| APTIOM® (eslicarbazepine acetate) tablets, for oral use
Initial U.S. Approval: 2013
The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32.
APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol.
Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: povidone, croscarmellose sodium, and magnesium stearate.
| Mechanism of Action
APTIOM is extensively converted to eslicarbazepine, which is considered to be responsible for therapeutic effects in humans. The precise mechanism(s) by which eslicarbazepine exerts anticonvulsant activity is unknown but is thought to involve inhibition of voltage-gated sodium channels.
| INDICATIONS AND USAGE
APTIOM is indicated as adjunctive treatment of partial-onset seizures.
WARNINGS AND PRECAUTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Sunovion at 1-877-737-7226 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
| DOSAGE AND ADMINISTRATION:
Start treatment at 400 mg once daily. After one week, increase dosage to 800 mg once daily (recommended maintenance dosage). Maximum recommended maintenance dosage is 1200 mg once daily (after a minimum of one week at 800 mg once daily).
Patients with moderate to severe renal impairment: Start treatment at 200 mg once daily. After two weeks, increase dosage to 400 mg once daily. Maximum recommended maintenance dosage is 600 mg once daily.
| Package insert data:
[Sunovion Pharmaceuticals Inc.]
Sunovion Pharmaceuticals Inc.
Marlborough, MA 01752 USA
Under license from Bial
Initial U.S. Approval: 2013
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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