Dosage: The following dosage recommendations apply to all patients who do not have impaired renal function. Serum level monitoring is not necessary for optimization of Trileptal therapy (see Pharmacokinetics under Actions).
Adults: Monotherapy: Initially, at a daily dose of 600 mg (8-10 mg/kg/day) given in 2 divided doses. The daily dose may be increased at 1-week intervals, in increments not exceeding 600 mg, in order to achieve the desired effect. The maintenance dose ranges from 600-2400 mg/day, with most patients responding to a dose of 900 mg/day.
Controlled studies with monotherapy in patients not previously treated with antiepileptics have shown the efficacy of a daily dose of 1200 mg. In hard-to-treat patients who have been switched from other antiepileptics to monotherapy with Trileptal, a daily dose of 2400 mg has proven effective.
Combination Therapy: Treatment with Trileptal may be initiated at a daily dose of 600 mg (8-10 mg/kg/day), given in 2 divided doses. The daily dose may be increased at 1-week intervals, in increments not exceeding 600 mg, in order to achieve the desired effect. The maintenance dose ranges from 600-2400 mg/day.
A controlled study with combination therapy has shown daily doses of 600-2400 mg to be effective. However, most patients did not tolerate a daily dose of 2400 mg without a reduction in the dose of the other concurrently administered antiepileptics, primarily due to adverse effects involving the central nervous system.
Daily doses >2400 mg were not systematically investigated.
Children ≥1 month: In monotherapy and combination therapy, treatment should be initiated at a dose of 8-10 mg/kg/day, given in 2 divided doses.
If clinically indicated, the daily dose may be increased at 1-week intervals, in increments not exceeding 10 mg/kg/day, up to a maximum daily dose of 60 mg/kg, in order to achieve the desired effect (see Pharmacokinetics under Actions).
In both combination therapy and monotherapy, clearance (L/hr/kg), based on body weight, decreases with age such that children from 1 month to <4 years may require twice as high a dose of oxcarbazepine per body weight as adults; children 4-12 years may require a dose of oxcarbazepine per body weight that is 50% higher than that in adults (see Pharmacokinetics under Actions).
In children 1 month to <4 years, the influence of enzyme-inducing antiepileptics on weight-normalized clearance appears higher than in older children. Children 1 month to <4 years receiving combination therapy with enzyme-inducing antiepileptics may require a dose (by body weight) of oxcarbazepine about 60% higher than the dose needed with either as monotherapy or combination therapy with non-enzyme-inducing antiepileptics. Older children (≥4 years) receiving enzyme-inducing antiepileptics may require only a slightly higher dose than their counterparts on monotherapy.
Trileptal is intended for use in children ≥1 month. There have been no controlled clinical studies in children aged <1 month.
The dosage recommendations previously mentioned are based on doses used in all age groups (adults, elderly patients and children) during clinical trials. However, lower starting doses may also be used where appropriate.
Elderly: Dose adjustment is recommended in elderly patients with impaired renal function. For patients at risk for hyponatremia (see Precautions).
Impaired Hepatic Function: No dose adjustment is required in patients with mild to moderate hepatic impairment. Trileptal has not been studied in patients with severe hepatic impairment. Caution is therefore required when giving Trileptal to patients with severe hepatic impairment (see Pharmacokinetics under Actions).
Impaired Renal Function: In patients with renal impairment (creatinine clearance <30 mL/min), Trileptal therapy should be initiated at half the usual starting dose (300 mg/day) and increased at intervals of not <1 week until the desired clinical response is achieved (see Pharmacokinetics under Actions). Patients with renal impairment must be closely monitored when doses are increased.
Administration: Trileptal is suitable for use either alone or in combination with other antiepileptic drugs. In both monotherapy and combination therapy, treatment with Trileptal should be initiated at a clinically effective dose, given as 2 divided doses per day. The dose may be increased depending on the patient's clinical response. In the event of combination therapy, it may be necessary to reduce the dose of the other antiepileptic and/or to increase the dose of Trileptal more slowly (see Interactions), due to the increase in the patient's total antiepileptic dose.
Trileptal may be taken with or without food.
The tablets are scored and can be broken in half to facilitate administration for the patient.
The oral suspension is available for younger children who are unable to swallow the tablets or in whom the prescribed dose cannot be attained using the tablets.
The bottle containing the oral suspension must be shaken well before use. The prescribed amount of solution should then be withdrawn from the bottle immediately. The amount should be rounded up to the nearest 0.5 mL if the 10 mL dosing syringe is being used (supplied with the 250 mL bottle for adults and older children) and to the nearest 0.1 mL if the 1 mL dosing syringe is being used (supplied with the 100 mL bottle for younger children).
The oral suspension may be swallowed directly from the dosing syringe or stirred into a small glass of water immediately before ingestion. After each use, the bottle must be closed and the outside of the dosing syringe wiped clean with a clean, dry tissue.
Trileptal film-coated tablets and oral suspension may be interchanged at equal doses.
The prescription for Trileptal oral suspension should be given in mL which is shown in the following conversion of mg to mL: 10 mg=0.2 mL; 20 mg=0.3 mL; 30 mg=0.5 mL; 40 mg=0.7 mL; 50 mg=0.8 mL; 60 mg=1 mL; 70 mg=1.2 mL; 80 mg=1.3 mL; 90 mg=1.5 mL; 100 mg=1.7 mL; 200 mg=3.3 mL; 300 mg=5 mL; 400 mg=6.7 mL; 500 mg=8.3 mL; 600 mg=10 mL; 700 mg=11.7 mL; 800 mg=13.3 mL; 900 mg=15 mL; 1000 mg=16.7 mL.