lamotrigine 150 MG Oral 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 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 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 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.
Taro Pharmaceuticals U.S.A., Inc.
ROUND WHITE TARO LMT 150
TARO LMT 150 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
LAMOTRIGINE Tablets USP, 25 mg: round, white, scored tablets. One side engraved with "TARO". Other side scored and engraved with "LMT" above the score and "25" below the score. Bottles of 30 NDC 51672-4130-6 Bottles of 60 NDC 51672-4130-4 Bottles of 100 NDC 51672-4130-1 Bottles of 1000 NDC 51672-4130-3 Unit dose packages of 100 NDC 51672-4130-0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in a dry place.
LAMOTRIGINE Tablets USP, 100 mg: round, light peach, scored tablets. One side engraved with "TARO". Other side scored and engraved with "LMT" above the score and "100" below the score. Bottles of 30 NDC 51672-4131-6 Bottles of 60 NDC 51672-4131-4 Bottles of 100 NDC 51672-4131-1 Bottles of 1000 NDC 51672-4131-3 Unit dose packages of 100 NDC 51672-4131-0
LAMOTRIGINE Tablets USP, 150 mg: round, cream, scored tablets. One side engraved with "TARO". Other side scored and engraved with "LMT" above the score and "150" below the score. Bottles of 30 NDC 51672-4132-6 Bottles of 60 NDC 51672-4132-4 Bottles of 100 NDC 51672-4132-1 Bottles of 500 NDC 51672-4132-2 Bottles of 1000 NDC 51672-4132-3 Unit dose packages of 100 NDC 51672-4132-0
LAMOTRIGINE Tablets USP, 200 mg: round, light blue, scored tablets. One side engraved with "TARO". Other side scored and engraved with "LMT" above the score and "200" below the score. Bottles of 30 NDC 51672-4133-6 Bottles of 60 NDC 51672-4133-4 Bottles of 100 NDC 51672-4133-1 Bottles of 500 NDC 51672-4133-2 Bottles of 1000 NDC 51672-4133-3 Unit dose packages of 100 NDC 51672-4133-0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in a dry place and protect from light. Blister Packs If the product is dispensed in a blister pack, the patient should be advised to examine the blister pack before use and not use if blisters are torn, broken, or missing.
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