Article

FDA Approves Extended-Release Antiepileptic

Levetiracetam now available in a once-daily pill


 

References

Indications: Levetiracetam (Elepsia XR) extended release tablets are indicated for adjunctive therapy in the treatment of partial onset seizures in patients with epilepsy ages 12 and older.

Dosing: The once-daily treatment, available in both 1,000 mg and 1,500 mg tablets, should be initiated with a dose of 1,000 mg, adjusting every 2 weeks in 1,000 mg increments to a maximum dose of 3,000 mg a day.

Pharmacokinetics: Time to peak plasma concentration with levetiracetam extended release is about 4 hours and 3 to 4.5 hours longer when taken with a high-fat, high-calorie breakfast. It is eliminated via renal excretion and is correlated to creatinine clearance.

Side Effects/Risks: The most common adverse reactions include somnolence and irritability. Patients should be monitored for behavioral abnormalities, including psychotic symptoms, irritability, aggressive behavior, and suicidal behavior or ideation. Levetiracetam needs to be withdrawn gradually due to the risk of withdrawal seizures.

More Information: Levetiracetam is not recommended for patients with moderate or severe renal impairment.

Source: Highlights of Prescribing Information: Elepsia XR. FDA website. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204417s000lbl.pdf. Updated March 2015. Accessed March 31, 2015.

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