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OXcarbazepine

Pronunciation

Pronunciation

(ox car BAZ e peen)

Index Terms

  • GP 47680
  • OCBZ

Dosage Forms

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 (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

Brand Names: U.S.

  • Oxtellar XR
  • Trileptal

Pharmacologic Category

  • Anticonvulsant, Miscellaneous

Pharmacology

Pharmacological activity results from both oxcarbazepine and its monohydroxy metabolite (MHD). Precise mechanism of anticonvulsant 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.

Absorption

Complete

Distribution

MHD: Vd: 49 L

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

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):

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

Children 4 to 12 years: Increased by ∼40% compared to adults

Children ≥13 years: Values approach adult clearance

Time to Peak

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

Half-Life Elimination

Children (Rey, 2004): 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

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

Protein Binding

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

Special Populations: Renal Function Impairment

If CrCl <30 mL/minute, elimination half-life of MHD is prolonged to 19 hours and there is a twofold increase in AUC.

Special Populations: Elderly

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

Use: Labeled Indications

Partial seizures:

Immediate-release:

U.S labeling: Monotherapy or adjunctive therapy in the treatment of partial seizures in adults, as monotherapy in the treatment of partial seizures in children 4 years and older with epilepsy, and as adjunctive therapy in children 2 years and older with partial seizures.

Canadian labeling: Monotherapy or adjunctive therapy in the treatment of partial seizures in patients 6 years and older.

Extended-release: Adjunctive therapy in the treatment of partial seizures in adults and in children 6 to 17 years of age.

Use: Unlabeled

Bipolar disorder; treatment of neuropathic pain

Contraindications

Hypersensitivity to oxcarbazepine or any component of the formulation

Dosing: Adult

Adjunctive therapy, partial seizures (epilepsy): Oral:

Immediate release (Trileptal): Initial: 600 mg daily in 2 divided doses; dose may be increased by as much as 600 mg/day increments at weekly intervals; recommended daily dose: 1200 mg daily in 2 divided doses. Although daily doses >1200 mg daily were somewhat more efficacious, most patients were unable to tolerate 2400 mg daily (due to CNS effects).

Extended release (Oxtellar XR): Initial: 600 mg once daily; dosage may be increased by 600 mg/day increments at weekly intervals. Recommended daily dose is 1200 to 2400 mg once daily. Although daily doses >1200 mg daily were somewhat more efficacious, most patients were unable to tolerate 2400 mg daily (due to CNS effects).

Conversion to monotherapy, partial seizures (epilepsy): Patients receiving concomitant antiepileptic drugs (AEDs): Oral: Immediate release (Trileptal): Initial: 600 mg daily in 2 divided doses while simultaneously reducing the dose of concomitant AEDs. Withdraw concomitant AEDs completely over 3 to 6 weeks, while increasing the oxcarbazepine dose in increments of 600 mg daily at weekly intervals, reaching the maximum oxcarbazepine dose (2400 mg daily) in about 2 to 4 weeks (lower doses have been effective in patients in whom monotherapy has been initiated).

Initiation of monotherapy, partial seizures (epilepsy): Patients not receiving prior AEDs: Oral: Immediate release (Trileptal): Initial: 600 mg daily in 2 divided doses. Increase dose by 300 mg daily every third day to a dose of 1200 mg daily. Higher dosages (2400 mg daily) have been shown to be effective in patients converted to monotherapy from other AEDs.

Conversion from immediate release (Trileptal) to extended release (Oxtellar XR): Higher doses of Oxtellar XR may be necessary.

Dosage adjustment with concomitant antiepileptic drugs (AEDs): Concomitant use with enzyme-inducing antiepileptic drugs (eg, carbamazepine, phenobarbital, phenytoin): Extended release (Oxtellar XR): Consider initiating dose at 900 mg once daily.

Neuropathic pain (off-label use): Oral: Initial: 300 mg/day; increase dose after 3 days to 300 mg twice daily, then adjust dose based on response and tolerability in increments of 300 mg every 5 days up to a maximum dose of 900 mg twice daily. Mean dose during clinical trial maintenance period was 1,445 mg/day (Dogra 2005).

Dosing: Geriatric

Immediate release (Trileptal): Refer to adult dosing.

Extended release (Oxtellar XR): Initial: 300 mg or 450 mg once daily should be considered; dosage may be increased by 300 to 450 mg daily increments at weekly intervals to desired clinical response.

Dosing: Pediatric

Adjunctive treatment, partial seizures (epilepsy): Oral:

Children 2 to 3 years (U.S. labeling): Immediate release (Trileptal):

Initial: 8 to 10 mg/kg/day, not to exceed 600 mg daily, given in 2 divided daily doses

Maintenance: The target maintenance dose should be achieved over 2 to 4 weeks, and is dependent upon patient weight (should not exceed 60 mg/kg/day given in 2 divided daily doses).

<20 kg: Consider initiating dose at 16 to 20 mg/kg/day; maximum maintenance dose should be achieved over 2 to 4 weeks and should not exceed 60 mg/kg/day

Children 4 to 16 years (U.S. labeling) or 6 to 16 years (Canadian labeling): Immediate release (Trileptal):

Initial: 8 to 10 mg/kg/day, not to exceed 600 mg daily, given in 2 divided daily doses

Maintenance: The target maintenance dose should be achieved over 2 weeks, and is dependent upon patient weight, according to the following:

20 to 29 kg: 900 mg daily in 2 divided doses

29.1 to 39 kg: 1200 mg daily in 2 divided doses

>39 kg: 1800 mg daily in 2 divided doses

Children 6 to 17 years: Extended release (Oxtellar XR):

Initial: 8 to 10 mg/kg once daily (not to exceed 600 mg daily in the first week)

Maintenance: The target maintenance dose should be achieved over 2 to 3 weeks with dose increases of 8 to 10 mg/kg/day increments at weekly intervals (maximum dosage incremental increase: 600 mg). Target maintenance dose depends on weight:

20 to 29 kg: 900 mg once daily

29.1 to 39 kg: 1200 mg once daily

>39 kg: 1800 mg once daily

Conversion to monotherapy, partial seizures (epilepsy): Patients receiving concomitant antiepileptic drugs (AEDs): Children 4 to 16 years (U.S. labeling) or 6 to 16 years (Canadian labeling): Oral: Immediate release (Trileptal): Initial: 8 to 10 mg/kg/day in twice daily divided doses, while simultaneously initiating the dose reduction of concomitant antiepileptic drugs; the concomitant drugs should be withdrawn over 3 to 6 weeks. Oxcarbazepine dose may be increased by a maximum of 10 mg/kg/day at weekly intervals. See below for recommended total daily dose by weight.

Initiation of monotherapy, partial seizures (epilepsy): Patients not receiving prior AEDs: Children 4 to 16 years (U.S. labeling) or 6 to 16 years (Canadian labeling): Oral: Immediate release (Trileptal): Initial: 8 to 10 mg/kg/day in twice daily divided doses; doses may be titrated by 5 mg/kg/day every third day. See below for recommended total daily dose by weight.

Range of maintenance doses by weight during monotherapy:

20 kg: 600 to 900 mg daily

25 to 30 kg: 900 to 1200 mg daily

35 to 40 kg: 900 to 1500 mg daily

45 kg: 1200 to 1500 mg daily

50 to 55 kg: 1200 to 1800 mg daily

60 to 65 kg: 1200 to 2100 mg daily

70 kg: 1500 to 2100 mg daily

Conversion from immediate release (Trileptal) to extended release (Oxtellar XR): Children ≥6 years and Adolescents: Refer to adult dosing.

Dosage adjustment with concomitant antiepileptic drugs (AEDs): Children ≥6 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

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

Severe impairment (CrCl <30 mL/minute): Immediate release (Trileptal), Extended release (Oxtellar XR): Therapy should be initiated at one-half the usual starting dose (300 mg daily in adults) 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: Hepatic Impairment

Mild-to-moderate impairment: No dosage adjustments necessary.

Severe impairment:

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

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

Administration

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.

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Storage

Store tablets and suspension at 25°C (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.

Drug Interactions

Alcohol (Ethyl): May enhance the CNS depressant effect of OXcarbazepine. Monitor therapy

ARIPiprazole: CYP3A4 Inducers may decrease the serum concentration of ARIPiprazole. Management: Double the oral aripiprazole dose and closely monitor response. Reduce oral aripiprazole dose to 10-15 mg/day (for adults) if the inducer is discontinued. Avoid use of CYP3A4 inducers for more than 14 days with extended-release injectable aripiprazole. Consider therapy modification

CarBAMazepine: May decrease serum concentrations of the active metabolite(s) of OXcarbazepine. Specifically, concentrations of the major active 10-monohydroxy metabolite may be reduced. Management: Consider increasing the initial adult oxcarbazepine extended release tablet (Oxtellar XR) dose to 900 mg/day. No specific recommendations are available for other oxcarbazepine formulations. Consider therapy modification

Cobicistat: OXcarbazepine may decrease the serum concentration of Cobicistat. Management: Consider an alternative antiepileptic when possible. Consider therapy modification

Contraceptives (Estrogens): OXcarbazepine may decrease the serum concentration of Contraceptives (Estrogens). Contraceptive failure is possible. Management: Use of an alternative, nonhormonal contraceptive is recommended. Consider therapy modification

Contraceptives (Progestins): OXcarbazepine may decrease the serum concentration of Contraceptives (Progestins). Management: Contraceptive failure is possible. Use of an additional or alternative, nonhormonal method of contraception is recommended. Consider therapy modification

Dolutegravir: OXcarbazepine may decrease the serum concentration of Dolutegravir. Avoid combination

Elvitegravir: OXcarbazepine may decrease the serum concentration of Elvitegravir. Management: For elvitegravir plus a ritonavir-boosted protease inhibitor, use of oxcarbazepine is not recommended; for elvitegravir/cobicistat/emtricitabine/tenofovir combination products, consider using an alternative antiepileptic when possible. Avoid combination

Eslicarbazepine: May enhance the adverse/toxic effect of OXcarbazepine. Avoid combination

Fosphenytoin-Phenytoin: May decrease serum concentrations of the active metabolite(s) of OXcarbazepine. Specifically, concentrations of the major active 10-monohydroxy metabolite may be reduced. OXcarbazepine may increase the serum concentration of Fosphenytoin-Phenytoin. Management: Consider increasing the initial adult oxcarbazepine extended release tablet (Oxtellar XR) dose to 900 mg/day. No specific recommendations are available for other oxcarbazepine formulations. Consider therapy modification

HYDROcodone: CYP3A4 Inducers (Weak) may decrease the serum concentration of HYDROcodone. Monitor therapy

Ledipasvir: OXcarbazepine may decrease the serum concentration of Ledipasvir. Avoid combination

Mefloquine: May diminish the therapeutic effect of Anticonvulsants. Mefloquine may decrease the serum concentration of Anticonvulsants. Management: Mefloquine is contraindicated for malaria prophylaxis in persons with a history of convulsions. Monitor anticonvulsant concentrations and treatment response closely with concurrent use. Consider therapy modification

Mianserin: May diminish the therapeutic effect of Anticonvulsants. Monitor therapy

NiMODipine: CYP3A4 Inducers (Weak) may decrease the serum concentration of NiMODipine. Monitor therapy

Orlistat: May decrease the serum concentration of Anticonvulsants. Monitor therapy

Perampanel: May increase the serum concentration of OXcarbazepine. OXcarbazepine may decrease the 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, especially with any changes to oxcarbazepine therapy. Consider therapy modification

PHENobarbital: May decrease serum concentrations of the active metabolite(s) of OXcarbazepine. Specifically, concentrations of the major active 10-monohydroxy metabolite may be reduced. OXcarbazepine may increase the serum concentration of PHENobarbital. Management: Consider increasing the initial adult oxcarbazepine extended release tablet (Oxtellar XR) dose to 900 mg/day. No specific recommendations are available for other oxcarbazepine formulations. Consider therapy modification

RifAMPin: May decrease serum concentrations of the active metabolite(s) of OXcarbazepine. Specifically, concentrations of the major active 10-monohydroxy metabolite may be reduced. Monitor therapy

Rilpivirine: OXcarbazepine may decrease the serum concentration of Rilpivirine. Avoid combination

SAXagliptin: CYP3A4 Inducers may decrease the serum concentration of SAXagliptin. Monitor therapy

Selegiline: OXcarbazepine may enhance the serotonergic effect of Selegiline. Avoid combination

Simeprevir: OXcarbazepine may decrease the serum concentration of Simeprevir. Avoid combination

Sofosbuvir: OXcarbazepine may decrease the serum concentration of Sofosbuvir. Avoid combination

Tenofovir Alafenamide: OXcarbazepine may decrease the serum concentration of Tenofovir Alafenamide. Avoid combination

Thiazide and Thiazide-Like Diuretics: May enhance the adverse/toxic effect of OXcarbazepine. Specifically, there may be an increased risk for hyponatremia. Monitor therapy

Ulipristal: OXcarbazepine may decrease the serum concentration of Ulipristal. Avoid combination

Valproate Products: May decrease the serum concentration of OXcarbazepine. Monitor therapy

Test Interactions

Thyroid function tests; may depress serum T4 without affecting T3 levels or TSH

Adverse Reactions

Frequency not always defined. Incidence in children was similar.

>10%:

Central nervous system: Dizziness (20% to 49%), drowsiness (12% to 36%), headache (8% to 32%), ataxia (2% to 31%), abnormal gait (≤17%), fatigue (3% to 15%), vertigo (2% to 15%)

Gastrointestinal: Vomiting (7% to 36%), nausea (15% to 29%), abdominal pain (10% to 13%)

Neuromuscular & skeletal: Tremor (4% to 16%)

Ophthalmic: Diplopia (10% to 40%), nystagmus (3% to 26%), visual disturbance (1% to 14%)

1% to 10%:

Cardiovascular: Lower extremity edema (2%), hypotension (≤2%), bradycardia, cardiac failure, flushing, hypertension, orthostatic hypotension, palpitations, syncope, tachycardia

Central nervous system: Equilibrium disturbance (7%), nervousness (2% to 5%), amnesia (4%), emotional lability (4%), falling (4%), abnormality in thinking (≤4%), insomnia (2% to 4%), dysmetria (1% to 3%), speech disorder (1% to 3%), agitation (2%), confusion (2%), convulsions (2%), lack of concentration (2%), abnormal electroencephalogram (≤2%), feeling abnormal (≤2%), myasthenia (1% to 2%), aggressive behavior, anxiety, apathy, aphasia, aura, cerebral hemorrhage, delirium, delusion, depression, dystonia, euphoria extrapyramidal reaction, hemiplegia, hyperkinesia, hyperreflexia, hypertonia, hypokinesia, hyporeflexia, hypotonia, hysteria, impaired consciousness, intoxicated feeling, malaise, manic behavior, migraine, neuralgia, nightmares, oculogyric crisis, panic disorder, paralysis, personality disorder, precordial pain, psychosis, rigors, seizure (aggravated), stupor, voice disorder

Dermatologic: Skin rash (4%), diaphoresis (3%), acne vulgaris (1% to 2%), alopecia, contact dermatitis, eczema, erythematosus rash, facial rash, folliculitis, genital pruritus, maculopapular rash, miliaria, psoriasis, skin photosensitivity, urticaria, vitiligo

Endocrine & metabolic: Decreased serum sodium (<135 mEq/L: 7% to 9%), hyponatremia (1% to 3%), weight gain (2%), change in libido, hot flash, hyperglycemia, hypermenorrhea, hypocalcemia, hypoglycemia, hypokalemia, increased gamma-glutamyl transferase, intermenstrual bleeding, weight loss

Gastrointestinal: Diarrhea (7%), dyspepsia (≤6%), constipation (4% to 6%), dysgeusia (5%), xerostomia (3%), gastritis (≤3%), upper abdominal pain (≤3%), aphthous stomatitis, biliary colic, bloody stools, cholelithiasis, colitis, duodenal ulcer, dysphagia, enteritis, eructation, esophagitis, flatulence, gastric ulcer, gingival hemorrhage, gingival hyperplasia, hematemesis, hemorrhoids, hiccups, increased appetite, retching, sialadenitis, stomatitis

Genitourinary: Urinary frequency (2%), dysuria, hematuria, leukorrhea, priapism, urinary tract pain

Hematologic & oncologic: Bruise (2%), purpura, rectal hemorrhage, thrombocytopenia

Hepatic: Increased liver enzymes

Hypersensitivity: Hypersensitivity reaction (2%), angioedema

Neuromuscular & skeletal: Weakness (2% to 7%), back pain (4%), muscle spasm (2%), sprain (≤2%), right hypochondrium pain, systemic lupus erythematosus, tetany

Ophthalmic: Blurred vision (4%), accommodation disturbance (≤2%), blepharoptosis, cataract, conjunctival hemorrhage, hemianopia, mydriasis, ocular edema, photophobia, scotoma, xerophthalmia

Otic: Otitis externa, tinnitus

Renal: Nephrolithiasis, polyuria, renal pain

Respiratory: Rhinitis (5% to 10%), upper respiratory tract infection (7%), pulmonary infection (4%), epistaxis (4%), sinusitis (≤4%), nasopharyngitis (≤3%), pneumonia (2%), asthma, dyspnea, laryngismus, pleurisy

Miscellaneous: Fever (3%)

Postmarketing and/or case reports (Limited to important or life-threatening): Abnormal thyroid function test (decreased total T4 and/or free T4), acute generalized exanthematous pustulosis, agranulocytosis, anaphylaxis, aplastic anemia, bone fracture (long-term therapy), decreased bone mineral density (long-term therapy), DRESS syndrome, erythema multiforme, folate deficiency, hepatic failure, hepatitis (Hsu, 2010), hypersensitivity reaction, hypothyroidism, increased serum amylase, increased serum lipase, leukopenia, multiorgan hypersensitivity (eosinophilia, arthralgia, rash, fever, lymphadenopathy), osteopenia (long-term therapy), osteoporosis (long-term therapy), pancreatitis, pancytopenia, Stevens-Johnson syndrome, suicidal ideation, suicidal tendencies, toxic epidermal necrolysis

Warnings/Precautions

Concerns related to adverse effects:

• Blood dyscrasias: Agranulocytosis, leukopenia, and pancytopenia have been reported with use (rare); discontinuation and conversion to alternate therapy may be required.

• Bone disorders: Long term use has been associated with decreased bone mineral density, osteopenia, osteoporosis, and fractures.

• CNS effects: Use has been associated with CNS-related adverse events, most significant of these were cognitive symptoms including psychomotor slowing, difficulty with concentration, and speech or language problems, somnolence or fatigue, and coordination abnormalities, including ataxia and gait disturbances. Caution patients about performing tasks which require mental alertness (eg, operating machinery or driving).

• Dermatologic reactions: Potentially serious, sometimes fatal, dermatologic reactions (eg, Stevens-Johnson, toxic epidermal necrolysis) have been reported in adults and children; reactions most commonly occurred 19 days after treatment initiation. Monitor for signs and symptoms of skin reactions; discontinuation and conversion to alternate therapy may be required.

• Hepatic dysfunction: Hepatitis and hepatic failure have been reported rarely (Hsu 2010; Trileptal Canadian product monograph 2013). Promptly evaluate any symptoms of hepatic dysfunction (eg, anorexia, nausea/vomiting, right upper quadrant pain, pruritus) and discontinue therapy immediately if significant abnormalities are confirmed.

• Hypersensitivity reactions: Rare cases of anaphylaxis and angioedema have been reported, even after initial dosing; permanently discontinue should symptoms occur. Use caution in patients with previous hypersensitivity to carbamazepine (cross-sensitivity occurs in 25% to 30% of patients). Potentially serious, sometimes fatal drug reaction with eosinophilia and systemic symptoms (DRESS) also known as multiorgan hypersensitivity reactions have also been reported in close association with initiation of oxcarbazepine; monitor for signs and symptoms of possible disparate manifestations associated with lymphatic, hepatic, renal, cardiovascular, and/or hematologic organ systems; discontinuation and conversion to alternate therapy may be required.

• Hyponatremia: Clinically-significant hyponatremia (serum sodium <125 mmol/L) may develop during use; consider monitoring serum sodium (particularly during the first 3 months of therapy) especially in patients at risk for hyponatremia.

• Hypothyroidism: Hypothyroidism has been reported; consider monitoring thyroid function, particularly in pediatric patients. Discontinuation of therapy has been associated with return of normal thyroxine levels.

• Suicidal ideation: Pooled analysis of trials involving various antiepileptics (regardless of indication) showed an increased risk of suicidal thoughts/behavior (incidence rate: 0.43% treated patients compared to 0.24% of patients receiving placebo); risk observed as early as 1 week after initiation and continued through duration of trials (most trials ≤24 weeks). Monitor all patients for notable changes in behavior that might indicate suicidal thoughts or depression; patients should be instructed to notify healthcare provider immediately if symptoms occur.

Disease-related concerns:

• Cardiovascular disease: Clinical trials excluded patients with significant cardiovascular disease or ECG abnormalities; Canadian labeling recommends using caution with cardiac conduction abnormalities or concomitant drugs that depress atrioventricular (AV) conduction and to avoid use in patients with AV block (Trileptal Canadian product monograph 2013). 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.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Asian ancestry: Consider screening patients of Asian descent for the variant human leukocyte antigen (HLA) allele B*1502 prior to initiating therapy. This genetic variant has been associated with a significantly increased risk of developing Stevens-Johnson syndrome and/or toxic epidermal necrolysis in patients receiving carbamazepine. Structural similarity of oxcarbazepine to carbamazepine, available clinical evidence, and data from nonclinical studies showing a direct interaction of oxcarbazepine with the HLA-B*1502 protein suggest patients receiving oxcarbazepine may also be at a similar risk. Consider avoiding use of oxcarbazepine in patients with a positive result. Screening is not recommending in low-risk populations or in current oxcarbazepine patients (risk usually during first few months of therapy).

Special handling:

• Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Dosage forms specific issues:

• Oral suspension: Contains sorbitol; Canadian labeling recommends avoiding use in patients with fructose intolerance.

Other warnings/precautions:

• Withdrawal: Anticonvulsants 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.

Monitoring Parameters

Seizure frequency; serum sodium as deemed necessary (particularly during first 3 months of therapy); symptoms of CNS depression (dizziness, headache, somnolence); hypersensitivity reactions. Additional serum sodium monitoring recommended during maintenance treatment in patients receiving other medications known to decrease sodium levels, in patients with signs/symptoms of hyponatremia, and in patients with an increase in seizure frequency or severity. Periodic thyroid function tests (particularly pediatric patients) and CBC. Monitor for suicidality (eg, suicidal thoughts, depression, behavioral changes). Serum levels of concomitant antiepileptic drugs during titration as necessary.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies; therefore, the manufacturer classifies oxcarbazepine as pregnancy category C. Oxcarbazepine, the active metabolite MHD and the inactive metabolite DHD, crosses the placenta and can be detected in the newborn. An increased risk in the overall rate of major congenital malformations has not been observed following maternal use of oxcarbazepine. Available studies have not been large enough to determine if there is an increased risk of specific defects. In general, the risk of teratogenic effects is higher with AED polytherapy than monotherapy. Plasma concentrations of MHD gradually decrease due to physiologic changes which occur during pregnancy; patients should be monitored during pregnancy and postpartum. Oxcarbazepine may decrease plasma concentrations of hormonal contraceptives.

Patients exposed to oxcarbazepine during pregnancy are encouraged to enroll themselves into the NAAED Pregnancy Registry by calling 1-888-233-2334. Additional information is available at www.aedpregnancyregistry.org.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, nausea, vomiting, abdominal pain, dizziness, fatigue, tremors, insomnia, change in taste, diarrhea, or constipation. Have patient report immediately to prescriber signs of infection, signs of depression (suicidal ideation, anxiety, emotional instability, or illogical thinking), signs of low sodium (headache, trouble focusing, memory problems, illogical thinking, weakness, seizures, or change in balance), signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), signs of kidney problems (urinary retention, blood in urine, change in amount of urine passed, or weight gain), shortness of breath, excessive weight gain, swelling of arms or legs, enlarged lymph nodes, severe muscle pain, severe muscle weakness, severe joint pain, severe joint edema, confusion, difficulty focusing, vision changes, angina, severe loss of strength and energy, seizures, bruising, bleeding, involuntary eye movements, memory impairment, abnormal gait, change in balance agitation, irritability, panic attacks, or mood changes, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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