lamotrigine 250 mg
1 INDICATIONS AND USAGE Lamotrigine extended-release tablets are indicated for: adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1 ) conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. ( 1.2 ) Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. ( 1.3 ) 1.1 Adjunctive Therapy Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. 1.2 Monotherapy Lamotrigine extended-release tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Safety and effectiveness of lamotrigine extended-release tablets have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.3 Limitation of Use Safety and effectiveness of lamotrigine extended-release tablets for use in patients younger than 13 years have not been established.
actavis pharma, inc.
OVAL YELLOW 638
638 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING Lamotrigine extended-release tablets, USP 25 mg - Each white to off-white, round, unscored, film-coated tablet imprinted with on one side and 410 on the other side contains 25 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1410-03). 50 mg - Each gray, round, unscored, film-coated tablet imprinted with on one side and 435 on the other side contains 50 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1435-03). 100 mg - Each gray, round, unscored, film-coated tablet imprinted with on one side and 422 on the other side contains 100 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1422-03). 200 mg - Each white to off-white, round, unscored, film-coated tablet imprinted with on one side and 453 on the other side contains 200 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1453-03). 250 mg - Each yellow, capsule-shaped, unscored, film-coated tablet imprinted with on one side and 638 on the other side contains 250 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1638-03). 300 mg - Each gray, capsule-shaped, unscored, film-coated tablet imprinted with on one side and 580 on the other side contains 300 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1580-03). Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. 1 1 1 1 1 1
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