{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "primidone",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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 primidone tablets: Days 1 to 3: 100 to 125 mg at bedtime.",
        "source": "US FDA label for primidone (Primidone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/primidone.json",
        "verbatim": true
      },
      {
        "text": "Days 7 to 9: 100 to 125 mg three times a day.",
        "source": "US FDA label for primidone (Primidone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/primidone.json",
        "verbatim": true
      },
      {
        "text": "Day 10 to maintenance: 250 mg three times a day.",
        "source": "US FDA label for primidone (Primidone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/primidone.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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 primidone tablets: Days 1 to 3: 100 to 125 mg at bedtime. Days 4 to 6: 100 to 125 mg twice a day. Days 7 to 9: 100 to 125 mg three times a day. Day 10 to maintenance: 250 mg three times a day.",
        "source": "US FDA label for primidone (Primidone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/primidone.json",
        "verbatim": true
      },
      {
        "text": "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 primidone tablets: Days 1 to 3: 100 to 125 mg at bedtime.",
        "source": "US FDA label for primidone (Primidone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/primidone.json",
        "verbatim": true
      },
      {
        "text": "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 three times a day or four times a day).",
        "source": "US FDA label for primidone (Primidone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/primidone.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for primidone (Primidone), retrieved 2026-08-29",
        "cached_file": "labels/primidone.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for primidone (Primidone), retrieved 2026-08-29",
        "cached_file": "labels/primidone.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "To provide information regarding the effects of in utero exposure to primidone tablets, physicians are advised to recommend that pregnant patients taking primidone tablets enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.",
        "source": "US FDA label for primidone (Primidone), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/primidone.json",
        "verbatim": true
      },
      {
        "text": "This can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves.",
        "source": "US FDA label for primidone (Primidone), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/primidone.json",
        "verbatim": true
      },
      {
        "text": "Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.",
        "source": "US FDA label for primidone (Primidone), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/primidone.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "There is evidence in mothers treated with primidone that the drug appears in breast milk in substantial quantities.",
        "source": "US FDA label for primidone (Primidone), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/primidone.json",
        "verbatim": true
      },
      {
        "text": "Since tests for the presence of primidone in biological fluids are too complex to be carried out in the average clinical laboratory, it is suggested that the presence of undue somnolence and drowsiness in nursing newborns of primidone-treated mothers be taken as an indication that nursing should be discontinued.",
        "source": "US FDA label for primidone (Primidone), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/primidone.json",
        "verbatim": true
      }
    ]
  }
}