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Primidone (Primidone) - Indications and Dosage

 
 



INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

Adult Dosage

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

Days 1 to 3: 100 to 125 mg at bedtime.
Days 4 to 6: 100 to 125 mg b.i.d.
Days 7 to 9: 100 to 125 mg t.i.d.
Day 10 to 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 primidone tablets, USP 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.

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

In Patients Already Receiving Other Anticonvulsants

Primidone tablets, USP 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be continued until satisfactory dosage level is achieved for the combination, or the other medication is completely withdrawn.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 primidone tablets, USP 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 to 3: 50 mg at bedtime.
Days 4 to 6: 50 mg b.i.d.
Days 7 to 9: 100 mg b.i.d.
Day 10 to 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 to 25 mg/kg/day in divided doses.

HOW SUPPLIED

Primidone Tablets USP 50 mg are supplied as white, round, flat faced tablets, debossed
AN above 44 on one side and cut-bisected on the other side.

NDC 50268-686-15   10 Tablets per card, 5 cards per carton

Primidone Tablets USP 250 mg are supplied as white, round, flat faced tablets, debossed
AN bisect 545 on one side and plain on the other side.

NDC 50268-687-15   10 Tablets per card, 5 cards per carton

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
[See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Dispensed in a blister punch material for Institutional Use Only.

Manufactured for:
AvKARE, Inc.
Pulaski, TN  38478

Mfg. Rev. 06/12

AvPAK
AV Rev. 02/13 (P)

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