lamotrigine 150 mg
1 INDICATIONS AND USAGE Lamotrigine, USP 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 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 ( 14.2 )] . 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.
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ROUND WHITE 1048
1048 ROUND WHITE
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lamotrigine 25 mg
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16 HOW SUPPLIED/STORAGE AND HANDLING
LAMOTRIGINE Tablets, USP 25-mg white to off white, round shape, flat face beveled edge, uncoated tablets debossed with "45" on one side and break line on other side. Bottle of 30 NDC-13668-045-30 Bottle of 60 NDC-13668-045-60 Bottle of 100 NDC-13668-045-01 Bottle of 500 NDC-13668-045-05 Bottle of 6600 NDC-13668-045-66 10 x 10 unit dose NDC-13668-045-74
LAMOTRIGINE Tablets, USP 100-mg white to off white, round shape, flat face beveled edge, uncoated tablets debossed with "1047" on one side and break line on other side. Bottle of 30 NDC-13668-047-30 Bottle of 60 NDC-13668-047-60 Bottle of 100 NDC-13668-047-01 Bottle of 500 NDC-13668-047-05 Bottle of 2500 NDC-13668-047-31 10 x 10 unit dose NDC-13668-047-74
LAMOTRIGINE Tablets, USP 150-mg white to off white, round shape, flat face beveled edge, uncoated tablets debossed with "1048" on one side and break line on other side. Bottle of 30 NDC-13668-048-30 Bottle of 60 NDC-13668-048-60 Bottle of 100 NDC-13668-048-01 Bottle of 500 NDC-13668-048-05 Bottle of 1600 NDC-13668-048-16 9 x 10 unit dose NDC-13668-048-64
LAMOTRIGINE Tablets, USP 200-mg white to off white, round shape, flat face beveled edge, uncoated tablets debossed with "1049" on one side and break line on other side. Bottle of 30 NDC-13668-049-30 Bottle of 60 NDC-13668-049-60 Bottle of 100 NDC-13668-049-01 Bottle of 500 NDC-13668-049-05 Bottle of 1300 NDC-13668-049-13 9 x 10 unit dose NDC-13668-049-64
LAMOTRIGINE Tablets, USP Starter Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate (orange Kit). 25-mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with "45" on one side and break line on other side. 100-mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with "1047" on one side and break line on other side. Blister pack of 42, 25-mg tablets and 7, 100-mg tablets NDC-13668-266-99
LAMOTRIGINE Tablets, USP Starter Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate (green Kit). 25-mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with "45" on one side and break line on other side. 100-mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with "1047" on one side and break line on other side. Blister pack of 84, 25-mg tablets and 14, 100-mg tablets NDC-13668-266-28
LAMOTRIGINE Tablets, USP Starter Kit for Patients Taking Valproate (blue Kit). 25-mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with "45" on one side and break line on other side. Blister pack of 35 tablets NDC-13668-045-29 Storage Store at 20 o to 25 o C (68 o to 77 o F); excursions permitted to 15 o to 30 o C (59 o to 86 o F) [See USP Controlled Room Temperature]
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