RVP

Drug Catalog - Product Detail

PRIMIDONE TB 50MG 500

NDC Mfr Size Str Form
00603-5371-28 PAR PHARMACEUTICALS 500 50MG TABLET
Product Image

PACKAGE FILES

Package Image
Package Image
Package Image
Package Image
Generic Name
PRIMIDONE
Substance Name
PRIMIDONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA040586
Description
DESCRIPTION Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. Structural formula: Primidone is a white, crystalline, highly stable substance, M.P. 279-284° C. It is poorly soluble in water (60 mg per 100 mL at 37° C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog. This is an image of the structural formula of primidone. Primidone 50 mg and 250 mg tablets contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and talc. Primidone 250 mg tablets also contain D&C yellow #10 aluminum lake and FD&C yellow #5 aluminum lake.
How Supplied
HOW SUPPLIED Primidone 50 mg Tablets, USP are white, round, flat faced, scored tablets debossed "5130" on one side and "V" on the reverse side and supplied as follows: Bottles of 100: NDC 0603-5371-21 Bottles of 500: NDC 0603-5371-28 Primidone 250 mg Tablets, USP are yellow, round, flat faced, scored tablets debossed "5131" on one side and "V" on the reverse side and supplied as follows: Bottles of 100: NDC 0603-5372-21 Bottles of 500: NDC 0603-5372-28 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.
Indications & Usage
INDICATIONS AND USAGE Primidone, 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 and Administration
DOSAGE AND 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: 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 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 may be necessary for optimal dosage adjustment. The clinically effective serum level for primidone is between 5 to 12 µg/mL. This is an image of a table for dosage and administration. In Patients Already Receiving Other Anticonvulsants Primidone 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 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.