Amitriptyline

DRUG INFORMATION

  ADULT
    - 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
    - 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
    - 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

  CHILD
    - 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
    - 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
    - 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

  RENAL IMPAIRMENT
    - 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

  HEPATIC IMPAIRMENT
    - 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

  PREGNANCY
    - 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
    - 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
    - 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

  BREASTFEEDING
    - Amitriptyline is excreted into breast milk.
      Source: US FDA label for amitriptyline (Amitriptyline Hydrochloride), section
      'nursing mothers', retrieved 2026-08-29
    - 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
    - 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