Pediatric News - Lamictal
(lamotrigine, GlaxoSmithKline)
The FDA expanded the indications for Lamictal (lamotrigine) tablets to include add-on therapy for partial seizures in children aged 2 years and older. Lamotrigine is already indicated as adjunctive therapy for children aged 2 years and older for the generalized seizures of Lennox-Gastaut syndrome.
* Recommended Dosage: Available as 2-mg, 5-mg, or 25-mg oral tablets that may be swallowed whole, chewed, or dispersed in water or diluted fruit juice. Available as 25-mg, 100-mg, 150-mg, 200-mg tablets.
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* Special Considerations: The most commonly observed adverse effects noted in pediatric patients with partial seizures (occurring at higher rates than placebo) were infection, vomiting, rash, fever, somnolence, accidental injury, dizziness, diarrhea, abdominal pain, nausea, ataxia, tremor, asthenia, bronchitis, flu syndrome, and diplopia. Serious rashes requiring hospitalization and discontinuation of Lamictal occurred in two patients.
* Comment: The risk of serious rash is now minimized, said Dr. Michael Duchowny, a lead investigator in clinical trials. “The dosing guidelines in the studies are no longer used, and slower titration rates are now recommended. The labeling also warns about coadministration of drugs that can lead to rash [valproic acid].”
In an 18-week, double-blind, placebo-controlled study in 199 children aged 2-16 years with partial seizures refractory to other antiepileptics, the Lamictal group had 36% reduction in frequency of partial seizures versus 7% in the placebo group.
“The tolerability is high, which in kids is often more important than efficacy,” said Dr. Duchowny, director of the Comprehensive Epilepsy Program at Miami Children’s Hospital. He has no conflict of interest regarding the drug or its manufacturer.
Primary care providers “need to recognize that Lamictal is a broad-spectrum antiepileptic drug and affords broad coverage,” Dr. Duchowny said. “It’s a good choice for them.”
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COPYRIGHT 2008 Gale, Cengage Learning
