lamotrigine 100 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 seizures (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.
American Health Packaging
ROUND WHITE ZC 80
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16 HOW SUPPLIED/STORAGE AND HANDLING
LAMOTRIGINE Tablets
LAMOTRIGINE Tablets USP, 25 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "79" and other side is plain and are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-318-01
LAMOTRIGINE Tablets USP, 100 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "80" and other side is plain and are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-319-01
LAMOTRIGINE Tablets USP, 150 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of “ZC” and other side is debossed with “81” and other side is plain and are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 60687-693-01
LAMOTRIGINE Tablets USP, 200 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of “ZC” and other side is debossed with “82” and other side is plain and are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 60687-704-01 Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] in a dry place. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
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