Oxcarbazepine: Pediatric drug information

For additional information see "Oxcarbazepine: Drug information" and "Oxcarbazepine: Patient drug information"

For abbreviations, symbols, and age group definitions show table

Brand Names: US

Oxtellar XR;
Trileptal

Brand Names: Canada

APO-OXcarbazepine;
JAMP-OXcarbazepine [DSC];
Trileptal

Therapeutic Category

Antiseizure Agent, Miscellaneous

Dosing: Pediatric

Dosage guidance:

Dosing: Dosage adjustment in pediatric patients with obesity is not necessary, based on pharmacokinetic analysis. For dosing calculations, in patients <3 years, use total body weight; in patients ≥3 years, use either total body weight or fat-free mass.

Dosage form information: Immediate-release preparations (oral suspension and tablets) are interchangeable on a mg per mg basis; immediate-release and extended-release preparations are not bioequivalent and not interchangeable on a mg per mg basis.

Focal onset seizures, monotherapy

Focal (partial) onset seizures, monotherapy:

Infants and Children <4 years: Limited data available: Oral: Immediate release (Trileptal): Initial: 3.75 to 5 mg/kg/dose twice daily; titrate dose in increments of 7.5 to 10 mg/kg/day every 5 to 7 days as tolerated; usual maximum daily dose: 60 mg/kg/day (Ref). In patients <2 years of age, pharmacokinetic data suggest higher doses (mg/kg/day) are needed compared to older patients to maintain therapeutic levels; doses up to 90 mg/kg/day have been reported (Ref). Some patients may require the daily dose as divided doses 3 times daily to achieve therapeutic levels and improve tolerability of an individual dose (Ref).

Children ≥4 years and Adolescents ≤16 years:

Initiation of monotherapy: Patients not receiving concomitant antiseizure drugs:

Immediate release (Trileptal):

Initial: Oral: 4 to 5 mg/kg/dose twice daily; usual initial daily dose in adults is 600 mg/day; increase dose every third day by 5 mg/kg/day to achieve the recommended monotherapy maintenance dose by weight, as follows:

Maintenance dose: Note: Dosing presented is total daily dose (mg/day).

20 to <25 kg: Oral: 600 to 900 mg/day in 2 divided doses.

25 to <35 kg: Oral: 900 to 1,200 mg/day in 2 divided doses.

35 to <45 kg: Oral: 900 to 1,500 mg/day in 2 divided doses.

45 to <50 kg: Oral: 1,200 to 1,500 mg/day in 2 divided doses.

50 to <60 kg: Oral: 1,200 to 1,800 mg/day in 2 divided doses.

60 to <70 kg: Oral: 1,200 to 2,100 mg/day in 2 divided doses.

≥70 kg: Oral: 1,500 to 2,100 mg/day in 2 divided doses.

Conversion to monotherapy: Patients receiving concomitant antiseizure drugs: Oral: Initial: 4 to 5 mg/kg/dose twice daily; usual initial daily dose in adults is 600 mg/day, with a simultaneous initial reduction of the dose of concomitant antiseizure drugs; withdraw concomitant antiseizure drugs completely over 3 to 6 weeks, while increasing oxcarbazepine dose as needed by no more than 10 mg/kg/day at approximately weekly intervals; increase oxcarbazepine dose to achieve the recommended monotherapy maintenance dose.

Adolescents ≥17 years:

Immediate release (Trileptal):

Initiation of monotherapy: Patients not receiving prior antiseizure drugs: Oral: Initial: 300 mg twice daily. Increase dose by 300 mg/day every third day to a maintenance dose of 1,200 mg/day in 2 divided doses per the manufacturer, although higher doses up to 2,400 mg/day have been reported (Ref).

Conversion to monotherapy: Patients receiving concomitant antiseizure drugs: Oral: Initial: 300 mg twice daily while simultaneously reducing the dose of concomitant antiseizure drugs. Withdraw concomitant antiseizure drugs completely over 3 to 6 weeks, while increasing the oxcarbazepine dose in increments of 600 mg/day at weekly intervals up to target maintenance dose of 2,400 mg/day in 2 divided doses in about 2 to 4 weeks.

Focal onset seizures, adjunctive therapy

Focal (partial) onset seizures, adjunctive therapy:

Immediate release (Trileptal):

Infants and Children <2 years: Limited data available: Oral: Initial: 3.75 to 5 mg/kg/dose twice daily; titrate dose in increments of 7.5 to 10 mg/kg/day every 5 to 7 days; maximum daily dose: 60 mg/kg/day. If intolerance develops during titration, decrease dose by 5 mg/kg/day as needed (Ref). In patients <2 years of age, pharmacokinetic data suggest higher doses (mg/kg/day) are needed compared to older patients to maintain therapeutic levels; doses up to 90 mg/kg/day have been reported (Ref); some patients may require the daily dose as divided doses 3 times daily to achieve therapeutic levels and improve tolerability of an individual dose (Ref).

Children 2 to <4 years:

Patient weight <20 kg: Oral: Initial: 4 to 5 mg/kg/dose twice daily; may consider initiating at a higher dose of 16 to 20 mg/kg/day due to increased clearance in this age; increase dose slowly over 2 to 4 weeks; maximum daily dose: 60 mg/kg/day per the manufacturer.

Patient weight ≥20 kg: Oral: Initial: 4 to 5 mg/kg/dose twice daily; usual maximum initial daily dose: 600 mg/day; increase dose slowly over 2 to 4 weeks; maximum daily dose: 60 mg/kg/day.

Note: In children 2 to 4 years of age, 50% of patients were titrated to a final dose of at least 55 mg/kg/day with target dose of 60 mg/kg/day. Due to a higher drug clearance, children 2 to <4 years of age may require up to twice the dose per body weight compared to adults.

Children ≥4 years and Adolescents ≤16 years:

Initial: Oral: 4 to 5 mg/kg/dose twice daily; usual maximum initial daily dose: 600 mg/day; increase dose slowly over 2 weeks to the target maintenance dose by weight, as follows:

Maintenance dose:

20 to 29 kg: Oral: 450 mg twice daily.

29.1 to 39 kg: Oral: 600 mg twice daily.

>39 kg: Oral: 900 mg twice daily.

Note: Use of these pediatric target maintenance doses in one clinical trial resulted in doses ranging from 6 to 51 mg/kg/day (median dose: 31 mg/kg/day) in pediatric patients 4 to 16 years of age (Ref). Due to a higher drug clearance, children 4 to ≤12 years of age may require a 50% higher dose per body weight compared to adults.

Adolescents ≥17 years: Oral: Initial: 300 mg twice daily; dose may be increased by ≤600 mg/day increments at weekly intervals up to target maintenance dose of 1,200 mg/day in 2 divided doses. Although doses >1,200 mg/day were somewhat more efficacious, most patients were unable to tolerate 2,400 mg/day (due to CNS effects).

Extended release (Oxtellar XR):

Children and Adolescents 6 to ≤16 years:

Initial: Oral: 8 to 10 mg/kg/dose once daily; maximum initial daily dose: 600 mg/day during the first week of therapy. Increase dose at weekly intervals in 8 to 10 mg/kg/day increments over 2 to 3 weeks (maximum dosage incremental increase: 600 mg/dose) to the target maintenance dose based on weight, as follows:

Maintenance dose:

20 to 29 kg: Oral: 900 mg once daily.

29.1 to 39 kg: Oral: 1,200 mg once daily.

>39 kg: Oral: 1,800 mg once daily.

Adolescents ≥17 years: Oral: Initial: 600 mg once daily; dosage may be increased by 600 mg/day increments at weekly intervals. Recommended daily dose is 1,200 to 2,400 mg once daily. Although daily doses >1,200 mg daily were somewhat more efficacious, most patients were unable to tolerate 2,400 mg/day (due to CNS effects).

Conversion from immediate release (Trileptal) to extended release (Oxtellar XR): Children ≥6 years and Adolescents: Higher doses of Oxtellar XR may be necessary; on a mg per mg basis dosage forms are not bioequivalent.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling.

Severe impairment (CrCl <30 mL/minute):

Immediate release (eg, Trileptal): Children ≥2 years and Adolescents: Oral: Therapy should be initiated at lower starting dose (eg, one-half the usual starting dose) and increased slowly to achieve desired clinical response.

Extended release (eg, Oxtellar XR):

Children 6 to ≤16 years: Oral: There are no specific recommendations for this age group in the manufacturer's labeling; in older pediatric patients, initial dosage reductions and a slower titration are recommended.

Adolescents ≥17 years: Oral: Therapy should be initiated at one-half the usual starting dose (300 mg/day) and increased slowly at weekly intervals in 300 to 450 mg/day increments to achieve desired clinical response.

End-stage kidney disease (ESKD) (on dialysis): Immediate-release formulations should be used instead of extended-release formulation.

Dosing: Liver Impairment: Pediatric

Children ≥2 years and Adolescents:

Mild to moderate impairment: Oral: Immediate release (eg, Trileptal), Extended release (eg, Oxtellar XR): No dosage adjustments are recommended.

Severe impairment: Oral:

Immediate release (eg, Trileptal): There are no dosage adjustments in the manufacturer's labeling; has not been studied; use caution particularly if concomitant antiseizure therapy.

Extended release (eg, Oxtellar XR): There are no dosage adjustment in the manufacturer's labeling; use is not recommended (has not been studied).

Dosing: Adult

(For additional information see "Oxcarbazepine: Drug information")

Dosage guidance:

Safety: Before use, test for the HLA-B*1502 allele in patients at increased genetic risk (eg, those of Asian ancestry, including South Asian patients) for oxcarbazepine-associated Stevens-Johnson syndrome/toxic epidermal necrolysis. Do not initiate oxcarbazepine in patients who test positive for HLA-B*1502 when other options are available (Ref).

Bipolar disorder

Bipolar disorder (off label) (alternative agent):

Acute mania and manic mixed episodes and maintenance treatment:

Note: Reserve as late-line option in patients who have not responded to adequate trials of all preferred agents alone and in combination due to significant drug-drug interactions, risk of hyponatremia, and limited evidence (Ref).

Oral: Initial: Extended or immediate release: 300 mg/day; may increase based on response and tolerability in increments of 300 mg every 2 to 3 days to a maximum dosage of 2,400 mg/day. Administer immediate release in 2 to 3 divided doses and extended release once daily (Ref).

Focal onset seizures

Focal (partial) onset seizures:

Note: Monotherapy and adjunctive therapy in the treatment of patients with focal onset seizures with or without secondary generalized tonic-clonic seizures. Avoid use in myoclonic or generalized nonmotor (absence) seizures due to potential to worsen generalized convulsions (Ref).

Oral:

Immediate release: Initial: 300 to 600 mg/day in 2 divided doses. May increase dose by ≤600 mg/day increments at weekly intervals to a maximum dose of 2.4 g/day in 2 to 3 divided doses (Ref).

Extended release: Initial: 600 mg once daily. May increase dose by 600 mg/day increments at weekly intervals to a maximum dose of 2.4 g/day (Ref).

Trigeminal neuralgia

Trigeminal neuralgia (off-label use): Oral: Immediate release: Initial: 300 to 600 mg/day in 2 divided doses; adjust dose based on response and tolerability in increments of 300 mg/day every ≥3 days up to a maximum dose of 1.8 g/day (Ref).

Discontinuation of therapy: In chronic therapy, withdraw gradually over 1 to 6 months based upon individual circumstance to minimize the potential of increased seizure frequency (in patients with epilepsy) unless safety concerns require more rapid withdrawal (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling.

Severe impairment (CrCl <30 mL/minute): Immediate release, Extended release: Therapy should be initiated at one-half the usual starting dose (300 mg daily) and increased slowly to achieve desired clinical response (eg, 300 to 450 mg daily at weekly intervals).

ESRD (on dialysis): Immediate release formulations should be used instead of extended release formulation.

Dosing: Liver Impairment: Adult

Mild to moderate impairment: No dosage adjustments necessary.

Severe impairment:

Immediate release: There are no dosage adjustments provided in the manufacturer's labeling; use caution (has not been studied).

Extended release: There are no dosage adjustments provided in the manufacturer's labeling; use is not recommended (has not been studied).

Adverse Reactions (Significant): Considerations

Blood dyscrasias

Agranulocytosis, leukopenia (Ref), aplastic anemia, pancytopenia (Ref), and thrombocytopenia (Ref) have been reported with oxcarbazepine. One retrospective study in pediatric patients in Korea reported an oxcarbazepine-induced leukopenia rate of ~5% which led to pancytopenia in two patients (1%) (Ref). Leukopenia often reverses, even with continued treatment; however, some cases may require dose reduction or discontinuation (Ref). The prevalence of thrombocytopenia is reported to be ~2% (Ref).

Mechanism: Unknown; may be due to immune-mediated or toxic mechanisms, similar to carbamazepine due to structural similarity (Ref). Thrombocytopenia may be due to hyper-destruction of platelets (Ref).

Onset: Varied; days or months after initiation of therapy. In one study, onset of leukopenia was observed 11 days to 14 years after initiation (Ref).

Risk factors:

• Leukopenia: Possible male predominance (Ref)

• Thrombocytopenia: Correlation with daily dose but not serum concentration (Ref)

Hypersensitivity reactions (delayed)

A variety of delayed hypersensitivity reactions, ranging from mild with maculopapular eruption (also known as morbilliform rash) to severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome, toxic epidermal necrolysis (SJS/TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported (Ref).

Mechanism: Non–dose-related; immunologic. Delayed hypersensitivity reactions, including maculopapular eruptions and SCARs are T-cell-mediated (Ref).

Onset: Delayed hypersensitivity reactions: Varied. Maculopapular rash usually occurs within 2 to 4 weeks after initiation (Ref). SCARs usually occur 1 to 8 weeks after initiation (Ref); reexposure may lead to more rapid onset (usually with 1 to 4 days) (Ref).

Risk factors:

• HLA-B*1502 allele increases risk of SJS/TEN especially in South-East Asian populations (Ref); avoidance of oxcarbazepine should be considered in oxcarbazepine-naive patients who test positive for HLA-B*1502 (Ref).

• Viral reactivation, in particular human herpesvirus 6 (HHV-6) reactivation may be associated with a prolonged and more severe course of DRESS (Ref).

• High degree of cross-reactivity exists between aromatic antiseizure medications, including phenytoin, carbamazepine, phenobarbital, primidone, and oxcarbazepine (Ref).

Hyponatremia

Hyponatremia is a common adverse reaction with oxcarbazepine in adult and pediatric patients. The reported incidence of oxcarbazepine-induced hyponatremia varies greatly in the literature (Ref). In a cohort study of adult patients with epilepsy treated with either carbamazepine or oxcarbazepine, hyponatremia (serum sodium ≤134 mmol/L) occurred in 46% of patients receiving oxcarbazepine; 22% of those cases classified as severe hyponatremia (≤128 mmol/L) (Ref). An earlier study demonstrated an incidence of 30% and 12% for hyponatremia and severe hyponatremia, respectively (Ref). In a study of pediatric patients, hyponatremia without clinical symptoms occurred in 27% of patients receiving oxcarbazepine; 3% of cases were severe (Ref). Hyponatremia associated with oxcarbazepine in the clinical trials was mostly asymptomatic. Study patients were monitored frequently with interventions such as reduction in fluid intake, dose reductions, or discontinuation of oxcarbazepine. Cases of symptomatic hyponatremia have been reported mostly with mild symptoms (eg, dizziness, diplopia, confusion, lethargy, headache), but symptoms can lead to seizures and in very severe cases coma (Ref).

Mechanism: Dose-related; unknown but may be caused by direct activation or enhanced sensitivity of vasopressin V₂receptors (V₂R), which play a key role in water reabsorption, as well as a direct effect on the renal collecting tubules. Hyponatremia does not appear to result from increased release of antidiuretic hormone (Ref).

Onset: Varied; clinically significant hyponatremia generally occurs during the first 3 months of treatment; although, there are reports of patients who developed a serum sodium <125 mmol/L more than 1 year after initiation of treatment.

Risk factors:

• High doses/serum drug concentrations (Ref)

• Females (Ref)

• Age >40 years (Ref)

• Concurrent use of other antiseizure medications (Ref)

• Concurrent use of medications known to decrease serum sodium (eg, diuretics)

• The study in pediatric patients did not find dose, serum levels, age, or concurrent use of other antiseizure medications to be predictive for the development of hyponatremia (Ref)

Neuropsychiatric effects

Oxcarbazepine is associated with CNS effects in adult and pediatric patients, including cognitive symptoms (eg, psychomotor slowing, lack of concentration, speech disturbance or language problems), dizziness, drowsiness, fatigue, and coordination abnormalities (eg, ataxia and abnormal gait). A postmarketing surveillance study obtained from dispensed British National Health Service prescriptions reported that the most frequent clinical reason for discontinuation was drowsiness/sedation (~2.5% of cohort) (Ref). According to the manufacturer, psychiatric effects such as manic behavior and psychosis have been reported. However, oxcarbazepine has also been associated with positive mood-stabilizing properties (Ref).

Mechanism: May be dose-related; related to pharmacologic action.

Risk factors:

• May be dose related

• Concurrent administration of other CNS sedating agents

Suicidal ideation

Antiseizure medications have been associated with suicidal ideation and suicidal tendencies. However, the FDA meta-analysis has been criticized due to several important limitations (Ref). The risk of suicide is increased in epilepsy (Ref), but the occurrence of suicidal ideation/tendencies in epilepsy is multifactorial. While some antiseizure medications (but not all) have been associated with treatment-emergent psychiatric effects such as anxiety and depression, other factors such as post-ictal suicidal behavior and pertinent patient history must also be evaluated to provide an accurate assessment of risk for any individual drug (Ref).

Onset: Varied; peak incidence of suicidality across antiseizure medications (not specific to individual agents) has been noted to occur between 1 and 12 weeks of therapy (Ref). A review of clinical trials noted that risk extended from 1 week to 24 weeks of therapy, corresponding to the duration of most trials.

Risk factors:

• History of depression (Ref)

• Use in conditions other than epilepsy or bipolar disorder (Ref)

• In patients with bipolar disorder, risk for repeat suicide attempt was increased in patients with alcohol/substance abuse disorder, rapid cycling, and earlier age at onset of first manic episode (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Incidence of adverse effects is from monotherapy and adjunctive antiseizure drug studies. Incidence in children was similar. Incidence is reported for immediate release (IR) formulation unless otherwise noted as extended release (ER).

>10%:

Endocrine & metabolic: Hyponatremia (ER, IR: 1% to 46%) (Ref) (table 1)Hyponatremia

**Oxcarbazepine: Adverse Reaction: Hyponatremia**
Drug (Oxcarbazepine)	Comparator (Carbamazepine)	Placebo	Population	Dose	Dosage Form	Number of Patients (Oxcarbazepine)	Number of Patients (Carbamazepine [C] or Placebo [P])	Comments
46%	26%	N/A	N/A	N/A	N/A	289	C: 1,132	Sodium level ≤134 mEq/L; Berghuis 2017
30%	14%	N/A	N/A	N/A	N/A	97	C: 451	Sodium level ≤134 mEq/L; Dong 2005
27%	N/A	N/A	Children and adolescents	N/A	N/A	75	N/A	Sodium level ≤135 mEq/L; Holtman 2002
22%	7%	N/A	N/A	N/A	N/A	289	C: 1,132	Sodium level ≤128 mEq/L; Berghuis 2017
12%	3%	N/A	N/A	N/A	N/A	97	C: 451	Sodium level ≤128 mEq/L; Dong 2005
10%	N/A	2%	N/A	1,200 mg/day	Extended-release oral	N/A	N/A	Shift in serum sodium concentrations from normal to low (<135 mEq/L)
7%	N/A	2%	N/A	2,400 mg/day	Extended-release oral	N/A	N/A	Shift in serum sodium concentrations from normal to low (<135 mEq/L)
5%	N/A	N/A	Adults	2,400 mg/day	Immediate-release oral	86	N/A	Monotherapy in patients previously treated with other antiseizure medications
3%	N/A	0%	N/A	N/A	Immediate-release oral	1,524	N/A	Sodium of less than 125 mmol/L at some point during treatment
3%	N/A	1%	Adults	600 mg/day	Immediate-release oral	163	P: 166	Adjunctive Therapy
3%	N/A	N/A	Children and adolescents	N/A	N/A	75	N/A	Sodium level ≤125 mEq/L; Holtman 2002
1%	N/A	1%	Adults	1,200 mg/day	Immediate-release oral	171	P: 166	Adjunctive Therapy
1%	N/A	N/A	N/A	N/A	Extended-release oral	N/A	N/A	Clinically significant hyponatremia

Gastrointestinal: Abdominal pain (5% to 13%), nausea (15% to 25%), vomiting (ER: 15%; IR: 7% to 33%)

Nervous system: Ataxia (ER: 1% to 3%; IR: 2% to 17%) (table 2)Ataxia, dizziness (ER, IR: 20% to 41%) (table 3)Dizziness, drowsiness (ER: 12% to 14%; IR: 19% to 31%) (table 4)Drowsiness, fatigue (ER: 3% to 6%; IR: 12% to 21%) (table 5)Fatigue, headache (ER: 8% to 15%; IR 13% to 32%), vertigo (2% to 12%)

**Oxcarbazepine: Adverse Reaction: Ataxia**
Drug (Oxcarbazepine)	Placebo	Population	Dose	Dosage Form	Number of Patients (Oxcarbazepine)	Number of Patients (Placebo)	Comments
13%	4%	Children and adolescents	N/A	Immediate-release oral	171	139	Adjunctive therapy/monotherapy in patients previously treated with other antiseizure medications
17%	5%	Adults	1,200 mg/day	Immediate-release oral	171	166	Adjunctive Therapy
9%	5%	Adults	600 mg/day	Immediate-release oral	163	166	Adjunctive Therapy
7%	N/A	Adults	2,400 mg/day	Immediate-release oral	86	N/A	Monotherapy in patients previously treated with other antiseizure medications
5%	0%	Adults	N/A	Immediate-release oral	55	49	Monotherapy in patients not previously treated with other antiseizure medications
4%	2%	Adults	N/A	Immediate-release oral	55	49	Monotherapy in patients not previously treated with other antiseizure medications; defined as "abnormal coordination"
3%	1%	Adults	1,200 mg/day	Extended-release oral	122	121	Patients receiving concomitant antiseizure medications
3%	1%	Adults	1,200 mg/day	Immediate-release oral	171	166	Adjunctive Therapy; defined as "abnormal coordination"
2%	N/A	Adults	2,400 mg/day	Immediate-release oral	86	N/A	Monotherapy in patients previously treated with other antiseizure medications; defined as "abnormal coordination"
1%	1%	Adults	600 mg/day	Immediate-release oral	163	166	Adjunctive Therapy; defined as "abnormal coordination"
1%	1%	Adults	2,400 mg/day	Extended-release oral	123	121	Patients receiving concomitant antiseizure medications

**Oxcarbazepine: Adverse Reaction: Dizziness**
Drug (Oxcarbazepine)	Placebo	Population	Dose	Dosage Form	Number of Patients (Oxcarbazepine)	Number of Patients (Placebo)	Comments
28%	8%	Children and adolescents	N/A	Immediate-release oral	171	139	Adjunctive therapy/monotherapy in patients previously treated with other antiseizure medications
41%	15%	Adults	2,400 mg/day	Extended-release oral	123	121	Patients receiving concomitant antiseizure medications
32%	13%	Adults	1,200 mg/day	Immediate-release oral	171	166	Adjunctive Therapy
28%	N/A	Adults	2,400 mg/day	Immediate-release oral	86	N/A	Monotherapy in patients previously treated with other antiseizure medications
26%	13%	Adults	600 mg/day	Immediate-release oral	163	166	Adjunctive Therapy
22%	6%	Adults	N/A	Immediate-release oral	55	49	Monotherapy in patients not previously treated with other antiseizure medications
20%	15%	Adults	1,200 mg/day	Extended-release oral	122	121	Patients receiving concomitant antiseizure medications

**Oxcarbazepine: Adverse Reaction: Drowsiness**
Drug (Oxcarbazepine)	Placebo	Population	Dose	Dosage Form	Number of Patients (Oxcarbazepine)	Number of Patients (Placebo)	Comments
31%	13%	Children and adolescents	N/A	Immediate-release oral	171	139	Adjunctive therapy/monotherapy in patients previously treated with other antiseizure medications
28%	12%	Adults	1,200 mg/day	Immediate-release oral	171	166	Adjunctive Therapy
20%	12%	Adults	600 mg/day	Immediate-release oral	163	166	Adjunctive Therapy
19%	N/A	Adults	2,400 mg/day	Immediate-release oral	86	N/A	Monotherapy in patients previously treated with other antiseizure medications
14%	9%	Adults	2,400 mg/day	Extended-release oral	123	121	Patients receiving concomitant antiseizure medications
12%	9%	Adults	1,200 mg/day	Extended-release oral	122	121	Patients receiving concomitant antiseizure medications

**Oxcarbazepine: Adverse Reaction: Fatigue**
Drug (Oxcarbazepine)	Placebo	Population	Dose	Dosage Form	Number of Patients (Oxcarbazepine)	Number of Patients (Placebo)	Comments
13%	9%	Children and adolescents	N/A	Immediate-release oral	171	139	Adjunctive therapy/monotherapy in patients previously treated with other antiseizure medications
21%	N/A	Adults	2,400 mg/day	Immediate-release oral	86	N/A	Monotherapy in patients previously treated with other antiseizure medications
15%	7%	Adults	600 mg/day	Immediate-release oral	163	166	Adjunctive Therapy
12%	7%	Adults	1,200 mg/day	Immediate-release oral	171	166	Adjunctive Therapy
6%	1%	Adults	1,200 mg/day	Extended-release oral	122	121	Patients receiving concomitant antiseizure medications
3%	1%	Adults	2,400 mg/day	Extended-release oral	123	121	Patients receiving concomitant antiseizure medications

Ophthalmic: Diplopia (ER: 10% to 13%; IR: 12% to 30%), nystagmus disorder (ER: 3%; IR: 2% to 20%), visual disturbance (ER: 1% to 3%; IR: 4% to 14%)

1% to 10%:

Cardiovascular: Chest pain (2%), edema (2%), hypotension (1%), lower extremity edema (2%)

Dermatologic: Acne vulgaris (1% to 2%), diaphoresis (3%), skin rash (4%)

Endocrine & metabolic: Hot flash (2%), increased thirst (2%), weight gain (2%)

Gastrointestinal: Anorexia (5%), constipation (4% to 5%), diarrhea (7%), dysgeusia (5%), dyspepsia (ER, IR: 2% to 6%), gastritis (ER, IR: 2% to 3%), toothache (2%), upper abdominal pain (ER: 3%), xerostomia (3%)

Genitourinary: Urinary frequency (2%), urinary tract infection (5%), vaginitis (2%)

Hematologic & oncologic: Bruise (4%), lymphadenopathy (2%), purpuric rash (2%), rectal hemorrhage (2%)

Hypersensitivity: Hypersensitivity reaction (2%)

Infection: Infection (2%), viral infection (7%),

Nervous system: Abnormal gait (ER: ≤3%; IR: 5% to 10%) (table 6)Abnormal Gait, abnormality in thinking (2%), amnesia (4% to 5%), anxiety (7%), balance impairment (ER: 7%), confusion (7%), dysmetria (1% to 2%), emotional lability (3% to 8%), falling (4%), feeling abnormal (1%), hypoesthesia (3%), insomnia (2% to 6%), lack of concentration (2%) (table 7)Lack of Concentration, myasthenia (1% to 2%), nervousness (2% to 7%), seizure (2%; decreased seizure threshold [exacerbation of seizures]: 5%), speech disturbance (1% to 3%) (table 8)Speech Disturbance

**Oxcarbazepine: Adverse Reaction: Abnormal Gait**
Drug (Oxcarbazepine)	Placebo	Population	Dose	Dosage Form	Number of Patients (Oxcarbazepine)	Number of Patients (Placebo)	Comments
8%	3%	Children and adolescents	N/A	Immediate-release oral	171	139	Adjunctive therapy/monotherapy in patients previously treated with other antiseizure medications
10%	1%	Adults	1,200 mg/day	Immediate-release oral	171	166	Adjunctive Therapy
5%	1%	Adults	600 mg/day	Immediate-release oral	163	166	Adjunctive Therapy
3%	1%	Adults	1,200 mg/day	Extended-release oral	122	121	Patients receiving concomitant antiseizure medications
0%	1%	Adults	2,400 mg/day	Extended-release oral	123	121	Patients receiving concomitant antiseizure medications

**Oxcarbazepine: Adverse Reaction: Lack of Concentration**
Drug (Oxcarbazepine)	Placebo	Population	Dose	Dosage Form	Number of Patients (Oxcarbazepine)	Number of Patients (Placebo)	Comments
2%	1%	Children and adolescents	N/A	Immediate-release oral	171	139	Adjunctive therapy/monotherapy in patients previously treated with other antiseizure medications

**Oxcarbazepine: Adverse Reaction: Speech Disturbance**
Drug (Oxcarbazepine)	Placebo	Population	Dose	Dosage Form	Number of Patients (Oxcarbazepine)	Number of Patients (Placebo)	Comments
3%	1%	Children and adolescents	N/A	Immediate-release oral	171	139	Adjunctive therapy/monotherapy in patients previously treated with other antiseizure medications
2%	N/A	Adults	2,400 mg/day	Immediate-release oral	86	N/A	Monotherapy in patients previously treated with other antiseizure medications
1%	0%	Adults	1,200 mg/day	Immediate-release oral	171	166	Adjunctive Therapy
1%	0%	Adults	600 mg/day	Immediate-release oral	163	166	Adjunctive Therapy

Neuromuscular & skeletal: Asthenia (ER, IR: 2% to 7%), back pain (4%), muscle spasm (2%), sprain (2%), tremor (ER, IR: 4% to 8%)

Ophthalmic: Blurred vision (ER: 4%)

Otic: Otalgia (2%), otic infection (2%)

Respiratory: Bronchitis (3%), cough (5%), epistaxis (4%), nasopharyngitis (ER: 3%), pharyngitis (3%), pneumonia (2%), pulmonary infection (4%), rhinitis (10%), sinusitis (ER, IR: 3% to 4%), upper respiratory tract infection (7% to 10%)

Miscellaneous: Fever (3%)

<1%: Nervous system: Suicidal ideation, suicidal tendencies

Frequency not defined:

Cardiovascular: Bradycardia, cardiac failure, flushing, hypertension, orthostatic hypotension, palpitations, syncope, tachycardia

Dermatologic: Alopecia, contact dermatitis, eczema, erythematosus rash, facial rash, folliculitis, genital pruritus, maculopapular rash, miliaria, psoriasis, skin photosensitivity, vitiligo

Endocrine & metabolic: Change in libido, decreased T4, heavy menstrual bleeding, hyperglycemia, hypocalcemia, hypoglycemia, hypokalemia, increased gamma-glutamyl transferase, intermenstrual bleeding, weight loss

Gastrointestinal: Aphthous stomatitis, biliary colic, blood in stool, cholelithiasis, colitis, duodenal ulcer, dysphagia, enteritis, eructation, esophagitis, flatulence, gastric ulcer, gingival hemorrhage, gingival hyperplasia, hematemesis, hemorrhoids, hiccups, increased appetite, retching, sialadenitis, stomatitis

Genitourinary: Dysuria, hematuria, leukorrhea

Hepatic: Increased liver enzymes

Nervous system: Aggressive behavior, apathy, aphasia, aura, cerebral hemorrhage, delirium, delusion, dystonia, euphoria, extrapyramidal reaction, hemiplegia, hyperreflexia, hypertonia, hyporeflexia, hypotonia, hysteria, impaired consciousness, intoxicated feeling, malaise, manic behavior, migraine, neuralgia, nightmares, panic disorder, paralysis, personality disorder, precordial pain, psychomotor retardation, psychosis, rigors, stupor, voice disorder

Neuromuscular & skeletal: Hyperkinetic muscle activity, hypokinesia, right hypochondrium pain, systemic lupus erythematosus, tetany

Ophthalmic: Accommodation disturbance, blepharoptosis, cataract, conjunctival hemorrhage, hemianopia, mydriasis, ocular edema, photophobia, scotoma, xerophthalmia

Otic: Otitis externa

Renal: Nephrolithiasis, polyuria, renal pain

Respiratory: Asthma, dyspnea, laryngismus, pleurisy

Postmarketing:

Cardiovascular: Atrioventricular block

Dermatologic: Acute generalized exanthematous pustulosis, erythema multiforme, Stevens-Johnson syndrome (Ref), toxic epidermal necrolysis (Ref), urticaria (Ref)

Endocrine & metabolic: Hypothyroidism, SIADH

Gastrointestinal: Increased serum amylase, increased serum lipase, pancreatitis

Genitourinary: Priapism (Ref)

Hematologic & oncologic: Agranulocytosis, aplastic anemia, leukopenia (Ref), pancytopenia (Ref), thrombocytopenia (Ref)

Hepatic: Hepatitis (Ref)

Hypersensitivity: Anaphylaxis, angioedema (Ref)

Immunologic: Drug reaction with eosinophilia and systemic symptoms (Ref)

Nervous system: Dysarthria

Neuromuscular & skeletal: Bone fracture (long-term therapy) (Ref), decreased bone mineral density (long-term therapy), osteoporosis (long-term therapy)

Ophthalmic: Oculogyric crisis (Ref)

Otic: Tinnitus (Ref)

Contraindications

Hypersensitivity to oxcarbazepine, eslicarbazepine acetate, or any component of the formulation.

Warnings/Precautions

Disease-related concerns:

• Bariatric surgery: Presurgical assessment of the indication for use, symptoms, and goals of therapy should be documented to enable postsurgical assessment. May consider pre- and postsurgical therapeutic drug monitoring in patients with epilepsy to evaluate exposure (Ref). Monitor for continued efficacy after bariatric surgery and consider switching to an alternate medication if symptoms worsen.

• Cardiovascular disease: Clinical trials excluded patients with significant cardiovascular disease or ECG abnormalities. Monitor body weight/fluid retention in patients with HF; evaluate serum sodium with worsening cardiac function or fluid retention.

• Renal impairment: Single-dose studies show that half-life of the primary active metabolite is prolonged 3- to 4-fold and AUC is doubled in patients with CrCl <30 mL/minute; dose adjustment required in these patients.

• Seizure disorder: Exacerbation of or new onset of seizures has been reported, particularly in children with juvenile myoclonic epilepsy; has also been reported in patients with Dravet syndrome (Fanella 2013; Gelisse 2004; Snoeijen-Schouwenaars 2015). In case of seizure aggravation, discontinue oxcarbazepine.

Other warnings/precautions:

• Withdrawal: Antiseizure medications should not be discontinued abruptly because of the possibility of increasing seizure frequency; therapy should be withdrawn gradually to minimize the potential of increased seizure frequency, unless safety concerns require a more rapid withdrawal.

Warnings: Additional Pediatric Considerations

Trileptal and Oxtellar XR are not bioequivalent and not interchangeable on a mg-per-mg basis; systemic absorption and resulting serum concentrations are lower with once-daily Oxtellar XR compared to twice-daily Trileptal when administered at the same total daily dose; higher doses of Oxtellar XR may be necessary.

Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Oral:

Trileptal: 300 mg/5 mL (250 mL) [contains alcohol, usp, methyl hydroxybenzoate, propyl hydroxybenzoate, propylene glycol, saccharin sodium; lemon flavor]

Generic: 300 mg/5 mL (5 mL, 250 mL)

Tablet, Oral:

Trileptal: 150 mg, 300 mg, 600 mg [scored]

Generic: 150 mg, 300 mg, 600 mg

Tablet Extended Release 24 Hour, Oral:

Oxtellar XR: 150 mg, 300 mg, 600 mg

Generic: 150 mg, 300 mg, 600 mg

Generic Equivalent Available: US

Yes

Pricing: US

Suspension (OXcarbazepine Oral)

300 mg/5 mL (per mL): $1.09 - $2.16

Suspension (Trileptal Oral)

300 mg/5 mL (per mL): $2.35

Tablet, 24-hour (OXcarbazepine ER Oral)

150 mg (per each): $10.29

300 mg (per each): $14.30

600 mg (per each): $26.18

Tablet, 24-hour (Oxtellar XR Oral)

150 mg (per each): $11.49

300 mg (per each): $15.96

600 mg (per each): $29.21

Tablets (OXcarbazepine Oral)

150 mg (per each): $0.12 - $1.45

300 mg (per each): $0.20 - $2.64

600 mg (per each): $0.36 - $4.85

Tablets (Trileptal Oral)

150 mg (per each): $5.21

300 mg (per each): $9.52

600 mg (per each): $17.50

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Oral:

Trileptal: 60 mg/mL (250 mL) [contains alcohol, usp, methylparaben, polyethylene glycol (macrogol), propylene glycol, propylparaben, saccharin sodium]

Tablet, Oral:

Trileptal: 300 mg, 600 mg

Generic: 150 mg, 300 mg, 600 mg

Administration: Pediatric

Oral:

Immediate release: May be taken without regard to meals

Suspension: Prior to using for the first time, firmly insert the manufacturer supplied plastic adapter into the neck of the bottle; cover the adapter with child-resistant cap when not in use; shake suspension well (for at least 10 seconds) before use; use manufacturer supplied oral syringe to withdraw appropriate dose; dose may be administered directly from syringe or mixed in a small amount of water immediately prior to use; after use, rinse oral syringe with warm water and allow to dry thoroughly; discard any unused portion 7 weeks after first opening bottle

Extended release: Administer on an empty stomach at least 1 hour before or 2 hours after food. Swallow whole; do not cut, crush, or chew the tablets.

Administration: Adult

Oral:

Immediate release: Administer twice daily without regard to meals.

Suspension: Prior to using for the first time, firmly insert the plastic adapter provided with the bottle. Cover adapter with child-resistant cap when not in use. Shake bottle for at least 10 seconds, remove child-resistant cap, and insert the oral dosing syringe provided to withdraw appropriate dose. Dose may be taken directly from oral syringe or may be mixed in a small glass of water immediately prior to swallowing. Rinse syringe with warm water after use and allow to dry thoroughly. Discard any unused portion after 7 weeks of first opening bottle.

Extended release: Administer once daily on an empty stomach at least 1 hour before or 2 hours after food. Swallow whole; do not cut, crush, or chew the tablets.

Bariatric surgery: Oxcarbazepine is available as an ER formulation and the release characteristics may be significantly altered in an unknown manner in patients who have undergone bariatric surgery; providers should determine if the condition being treated can be safely monitored or if a switch to an alternative formulation is necessary (Ref). Oxcarbazepine is also available in an IR formulation. Oral suspensions may contain nonabsorbable sugars (eg, mannitol, sorbitol, xylitol) that can cause dumping syndrome after bariatric surgery; refer to manufacturer labeling and monitor for tolerability with use (Ref).

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 2]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Storage/Stability

Store tablets and suspension at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store suspension in the original container; use within 7 weeks of first opening container. Dispense extended release tablets in a tight, light-resistant container; protect from light and moisture.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Trileptal: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246799.pdf

Oxtellar XR: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202810s020lbl.pdf#page=24

Use

Oral:

Immediate release; suspension, tablet (Trileptal): Treatment of focal onset seizures (FDA approved as monotherapy in ages ≥4 years and adults; FDA approved as adjunctive therapy in ages ≥2 years and adults).

Extended release; tablet (Oxtellar XR): Adjunctive therapy for treatment of focal onset seizures (FDA approved in ages ≥6 years and adults).

Medication Safety Issues

Sound-alike/look-alike issues:

OXcarbazepine may be confused with carBAMazepine, oxaprozin, oxazepam

Trileptal may be confused with TriLipix

Older Adult: High-Risk Medication:

Beers Criteria: Oxcarbazepine is identified in the Beers Criteria as a potentially inappropriate medication to be used with caution in patients 65 years and older due to the potential to cause or exacerbate syndrome of inappropriate antidiuretic hormone secretion (SIADH) or hyponatremia; monitor sodium concentration closely when initiating or adjusting the dose in older adults (Beers Criteria [AGS 2023]).

Metabolism/Transport Effects

Substrate of CYP3A4 (Major with inducers), CYP3A4 (Minor with inhibitors); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Induces CYP3A4 (Weak);

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Alcohol (Ethyl): May increase CNS depressant effects of OXcarbazepine. Risk C: Monitor

Atazanavir: OXcarbazepine may decrease serum concentration of Atazanavir. Risk C: Monitor

Atogepant: CYP3A4 Inducers (Weak) may decrease serum concentration of Atogepant. Management: For treatment of episodic migraine, the recommended dose of atogepant is 30 mg once daily or 60 mg once daily when combined with CYP3A4 inducers. When used for treatment of chronic migraine, use of atogepant with CYP3A4 inducers should be avoided. Risk D: Consider Therapy Modification

Bictegravir: OXcarbazepine may decrease serum concentration of Bictegravir. Management: When possible consider using an alternative antiseizure drug with concurrent bictegravir, emtricitabine, and tenofovir alafenamide. If the combination must be used, monitor closely for evidence of reduced antiviral effectiveness. Risk D: Consider Therapy Modification

Cabotegravir: OXcarbazepine may decrease serum concentration of Cabotegravir. Risk X: Avoid

CarBAMazepine: CYP3A4 Inducers (Weak) may decrease serum concentration of CarBAMazepine. Risk C: Monitor

CloZAPine: CYP3A4 Inducers (Weak) may decrease serum concentration of CloZAPine. Risk C: Monitor

Cobicistat: OXcarbazepine may decrease serum concentration of Cobicistat. Management: Consider an alternative antiseizure medication when possible. Risk D: Consider Therapy Modification

CYP3A4 Inducers (Strong): May decrease serum concentration of OXcarbazepine. Specifically, the concentrations of the 10-monohydroxy active metabolite of oxcarbazepine may be decreased. Risk C: Monitor

Daclatasvir: OXcarbazepine may decrease serum concentration of Daclatasvir. Risk X: Avoid

Desmopressin: Hyponatremia-Associated Agents may increase hyponatremic effects of Desmopressin. Risk C: Monitor

Dolutegravir: OXcarbazepine may decrease serum concentration of Dolutegravir. Risk X: Avoid

Doravirine: OXcarbazepine may decrease serum concentration of Doravirine. Risk X: Avoid

Eslicarbazepine: May increase adverse/toxic effects of OXcarbazepine. Risk X: Avoid

Fosphenytoin-Phenytoin: May decrease active metabolite exposure of OXcarbazepine. Specifically, concentrations of the major active 10-monohydroxy metabolite may be reduced. OXcarbazepine may increase serum concentration of Fosphenytoin-Phenytoin. Risk C: Monitor

Hormonal Contraceptives: OXcarbazepine may decrease serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing oxcarbazepine to ensure contraceptive reliability. Risk D: Consider Therapy Modification

Lacosamide: Antiseizure Agents (Sodium Channel Blockers) may increase adverse/toxic effects of Lacosamide. Specifically the risk for bradycardia, ventricular tachyarrhythmias, or a prolonged PR interval may be increased. Risk C: Monitor

LamoTRIgine: Antiseizure Agents (Sodium Channel Blockers) may increase arrhythmogenic effects of LamoTRIgine. Management: Consider the risk of serious arrhythmias or death versus any expected benefit of lamotrigine in patients receiving concomitant sodium channel blockers. Risk D: Consider Therapy Modification

Ledipasvir: OXcarbazepine may decrease serum concentration of Ledipasvir. Risk X: Avoid

Lenacapavir: OXcarbazepine may decrease serum concentration of Lenacapavir. Risk X: Avoid

LevETIRAcetam: OXcarbazepine may decrease serum concentration of LevETIRAcetam. Risk C: Monitor

Mefloquine: May decrease therapeutic effects of Antiseizure Agents. Mefloquine may decrease serum concentration of Antiseizure Agents. Management: Mefloquine is contraindicated for malaria prophylaxis in persons with a history of seizures. If antiseizure drugs are being used for another indication, monitor antiseizure drug concentrations and treatment response closely with concurrent use. Risk D: Consider Therapy Modification

MetyraPONE: Coadministration of Antiseizure Agents and MetyraPONE may alter diagnostic results. Management: Consider alternatives to the use of the metyrapone test in patients taking antiseizure agents. Risk D: Consider Therapy Modification

Mianserin: May decrease therapeutic effects of Antiseizure Agents. Risk C: Monitor

NiMODipine: CYP3A4 Inducers (Weak) may decrease serum concentration of NiMODipine. Risk C: Monitor

Orlistat: May decrease serum concentration of Antiseizure Agents. Risk C: Monitor

Perampanel: May increase serum concentration of OXcarbazepine. OXcarbazepine may decrease serum concentration of Perampanel. Management: Increase the perampanel starting dose to 4 mg/day when perampanel is used with oxcarbazepine. Patients receiving this combination should be followed closely for response to perampanel and oxcarbazepine toxicities. Risk D: Consider Therapy Modification

Phenobarbital-Primidone: May decrease serum concentration of OXcarbazepine. Risk C: Monitor

Rilpivirine: OXcarbazepine may decrease serum concentration of Rilpivirine. Risk X: Avoid

Rivaroxaban: OXcarbazepine may decrease serum concentration of Rivaroxaban. Risk C: Monitor

Selpercatinib: CYP3A4 Inducers (Weak) may decrease serum concentration of Selpercatinib. Risk C: Monitor

Simeprevir: OXcarbazepine may decrease serum concentration of Simeprevir. Risk X: Avoid

Sirolimus (Conventional): CYP3A4 Inducers (Weak) may decrease serum concentration of Sirolimus (Conventional). Risk C: Monitor

Sirolimus (Protein Bound): CYP3A4 Inducers (Weak) may decrease serum concentration of Sirolimus (Protein Bound). Risk C: Monitor

Sofosbuvir: OXcarbazepine may decrease serum concentration of Sofosbuvir. Risk X: Avoid

Tacrolimus (Systemic): CYP3A4 Inducers (Weak) may decrease serum concentration of Tacrolimus (Systemic). Risk C: Monitor

Tenofovir Alafenamide: OXcarbazepine may decrease serum concentration of Tenofovir Alafenamide. Risk X: Avoid

Ubrogepant: CYP3A4 Inducers (Weak) may decrease serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 100 mg and second dose (if needed) of 100 mg when used with a weak CYP3A4 inducer. Risk D: Consider Therapy Modification

Ulipristal: OXcarbazepine may decrease serum concentration of Ulipristal. Risk X: Avoid

Valproic Acid and Derivatives: May decrease serum concentration of OXcarbazepine. Risk C: Monitor

Reproductive Considerations

Oxcarbazepine may decrease plasma concentrations of hormonal contraceptives. Contraceptive failure and unintended pregnancies may occur (Sarayani 2021). A barrier method of contraception is recommended in addition to the combination hormonal contraceptive when an enzyme-inducing antiseizure medication such as oxcarbazepine is used in patients who could become pregnant (ACOG 2020). Consult drug interactions database for more detailed information related to the use of oxcarbazepine and specific contraceptives.

Oxcarbazepine can be considered to treat people with epilepsy of childbearing potential (Pack 2024). Manage epilepsy in patients who could become pregnant based on a shared decision-making process that optimizes seizure control and considers the possibility of pregnancy during treatment (Pack 2024). Regularly discuss age-specific and developmental needs, including pregnancy planning and contraceptive options during the patient's reproductive lifespan (ACOG 2020; NICE 2022).

Evaluate pregnancy status and provide preconception counseling prior to initiating treatment in patients with bipolar disorder who could become pregnant (BAP [McAllister-Williams 2017]; CANMAT [Yatham 2018]). Patients effectively treated may continue their current medication when planning a pregnancy unless contraindications exist (ACOG 2023; BAP [McAllister-Williams 2017]); the lowest effective dose and avoidance of polytherapy is recommended (CANMAT [Yatham 2018]). Manage mental health conditions in patients who could become pregnant based on a shared decision-making process that considers the possibility of pregnancy during treatment and the risks of discontinuing therapy (ACOG 2023; BAP [McAllister-Williams 2017]; CANMAT [Yatham 2018]).

Obtain reference serum concentrations twice prior to pregnancy and test liver function while patient has stable seizure control and is on a minimal dose (Arfman 2020).

Pregnancy Considerations

Oxcarbazepine, the active 10-hydroxy metabolite (MHD) and the inactive metabolite 11-dihydroxy derivative (DHD), cross the placenta and can be detected in the newborn (Myllynen 2001; Schmidt 2023).

Oxcarbazepine monotherapy in pregnant patients with epilepsy is associated with lower risks of major congenital malformations compared to some other antiseizure medications (Pack 2024). According to the manufacturer, limited data collected from pregnancy registries suggest congenital malformations may be associated with oxcarbazepine monotherapy, including craniofacial defects (such as oral clefts) and cardiac malformations (such as ventricular septal defects). In case reports, symptoms similar to neonatal abstinence syndrome have been observed in newborns following in utero oxcarbazepine exposure (Chen 2017; Rolnitsky 2013). There is possibly no difference in the prevalence of autism spectrum disorder or the risk of autism spectrum disorder among children following in utero exposure to oxcarbazepine compared to those exposed to valproic acid. There is insufficient evidence on all IQ outcomes with exposure to oxcarbazepine (Pack 2024). Screen for major congenital malformations and monitor fetal growth when antiseizure medications are used during pregnancy. Conduct age-appropriate developmental screening in children who had in utero exposure to antiseizure medications (Pack 2024).

Due to pregnancy-induced physiologic changes (increased clearance and changes in hepatic metabolism), plasma concentrations of oxcarbazepine and the active metabolite, MHD, gradually decrease during pregnancy. Dose adjustments may be required beginning in the second trimester (He 2022; Pennell 2022; Schoretsanitis 2024; Voinescu 2018; Wei 2023). Monitor total serum trough concentrations every 4 weeks during pregnancy; consider monitoring liver function once each trimester (Arfman 2020). Adjust doses based on decreasing concentrations and seizure control (Pack 2024). Formulate a plan to return to prepregnancy doses after delivery (NICE 2022).

Epilepsy is associated with adverse maternal and fetal outcomes (Kuang 2024; Mazzone 2023). Convulsive seizures should be minimized to reduce risks to the fetus and pregnant patient. Use caution if removing or replacing an effective seizure medication in patients who become pregnant during therapy. Folic acid supplementation prior to and during pregnancy minimizes the risk of congenital malformations and poor neurodevelopment (Pack 2024).

Untreated bipolar disorder is associated with fetal growth restriction, preterm birth, adverse neurodevelopment, and may increase the risk of postpartum psychosis, worsening mood, and postpartum hospitalization. Discontinuing effective medications during pregnancy increases the risk of symptom relapse. Patients effectively treated for bipolar disorder prepregnancy may use the same medication during pregnancy unless contraindications exist. Management of mental health conditions should be made as part of a shared decision-making process. Treatment should not be withheld or discontinued based only on pregnancy status. When medications are used, the lowest effective dose of a single agent is recommended. Optimize dosing prior to changing a medication or adding additional agents whenever possible. Close monitoring for symptom improvement with a validated screening tool during pregnancy is recommended. Manage side effects as needed (ACOG 2023).

Data collection to monitor pregnancy outcomes following exposure to antiepileptic drugs is ongoing. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry (888-233-2334 or www.aedpregnancyregistry.org).

Monitoring Parameters

Seizure frequency, duration and severity; symptoms of CNS depression (dizziness, headache, somnolence); CBC, serum sodium (particularly during first three months of therapy) especially in patients who receive other drugs that may cause hyponatremia and in patients with symptoms of hyponatremia; hypersensitivity reactions; periodic thyroid function tests (particularly pediatric patients); monitor for suicidality (eg, suicidal thoughts, depression, behavioral changes). Serum levels of concomitant antiseizure drugs during titration as necessary.

Reference Range

The metabolite of oxcarbazepine, 10-monohydroxy metabolite (10-hydroxycarbazepine [MHD]), is considered the active entity primarily responsible for the therapeutic effects. A high degree of variability has been observed and within the pediatric population, the influence of pharmacokinetic differences in younger pediatric patients (faster MHD clearance) on therapeutic range has been reported (Chen 2021; Wu 2024). Use of MHD monitoring should be considered for individualized therapeutic drug monitoring programs. Therapeutic drug monitoring of MHD may be beneficial in optimizing seizure control in the following situations: extremes of age; investigation of a possible correlation between drug concentrations and toxicity, especially with concurrent disease states such as renal impairment, acute, or suspected change in pharmacokinetic profile; to identify potential drug interactions; upon initiation, discontinuation, or modification of a drug shown to have significant interaction; to assess reasons for therapeutic failure; or to rule out nonadherence (Bring 2008; Chen 2021; Krasowski 2010; Lim 2023; May 2003; Patsalos 2018; Sattler 2015).

MHD: 3 to 35 mg/L (12 to 139 micromole/L) (Patsalos 2018).

Mechanism of Action

Pharmacological activity results from both oxcarbazepine and its monohydroxy metabolite (MHD). Precise mechanism of antiseizure effect has not been defined. Oxcarbazepine and MHD block voltage-sensitive sodium channels, stabilizing hyperexcited neuronal membranes, inhibiting repetitive firing, and decreasing the propagation of synaptic impulses. These actions are believed to prevent the spread of seizures. Oxcarbazepine and MHD also increase potassium conductance and modulate the activity of high-voltage activated calcium channels.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Complete.

Distribution: Oxcarbazepine: Infants: Median: 1.38 L/kg; Children (10 years, 30 kg): Median: 0.78 L/kg; Adults (40 years, 70 kg): Median: 0.45 L/kg; MHD: V_d: 49 L (Chen 2021; manufacturer's labeling).

Protein binding: Oxcarbazepine: 67%; MHD: 40%, primarily to albumin; parent drug and metabolite do not bind to alpha-1 acid glycoprotein.

Metabolism: Oxcarbazepine is extensively metabolized in the liver to its active 10-monohydroxy metabolite (MHD); MHD undergoes further metabolism via glucuronide conjugation; 4% of dose is oxidized to the 10,11-dihydroxy metabolite (DHD) (inactive); 70% of serum concentration appears as MHD, 2% as unchanged oxcarbazepine, and the rest as minor metabolites; Note: Unlike carbamazepine, autoinduction of metabolism has not been observed and biotransformation of oxcarbazepine does not result in an epoxide metabolite.

Bioavailability: Immediate release tablets and suspension have similar bioavailability (based on MDH serum concentrations). Extended release tablets and immediate release products are not bioequivalent. Immediate release: Decreased in children <8 years; increased in elderly >60 years.

Half-life elimination:

Children: 2 to 5 years: MHD: Single dose: Mean range: 4.8 to 6.7 hours; 6 to 12 years: MHD: Single dose: Mean range: 7.2 to 9.3 hours (Rey 2004).

Adults: Immediate release: Parent drug: 2 hours; MHD: 9 hours; renal impairment (CrCl 30 mL/minute): MHD: 19 hours; Extended release: Parent drug: 7 to 11 hours; MHD: 9 to 11 hours.

Time to peak, serum:

Children 2 to 12 years: Immediate release: Oxcarbazepine: 1 hour; MHD: 3 to 4 hours (Rey 2004).

Adults: Immediate release: MHD: Tablets: Median: 4.5 hours (range: 3 to 13 hours); Suspension: Median 6 hours; Extended release: MHD: 7 hours.

Excretion: Urine (95%, <1% as unchanged oxcarbazepine, 27% as unchanged MHD, 49% as MHD glucuronides, 3% as DHD (inactive), and 13% as conjugate of oxcarbazepine and MHD); feces (<4%).

Clearance (per body weight):

Infants (1 year, 10 kg): Median: 0.078 L/hour/kg (Chen 2021).

Children 2 to <4 years: Increased by ∼80% compared to adults.

Children 4 to 12 years: Increased by ∼40% compared to adults; Children (10 years, 30 kg): 0.058 L/hour/kg (Chen 2021).

Children ≥13 years: Values approach adult clearance.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: If CrCl <30 mL/minute, elimination half-life of MHD is prolonged to 19 hours and there is a 2-fold increase in AUC.

Older adult: Max plasma concentration and AUC values of MHD were 30% to 60% higher.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Trileptal;
(AR) Argentina: Atoxecar | Aurene | Oxcarba | Oxcarbazepina | Oxcarbazepina dosa | Rupox | Trileptal;
(AT) Austria: Oxcarbazepin Arcana | Trileptal;
(AU) Australia: Trileptal;
(BD) Bangladesh: Leptal | Oxazep | Trileptal;
(BE) Belgium: Trileptal;
(BG) Bulgaria: Tevaleptin | Trileptal;
(BR) Brazil: Auram | Oleptal | Oxcarb | Oxcarbazepina | Trileptal | Zyoxipina;
(CH) Switzerland: Apydan | Trileptal;
(CL) Chile: Alox | Coxepta | Oxicodal | Trileptal;
(CN) China: Mo yi | Ren ao | Trileptal | Wan Yi;
(CO) Colombia: Kallion xr | Lonazet | Nitris | Oxcar | Oxcarbazepina | Oxicodal | Oxycarbamazepina | Oxycarbazepina | Trileptal;
(CZ) Czech Republic: Trileptal;
(DE) Germany: Apydan | Desidox extent | Oxcarbazepin | Oxcarbazepin 1a pharma | Oxcarbazepin CT | Oxcarbazepin Hexal | Oxcarbazepin neuraxpharm | Oxcarbazepin Ratiopharm | Oxcarbazepin Stada | Oxcarbazepin Teva | Timox | Trileptal;
(DO) Dominican Republic: Actinium | Oxicodal | Trileptal | Zenoxa;
(EC) Ecuador: Deprectal | Oxcarbazepina | Oxcarpin | Oxetol | Oxicodal | Trileptal;
(EE) Estonia: Apydan | Oxcarbazepine Teva | Trileptal;
(EG) Egypt: Andoxezine | Oxaleptal | Oxatrilepazine | Oxigrex | Shorsalin | Trileptal;
(ES) Spain: Epilexter | Oxcarbazepina cinfa | Oxcarbazepina normon | Oxcarbazepina pensa | Oxcarbazepina Tecnigen | Oxcarbazepina Teva | Oxcarmylan | Trileptal;
(FI) Finland: Apydan | Apydan desitin | Oxcarbazepin orion | Oxcarbazepine stada | Trileptal;
(FR) France: Oxcarbazepine Mylan | Oxcarbazepine Sandoz | Oxcarbazepine Teva | Trileptal;
(GB) United Kingdom: Trileptal;
(GR) Greece: Oxcarbazepine Generics | Oxcarbazepine/Generics | Trileptal;
(HK) Hong Kong: Trileptal;
(HR) Croatia: Oxalept | Trileptal;
(HU) Hungary: Apydan | Trileptal;
(ID) Indonesia: Trileptal;
(IE) Ireland: Trileptal;
(IL) Israel: Trexapin | Trileptin;
(IN) India: Auxigin | Carbanerve | Carbox | Eoptal | Epigold xr | Epizox od | Epocarb | Euresta | Fobigone ox | Lovax | Mezalog | Nictal | Olepsy | Oleptal | Ox-mazetol | Oxahet | Oxalepsy | Oxana | Oxapine | Oxcarb | Oxcazo | Oxcee | Oxene | Oxep | Oxepin | Oxepin sr | Oxeptal | Oxetol | Oxicar | Oxileptin | Oxmazetol | Oxrate | Oxring | Oxyrise od | Psycarb | Seizurone OX | Selzic | Trioptal | Vinlep | Zenoxa;
(IT) Italy: Oxcarbazepina MG | Oxcarbazepina Tecnigen | Tolep | Zigabal;
(JO) Jordan: Oxcarbatol | Trileptal;
(KE) Kenya: Trileptal;
(KR) Korea, Republic of: Oxazepine | Oxpin | Trileptal | Triptal | Unilepsy;
(KW) Kuwait: Trileptal;
(LB) Lebanon: Trileptal;
(LT) Lithuania: Oxcarbazepine Teva | Trileptal;
(LU) Luxembourg: Trileptal;
(LV) Latvia: Oxcarbazepine Teva | Trileptal;
(MA) Morocco: Trileptal;
(MX) Mexico: Actinium | Deprectal | Deprectal S | Kallion xr | Mhide | Obepanac | Oxcarbazepina | Oxetol | Sinfonil | Trileptal | Zetoxen;
(MY) Malaysia: Trileptal;
(NL) Netherlands: Oxcarbazepine Jubilant | Oxcarbazepine Sandoz | Trileptal;
(NO) Norway: Apydan extent | Timox | Trileptal;
(NZ) New Zealand: Trileptal;
(PA) Panama: Trileptal;
(PE) Peru: Deprectal | Lakproplus | Oxetol | Oxicodal | Oxolon | Selzic | Trileptal;
(PH) Philippines: Carbox | Kusapin | Oleptal | Trileptal;
(PK) Pakistan: Oxalepsy | Oxaze | Oxcarb | Oxicarb | Telox;
(PL) Poland: Apydan | Karbostad | Oxcarbazepin NeuroPharma | Oxepilax | Trileptal;
(PR) Puerto Rico: Oxtellar xr | Trileptal;
(PT) Portugal: Epilfarmo | Proaxen | Zigabal;
(PY) Paraguay: Fluxaten | Oxantakal | Oxcarbazepina dallas | Oxcarbazepina dosa | Oxcarbazepina heisecke | Oxicodal | Oxidan | Quimiun | Trileptal;
(QA) Qatar: Trileptal;
(RU) Russian Federation: Oxcarbazepine native | Trileptal;
(SA) Saudi Arabia: Carpazio | Trileptal;
(SE) Sweden: Oxcarbazepin mylan | Oxcarbazepine stada | Trileptal;
(SG) Singapore: Trileptal;
(SI) Slovenia: Karbox | Okskarbazepin Stada | Trileptal;
(SK) Slovakia: Trileptal;
(TH) Thailand: Trileptal;
(TR) Turkey: Apilep | Epsile | Oxcarpin | Trileptal;
(TW) Taiwan: Trileptal;
(UA) Ukraine: Oxapin;
(UG) Uganda: Oxeptal | Trileptal;
(UY) Uruguay: Oxcarbazepina | Oxolon | Trileptal;
(VE) Venezuela, Bolivarian Republic of: Oxcarbazepina | Oxicodal | Trileptal;
(VN) Viet Nam: Carbamaz;
(ZA) South Africa: Mylan oxcarbazepine | Trileptal

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Oxcarbazepine: Pediatric drug information