Eslicarbazepine acetate

What is Eslicarbazepine acetate?

• Eslicarbazepine acetate (APTIOM) used for the treatment of partial-onset seizures in patients 4 years of age and older.

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Eslicarbazepine

What are the uses of this medicine?

• This medicine is used to treat partial-onset seizures.
• It is not known if APTIOM is safe and effective in children under 4 years of age.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine.

What drug interactions can this medicine cause?

• Several AEDs (e.g., carbamazepine, phenobarbital, phenytoin, and primidone) can induce enzymes that metabolize APTIOM and can cause decreased plasma concentrations of eslicarbazepine. May need dose adjustment for APTIOM or carbamazepine.
• APTIOM can inhibit CYP2C19, which can cause increased plasma concentrations of drugs that are metabolized by this isoenzyme (e.g., phenytoin, clobazam, and omeprazole). Dose adjustment may be needed.
• Dose adjustment of simvastatin and lovastatin may be needed if a clinically significant change in lipids is noted.
• Because concomitant use of APTIOM and ethinylestradiol and levonorgestrel is associated with lower plasma levels of these hormones, females of reproductive potential should use additional or alternative non-hormonal birth control.

Is this medicine FDA approved?

• Initial U.S. Approval: 2013

How should this medicine be used?

Recommended Dosage: Adult Patients:

• The recommended initial dosage of APTIOM is 400 mg once daily.
• For some patients, treatment may be initiated at 800 mg once daily if the need for seizure reduction outweighs an increased risk of adverse reactions.
• Increase the dose in weekly increments of 400 mg to 600 mg once daily, based on clinical response and tolerability, to a recommended maintenance dosage of 800 mg to 1600 mg once daily.

Pediatric Patients:

• The recommended dosage of APTIOM is based on body weight and is administered orally once daily.
• Increase the dose in weekly intervals based on clinical response and tolerability, to the recommended maintenance dosage.

Patients with Moderate or Severe Renal Impairment:

• Reduce dosage by 50%.

Administration

• Take APTIOM exactly as your healthcare provider tells you to take it.
• Do not stop taking APTIOM without talking to your healthcare provider. Stopping APTIOM suddenly can cause serious problems, including seizures that will not stop (status epilepticus).
• Your healthcare provider may change your dose.
• Your healthcare provider will tell you how much APTIOM to take.
• APTIOM can be taken with or without food.
• APTIOM can be taken as a whole tablet or crushed.
• If you take too much APTIOM, call your healthcare provider or go to the nearest hospital emergency room right away.
• Talk with your healthcare provider about what you should do if you miss a dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

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

This medicine is available in fallowing brand namesː

• APTIOM

What side effects can this medication cause?

The most common side effects of this medicine include:

• dizziness
• vomiting
• sleepiness
• feeling tired
• nausea
• blurred vision
• headache
• shakiness
• double vision
• problems with coordination

APTIOM may cause other serious side effects including:

• Nervous system problems
• Liver problems

What special precautions should I follow?

• Antiepileptic drugs (AEDs), including APTIOM, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor for suicidal thoughts or behavior.
• Serious dermatologic reactions including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with APTIOM use. Monitor and discontinue if another cause cannot be established.
• Clinically significant hyponatremia (sodium <125 mEq/L) can develop in patients taking APTIOM. Monitor sodium levels in patients at risk or patients experiencing hyponatremia symptoms.
• APTIOM causes dose-related increases in adverse reactions related to dizziness and disturbance in gait and coordination (dizziness, ataxia, vertigo, balance disorder, gait disturbance, nystagmus, and abnormal coordination). Use caution when driving or operating machinery.
• Withdraw APTIOM gradually to minimize the risk of increased seizure frequency and status epilepticus.
• Hepatic effects, ranging from mild to moderate elevations in transaminases (>3 times the upper limit of normal) to rare cases with concomitant elevations of total bilirubin (>2 times the upper limit of normal) have been reported with APTIOM use. Discontinue APTIOM in patients with jaundice or evidence of significant liver injury.
• Rare cases of pancytopenia, agranulocytosis, and leukopenia have been reported during postmarketing use in patients treated with APTIOM. Consider discontinuing.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hyponatremia (sometimes severe)
• dizziness
• nausea
• vomiting
• somnolence
• euphoria
• oral paraesthesia
• ataxia
• walking difficulties
• diplopia

Management of overdosage:

• There is no specific antidote for overdose with APTIOM.
• Symptomatic and supportive treatment should be administered as appropriate.
• Removal of the drug by gastric lavage and/or inactivation by administering activated charcoal should be considered.
• Standard hemodialysis procedures result in partial clearance of APTIOM.
• Hemodialysis may be considered based on the patient's clinical state or in patients with significant renal impairment.

Can this medicine be used in pregnancy?

• Limited available data with APTIOM use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• Safety and effectiveness of APTIOM have been established in the age groups 4 to 17 years.
• Safety and effectiveness in pediatric patients below the age of 4 years have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: eslicarbazepine acetate
• Inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone

Who manufactures and distributes this medicine?

• Manufactured for: Sunovion Pharmaceuticals Inc., Marlborough,USA

What should I know about storage and disposal of this medication?

• Store APTIOM at 68oF to 77oF (20oC to 25oC).
• Safely throw away medicine that is out of date or no longer needed.
• Keep APTIOM and all medicines out of reach of children.

• Dailymed label info on Eslicarbazepine acetate
• FDA Eslicarbazepine acetate

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