Antiepileptic drug can now be used in pediatric patients

June 5, 2015

FDA has expanded the indication for topiramate (Qudexy XR, Upsher-Smith Laboratories) extended-release capsules within the pediatric population.

FDA has expanded the indication for topiramate (Qudexy XR, Upsher-Smith Laboratories) extended-release capsules within the pediatric population.

Qudexy XR, a once-daily, broad-spectrum antiepileptic drug, was previously approved for use as initial monotherapy in patients aged 10 years and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures. With this approval, it now offers prescribers an additional first-line treatment option in patients aged 2 years and older who are experiencing these seizures.

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The ability to sprinkle the drug onto soft food makes it a useful option for young children who may have difficulty swallowing whole capsules or tablets. 

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It is also approved as an adjunctive therapy in patients aged 2 years or older with POS, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome.

Qudexy XR has been available in the United States since June 2014.

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