{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "amitriptyline",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Initial Dosage for Adults For outpatients, 75 mg of amitriptyline hydrochloride a day in divided doses is usually satisfactory.",
        "source": "US FDA label for amitriptyline (Amitriptyline Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amitriptyline.json",
        "verbatim": true
      },
      {
        "text": "If necessary, this may be increased to a total of 150 mg per day.",
        "source": "US FDA label for amitriptyline (Amitriptyline Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amitriptyline.json",
        "verbatim": true
      },
      {
        "text": "An alternate method of initiating therapy in outpatients is to begin with 50 mg to 100 mg amitriptyline hydrochloride at bedtime.",
        "source": "US FDA label for amitriptyline (Amitriptyline Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amitriptyline.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and W ARNINGS: Clinical Worsening and Suicide Risk ). Anyone considering the use of amitriptyline in a child or adolescent must balance the potential risks with the clinical need.",
        "source": "US FDA label for amitriptyline (Amitriptyline Hydrochloride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/amitriptyline.json",
        "verbatim": true
      },
      {
        "text": "Oral Dosage Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Initial Dosage for Adults For outpatients, 75 mg of amitriptyline hydrochloride a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses.",
        "source": "US FDA label for amitriptyline (Amitriptyline Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amitriptyline.json",
        "verbatim": true
      },
      {
        "text": "Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages.",
        "source": "US FDA label for amitriptyline (Amitriptyline Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amitriptyline.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 amitriptyline (Amitriptyline Hydrochloride), retrieved 2026-08-29",
        "cached_file": "labels/amitriptyline.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 amitriptyline (Amitriptyline Hydrochloride), retrieved 2026-08-29",
        "cached_file": "labels/amitriptyline.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Usage in Pregnancy Pregnancy Teratogenic effects were not observed in mice, rats, or rabbits when amitriptyline was given orally at doses of 2 to 40 mg/kg/day (up to 13 times the maximum recommended human dose 1 ).",
        "source": "US FDA label for amitriptyline (Amitriptyline Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/amitriptyline.json",
        "verbatim": true
      },
      {
        "text": "Studies in the literature have shown amitriptyline to be teratogenic in mice and hamsters when given by various routes of administration at doses of 28 to 100 mg/kg/day (9 to 33 times the maximum recommended human dose), producing multiple malformations.",
        "source": "US FDA label for amitriptyline (Amitriptyline Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/amitriptyline.json",
        "verbatim": true
      },
      {
        "text": "Another study in the rat reported that an oral dose of 25 mg/kg/day (8 times the maximum recommended human dose) produced delays in ossification of fetal vertebral bodies without other signs of embryotoxicity.",
        "source": "US FDA label for amitriptyline (Amitriptyline Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/amitriptyline.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Amitriptyline is excreted into breast milk.",
        "source": "US FDA label for amitriptyline (Amitriptyline Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/amitriptyline.json",
        "verbatim": true
      },
      {
        "text": "In one report in which a patient received amitriptyline 100 mg/day while nursing her infant, levels of 83 to 141 ng/mL were detected in mother’s serum.",
        "source": "US FDA label for amitriptyline (Amitriptyline Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/amitriptyline.json",
        "verbatim": true
      },
      {
        "text": "Levels of 135 to 151 ng/mL were found in the breast milk, but no trace of the drug could be detected in the infant’s serum.",
        "source": "US FDA label for amitriptyline (Amitriptyline Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/amitriptyline.json",
        "verbatim": true
      }
    ]
  }
}