Products (5)
Aptiom
63402-202
NDA022416
NDA (C73594)
ORAL
March 28, 2019
Aptiom
63402-206
NDA022416
NDA (C73594)
ORAL
March 28, 2019
Aptiom
63402-248
NDA022416
NDA (C73594)
ORAL
March 28, 2019
Aptiom
63402-208
NDA022416
NDA (C73594)
ORAL
March 28, 2019
Aptiom
63402-204
NDA022416
NDA (C73594)
ORAL
March 28, 2019
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL – TITRATION SAMPLE PACK CARTON
NDC 63402-248-56
ONCE DAILY
Aptiom®
(eslicarbazepine acetate) Tablets
400 mg and 800 mg
ATTENTION DISPENSER: Dispense an enclosed
Medication Guide to each patient.
Rx Only
This package contains 56 tablets in 4 titration sample packs.
Each titration sample pack contains 14 tablets
(7 tablets of 400 mg and 7 tablets of 800 mg).
Please see the enclosed full Prescribing Information.
400 mg
per tablet and
800 mg
per tablet
Titration Sample Pack
Professional Samples
Not for Sale or
Reimbursement
DESCRIPTION SECTION
11 DESCRIPTION
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. The chemical structure is:
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: croscarmellose sodium, magnesium stearate, and povidone.
INDICATIONS & USAGE SECTION
Highlight: APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. (1)
1 INDICATIONS AND USAGE
APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
CONTRAINDICATIONS SECTION
Highlight: Hypersensitivity to eslicarbazepine acetate or oxcarbazepine. (4)
4 CONTRAINDICATIONS
APTIOM is contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine [see Warnings and Precautions (5.2, 5.3, and 5.4)].
REFERENCES SECTION
15 REFERENCES
French JA, Wang S, Warnock B, Temkin N. Historical control monotherapy design in the treatment of epilepsy. Epilepsia 2010;51(10):1936-43.