Label: PRIMIDONE tablet

  • NDC Code(s): 72888-045-01, 72888-045-05, 72888-046-01, 72888-046-05, view more
  • Packager: Advagen Pharma Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 11, 2023

If you are a consumer or patient please visit this version.

  • 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 ...
  • 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 ...
  • CONTRAINDICATIONS
    Primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see - ACTIONS).
  • WARNINGS
    The abrupt withdrawal of antiepileptic medication may precipitate status epilepticus. The therapeutic efficacy of a dosage regimen takes several weeks before it can be assessed. Suicidal ...
  • PRECAUTIONS
    The total daily dosage should not exceed 2 g. Since primidone tablets therapy generally extends over prolonged periods, a complete blood count and a sequential multiple analysis-12 (SMA-12) test ...
  • ADVERSE REACTIONS
    The most frequently occurring early side effects are ataxia and vertigo. These tend to disappear with continued therapy, or with reduction of initial dosage. Occasionally, the following have been ...
  • DOSAGE AND ADMINISTRATION
    Usual Dosage - Patients 8 years of age and older who have received no previous treatment may be started on primidone tablets according to the following regimen using either 50 mg or scored 250 mg ...
  • HOW SUPPLIED
    Primidone Tablets, USP - 50 mg : White to off white, round tablets debossed with ‘Λ’ on one side and scored on the other side in bottles of 100 (NDC72888-045-01) and 500 (NDC72888-045-05) ...
  • MEDICATION GUIDE
    Primidone (Pri-MI-done) Tablets USP, 50 mg, 125 mg and 250 mg - Read this Medication Guide before you start taking primidone and each time you get a refill. There may be new information. This ...
  • PRINCIPAL DISPLAY PANEL
    Primidone Tablets, USP 50 mg - 100 Tablets - NDC 72888-045-01 - Primidone Tablets, USP 50 mg - 500 Tablets - NDC 72888-045-05 - Primidone Tablets, USP 125 mg - 30 Tablets - NDC ...
  • INGREDIENTS AND APPEARANCE
    Product Information