Recommended Dosing Levels for Atomoxetine (Strattera)
The recommended dosing for atomoxetine is weight-based: 0.5 mg/kg/day initially, increased after at least 3 days to a target dose of 1.2 mg/kg/day for children and adolescents up to 70 kg, or starting at 40 mg/day and increasing to 80 mg/day for adults and children over 70 kg. 1
Initial Dosing
Children and adolescents up to 70 kg:
- Start at 0.5 mg/kg/day
- Increase after minimum 3 days to target dose of 1.2 mg/kg/day
- Maximum dose: 1.4 mg/kg/day or 100 mg/day (whichever is less)
- May be given as a single morning dose or divided into morning and late afternoon doses 1
Adults and children over 70 kg:
- Start at 40 mg/day
- Increase after minimum 3 days to target dose of 80 mg/day
- May increase to maximum 100 mg/day after 2-4 additional weeks if optimal response not achieved
- May be given as a single morning dose or divided into morning and late afternoon doses 1
Special Populations
Hepatic Impairment:
- Moderate impairment (Child-Pugh Class B): Reduce initial and target doses to 50% of normal
- Severe impairment (Child-Pugh Class C): Reduce initial and target doses to 25% of normal 1
CYP2D6 Poor Metabolizers or Patients Taking CYP2D6 Inhibitors:
- Children and adolescents up to 70 kg: Start at 0.5 mg/kg/day, increase to 1.2 mg/kg/day only if needed after 4 weeks
- Adults and children over 70 kg: Start at 40 mg/day, increase to 80 mg/day only if needed after 4 weeks 1, 2
Administration Guidelines
- May be taken with or without food
- Capsules should be swallowed whole, not opened
- Can be discontinued without tapering 1
Efficacy and Dose-Response
- Clinical trials demonstrate a graded dose-response relationship
- 1.2 mg/kg/day appears to be as effective as 1.8 mg/kg/day for most patients 3
- No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day 1
- Safety of single doses over 120 mg and total daily doses above 150 mg has not been systematically evaluated 1
Monitoring
- Monitor for side effects during initial titration phase
- Regular assessment of cardiovascular parameters (blood pressure and heart rate)
- Periodic reevaluation of long-term usefulness for individual patients 2, 1
Common Side Effects
- Children and adolescents: Dyspepsia, nausea, vomiting, decreased appetite, weight loss 4
- Adults: Dry mouth, insomnia, nausea, decreased appetite, constipation, urinary difficulties, sexual dysfunction 4, 5
Important Considerations
- Atomoxetine is the first non-stimulant medication approved for ADHD and the only agent approved for adults with ADHD 4, 6
- Unlike stimulants, atomoxetine is not a controlled substance and has no abuse potential 5
- Screen for bipolar disorder prior to initiating treatment 1
- Use caution in patients with cardiovascular disorders or hypertension 4
Atomoxetine offers an effective alternative for patients who cannot tolerate or do not respond to stimulant medications, with comparable efficacy to methylphenidate in controlling ADHD symptoms 4, 6.