lamotrigine 200 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.
alembic pharmaceuticals inc.
ROUND BLUE A196
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lamotrigine 300 mg
alembic pharmaceuticals inc.
lamotrigine 250 mg
alembic pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
LAMOTRIGINE Extended-Release Tablets, USP 200 mg, blue colored, round shaped, biconvex film-coated tablet imprinted in black ink with “A196” on one side and plain on other side. They are available as follows: NDC 62332-417-30 Bottle of 30 tablets with child-resistant closure NDC 62332-417-91 Bottle of 1000 tablets 250 mg, purple colored, caplet shaped, biconvex film-coated tablet imprinted in black ink with “A197”on one side and plain on other side. They are available as follows: NDC 62332-418-30 Bottle of 30 tablets with child-resistant closure NDC 62332-418-91 Bottle of 1000 tablets 300 mg, grey colored, caplet shaped, biconvex film-coated tablet imprinted in black ink with “A198” on one side and plain on other side. They are available as follows: NDC 62332-419-30 Bottle of 30 tablets with child-resistant closure NDC 62332-419-91 Bottle of 1000 tablets Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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