Praxis Medical Insights

Est. 2024 • Clinical Guidelines Distilled

Made possible by volunteer editors from the University of Calgary & University of Alberta

Last Updated: 8/15/2025

Medication Use in Special Populations

Dosing and Administration

  • The American College of Obstetricians and Gynecologists recommends a starting dose of 40 mg daily for atomoxetine in adults, with titration every 7-14 days to 60 mg then 80 mg daily, and a maximum dose of 1.4 mg/kg/day or 100 mg daily (whichever is lower) 1
  • The American College of Obstetricians and Gynecologists recommends a starting dose of 100-150 mg daily for bupropion SR formulation, with maintenance of 100-150 mg twice daily, and a starting dose of 150 mg daily for XL formulation, with maintenance of 150-300 mg daily, and a maximum dose of 450 mg per day 1
  • The initial dose of atomoxetine is recommended to be 0.5 mg/kg/day for children and adolescents up to 70 kg or 40 mg daily for adults and children over 70 kg, with increases after a minimum of 3 days to a target dose of 1.2 mg/kg/day or 80 mg daily, respectively 1, 2
  • Dose adjustments may be necessary for patients with hepatic impairment, with reductions to 50% of the normal dose for moderate impairment and 25% for severe impairment 1, 2
  • The following table summarizes the recommended dosing for atomoxetine:
Population Initial Dose Target Dose Maximum Dose
Children and adolescents up to 70 kg 0.5 mg/kg/day 1.2 mg/kg/day 1.4 mg/kg/day or 100 mg/day
Adults and children over 70 kg 40 mg daily 80 mg daily 1.4 mg/kg/day or 100 mg/day
Patients with moderate hepatic impairment 50% of normal dose 50% of normal dose 50% of normal dose
Patients with severe hepatic impairment 25% of normal dose 25% of normal dose 25% of normal dose

Safety and Efficacy

  • Atomoxetine does not appear to be associated with major congenital malformations, according to the American College of Obstetricians and Gynecologists 1
  • Bupropion has been associated with a small absolute increase in risk of cardiovascular malformations in some studies, though data are conflicting, as reported by the American College of Obstetricians and Gynecologists 1
  • A recent large, well-controlled study showed no increased risks for long-term developmental outcomes in children exposed to atomoxetine during pregnancy 1
  • Possible increased risk for spontaneous abortion has been noted, but confounding factors cannot be ruled out 1

Use During Breastfeeding

  • Bupropion is present in breast milk at low levels, with two case reports of seizures in breastfed infants, according to the American College of Obstetricians and Gynecologists 1
  • No published studies specifically examine atomoxetine during breastfeeding, but based on pharmacokinetics, atomoxetine is likely present in breast milk, and effects on nursing infants are unknown, with caution advised during breastfeeding 1

Combination Therapy

  • Patients with comorbid ADHD and depression or anxiety disorders may benefit from combination therapy, but it is crucial to exercise extreme caution or avoid it in patients with cardiovascular disease, hepatic impairment, history of seizures, narrow-angle glaucoma, or history of suicidal ideation or behavior 3, 4
  • The combination may be appropriate for cases where monotherapy has provided partial but inadequate symptom relief, according to the American Academy of Child and Adolescent Psychiatry 3, 4
  • When initiating atomoxetine in a patient already on fluoxetine, the American Academy of Child and Adolescent Psychiatry suggests starting at 50% of the normal dose and increasing doses slowly, with at least 1-2 weeks between adjustments, to minimize the risk of side effects due to the significant drug interaction through the CYP2D6 pathway 3, 4
  • Common side effects of the combination include headache, abdominal pain, decreased appetite, vomiting, somnolence, nausea, and cardiovascular effects such as increased heart rate and blood pressure, which should be closely monitored by healthcare providers 3, 4

Monitoring and Psychotherapy

  • Patients on combination therapy should be monitored for cardiovascular parameters (blood pressure and heart rate) at each visit, as well as mental health status, including watching for signs of serotonin syndrome (confusion, agitation, tremors, hyperreflexia, hyperthermia) 4
  • Regular checks of blood pressure, heart rate, and hepatic function are necessary, as both hormone therapy and atomoxetine can affect these parameters 1
  • Mental health should be closely monitored, with vigilance for mood changes, as both gender-affirming hormone therapy and ADHD medications can impact mood 1
  • Cognitive behavioral therapy (CBT) is the most extensively studied and effective psychotherapy for ADHD, focusing on developing executive functioning skills and teaching adaptive behavioral skills 1
  • Dialectical behavior therapy (DBT) and mindfulness-based stress reduction (MBSR) are also recommended, helping with inattention symptoms, emotion regulation, and quality of life 1