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| The 2004 AAN/AES Treatment Guidelines
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The 2004 AAN/AES treatment guidelines support the use of LAMICTAL
Evidence-based guidelines recommend LAMICTAL for the following approved indications1
| INDICATION FOR USE
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AAN/AES
RECOMMENDATION
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| Adjunctive therapy for pediatric patients > 2 years with partial seizures*
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| Adjunctive therapy for generalized seizures of LGS(atonic, tonic, major myoclonic, and tonic-clonic)‡
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| Adjunctive therapy for adults with partial seizures#
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| Adjunctive therapy for pediatric and adult patients with primary generalized tonic-clonic seizures
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These guidelines preceded publication of the study supporting approval of the PGTC seizure indication
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| Conversion to monotherapy for adults with partial seizures taking carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED$
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*Described as "pediatric partial"in the AAN/AES guidelines.
†Described as "symptomatic generalized" in the AAN/AES guidelines.
#Described as "partial adjunctive adult" in the AAN/AES guidelines.
$Described as "partial monotherapy" in the AAN/AES guidelines.
RESULTS FROM: FRENCH ET AL. Efficacy and tolerability of the new antiepileptic drugs II. Neurology. 2004;62:1261-1273.
Guideline Methodology: A structured literature search was conducted, and the data were rated according to stringent criteria set by the committee. Recommendations for use were based on the weight and quality of the evidence demonstrating efficacy and tolerability of the newer AEDs for each seizure type/population assessed.
This project was sponsored by unrestricted grants from Abbott Laboratories, GlaxoSmithKline, Novartis Pharmaceuticals, and UCB Pharma.
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 2 or more concomitant AEDs.
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| EFFICACY AND TOLERABILITY
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| Initiate with ease—convert with confidence. Learn more.
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| IMPORTANT SAFETY INFORMATION
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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 |
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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 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 |
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— 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 |
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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 patient should be evaluated immediately, and 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 |
Complete Prescribing Information for LAMICTAL® (lamotrigine) Tablets |
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