24 hr lamotrigine 25 mg extended release oral tablet
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.
trupharma, llc
ROUND YELLOW H 012
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16 HOW SUPPLIED/STORAGE AND HANDLING Lamotrigine Extended-Release Tablets, USP 25 mg, white to off-white, round, film-coated tablets engraved with “H008” on one side and plain on the other side supplied in unit-of-use bottles of 30 tablets (NDC 52817-240-30). 50 mg, peach, round, film-coated tablets engraved with “H009” on one side and plain on the other side supplied in unit-of-use bottles of 30 tablets (NDC 52817-241-30). 100 mg, yellow, round, film-coated tablets engraved with “H012” on one side and plain on the other side supplied in unit-of-use bottles of 30 tablets (NDC 52817-242-30). 200 mg, blue, round, film-coated tablets engraved with “H011” on one side and plain on the other side supplied in unit-of-use bottles of 30 tablets (NDC 52817-243-30). Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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