PRESCRIBING HIGHLIGHTS: Please see package insert for additional information and possible updates
to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh
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APTIOM® (eslicarbazepine acetate) tablets, for oral use
Initial U.S. Approval: 2013
The chemical name of APTIOM (eslicarbazepine acetate) is
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
Suicidal Behavior and Ideation: Monitor for suicidal
thoughts or behavior.
Serious Dermatologic Reactions: Monitor for dermatologic
reactions and discontinue in the case of serious
Drug Reaction with Eosinophilia and Systemic Symptoms:
Monitor for hypersensitivity. Discontinue if another cause
cannot be established.
Anaphylactic Reactions and Angioedema: Monitor for
breathing difficulties or swelling. Discontinue if another
cause cannot be established.
Hyponatremia: Monitor sodium levels in patients at risk
or patients experiencing hyponatremia symptoms.
Neurological Adverse Reactions: Monitor for dizziness,
disturbance in gait and coordination, somnolence, fatigue,
cognitive dysfunction, and visual changes. Use caution when
driving or operating machinery.
Withdrawal of APTIOM: Withdraw APTIOM gradually to
minimize the risk of increased seizure frequency and status
Drug Induced Liver Injury: Discontinue APTIOM in
patients with jaundice or evidence of significant liver
The most common adverse reactions in patients receiving APTIOM (4%
greater than placebo) were dizziness, somnolence, nausea,
headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred
vision, and tremor. (
To report SUSPECTED ADVERSE REACTIONS, contact Sunovion at
1-877-737-7226 or FDA at 1-800-FDA-1088 or
Carbamazepine: May need dose adjustment for APTIOM or
Phenytoin: Higher dosage of APTIOM may be necessary and
dose adjustment may be needed for phenytoin based on
clinical response and serum levels of phenytoin.
Phenobarbital or Primidone: Higher dosage of APTIOM may
Hormonal Contraceptives: APTIOM may decrease the
effectiveness of hormonal contraceptives. Females of
reproductive potential should use additional or alternative
non-hormonal birth control.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm.
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.