MYSOLINE Tablet Ref.[50489] Active ingredients: Primidone

Usual Dosage

Patients 8 years of age and older who have received no previous treatment may be started on MYSOLINE according to the following regimen using either 50 mg or scored 250 mg MYSOLINE tablets:

Days 1 to 3: 100 to 125 mg at bedtime.
Days 4 to 6: 100 to 125 mg twice a day.
Days 7 to 9: 100 to 125 mg three times a day.
Day 10 to maintenance: 250 mg three times a day.

For most adults and children 8 years of age and over, the usual maintenance dosage is three to four 250 mg MYSOLINE tablets in divided doses (250 mg three times a day or four times a day). If required, an increase to five or six 250 mg tablets daily may be made, but daily doses should not exceed 500 mg four times a day.

Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations of primidone may be necessary for optimal dosage adjustment. The clinically effective serum level for primidone is between 5 to 12 mcg/mL.

Patients Already Receiving Other Anticonvulsants

MYSOLINE should be started at 100 to 125 mg at bedtime and gradually increased to maintenance level as the other drug is gradually decreased. This regimen should be continued until satisfactory dosage level is achieved for the combination, or the other medication is completely withdrawn. When therapy with MYSOLINE alone is the objective, the transition from concomitant therapy should not be completed in less than 2 weeks.

Pediatric Dosage

For children under 8 years of age, the following regimen may be used:

Days 1 to 3: 50 mg at bedtime.
Days 4 to 6: 50 mg twice a day.
Days 7 to 9: 100 mg twice a day.
Day 10 to maintenance: 125 mg three times a day to 250 mg three times a day.

For children under 8 years of age, the usual maintenance dosage is 125 to 250 mg three times daily or, 10 to 25 mg/kg/day in divided doses.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container with a child-resistant closure.