APTIOM® (eslicarbazepine acetate) tablets

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.

WARNINGS AND PRECAUTIONS

1. Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behavior.
2. Serious Dermatologic Reactions: Monitor for dermatologic reactions and discontinue in the case of serious dermatologic reaction.
3. Drug Reaction with Eosinophilia and Systemic Symptoms: Monitor for hypersensitivity. Discontinue if another cause cannot be established.
4. Anaphylactic Reactions and Angioedema: Monitor for breathing difficulties or swelling. Discontinue if another cause cannot be established.
5. Hyponatremia: Monitor sodium levels in patients at risk or patients experiencing hyponatremia symptoms.
6. 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.
7. Withdrawal of APTIOM: Withdraw APTIOM gradually to minimize the risk of increased seizure frequency and status epilepticus.
8. Drug Induced Liver Injury: Discontinue APTIOM in patients with jaundice or evidence of significant liver injury.

ADVERSE REACTIONS
The most common adverse reactions in patients receiving APTIOM (≥4% and ≥2% 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 www.fda.gov/medwatch.

DRUG INTERACTIONS

1. Carbamazepine: May need dose adjustment for APTIOM or carbamazepine.
2. 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.
3. Phenobarbital or Primidone: Higher dosage of APTIOM may be necessary.
4. 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.

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.

Under license from Bial
© 2013 Sunovion Pharmaceuticals Inc. All rights reserved.
Revised: November 2013 . Accessed: Jan 2014

DRUG UPDATES:
Drug:  APTIOM ® (eslicarbazepine acetate) tablets, for oral use
[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2013