IT IS NOT INDICATED AS A FIRST LINE ANTIEPILEPTIC TREATMENT. FELBAMATE IS RECOMMENDED FOR USE ONLY IN THOSE PATIENTS WHO RESPOND INADEQUATELY TO ALTERNATIVE TREATMENTS AND WHOSE EPILEPSY IS SO SEVERE THAT A SUBSTANTIAL RISK OF APLASTIC ANEMIA AND/OR LIVER FAILURE IS DEEMED ACCEPTABLE IN LIGHT OF THE BENEFITS CONFERRED BY ITS USE.
INITIATE TREATMENT AT 1200 MG/DAY IN DIVIDED DOSES 3 - 4 TIMES DAILY. IT IS ADVISED TO TITRATE PREVIOUSLY UNTREATED PATIENTS UNDER CLOSE CLINICAL SUPERVISION, INCREASING THE DOSAGE IN 600-MG INCREMENTS EVERY 2 WEEKS TO 2400 MG/DAY BASED ON CLINICAL RESPONSE AND THEREAFTER TO 3600 MG/DAY IF CLINICALLY INDICATED.
CHILDREN WITH LENNOX-GASTAUT SYNDROME (AGES 2-14 YEARS)
ADJUNCTIVE THERAPY: FELBAMATE SHOULD BE ADDED AT 15 MG/KG/DAY IN DIVIDED DOSES THREE OR FOUR TIMES DAILY WHILE REDUCING PRESENT AEDS BY 20% IN ORDER TO CONTROL PLASMA LEVELS OF CONCURRENT PHENYTOIN, VALPROIC ACID, PHENOBARBITAL, AND CARBAMAZEPINE AND ITS METABOLITES. FURTHER REDUCTIONS OF THE CONCOMITANT AEDS DOSAGE MAY BE NECESSARY TO MINIMIZE SIDE EFFECTS DUE TO DRUG INTERACTIONS. INCREASE THE DOSAGE OF FELBAMATE BY 15 MG/KG/DAY INCREMENTS AT WEEKLY INTERVALS TO 45 MG/KG/DAY.
CONVERSION TO MONOTHERAPY: INITIATE FELBAMATE AT 1200 MG/DAY IN DIVIDED DOSES THREE OR FOUR TIMES DAILY. REDUCE THE DOSAGE OF CONCOMITANT AEDS BY ONE-THIRD AT INITIATION OF FELBAMATE THERAPY. AT WEEK 2, INCREASE THE FELBAMATE DOSAGE TO 2400 MG/DAY WHILE REDUCING THE DOSAGE OF OTHER AEDS UP TO AN ADDITIONAL ONE-THIRD OF THEIR ORIGINAL DOSAGE. AT WEEK 3, INCREASE THE FELBAMATE DOSAGE UP TO 3600 MG/DAY AND CONTINUE TO REDUCE THE DOSAGE OF OTHER AEDS AS CLINICALLY INDICATED.
ADJUNCTIVE THERAPY: FELBAMATE SHOULD BE ADDED AT 1200 MG/DAY IN DIVIDED DOSES THREE OR FOUR TIMES DAILY WHILE REDUCING PRESENT AEDS BY 20% IN ORDER TO CONTROL PLASMA CONCENTRATIONS OF CONCURRENT PHENYTOIN, VALPROIC ACID, PHENOBARBITAL, AND CARBAMAZEPINE AND ITS METABOLITES. FURTHER REDUCTIONS OF THE CONCOMITANT AEDS DOSAGE MAY BE NECESSARY TO MINIMIZE SIDE EFFECTS DUE TO DRUG INTERACTIONS. INCREASE THE DOSAGE OF FELBAMATE BY 1200 MG/DAY INCREMENTS AT WEEKLY INTERVALS TO 3600 MG/DAY. MOST SIDE EFFECTS SEEN DURING FELBAMATE ADJUNCTIVE THERAPY RESOLVE AS THE DOSAGE OF CONCOMITANT AEDS IS DECREASED.