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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL.
LAMICTAL (lamotrigine) Tablets
LAMICTAL (lamotrigine) Chewable Dispersible Tablets
LAMICTAL ODT (lamotrigine) Orally Disintegrating Tablets
Initial U.S. Approval: 1994
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WARNING: SERIOUS SKIN RASHES
See full prescribing information for complete boxed warning.
Cases of life-threatening serious rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death, have been caused by LAMICTAL. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include (5.1):
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coadministration with valproate
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exceeding recommended initial dose of LAMICTAL
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exceeding recommended dose escalation of LAMICTAL
Benign rashes are also caused by LAMICTAL; however, it is not possible to predict which rashes will prove to be serious or life-threatening. LAMICTAL should be discontinued at the first sign of rash, unless the rash is clearly not drug-related.(5.1)
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RECENT MAJOR CHANGES
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Dosage and Administration, LAMICTAL ODT (2.6)
Warnings and Precautions, Suicidal Behavior and Ideation (5.5)
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May/2009
April/2009
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INDICATIONS AND USAGE
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LAMICTAL is an antiepileptic drug (AED) indicated for:
Epilepsy—adjunctive therapy in patients ≥2years of age: (1.1)
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partial seizures.
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primary generalized tonic-clonic seizures.
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generalized seizures of Lennox-Gastaut syndrome.
Epilepsy—monotherapy in patients ≥16years of age: conversion to monotherapy in patients with partial seizures who are receiving treatment with carbamazepine, phenobarbital, phenytoin, primidone, or valproate as the single AED. (1.1)
Bipolar Disorder in patients ≥18years of age: maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2)
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DOSAGE AND ADMINISTRATION
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Dosing is based on concomitant medications, indication, and patient age. (2.2, 2.4)
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To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations should
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