Details
Oxapin Indications
For the treatment of partial seizures with or without secondary generalized tonic-clonic seizures as monotherapy or adjunctive therapy in adults and children over 6 years of age.
Contradictions
Hypersensitivity to oxcarbazepine, eslicarbazepine or to any of the excipients.
Dosage & Administration
Monotherapy.
Oxcarbazepine should be started at a dose of 600 mg / day (8-10 mg / kg / day) in two divided doses.
If clinically necessary, the dose can be increased at approximately weekly intervals by no more than 600 mg per day from the initial dose to achieve the expected therapeutic effect. Therapeutic effects are observed in the range of doses of 600-2400 mg per day.
There is evidence that in patients who are not currently receiving antiepileptic drugs, the effective dose of oxcarbazepine as monotherapy is 1200 mg per day. However, a dose of 2400 mg per day is known to be effective in more resistant patients who are switched to oxcarbazepine monotherapy from other antiepileptic drugs.
Under controlled hospital conditions, increasing the dose to 2400 mg per day was achieved within 48 hours.
Additional therapy.
Oxcarbazepine should be started at a dose of 600 mg / day (8-10 mg / kg / day) in two divided doses.
If clinically necessary, the dose can be increased at approximately weekly intervals by no more than 600 mg per day from the initial dose to achieve the expected therapeutic effect. Therapeutic effects are observed in the range of doses of 600-2400 mg per day.
There are data that in patients receiving oxcarbazepine as adjunctive therapy, daily doses of 600 to 2400 mg / day are effective, although most patients were unable to tolerate the dose of 2400 mg / day without reducing the dose of concomitant antiepileptic drugs, mainly due to undesirable phenomena of the CNS.
The use of oxcarbazepine in daily doses above 2400 mg has not been studied.
Elderly patients (over 65 years of age)
No special dosage recommendations are required, as therapeutic doses are selected individually. Dose adjustment is recommended for elderly patients with impaired renal function (creatinine clearance less than 30 ml / min).
Patients with hyponatremia or risk of hyponatremia.
Careful monitoring of sodium levels is required (see section "Special warnings and precautions for use").
Patients with hepatic insufficiency.
No dosage adjustment is required for patients with mild to moderate hepatic impairment. Oxcarbazepine has not been studied in patients with severe hepatic impairment. Therefore, caution should be exercised when treating patients with severe hepatic impairment.
Patients with renal insufficiency.
In patients with impaired renal function (creatinine clearance less than 30 ml / min), oxcarbazepine therapy should be initiated at half the usual starting dose (300 mg / day), which is increased at least weekly intervals to achieve the expected therapeutic effect.
When increasing the dose for patients with renal insufficiency may require more careful monitoring.
