Lamotrigine ER
Drug Details
- Generic Name
- Lamotrigine ER
- Brand Names
- Lamotrigine ER
- Application Number
- ANDA213949
- Sponsor
- Direct_rx
- NDC Codes
- 2
- Dosage Forms
- TABLET, FILM COATED, EXTENDED RELEASE, TABLET, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- LAMOTRIGINE
Indications and Usage
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.