lamotrigine 25 MG Oral 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 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 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 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 has 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 two 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 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 (14.2) ]. 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.
Mylan Institutional Inc.
ROUND WHITE M L 51
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16 HOW SUPPLIED/STORAGE AND HANDLING Lamotrigine Tablets, USP are available containing 25 mg, 100 mg, 150 mg or 200 mg of lamotrigine, USP. The 25 mg tablets are white to off-white, round, scored tablets debossed with M on one side of the tablet and L above the score and 51 below the score on the other side. They are available as follows: NDC 51079-498-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 100 mg tablets are white to off-white, round, scored tablets debossed with M above the score and L52 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-499-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 150 mg tablets are white to off-white, round, scored tablets debossed with M above the score and L53 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-865-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 200 mg tablets are green, round, scored tablets debossed with M above the score and L54 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-866-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. PHARMACIST: Dispense a Medication Guide with each prescription.
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