Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland
Trileptal is indicated for the treatment of partial seizures with or without secondarily generalised tonic-clonic seizures.
Trileptal is indicated for use as monotherapy or adjunctive therapy in adults and in children of 6 years of age and above.
In mono- and adjunctive therapy, treatment with Trileptal is initiated with a clinically effective dose given in two divided doses. The dose may be increased depending on the clinical response of the patient. When other antiepileptic medicinal products are replaced by Trileptal, the dose of the concomitant antiepileptic medicinal product(s) should be reduced gradually on initiation of Trileptal therapy. In adjunctive therapy, as the total antiepileptic medicinal product load of the patient is increased, the dose of concomitant antiepileptic medicinal product(s) may need to be reduced and/or the Trileptal dose increased more slowly (see section 4.5).
The therapeutic effect of oxcarbazepine is primarily exerted through the active metabolite 10-monohydroxy derivative (MHD) of oxcarbazepine (see section 5).
Plasma level monitoring of oxcarbazepine or MHD is not routinely warranted. However, may be useful in situations where an alteration in MHD clearance is to be expected (see section 4.4). In such situations, the dose of Trileptal may be adjusted (based on plasma levels measured 2-4 hours post dose) to maintain peak MHD plasma levels < 35 mg/L.
Recommended initial dose:
Trileptal should be initiated with a dose of 600 mg/day (8-10 mg/kg/day) given in 2 divided doses.
Maintenance dose:
If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals from the starting dose to achieve the desired clinical response.
Therapeutic effects are seen at doses between 600 mg/day and 2,400 mg/day.
Controlled monotherapy trials in patients not currently being treated with antiepileptic medicinal products showed 1,200 mg/day to be an effective dose; however, a dose of 2,400 mg/day has been shown to be effective in more refractory patients converted from other antiepileptic medicinal products to Trileptal monotherapy.
Maximum recommended dose:
In a controlled hospital setting, dose increases up to 2,400 mg/day have been achieved over 48 hours.
Recommended initial dose:
Trileptal should be initiated with a dose of 600 mg/day (8-10 mg/kg/day) given in 2 divided doses.
Maintenance dose:
If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals from the starting dose to achieve the desired clinical response.
Therapeutic responses are seen at doses between 600 mg/day and 2,400 mg/day.
Maximum recommended dose:
Daily doses from 600 to 2,400 mg/day have been shown to be effective in a controlled adjunctive therapy trial, although most patients were not able to tolerate the 2,400 mg/day dose without reduction of concomitant antiepileptic medicinal products, mainly because of CNS-related adverse events. Daily doses above 2,400 mg/day have not been studied systematically in clinical trials.
No special dose recommendations are necessary in elderly patients because therapeutic doses are individually adjusted. Dosage adjustments are recommended in elderly patients with renal impairment (creatinine clearance less than 30 ml/min) (see information below on dosage in renal impairment).
Close monitoring of sodium levels is required in patients at risk of hyponatremia (see section 4.4).
No dosage adjustment is required for patients with mild to moderate hepatic impairment. Trileptal has not been studied in patients with severe hepatic impairment, therefore, caution should be exercised when dosing severely impaired patients (see section 5.2).
In patients with impaired renal function (creatinine clearance less than 30 ml/min) Trileptal therapy should be initiated at half the usual starting dose (300 mg/day) and increased, in at least weekly intervals, to achieve the desired clinical response (see section 5.2).
Dose escalation in renally impaired patients may require more careful observation.
Recommended initial dose:
In mono- and adjunctive therapy, Trileptal should be initiated with a dose of 8-10 mg/kg/day given in 2 divided doses.
Maintenance dose:
In adjunctive therapy trials, a maintenance dose of 30-46 mg/kg/day, achieved over two weeks, is shown to be effective and well tolerated in children. Therapeutic effects were seen at a median maintenance dose of approximately 30 mg/kg/day.
Maximum recommended dose:
If clinically indicated, the dose may be increased by a maximum of 10 mg/kg/day at approximately weekly intervals from the starting dose, to a maximum dose of 46 mg/kg/day, to achieve the desired clinical response (see section 5.2).
Trileptal is recommended for use in children of 6 years of age and above. Safety and efficacy have been evaluated in controlled clinical trials involving approximately 230 children aged less than 6 years (down to 1 month). Trileptal is not recommended in children aged less than 6 years since safety and efficacy have not been adequately demonstrated.
All the above dosing recommendations (adults, elderly and children) are based on the doses studied in clinical trials for all age groups. However, lower initiation doses may be considered where appropriate.
The tablets are scored and can be broken into two halves in order to make it easier for the patient to swallow the tablet. However, the tablet cannot be divided into equal doses. For children, who cannot swallow tablets or where the required dose cannot be administered using tablets, a Trileptal oral suspension is available.
Trileptal can be taken with or without food.
Isolated cases of overdose have been reported. The maximum dose taken was approximately 48,000 mg.
Electrolyte and fluid balance conditions: hyponatraemia
Eye disorders: diplopia, miosis, blurred vision
Gastrointestinal disorders: nausea, vomiting, hyperkinesia
General disorders and administration site conditions: fatigue
Investigations: respiratory rate depression, QTc prolongation
Nervous system disorders: drowsiness and somnolence, dizziness, ataxia and nystagmus, tremor, disturbances in coordination (coordination abnormal), convulsion, headache, coma, loss of consciousness, dyskinesia
Psychiatric disorders: aggression, agitation, confusional state
Vascular disorders: hypotension
Respiratory, thoracic and mediastinal disorders: dyspnoea
There is no specific antidote. Symptomatic and supportive treatment should be administered as appropriate. Removal of the medicinal product by gastric lavage and/or inactivation by administering activated charcoal should be considered.
3 years.
This medicinal product does not require any special storage conditions.
Blister containing 10 tablets. Blister material: PVC/PE/PVDC with aluminium foil backing.
Tablets 150 mg: blister pack of 30, 50, 100, 200 and/or 500 tablets.
Tablets 300 mg: blister pack of 30, 50, 100, 200 and/or 500 tablets.
Tablets 600 mg: blister pack of 30, 50, 100, 200 and/or 500 tablets.
Not all pack sizes may be marketed.
No special requirements.
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