Usual Adult Dose for Epilepsy

Monotherapy:
Initiation of monotherapy:
Immediate-release:
Initial dose: 300 mg orally twice a day, increased by increments of 300 mg per day every third day as clinically indicated
Maintenance dose: 300 to 1,200 mg orally twice a day
Maximum dose: 1,200 mg orally twice a day

Conversion to monotherapy:
Immediate-release:
Initial dose: 300 mg orally twice a day, increased by increments of up to 600 mg per day at approximately weekly intervals as clinically indicated
Maintenance dose: 300 to 1,200 mg orally twice a day
Maximum dose: 1,200 mg orally twice a day

Comments:

• When converting to oxcarbazepine monotherapy, concomitant antiepileptics should be completely withdrawn over 3 to 6 weeks, while a maximum dose should be reached in about 2 to 4 weeks.
• Patients should be closely observed during the transition from adjunctive to monotherapy with oxcarbazepine.

Adjunctive Therapy:
Immediate-release:
Initial dose: 300 mg orally twice a day, increased by increments of up to 600 mg per day at approximately weekly intervals as clinically indicated
Maintenance dose: 300 mg to 1,200 mg orally twice a day
Maximum dose: 1,200 mg orally twice a day

Extended-release:
Initial dose: 600 mg orally once a day for one week, increased by increments of 600 mg per day at weekly intervals as clinically indicated
Maintenance dose: 1,200 to 2,400 mg orally once a day
Maximum dose: 2,400 mg orally once a day

Comments:

• Immediate release: Plasma levels of concomitant antiepileptic drugs should be monitored during titration of oxcarbazepine. In controlled trials, most patients were not able to tolerate a dose of 2,400 mg per day, mainly due to CNS effects.
• Extended-release: A dose of 2,400 mg per day showed slightly greater efficacy than 1,200 mg per day; however, it was associated with an increased risk of side effects.

Use(s): Monotherapy or adjunctive therapy for the treatment of partial seizures; extended-release oral tablets are only indicated as adjunctive therapy.

Usual Geriatric Dose for Epilepsy

Extended-release:
Initial dose: 300 to 450 mg orally once a day, increased by increments of 300 to 450 mg per day at weekly intervals as clinically indicated.

Use(s): Extended-release oral tablets are only indicated as adjunctive therapy for the treatment of partial seizures

Usual Pediatric Dose for Epilepsy

Monotherapy:
4 to 16 years of age:
Immediate-release:
Initiation of monotherapy: 4 to 5 mg/kg orally twice a day (up to 600 mg per day), increased by an increment of 5 mg/kg per day every third day as clinically indicated
Conversion to monotherapy: 4 to 5 mg/kg orally twice a day (up to 600 mg per day), increased by an increment of 10 mg/kg per day at approximately weekly intervals as clinically indicated

Maintenance dose:
Body weight:
20 kg: 300 to 450 mg orally twice a day
25 to 30 kg: 450 to 600 mg orally twice a day
35 to 40 kg: 450 to 750 mg orally twice a day
45 kg: 600 to 750 mg orally twice a day
50 to 55 kg: 600 to 900 mg orally twice a day
60 to 65 kg: 600 to 1,050 mg orally twice a day
70 kg: 750 to 1,050 mg orally twice a day

Comments:

• When converting to oxcarbazepine monotherapy, concomitant antiepileptics may be completely withdrawn over 3 to 6 weeks.
• Patients should be closely observed during the transition phase.

Adjunctive therapy:
2 to 4 years of age:
Immediate-release:
Initial dose:
Body weight:
20 kg or more: 4 to 5 mg/kg orally twice a day (up to 600 mg per day)
Less than 20 kg: 8 to 10 mg/kg orally twice a day
Maximum dose: 30 mg/kg orally twice a day

Comments:

• The maximum recommended dose should be achieved over 2 to 4 weeks

4 to 16 years of age:
Immediate-release:
Initial dose: 4 to 5 mg/kg orally twice a day (up to 600 mg per day)
Maintenance dose:
Body weight:
20 to 29 kg: 900 mg orally per day
29.1 to 39 kg: 1,200 mg orally per day
Greater than 39 kg: 1,800 mg orally per day

Comments:

• The target maintenance dose should be achieved over 2 weeks

6 to 17 years of age:
Extended-release:
Initial dose: 8 to 10 mg/kg (up to 600 mg) orally once a day, increased by an increment of 8 to 10 mg/kg per day (up to 600 mg) at weekly intervals if clinically indicated
Maintenance dose:
Body weight:
20 to 29 kg: 900 mg orally once a day
29.1 to 39 kg: 1,200 mg orally once a day
Greater than 39 kg: 1,800 mg orally once a day

Comments:

• Use is not recommended in patients younger than 6 years of age due to tablet size; data are not available in patients younger than 4 years of age.

Use(s): Monotherapy for the treatment of partial seizures in children 4 to 16 years; adjunctive therapy for the treatment of partial seizures in children 2 to 16 years; extended-release oral tablets are only indicated as adjunctive therapy.

Renal Dose Adjustments

Adults:
CrCl 29 mL/min or less:
Immediate-release:
Initial dose: 150 mg orally twice a day; increase at a slower than usual rate as clinically indicated

Extended-release:
Initial dose: 300 mg orally once a day; increase in increments of 300 to 450 mg per day at weekly intervals as clinically indicated

Liver Dose Adjustments

Immediate-release:
Mild to moderate liver dysfunction: No adjustment recommended

Extended-release:
Severe liver dysfunction: Data not available

Dose Adjustments

Treatment withdrawal: Oxcarbazepine should be withdrawn gradually to minimize the potential for increased seizure frequency.

Conversion from immediate-release to extended-release oral oxcarbazepine: Greater doses of extended-release oxcarbazepine may be required.

Extended-release: The manufacturer recommends that an increased initial oxcarbazepine dose of 900 mg orally once a day be considered when given concomitantly with enzyme-inducing antiepileptic medicines.

Precautions

Safety and efficacy have not been established in patients younger than 2 years of age (immediate-release oral tablets) and 6 years of age (extended-release oral tablets). Immediate-release oral tablets are only indicated for adjunctive therapy in children over 2 years of age and as monotherapy in children over 4 years of age. Extended-release oral tablets are only indicated for adjunctive therapy in patients over 6 years of age.

Consult WARNINGS section for additional precautions.

Dialysis

Immediate-release: Data not available
Extended-release: Use is not recommended

Other Comments

Administration advice:
Immediate-release oral formulations:

• Doses may be taken with or without food
• The bottle containing the oral suspension should be shaken well immediately before preparing the dose
• Oxcarbazepine oral suspension may be swallowed directly from the oral dosing syringe provided with the bottle or mixed in a small glass of water just prior to administration.

Extended-release oral formulation:

• Doses should be swallowed whole and not cut, crushed or chewed
• Doses should be taken at least 1 hour before or 2 hours after meals
• For adults or pediatric patients with difficulty swallowing, daily doses may be achieved using multiples of the appropriate lower strength tablets, e.g., 150 mg tablets.

Storage requirements:

• Oxcarbazepine oral suspension should be stored at 25 C (77 F) and used within 7 weeks of opening.

General:

• Oxcarbazepine oral suspension and oxcarbazepine oral tablets may be interchanged at equal doses.
• Plasma levels of concomitant antiepileptic drugs may be altered during concomitant therapy with oxcarbazepine, particularly at doses greater than 1,200 mg per day
• There may be an increased risk of side effects if extended-release oxcarbazepine is taken with food, due to an increase in peak levels.
• Regardless of concomitant antiepileptic therapy, apparent clearance (L/hr/kg; normalized by body weight) decreases with increasing age.
• Compared to adults, children from 2 to 3 years of age may require up to twice the oxcarbazepine dose per body weight, and children 4 to 12 years may require a 50% greater dose per body weight.
• In the clinical trials 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.

Monitoring:

• Dermatologic: Serious dermatologic reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis
• Hypersensitivity: Hypersensitivity reactions, particularly in patients with prior hypersensitivity reactions to carbamazepine
• Metabolic: Hyponatremia
• Nervous system: Seizures, somnolence, dizziness
• Pregnancy: Planned or unplanned pregnancy
• Psychiatric: Emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior

Patient advice:

• Tell your healthcare provider about all of the medicines that you take, including prescription and non-prescription medicines.
• Antiepileptic drugs, including this medicine, may increase the risk of suicidal thoughts and behavior. Be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report any behavior of concern to your healthcare provider as soon as possible.
• This medicine may cause drowsiness and dizziness; do not drive a car or operate dangerous machinery until you know how this drug affects you.
• Do not drink alcohol or take other medicines that may cause sleepiness or dizziness while taking this medicine until you talk to your healthcare provider.