For: Epilepsy
Elepsia XR (levetiracetam) is an extended-release formulation of the antiepileptic drug levetiracetam designed to reduce pill burden in patients receiving high doses for the treatment of partial onset seizures. Levetiracetam extended-release tablets, 1,000 mg are oval biconvex, coated, blue and white to off-white, bilayer tablet with drilled portal on the blue layer; imprinted with "574" with black ink on one side and plain on the other side. They are supplied as follows:
Bottles of 30with child resistant cap�................... NDC 47133-574-83
Bottles of 100 with child resistant cap�................. NDC 47133-574-88
Bottles of 500 with non-child resistant cap���. NDC 47133-574-13
Levetiracetam extended-release tablets, 1,500 mg are oval biconvex, coated, blue and white to off-white, bilayer tablet with drilled portal on the blue layer; imprinted with "575" with black ink on one side and plain on the other side. They are supplied as follows:
Bottles of 30 with child resistant cap�................... NDC 47133-575-83
Bottles of 100 with child resistant cap�................. NDC 47133-575-88
Bottles of 500 with non-child resistant cap���. NDC 47133-575-13
16.2 Storage
Store at 20�C to 25�C (68�F to 77�F); excursions permitted between 15�C and 30�C (59�F and 86�F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container. These highlights do not include all the information needed to use ELEPSIA XR safely and effectively. See full prescribing information for ELEPSIA XR.
ELEPSIA� XR (levetiracetam) extended-release tablets, for oral use
Initial U.S. Approval: 1999
INDICATIONS AND USAGE
ELEPSIA XR is indicated for adjunctive therapy in the treatment of partial onset seizures in patients ?12 years of age with epilepsy(1)
DOSAGE AND ADMINISTRATION
ELEPSIA XR is administered once daily; treatment should be initiated with a dose of 1,000 mg once daily; the dosage may be adjusted in increments of 1,000 mg every 2 weeks, to a maximum recommended dose of 3,000 mg once daily (2.1)
ELEPSIA XR should be taken whole; do not split or cut tablets (2.1)
Not recommended for use in patients with moderate or severe renal impairment; the maximum recommended dose in patients with mild renal impairment is 2,000 mg (2.2)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets, 1,000 mg, 1,500 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Psychiatric Reactions: Monitor patients for behavioral abnormalities including psychotic symptoms, irritability, and aggressive behavior (5.1)
Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior (5.2)
Somnolence and Fatigue: Monitor patients for these symptoms and advise patients not to drive or operate machinery until they have gained sufficient experience on ELEPSIA XR (5.3)
Withdrawal Seizures: ELEPSIA XR must be withdrawn gradually (5.6)
ADVERSE REACTIONS
Most common adverse reactions (incidence ?5% greater in ELEPSIA XR-treated patients than on placebo) include somnolence and irritability (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: Plasma levels of levetiracetam may be decreased during pregnancy and need to be monitored closely. Based on animal data, may cause fetal harm (5.8, 8.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 2/2015
