Mysoline (Primidone) - Indications and Dosage

INDICATIONS AND USAGE

Mysoline, used alone or concomitantly with other anticonvulsants, are indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.

DOSAGE AND ADMINISTRATION

Adult 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 1-3: 100 to 125 mg at bedtime
      Days 4-6: 100 to 125 mg b.i.d.
      Days 7-9: 100 to 125 mg t.i.d.
      Day 10-maintenance: 250 mg t.i.d.

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

INITIAL: ADULTS AND CHILDREN OVER 8

KEY: • = 50 mg tablet					● = 250 mg tablet
DAY	1	2	3	4	5	6
AM				‥	‥	‥
NOON
PM	‥	‥	‥	‥	‥	‥
DAY	7	8	9	10	11	12
AM	‥	‥	‥	●
NOON	‥	‥	‥	●	Adjust to
PM	‥	‥	‥	●	Maintenance

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 5-12 μg/mL.

In 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be continued until satisfactory dosage level is achieved for the combination, or the other medication is completely withdrawn.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 two weeks.

Pediatric dosage

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

      Days 1-3: 50 mg at bedtime
      Days 4-6: 50 mg b.i.d.
      Days 7-9: 100 mg b.i.d.
      Day 10-maintenance: 125 mg t.i.d. to 250 mg t.i.d.

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

HOW SUPPLIED

Mysoline Tablets

Each round, scored, white tablet, identified by “MYSOLINE 250” contains 250 mg of primidone, USP, in bottles of 100 (NDC 66490-691-10).

Also available in a unit-dose package of 100 (NDC 66490- 691-81).

Each square-shaped, scored, white tablet, identified by “MYSOLINE 50” and an embossed M, contains 50 mg of primidone, USP, in bottles of 100 (NDC 66490-690-10) and 500 (NDC 66490-690-50).

The appearance of the 50 mg tablets is a trademark of Valeant Pharmaceuticals North America.

Store at 20°C-25°C (68°F-77°F). [See USP controlled room temperature].

Dispense in a well-closed container with a child-resistant closure.

250 mg tablet manufactured by:
Watson Laboratories, Inc.
Corona, CA 92880 USA

50 mg tablet manufactured by:
Astellas Pharma Technologies Inc.
Norman, OK 73072 USA

Distributed by:
Valeant Pharmaceuticals N.A.
Aliso Viejo, CA 92656 USA

Rev.: 08-07