1. Home
  2. Product
  3. Medications: Trileptal® – oxcarbazepine

Medications: Trileptal® – oxcarbazepine

MEDICATIONS

Trileptal® – oxcarbazepine (View the FDA label)

Trileptal is an antiepileptic drug indicated for:

  • Adults:
    – Monotherapy or adjunctive therapy in the treatment of partial seizures
  • Children:
    – Monotherapy in the treatment of partial seizures in children 4-16 years
    – Adjunctive

DOSAGE AND ADMINISTRATION

ADULTS: initiated with a dose of 600 mg/day, given in twice-a-day regimen

  • Adjunctive Therapy: Maximum increment of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1200 mg/day (2.1)
  • Conversion to Monotherapy: Concomitant AEDs should be completely withdrawn over 3-6 weeks, while maximum dose of Trileptal should be reached in about 2-4 weeks. Maximum increment of 600 mg/day at approximately weekly intervals to a recommended daily dose of 2400 mg/day
    (2.2)
  • Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1200 mg/day. (2.3)

CHILDREN: initiation with 8-10 mg/kg/day, given in twice-a-day regimen. For patients aged 2 – <4 years and under 20 kg, a starting dose of 16 to 20 mg/kg/day may be considered. Recommended daily dose is dependent upon patient weight

  • Adjunctive Patients (Aged 2-16 Years): For patients aged 4-16 years, target maintenance dose should be achieved over 2 weeks (2.4). For patients aged 2
    – <4 years, maximum maintenance dose should be achieved over 2-4 weeks and should not to exceed 60mg/kg/day (2.4)
  • Conversion to Monotherapy for Patients (Aged 4-16 Years) Maximum increment of 10 mg/kg/day at weekly intervals, concomitant antiepileptic drugs can be completely withdrawn over 3-6 weeks (2.5)
  • Initiation of Monotherapy for Patients (Aged 4-16 Years) Increments of 5 mg/kg/day every third day (2.6)

The most commonly observed (>=5%) adverse experiences were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, abnormal gait, and in pediatric patients <4 years old, also infections and infestations. (6.1)

  • Hyponatremia (5.1)
  • Anaphylactic Reactions and Angioedema (5.2)
  • Patients with a Past History of Hypersensitivity Reaction to Carbamazepine (5.3)
  • Serious Dermatological Reactions (5.4)
  • Suicidal Behavior and Ideation (5.5)
  • Withdrawal of AEDs (5.6)
  • Cognitive/Neuropsychiatric Adverse Events (5.7)
  • Multi-Organ Hypersensitivity (5.8)
  • Hematologic Events (5.9)
  • Seizure Control During Pregnancy (5.10)
  • Laboratory Tests (5.11)
  • Phenytoin: Increased phenytoin levels. Reduced dose of phenytoin may be required. (7.1)
  • Carbamazepine: Decreased plasma levels of MHD (the active metabolite). Dose adjustments may be necessary. (7.1)
  • Phenobarbital: Decreased plasma levels of MHD. Dose adjustments may be necessary. (7.1)
  • Oral Contraceptive: Patients should be advised that Trileptal may decrease the effectiveness of hormonal contraceptives. (7.2)

Human Overdose Experience

Isolated cases of overdose with Trileptal have been reported. The maximum dose taken was approximately 24,000 mg. All patients recovered with symptomatic treatment.

Treatment and Management

There is no specific antidote. Symptomatic and supportive treatment should be administered as appropriate. Removal of the drug by gastric lavage and/or inactivation by administering activated charcoal should be considered.

Uses

Trileptal is an antiepileptic drug indicated for:

  • Adults:
    – Monotherapy or adjunctive therapy in the treatment of partial seizures
  • Children:
    – Monotherapy in the treatment of partial seizures in children 4-16 years
    – Adjunctive

DOSAGE AND ADMINISTRATION

ADULTS: initiated with a dose of 600 mg/day, given in twice-a-day regimen

  • Adjunctive Therapy: Maximum increment of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1200 mg/day (2.1)
  • Conversion to Monotherapy: Concomitant AEDs should be completely withdrawn over 3-6 weeks, while maximum dose of Trileptal should be reached in about 2-4 weeks. Maximum increment of 600 mg/day at approximately weekly intervals to a recommended daily dose of 2400 mg/day
    (2.2)
  • Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1200 mg/day. (2.3)

CHILDREN: initiation with 8-10 mg/kg/day, given in twice-a-day regimen. For patients aged 2 – <4 years and under 20 kg, a starting dose of 16 to 20 mg/kg/day may be considered. Recommended daily dose is dependent upon patient weight

  • Adjunctive Patients (Aged 2-16 Years): For patients aged 4-16 years, target maintenance dose should be achieved over 2 weeks (2.4). For patients aged 2
    – <4 years, maximum maintenance dose should be achieved over 2-4 weeks and should not to exceed 60mg/kg/day (2.4)
  • Conversion to Monotherapy for Patients (Aged 4-16 Years) Maximum increment of 10 mg/kg/day at weekly intervals, concomitant antiepileptic drugs can be completely withdrawn over 3-6 weeks (2.5)
  • Initiation of Monotherapy for Patients (Aged 4-16 Years) Increments of 5 mg/kg/day every third day (2.6)
Side Effects

The most commonly observed (>=5%) adverse experiences were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, abnormal gait, and in pediatric patients <4 years old, also infections and infestations. (6.1)

Precautions
  • Hyponatremia (5.1)
  • Anaphylactic Reactions and Angioedema (5.2)
  • Patients with a Past History of Hypersensitivity Reaction to Carbamazepine (5.3)
  • Serious Dermatological Reactions (5.4)
  • Suicidal Behavior and Ideation (5.5)
  • Withdrawal of AEDs (5.6)
  • Cognitive/Neuropsychiatric Adverse Events (5.7)
  • Multi-Organ Hypersensitivity (5.8)
  • Hematologic Events (5.9)
  • Seizure Control During Pregnancy (5.10)
  • Laboratory Tests (5.11)
Interactions
  • Phenytoin: Increased phenytoin levels. Reduced dose of phenytoin may be required. (7.1)
  • Carbamazepine: Decreased plasma levels of MHD (the active metabolite). Dose adjustments may be necessary. (7.1)
  • Phenobarbital: Decreased plasma levels of MHD. Dose adjustments may be necessary. (7.1)
  • Oral Contraceptive: Patients should be advised that Trileptal may decrease the effectiveness of hormonal contraceptives. (7.2)
Overdose

Human Overdose Experience

Isolated cases of overdose with Trileptal have been reported. The maximum dose taken was approximately 24,000 mg. All patients recovered with symptomatic treatment.

Treatment and Management

There is no specific antidote. Symptomatic and supportive treatment should be administered as appropriate. Removal of the drug by gastric lavage and/or inactivation by administering activated charcoal should be considered.

Interpreting the GeneSight® Test:
Gene-Drug Interaction Chart

Menu