Lamictal Xr

Product manufactured by Glaxosmithkline Llc

Application Nr Approved Date Route Status External Links
NDA022115 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Lamictal Xr Is 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 Lamictal Xr Is 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 Lamictal Xr 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 Lamictal Xr 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 Lamictal Xr For Use In Patients Younger Than 13 Years Have Not Been Established.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lamotrigine LAMOTRIGINE ZINC13156

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