| • |
Safety and effectiveness of LAMICTAL have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate, or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs |
| Important Safety Information |
| • |
Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of LAMICTAL, some of which have included Stevens-Johnson syndrome |
|
— Epilepsy clinical trials: The incidence of these rashes is approximately 0.8% (8/1000) in pediatric patients (age <16 years) receiving LAMICTAL as adjunctive therapy for epilepsy and 0.3% (3/1000) in adults on adjunctive therapy for epilepsy. In a prospectively followed cohort of 1983 pediatric patients with epilepsy taking adjunctive LAMICTAL, there was 1 rash-related death |
|
— Mood disorders: In clinical trials of bipolar and other mood disorders, the incidence of these rashes was 0.08% (0.8/1000) in adults receiving LAMICTAL as initial monotherapy and 0.13% (1.3/1000) in adult patients receiving LAMICTAL as adjunctive therapy |
| • |
In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate |
| • |
Hypersensitivity reactions, some fatal or life-threatening, have occurred in association with the use of LAMICTAL. It is important to note that early manifestations of hypersensitivity (eg, fever, lymphadenopathy) may be present even though a rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately, and LAMICTAL should be discontinued if an alternative etiology cannot be established |
| • |
Prior to initiation of treatment with LAMICTAL, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (eg, fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately |
| • |
To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL should not be exceeded |
| • |
LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related |
Complete Prescribing Information for LAMICTAL® (lamotrigine) Tablets |
