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24 HR lamotrigine 100 MG Extended Release Oral Tablet

1 INDICATIONS AND USAGE Lamotrigine extended-release tablet is an antiepileptic drug (AED) 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 AED. (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 is 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.

Wockhardt USA LLC.


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2 months ago ROUND BROWN W 273 24 HR lamotrigine 100 MG Extended Release Oral Tablet

ROUND BROWN W 273












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