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APTIOM® (eslicarbazepine acetate) tablets

DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS
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 Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  
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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

WARNINGS  top of page

See warnings and precautions below.

DESCRIPTION  top of page

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.

CLINICAL PHARMACOLOGY: top of page

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  top of page

INDICATIONS AND USAGE
APTIOM is indicated as adjunctive treatment of partial-onset seizures.

CONTRAINDICATIONS top of page

Hypersensitivity to eslicarbazepine acetate or oxcarbazepine.

PRECAUTIONS top of page

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 top of page

ADVERSE REACTIONS
The most common adverse reactions in patients receiving APTIOM (geq4% and geq2% 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.

DOSAGE AND ADMINISTRATION  top of page

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.

HOW SUPPLIED top of page

DOSAGE FORMS AND STRENGTHS

Tablets: 200 mg, 400 mg, 600 mg, 800 mg

REFERENCE

Package insert data:
[Sunovion Pharmaceuticals Inc.]
Manufactured for:
Sunovion Pharmaceuticals Inc.
Marlborough, MA 01752 USA

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

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