lamotrigine tablet
1 INDICATIONS AND USAGE Lamotrigine tablets, USP 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 tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: Monotherapy Lamotrigine 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 tablets 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 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.
Cipla USA Inc.
OVAL WHITE C152
C152 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
LAMOTRIGINE Tablets, USP 25 mg, light pink, capsule-shaped, uncoated, biconvex tablet with "C148" debossed on one side and central breakline on the other side, supplied in bottles of 30 (NDC 69097-148-02), bottles of 100 (NDC 69097-148-07), bottles of 500 (NDC 69097-148-12) and bottles of 1000 (NDC 69097-148-15). 100 mg, light pink, capsule-shaped, uncoated, biconvex tablet with "C149" debossed on one side and central breakline on the other side, supplied in bottles of 30 (NDC 69097-149-02), bottles of 100 (NDC 69097-149-07), bottles of 500 (NDC 69097-149-12) and bottles of 1000 (NDC 69097-149-15). 150 mg, light pink, capsule-shaped, uncoated, biconvex tablet with "C151" debossed on one side and central breakline on the other side, supplied in bottles of 30 (NDC 69097-151-02), bottles of 60 (NDC 69097-151-03), bottles of 500 (NDC 69097-151-12) and bottles of 1000 (NDC 69097-151-15). 200 mg, light pink, capsule-shaped, uncoated, biconvex tablet with "C152" debossed on one side and central breakline on the other side, supplied in bottles of 30 (NDC 69097-152-02), bottles of 60 (NDC 69097-152-03), bottles of 500 (NDC 69097-152-12) and bottles of 1000 (NDC 69097-152-15). Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] in a dry place and protect from light.
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