oxcarbazepine (Rx)Brand and Other Names:Trileptal, Oxtellar XR

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 150mg
  • 300mg
  • 600mg

tablet, extended-release

  • 150mg
  • 300mg
  • 600mg

oral suspension

  • 300mg/5mL
more...

Partial Seizures

Adjunctive treatment

  • Trileptal: 300 mg PO q12hr initially; may increase at weekly intervals by 600 mg/day up to 1200 mg/day
  • Oxtellar XR: 600 mg PO qDay initially; may increase at weekly intervals by 600 mg/day increments to target dosage range of 1200-2400 mg qDay

Monotherapy (if converting from other AED)

  • Initial: 300 mg PO q12hr; increase by 600 mg/day qWeek up to 2400 mg/day
  • Reduce and withdraw concomitant antiepileptic drugs (AEDs) over 3-6 weeks while reaching maximum oxcarbazepine dose in 2-4 weeks

Monotherapy (if AED naive)

  • Initial: 300 mg PO q12hr; increase by 300 mg/day q3Day to 1200 mg/day divided q12hr

Bipolar Disorder (Off-label)

300 mg/day PO initially; may titrate to 1800-2400 mg/day maximum

Diabetic Neuropathy (Off-label)

150-300 mg/day PO initially; may increase to 900-1200 mg/day (general recommendation)

Doses up to 1800 mg/day studied, with positive results

Neuralgia/Neuropathy (Off-label)

300 mg PO q8-12hr initially; may adjust dose to 400-2000 mg divided q8-12hr (maximum tolerated or effective dose)

Dosing Considerations

Coadministration with CYP-inducing AEDs (eg, carbamazepine, phenobarbital, phenytoin): Increased oxcarbazepine dose may be required because of decreased exposure to 10-monohydroxy derivative (MHD [active metabolite])

Conversion from immediate release to Oxtellar XR: Higher doses of Oxtellar XR may be required

Dosing Modifications

Renal impairment

  • CrCl <30 mL/min: Decrease initial dose by 50%; titrate up slowly

Hepatic impairment

  • Mild to moderate: No dose adjustment required
  • Severe: Unknown if dosage adjustment necessary

Dosage Forms & Strengths

tablet

  • 150mg
  • 300mg
  • 600mg

tablet, extended-release

  • 150mg
  • 300mg
  • 600mg

oral suspension

  • 300mg/5mL
more...

Partial Seizures (Adjunctive Treatment)

Trileptal (age 2-4 years)

  • Initial: 8-10 mg/kg/day PO divided q12hr; not to exceed 600 mg/day 
  • <20 kg: May start with16-20 mg/kg/day; may titrate to higher dose over 2-4 weeks; not to exceed 60 mg/kg/day

Trileptal (age 4-16 years)

  • Initial: 8-10 mg/kg/day PO divided q12hr; not to exceed 600 mg/day 
  • Target maintenance dose: May titrate to higher dose over 2 weeks to reach the following dosage ranges
  • 20-29 kg: 450 mg PO q12hr
  • 29.1-39 kg: 600 mg PO q12hr
  • >39 kg: 900 mg PO q12hr

Oxtellar XR (age 6-17 years)

  • Initial: 8-10 mg/kg PO qDay; not to exceed 600 mg/day in the first week
  • Target maintenance dose: May titrate to higher dose at weekly intervals in 8-10 mg/kg/day increments (not to exceed 600 mg) to reach the following target maintenance dosage ranges over a 2-3 week period
  • 20-29 kg: 900 mg PO qDay
  • 29.1-39 kg: 1200 mg PO qDay
  • >39 kg: 1800 mg PO qDay

Partial Seizures (Monotherapy)

Trileptal (age 4-16 years)

  • AED: Initial, 8-10 mg/kg/day PO divided q12hr; may increase qWeek by maximum increment of 10 mg/kg/day 
  • AED-naive: Initial 8-10 mg/kg/day PO divided q12hr; may increase q3Days by 5 mg/kg/day
  • Target maintenance: Weight-based dosing may be as high as 2100 mg/day for >60 kg
  • 20-24.99 kg: 600-900 mg/day
  • 25-34.99 kg: 900-1200 mg/day
  • 35-44.99 kg: 900-1500 mg/day
  • 45-49.99 kg: 1200-1500 mg/day
  • 50-59.99 kg: 1200-1800 mg/day
  • 60-69.99 kg: 1200-2100 mg/day
  • 70 kg: 1500-2100 mg/day

Dosing Considerations

Coadministration with CYP-inducing AEDs (eg, carbamazepine, phenobarbital, phenytoin): Increased oxcarbazepine dose may be required because of decreased exposure to MHD (active metabolite)

Conversion from immediate-release to Oxtellar XR: Higher doses of Oxtellar XR may be required

Dosage Modifications

Renal impairment

  • CrCl <30 mL/min: Decrease initial dose by 50%, titrate up slowly

Hepatic impairment

  • Mild to moderate: No dose adjustment required
  • Severe: Unknown if dosage adjustment necessary for immediate release dosage form; extended release, not recommended

For extended-release dosage administration consider initial dose of 300-450 mg/day

May increase at weekly intervals to desired effect; not to exceed 2400 mg/day

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Interactions

Interaction Checker

oxcarbazepine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dizziness (30-50%)

            Diplopia (30-50%)

            Headache (26-30%)

            Nausea/vomiting (26-30%)

            Nystagmus (26-30%)

            Somnolence (26-30%)

            Ataxia (10-30%)

            Abnormal gait (16-20%)

            Tremor (16-20%)

            Abdominal pain (11-15%)

            Fatigue (11-15%)

            Vertigo (11-15%)

            Vision abnormalities (11-15%)

            1-10%

            Dyspepsia (5-6%)

            Rash (4%)

            Insomnia (2-4%)

            Abnormal thinking (<4%)

            Hyponatremia (1-3%)

            Muscle weakness (1-2%)

            Hypotension (<2%)

            Speech disorder (1%)

            Asthenia

            Postmarketing Reports

            Angioedema

            Anaphylaxis

            Multiorgan immune hypersensitivity reaction

            Hematic and lymphatic systems: Bone marrow depression, agranulocytosis, aplastic anemia, pancytopenia, neutropenia

            Digestive system: Pancreatitis and/or lipase and/or amylase increased

            Metabolism and nutrition disorders: Folic acid deficiency, hypothyroidism

            Skin and appendages: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

            Skeletal: Fractures, decreased bone mineral, osteoporosis

            Body as a whole: Multiorgan hypersensitivity disorders characterized by features such as rash, fever, lymphadenopathy, abnormal liver function tests, eosinophilia, and arthralgia

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            See FDA warning on potential suicidal behavior; monitor patients for notable changes in behavior that might be associated with suicidal thoughts or depression (notify health-care provider immediately if symptoms occur)

            Caution performing tasks that require mental alertness

            Potentially fatal skin reactions may occur (eg, Stevens-Johnson syndrome)

            May render oral contraceptives ineffective because of metabolic enzyme induction

            Discontinue if dermatological reactions occur

            Significant hyponatremia may develop (monitor especially in patients at risk of hyponatremia)

            Pancytopenia, agranulocytosis, and leukopenia reported rarely

            May reduce efficacy of oral contraceptives; additional contraceptive measures recommnended

            Long term use has been associated with decreased mineral density, osteopenia, osteoporosis, and fractures, CNS-related adverse effects including difficulty with concentration, psychomotor slowing, speech or language problems, somonolence or fatigue, coordination of abnormalities, including ataxia and gait disturbances

            Hypothyroidism reported; monitor thyroid function, especially in children; discontinuation of therapy associated with return of normal thyroxine levels

            Patients carrying the HLA-B*1502 allele may be at increased risk for Stevens-Johnson syndrome and epidermal necrolysis

            Half-life of primary active metabolite is prolonged 3- to 4-fold and AUC is doubled in patients with CrCl <30 mL/min; adjust dose in these patients

            Do not discontinue anticonvulsants abruptly

            DRESS

            • Drug reaction with eosinophilia and systemic symptoms (DRESS), also known as multi-organ hypersensitivity, reported
            • Some of these events have been fatal or life-threatening
            • DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement (eg, hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis), sometimes resembling an acute viral infection
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            Pregnancy & Lactation

            Pregnancy category: C

            Due to physiologic changes during pregnancy, plasma levels of the active metabolite of oxcarbazepine, MHD, may gradually decrease throughout pregnancy

            Lactation: Oxcarbazepine and its active metabolite (MHD) are excreted in human milk; milk-to-plasma concentration ratio of 0.5 was found for both

            Because of the potential for serious adverse reactions in nursing infants, a decision should be made as to whether a mother should discontinue nursing or whether she should discontinue use of the drug, taking into account the drug's importance to the mother

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            MHD stabilizes neuronal membranes by blocking Na+ channels; this may inhibit repetitive firing and may decrease the propagation of synaptic impulses; may also increase potassium conductance and modulate the activity of high-voltage activated calcium channels

            Absorption

            Bioavailability: Complete

            Peak serum time: 4-6 hr

            Distribution

            Protein bound: 40% (MHD); primarily bound to albumin

            Vd: 49 L

            Metabolism

            Rapidly reduces by cytosolic enzymes in the liver to active metabolite

            Metabolites (active): MHD

            Enzymes induced: CYP3A4

            Enzymes inhibited: CYP2C19

            Elimination

            Half-life: 2 hr (immediate-release parent drug); 9 hr (immediate-release derivative MHD); 7-11 hr (extended-release parent drug); 9-11 hr (extended-release derivative MHD)

            Excretion: Urine (>95%)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
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            ST Step Therapy
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            OR Other Restrictions
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