lamotrigine 200 MG Oral Tablet
1 INDICATIONS AND USAGE Lamotrigine tablets USP are indicated for: Epilepsyβadjunctive therapy in patients aged 2 years and older: Partial-onset seizures. primary generalized tonic-clonic seizures. generalized seizures of Lennox-Gastaut syndrome. ( 1.1 ) Epilepsyβmonotherapy 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: 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 tablets USP in the acute treatment of mood episodes has not been established. 1.1 Epilepsy Adjunctive Therapy Lamotrigine tablets USP 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 tablets USP 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 tablets USP 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 tablets USP 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 ( 14.1 ) ]. Limitations of Use Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.
teva pharmaceuticals usa, inc.
DIAMOND BLUE 9 3 7248
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lamotrigine 25 mg
Teva Pharmaceuticals USA, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Lamotrigine tablets USP are supplied as follows: 25 mg β white to off-white, diamond-shaped tablets, debossed with the number β93β on one side and scored between the two numbers, and debossed β39β on the other side of the tablet. They are available in bottles of 100 and 500. NDC 0093-0039-01 β Bottle of 100 NDC 0093-0039-05 β Bottle of 500 100 mg β peach, diamond-shaped tablets, debossed with the number β93β on one side and scored between the two numbers, and debossed β463β on the other side of the tablet. They are available in bottles of 100 and 500. NDC 0093-0463-01 β Bottle of 100 NDC 0093-0463-05 β Bottle of 500 150 mg β cream, diamond-shaped tablets, debossed with the number β93β on one side and scored between the two numbers, and debossed β7247β on the other side of the tablet. They are available in bottles of 60 and 500. NDC 0093-7247-06 β Bottle of 60 NDC 0093-7247-05 β Bottle of 500 200 mg β blue, diamond-shaped tablets, debossed with the number β93β on one side and scored between the two numbers, and debossed β7248β on the other side of the tablet. They are available in bottles of 60 and 500. NDC 0093-7248-06 β Bottle of 60 NDC 0093-7248-05 β Bottle of 500 Store at 20Β° to 25Β°C (68Β° to 77Β°F) [See USP Controlled Room Temperature] in a dry place and protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
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