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.

Amneal Pharmaceuticals LLC

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] off label use` `[4] dyspnoea` `[5] nausea` `[6] headache` `[7] pain` `[8] pyrexia` `[9] diarrhoea` `[10] toxicity to various agents`

4 years ago

ROUND YELLOW A 949

16 HOW SUPPLIED/STORAGE AND HANDLING

LAMOTRIGINE extended-release tablets USP, 25 mg, are supplied as yellow, round shaped, film-coated tablets debossed with “A” above “949” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-949-03 Bottles of 90: NDC 65162-949-09

LAMOTRIGINE extended-release tablets USP, 50 mg, are supplied as green, round shaped, film-coated tablets debossed with “A” above “956” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-956-03 Bottles of 90: NDC 65162-956-09

LAMOTRIGINE extended-release tablets USP, 100 mg, are supplied as beige, round shaped, film-coated tablets debossed with “A” above “958” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-958-03 Bottles of 90: NDC 65162-958-09

LAMOTRIGINE extended-release tablets USP, 200 mg, are supplied as blue, round shaped, film-coated tablets debossed with “A” above “986” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-986-03 Bottles of 90: NDC 65162-986-09

LAMOTRIGINE extended-release tablets USP, 250 mg, are supplied as purple, capsule shaped, film-coated tablets debossed with “AN 988” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-988-03 Bottles of 90: NDC 65162-988-09

LAMOTRIGINE extended-release tablets USP, 300 mg, are supplied as gray, capsule shaped, film-coated tablets debossed with “AN 990” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-990-03 Bottles of 90: NDC 65162-990-09 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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