lamotrigine
lamotrigine is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including LAMICTAL, LAMICTAL XR, LAMICTAL ODT. Available dosage forms: tablet, for suspension, tablet, tablet, film coated, extended release, tablet, orally disintegrating, kit.
Drug Details
- Generic Name
- lamotrigine
- Brand Names
- LAMICTAL, LAMICTAL XR, LAMICTAL ODT, Lamotrigine Extended-Release, LAMOTRIGINE, lamotrigine
- Application Number
- NDA020764
- Sponsor
- GlaxoSmithKline LLC
- NDC Codes
- 50
- Dosage Forms
- TABLET, FOR SUSPENSION, TABLET, TABLET, FILM COATED, EXTENDED RELEASE, TABLET, ORALLY DISINTEGRATING, KIT
- Routes
- ORAL
- Active Ingredients
- LAMOTRIGINE
Indications and Usage
1 INDICATIONS AND USAGE Lamotrigine extended-release tablets are indicated for: adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) 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 (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 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.