Interaksi Felbamat dan Rufinamid

IT IS NOT KNOWN WHETHER CONCOMITANT USE OF OTHER ANTIEPILEPTIC DRUGS AND/OR OTHER DRUGS AFFECT THE INCIDENCE OF HEPATIC FAILURE.

Use in Conjunction with Other Antiepileptic Drugs (see DOSAGE AND ADMINISTRATION ) The addition of Felbatol ® to antiepileptic drugs (AEDs) affects the steady-state plasma concentrations of AEDs.

CBZ epoxide ↓ ↑ ↓ Phenobarbital ↑ ↓ Specific Effects of Felbatol® on Other Antiepileptic Drugs Phenytoin Felbatol ® causes an increase in steady-state phenytoin plasma concentrations.

Effects of Other Antiepileptic Drugs on Felbatol ® Phenytoin Phenytoin causes an approximate doubling of the clearance of Felbatol ® (felbamate) at steady-state and, therefore, the addition of phenytoin causes an approximate 45% decrease in the steady-state trough concentrations of Felbatol ® as compared to the same dose of Felbatol ® given as monotherapy.

The net effect of these interactions is summarized in Table 2: Table 2 Steady-State Plasma Concentrations of Felbatol When Coadministered With Other AEDs AED Coadministered AED Concentration Felbatol ® Concentration Phenytoin ↑ ↓ Valproate ↑ ↔ No significant effect.

Table 6: Summary of drug-drug interactions of BANZEL with other antiepileptic drugs AED Co-administered Influence of Rufinamide on AED concentration a) Influence of AED on Rufinamide concentration Carbamazepine Decrease by 7 to 13% b) Decrease by 19 to 26% Dependent on dose of carbamazepine Lamotrigine Decrease by 7 to 13% b) No Effect Phenobarbital Increase…

Effects of Other AEDs on BANZEL Potent cytochrome P450 enzyme inducers, such as carbamazepine, phenytoin, primidone, and phenobarbital, appear to increase the clearance of BANZEL (see Table 6).

If abrupt discontinuation of the drug is medically necessary, the transition to another AED should be made under close medical supervision.

Effects of BANZEL on other AEDs Population pharmacokinetic analysis of average concentration at steady state of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, and valproate showed that typical rufinamide C avss levels had little effect on the pharmacokinetics of other AEDs.

Table 6 summarizes the drug-drug interactions of BANZEL with other AEDs.