Label: PRIMIDONE tablet

  • NDC Code(s): 69584-684-10, 69584-684-50, 69584-685-10, 69584-685-50
  • Packager: Oxford Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 5, 2022

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  • 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 ...
  • ACTIONS
    Primidone raises electro- or chemoshock seizure thresholds or alters seizure patterns in experimental animals. The mechanism(s) of primidone's antiepileptic action is not known. Primidone per se ...
  • 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 therapy generally extends over prolonged periods, a complete blood count and a sequential multiple analysis-12 (SMA-12) test should be ...
  • 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 according to the following regimen using either 50 mg or scored 250 mg ...
  • HOW SUPPLIED
    Primidone 50 mg Tablets, USP are white, round, flat faced, beveled edge, scored tablets debossed "684" above bisect on one side and "O" on the other side. Supplied in: bottles of 100, NDC ...
  • MEDICATION GUIDE
    Primidone Tablets, USP, 50 mg and 250 mg - Dispense with Medication Guide available at: https://www.oxford-rx.com/med-guides - Read this Medication Guide before you start taking primidone tablets ...
  • PRINCIPAL DISPLAY PANEL
    NDC 69584-684-10 - Primidone - Tablets, USP - 50 mg ANTICONVULSANT - PHARMACIST: DISPENSE THE - ACCOMPANYING MEDICATION - GUIDE TO EACH PATIENT - Rx only        100 ...
  • INGREDIENTS AND APPEARANCE
    Product Information