lamotrigine 200 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 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 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: 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 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 (14.2)] . 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.
NorthStar RxLLC
ROUND WHITE L124
L124 ROUND WHITE
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16. HOW SUPPLIED/STORAGE AND HANDLING Lamotrigine Tablets USP, 25 mg white to off-white, capsule shaped tablets, with break line on one side and debossed with “L121” on other side. They are supplied as follows: NDC 16714-371-01 bottle of 30 units NDC 16714-371-02 bottle of 100 units NDC 16714-371-03 bottle of 1000 units Lamotrigine Tablets USP, 100 mg white to off-white, round tablets with break line on one side and debossed with “L122” on other side. They are supplied as follows: NDC 16714-372-01 bottle of 30 units NDC 16714-372-02 bottle of 100 units NDC 16714-372-03 bottle of 1000 units Lamotrigine Tablets USP, 150 mg white to off-white, round tablets with break line on one side and debossed with “L123” on other side. They are supplied as follows: NDC 16714-373-01 bottle of 30 units NDC 16714-373-04 bottle of 60 units NDC 16714-373-02 bottle of 100 units NDC 16714-373-03 bottle of 1000 units Lamotrigine Tablets USP, 200 mg white to off-white, round tablets with break line on one side and debossed with “L124” on other side. They are supplied as follows: NDC 16714-374-01 bottle of 30 units NDC 16714-374-04 bottle of 60 units NDC 16714-374-02 bottle of 100 units NDC 16714-374-03 bottle of 1000 units Store at 20º to 25°C (68º to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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