with "L5" on one side and "T" on the other side. Bottles of 30 NDC 51672-4139-6 Bottles of 100 NDC 51672-4139-1 Bottles of 1000 NDC 51672-4139-3 Cartons of 100 (10 × 10 Unit-Dose) NDC 51672-4139-0 Lamotrigine Tablets (Chewable, Dispersible), 25 mg: white, round tablets, engraved with "L25" on one side and "T" on the other side. Bottles of 30 NDC 51672-4140-6 Bottles of 100 NDC 51672-4140-1 Bottles of 1000 NDC 51672-4140-3 Cartons of 100 (10 × 10 Unit-Dose) NDC 51672-4140-0 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] in a dry place.
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