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Indicated for the most common seizure types affecting your patients.
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| Simple and complex partial seizures |
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- Adjunctive therapy
in patients as young as 2 years
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- Conversion to monotherapy in adults taking carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED
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| For the difficult-to-treat generalized seizures of Lennox-Gastaut syndrome (LGS) |
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- Adjuctive therapy in patients as young as 2 years of age
- Common seizure types include tonic, tonic-clonic, atonic, and major myoclonic seizures
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- Safety and effectiveness 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 two or more concomitant AEDs
- Safety and effectiveness in pediatric
patients below the age of 16, other than those with partial
seizures and the generalized seizures of LGS, have not been
established
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Read Frequently Asked Questions About LAMICTAL to learn more about LAMICTAL.
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Important Safety Information
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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
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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 and 0.3% (3/1000) in adults on adjunctive therapy. In a prospectively followed cohort of 1983 pediatric patients taking adjunctive LAMICTAL, there was 1 rash-related death
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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
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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 patients should be evaluated immediately. LAMICTAL should be discontinued if an alternative etiology cannot be established
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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
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To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL should not be exceeded
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LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related
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Complete Prescribing Information for LAMICTAL® (lamotrigine) Tablets
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