Oxcarbazepine

Oxcarbazepine
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: Vignesh Ponnusamy, M.B.B.S. [2]

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Overview

Oxcarbazepine is an antiepileptic drug that is FDA approved for the {{{indicationType}}} of partial seizures. Common adverse reactions include dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, abnormal gait.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Partial Seizure

• Adjunctive Therapy for Adults

• Treatment with Oxcarbazepine should be initiated with a dose of 600 mg/day, given in a twice-a-day regimen. If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals; the recommended daily dose is 1200 mg/day. Daily doses above 1200 mg/day show somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of CNS effects. It is recommended that the patient be observed closely and plasma levels of the concomitant AEDs be monitored during the period of Oxcarbazepine titration, as these plasma levels may be altered, especially at Oxcarbazepine doses greater than 1200 mg/day [see Drug Interactions (7.1)].

• Conversion to Monotherapy for Adults

• Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with Oxcarbazepine at 600 mg/day (given in a twice-a-day regimen) while simultaneously initiating the reduction of the dose of the concomitant AEDs. The concomitant AEDs should be completely withdrawn over 3-6 weeks, while the maximum dose of Oxcarbazepine should be reached in about 2-4 weeks. Oxcarbazepine may be increased as clinically indicated by a maximum increment of 600 mg/day at approximately weekly intervals to achieve the recommended daily dose of 2400 mg/day. A daily dose of 1200 mg/day has been shown in one study to be effective in patients in whom monotherapy has been initiated with Oxcarbazepine. Patients should be observed closely during this transition phase.

• Initiation of Monotherapy for Adults

• Patients not currently being treated with AEDs may have monotherapy initiated with Oxcarbazepine. In these patients, Oxcarbazepine should be initiated at a dose of 600 mg/day (given in a twice-a-day regimen); the dose should be increased by 300 mg/day every third day to a dose of 1200 mg/day. Controlled trials in these patients examined the effectiveness of a 1200 mg/day dose; a dose of 2400 mg/day has been shown to be effective in patients converted from other AEDs to Oxcarbazepine monotherapy

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Adjunctive Therapy for Pediatric Patients (Aged 2-16 Years)

• In pediatric patients aged 4-16 years, treatment should be initiated at a daily dose of 8-10 mg/kg generally not to exceed 600 mg/day, given in a twice-a-day regimen. The target maintenance dose of Oxcarbazepine should be achieved over two weeks, and is dependent upon patient weight, according to the following chart:
  • 20-29 kg - 900 mg/day
  • 29.1-39 kg - 1200 mg/day
  • >39 kg – 1800 mg/day

• In the clinical trial, in which the intention was to reach these target doses, the median daily dose was 31 mg/kg with a range of 6-51 mg/kg.
• In pediatric patients aged 2-<4 years, treatment should also be initiated at a daily dose of 8-10 mg/kg generally not to exceed 600 mg/day, given in a twice-a-day regimen. For patients under 20 kg, a starting dose of 16-20 mg/kg may be considered [see Clinical Pharmacology (12.3)]. The maximum maintenance dose of Oxcarbazepine should be achieved over 2-­4 weeks and should not exceed 60 mg/kg/day in a twice-a-day regimen.
• In the clinical trial in pediatric patients (2 to 4 years of age) in which the intention was to reach the target dose of 60 mg/kg/day, 50% of patients reached a final dose of at least 55 mg/kg/day.
• Under adjunctive therapy (with and without enzyme-inducing AEDs), when normalized by body weight, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to <4 years of age may require up to twice the oxcarbazepine dose per body weight compared to adults; and children 4 to ≤12 years of age may require a 50% higher oxcarbazepine dose per body weight compared to adults.

• Conversion to Monotherapy for Pediatric Patients (Aged 4-16 Years)

• Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with Oxcarbazepine at approximately 8-10 mg/kg/day given in a twice-a-day regimen, while simultaneously initiating the reduction of the dose of the concomitant antiepileptic drugs. The concomitant antiepileptic drugs can be completely withdrawn over 3-6 weeks while Oxcarbazepine may be increased as clinically indicated by a maximum increment of 10 mg/kg/day at approximately weekly intervals to achieve the recommended daily dose. Patients should be observed closely during this transition phase.
• The recommended total daily dose of Oxcarbazepine is shown in the table below.

• Initiation of Monotherapy for Pediatric Patients (Aged 4-16 Years)

• Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with Oxcarbazepine. In these patients, Oxcarbazepine should be initiated at a dose of 8-10 mg/kg/day given in a twice-a-day regimen. The dose should be increased by 5 mg/kg/day every third day to the recommended daily dose shown in the table below.

T1

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Contraindications

• Oxcarbazepine should not be used in patients with a known hypersensitivity to oxcarbazepine or to any of its components.

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Oxcarbazepine Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Oxcarbazepine 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 Oxcarbazepine in the drug label.

Precautions with Alcohol

• Alcohol-Oxcarbazepine 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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