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Oxcarbazepine

Medical and Pharmacy Editor:

Brand Name: Trileptal, Oxtellar XR

Generic Name: Oxcarbazepine

Drug Class: Anticonvulsants, Other

What Is Oxcarbazepine and How Does It Work?

Oxcarbazepine is an anticonvulsant, or antiepileptic drug, used to treat partial seizures in adults and children who are at least 2 years old.

Oxcarbazepine is available under the following different brand names: Trileptal, and Oxtellar XR.

Dosages of Oxcarbazepine

Dosage Forms and Strengths

Tablet

  • 150 mg
  • 300 mg
  • 600 mg

Tablet, extended-release

  • 150 mg
  • 300 mg
  • 600 mg

Oral suspension

  • 300 mg/5 mL

Dosage Considerations – Should be Given as Follows:

Partial Seizures

Adjunctive treatment, Adult

  • Trileptal: 300 mg orally every 12 hours initially; may increase at weekly intervals by 600 mg/day up to 1200 mg/day
  • Oxtellar XR: 600 mg orally once/day initially; may increase at weekly intervals by 600 mg/day increments to target dosage range of 1200-2400 mg once/day

Adjunctive treatment, Pediatric

Trileptal (age 2-4 years)

  • Initial: 8-10 mg/kg/day orally divided every 12 hours; not to exceed 600 mg/day
  • Less than 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 orally divided every 12 hours; 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 orally every 12 hours
    • 29.1-39 kg: 600 mg orally every 12 hours
    • Greater than 39 kg: 900 mg orally every 12 hours

    Oxtellar XR (age 6-17 years)

    • Initial: 8-10 mg/kg orally once/day; 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 orally once/day
    • 29.1-39 kg: 1200 mg orally once/day
    • Greater than 39 kg: 1800 mg orally once/day

    Monotherapy (if converting from other antiepileptic drug [AED]), Adult

    • Initial: 300 mg orally every 12 hours; increase by 600 mg/day once/week 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 antiepileptic drug [AED] naive), Adult

    • Initial: 300 mg orally every 12 hours; increase by 300 mg/day every 3 days to 1200 mg/day divided every 12 hours

    Monotherapy, Pediatric

    Trileptal (age 4-16 years)

    • Antiepileptic drug (AED) conversion: Initial, 8-10 mg/kg/day orally divided every 12 hours; may increase once/week by maximum increment of 10 mg/kg/day
    • Antiepileptic drug (AED)-naive: Initial 8-10 mg/kg/day orally divided every 12 hours; may increase every 3 days by 5 mg/kg/day
    • Target maintenance: Weight-based dosing may be as high as 2100 mg/day for greater than 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

    Bipolar Disorder (Off-label)

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

    Diabetic Neuropathy (Off-label)

      150-300 mg/day orally 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 orally every 8-12 hours initially; may adjust dose to 400-2000 mg divided every 8-12 hours (maximum tolerated or effective dose)

    Dosing Considerations

    Co-administration with CYP-inducing AEDs (e.g., 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 less than 30 mL/min: Decrease initial dose by 50%; titrate up slowly

    Hepatic impairment

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

    What Are Side Effects Associated with Using Oxcarbazepine?

    Common side effects of oxcarbazepine include:

    Serious side effects of oxcarbazepine include:

    • Changes in vision
    • Involuntary, repetitive eye movements
    • Difficulty speaking
    • Difficulty concentrating
    • Loss of coordination
    • Trouble walking (abnormal gait)
    • Dulled sense of touch
    • Easy bleeding or bruising
    • Chest pain
    • Persistent sore throat
    • Stomach or abdominal pain
    • Bloody stool
    • Dark urine
    • Changes in amount of urine
    • Yellowing of eyes or skin

    Postmarketing side effects of oxcarbazepine reported include:

    This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    What Other Drugs Interact with Oxcarbazepine?

    If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

    Oxcarbazepine has severe interactions with at least 21 different drugs.

    Oxcarbazepine has serious interactions with at least 62 different drugs.

    Oxcarbazepine has moderate interactions with at least 141 different drugs.

    Oxcarbazepine has mild interactions with at 94 different drugs.

    This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

    What Are Warnings and Precautions for Oxcarbazepine?

    Warnings

    This medication contains oxcarbazepine. Do not take Trileptal or Oxtellar XR if you are allergic to oxcarbazepine or any ingredients contained in this drug.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

    Contraindications

    • Hypersensitivity

    Effects of Drug Abuse

    • None

    Short-Term Effects

    • See "What Are Side Effects Associated with Using Oxcarbazepine?"

    Long-Term Effects

    • See "What Are Side Effects Associated with Using Oxcarbazepine?"

    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 (e.g., Stevens-Johnson syndrome).

    May render oral contraceptives ineffective because of metabolic enzyme induction. May reduce efficacy of oral contraceptives; additional contraceptive measures recommended.

    Discontinue if dermatological reactions occur.

    Significant low blood sodium (hyponatremia) may develop (monitor especially in patients at risk of hyponatremia).

    Pancytopenia, agranulocytosis, and leukopenia reported rarely.

    Long term use has been associated with decreased mineral density, osteopenia, osteoporosis, and fractures, central nervous system (CNS)-related adverse effects including difficulty with concentration, psychomotor slowing, speech or language problems, somnolence or fatigue, coordination of abnormalities, including loss of control of bodily movements 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 less than 30 mL/min; adjust dose in these patients.

    Do not discontinue anticonvulsants abruptly.

    Drug reaction with eosinophilia and systemic symptoms (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 (e.g., hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis), sometimes resembling an acute viral infection

    Pregnancy and Lactation

    Use oxcarbazepine with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.

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

    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.

    Reviewed on 1/22/2018

    References:
    Medscape. Oxcarbazepine.
    https://reference.medscape.com/drug/trileptal-oxtellar-xr-oxcarbazepine-343014
    RxList. Trileptal.
    https://www.rxlist.com/trileptal-side-effects-drug-center.htm

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