INDICATION AND USES:
TRILEPTAL is indicated for:
- Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures
- Pediatrics: – Monotherapy in the treatment of partial-onset seizures in children 4–16 years – Adjunctive therapy in the treatment of partial-onset seizures in children 2–16 years (1)
DOSAGE AND ADMINISTRATION
Adults: initiate with a dose of 600 mg/day, given twice-a-day
- 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: withdrawal concomitant over 3 to 6 weeks; reach maximum dose of TRILEPTAL in 2 to 4 weeks with increments of 600 mg/day at 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)
- Initiate at one-half the usual starting dose and increase slowly in patients with a creatinine clearance <30 mL/min, (2.7)
Pediatrics: initiation with 8 to 10 mg/kg/day, given twice-a-day. For patients aged 2 to <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 to 16 years, target maintenance dose should be achieved over 2 weeks (2.4). For patients aged 2 to <4 years, maximum maintenance dose should be achieved over 2 to 4 weeks and should not to exceed 60 mg/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4–16 Years) Maximum increment of 10 mg/kg/day at weekly intervals, concomitant antiepileptic drugs can be completely withdrawn over 3 to 6 weeks (2.5)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 common (³10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions in adults and pediatrics were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus, tremor, and abnormal gait. (6.1)
CONTRAINDICATIONS:
Known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate (4, 5.2)
WARNINGS AND PRECAUTIONS:
- Hyponatremia: Monitor serum sodium levels (5.1)
- Cross Hypersensitivity Reaction to Carbamazepine: Discontinue immediately if hypersensitivity occurs (5.3)
- Serious Dermatological Reactions: If occurs consider discontinuation (5.4)
- Suicidal Behavior and Ideation: Monitor for suicidal thoughts/ behavior (5.5)
- Withdrawal of AEDs: Withdraw TRILEPTAL gradually (5.6)
- Cognitive/Neuropsychiatric Adverse Reactions: May cause cognitive dysfunction, somnolence, coordination abnormalities. Use caution when operating machinery (5.7)
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/MultiOrgan Hypersensitivity: Monitor and discontinue if another cause cannot be established (5.8)
- Hematologic Events: Consider discontinuing (5.9)
- Seizure Control During Pregnancy: Active metabolite may decrease (5.10)
- Risk of Seizure Aggravation: Discontinue if occurs. (5.11)
DRUG INTERACTIONS:
- Phenytoin: Increased phenytoin levels. Reduced dose of phenytoin may be required (7.1)
- Carbamazepine, Phenytoin, Phenobarbital: Decreased plasma levels of MHD (the active metabolite). Dose adjustments may be necessary (7.1)
- Oral Contraceptive: TRILEPTAL may decrease the effectiveness of hormonal contraceptives (7.2)
OVERDOSE:
Isolated cases of overdose with TRILEPTAL have been reported. The maximum dose taken was approximately 48,000 mg. All patients recovered with symptomatic treatment. Nausea, vomiting, somnolence, aggression, agitation, hypotension, and tremor each occurred in more than one patient. Coma, confusional state, convulsion, dyscoordination, depressed level of consciousness, diplopia, dizziness, dyskinesia, dyspnea, QT prolongation, headache, miosis, nystagmus, overdose, decreased urine output, blurred vision also occurred. 1
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
-
INDICATION AND USES:
TRILEPTAL is indicated for:
- Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures
- Pediatrics: – Monotherapy in the treatment of partial-onset seizures in children 4–16 years – Adjunctive therapy in the treatment of partial-onset seizures in children 2–16 years (1)
DOSAGE AND ADMINISTRATION
Adults: initiate with a dose of 600 mg/day, given twice-a-day
- 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: withdrawal concomitant over 3 to 6 weeks; reach maximum dose of TRILEPTAL in 2 to 4 weeks with increments of 600 mg/day at 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)
- Initiate at one-half the usual starting dose and increase slowly in patients with a creatinine clearance <30 mL/min, (2.7)
Pediatrics: initiation with 8 to 10 mg/kg/day, given twice-a-day. For patients aged 2 to <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 to 16 years, target maintenance dose should be achieved over 2 weeks (2.4). For patients aged 2 to <4 years, maximum maintenance dose should be achieved over 2 to 4 weeks and should not to exceed 60 mg/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 to 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
-
SIDE EFFECTS:
The most common (³10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions in adults and pediatrics were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus, tremor, and abnormal gait. (6.1)
- Precautions
-
CONTRAINDICATIONS:
Known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate (4, 5.2)
WARNINGS AND PRECAUTIONS:
- Hyponatremia: Monitor serum sodium levels (5.1)
- Cross Hypersensitivity Reaction to Carbamazepine: Discontinue immediately if hypersensitivity occurs (5.3)
- Serious Dermatological Reactions: If occurs consider discontinuation (5.4)
- Suicidal Behavior and Ideation: Monitor for suicidal thoughts/ behavior (5.5)
- Withdrawal of AEDs: Withdraw TRILEPTAL gradually (5.6)
- Cognitive/Neuropsychiatric Adverse Reactions: May cause cognitive dysfunction, somnolence, coordination abnormalities. Use caution when operating machinery (5.7)
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/MultiOrgan Hypersensitivity: Monitor and discontinue if another cause cannot be established (5.8)
- Hematologic Events: Consider discontinuing (5.9)
- Seizure Control During Pregnancy: Active metabolite may decrease (5.10)
- Risk of Seizure Aggravation: Discontinue if occurs. (5.11)
- Interactions
-
DRUG INTERACTIONS:
- Phenytoin: Increased phenytoin levels. Reduced dose of phenytoin may be required (7.1)
- Carbamazepine, Phenytoin, Phenobarbital: Decreased plasma levels of MHD (the active metabolite). Dose adjustments may be necessary (7.1)
- Oral Contraceptive: TRILEPTAL may decrease the effectiveness of hormonal contraceptives (7.2)
- Overdose
-
OVERDOSE:
Isolated cases of overdose with TRILEPTAL have been reported. The maximum dose taken was approximately 48,000 mg. All patients recovered with symptomatic treatment. Nausea, vomiting, somnolence, aggression, agitation, hypotension, and tremor each occurred in more than one patient. Coma, confusional state, convulsion, dyscoordination, depressed level of consciousness, diplopia, dizziness, dyskinesia, dyspnea, QT prolongation, headache, miosis, nystagmus, overdose, decreased urine output, blurred vision also occurred. 1
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.