Eslicarbazepine acetate

Eslicarbazepine acetate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Eslicarbazepine acetate is a antticonvulsant that is FDA approved for the treatment of partial-onset seizures. Common adverse reactions include dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Partial-Onset Seizures APTIOM (eslicarbazepine acetate) is indicated as adjunctive treatment of partial-onset seizures.

Dosage

Important Administration Instructions Instruct patients to administer APTIOM either as whole or as crushed tablets. Instruct patients to take APTIOM either with or without food.

2.2 Dosage for Partial-Onset Seizures Start treatment at 400 mg once daily. After one week, increase dosage to 800 mg once daily, which is the recommended maintenance dosage. Some patients may benefit from the maximum recommended maintenance dosage of 1200 mg once daily, although this dosage is associated with an increase in adverse reactions. A maximum dose of 1200 mg daily should only be initiated after the patient has tolerated 800 mg daily for at least a week. For some patients, treatment may be initiated at 800 mg once daily if the need for additional seizure reduction outweighs an increased risk of adverse reactions during initiation [see Adverse Reactions (6.1)].

2.3 Dosage Modifications with Other Antiepileptic Drugs APTIOM should not be taken as an adjunctive therapy with oxcarbazepine.

Some adverse reactions occur more frequently when patients take APTIOM with carbamazepine [see Warnings and Precautions (5.6)]. However, carbamazepine reduces the plasma concentration of eslicarbazepine [see Drug Interactions (7.2)]. When APTIOM and carbamazepine are taken concomitantly, the dose of APTIOM or carbamazepine may need to be adjusted based on efficacy and tolerability. For patients taking other enzyme-inducing antiepileptic drugs (AEDs) (i.e., phenobarbital, phenytoin, and primidone), higher doses of APTIOM may be needed [see Drug Interactions (7.2)].

2.4 Dosage Modifications in Patients with Renal Impairment A dose reduction is recommended in patients with moderate and severe renal impairment (i.e., creatinine clearance < 50 mL/min). Start treatment at 200 mg once daily. After two weeks, increase dosage to 400 mg once daily, which is the recommended maintenance dosage. Some patients may benefit from the maximum recommended maintenance dosage of 600 mg once daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

2.5 Patients with Hepatic Impairment Dose adjustments are not required in patients with mild to moderate hepatic impairment. Use of APTIOM in patients with severe hepatic impairment has not been studied, and use in these patients is not recommended [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

2.6 Discontinuation of APTIOM When discontinuing APTIOM, reduce the dosage gradually and avoid abrupt discontinuation in order to minimize the risk of increased seizure frequency and status epilepticus

3 DOSAGE FORMS AND STRENGTHS APTIOM tablets are available in the following shapes and color (TABLE 1) with respective one-sided engraving:

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Eslicarbazepine acetate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Eslicarbazepine acetate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Eslicarbazepine acetate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Eslicarbazepine acetate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Eslicarbazepine acetate in pediatric patients.

Contraindications

• APTIOM is contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Eslicarbazepine acetate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Eslicarbazepine acetate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Eslicarbazepine acetate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Eslicarbazepine acetate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Eslicarbazepine acetate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Eslicarbazepine acetate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Eslicarbazepine acetate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Eslicarbazepine acetate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Eslicarbazepine acetate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Eslicarbazepine acetate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Eslicarbazepine acetate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Eslicarbazepine acetate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Eslicarbazepine acetate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Eslicarbazepine acetate in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Eslicarbazepine acetate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Eslicarbazepine acetate in the drug label.

Pharmacology

There is limited information regarding Eslicarbazepine acetate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Eslicarbazepine acetate01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Eslicarbazepine acetate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Eslicarbazepine acetate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Eslicarbazepine acetate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Eslicarbazepine acetate in the drug label.

How Supplied

Storage

There is limited information regarding Eslicarbazepine acetate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Eslicarbazepine acetate in the drug label.

Precautions with Alcohol

• Alcohol-Eslicarbazepine acetate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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