What is the recommended dose titration schedule for atomoxetine (Strattera)?

From the Guidelines

The recommended dose titration schedule for atomoxetine (Strattera) is a sequential, weight-based approach, with a maximum recommended dosage of 1.4 mg/kg/day or 100 mg/day, whichever is lower. This approach is based on the most recent evidence from 2022, which emphasizes the importance of careful dose titration to minimize the risk of adverse effects 1.

Key Considerations

• The dose titration schedule should be individualized based on the patient's weight, with a maximum recommended dosage of 1.4 mg/kg/day or 100 mg/day, whichever is lower.
• Patients with hepatic impairment or who are known CYP2D6 poor metabolizers should start at 50% of the normal dose with more gradual titration.
• Common side effects during titration include decreased appetite, nausea, and fatigue, which often improve with continued treatment.
• Full therapeutic effects may take 2-4 weeks to develop, so patience during the titration period is important.

Monitoring and Precautions

• All children being treated with atomoxetine should be monitored closely for suicidality, clinical worsening, and unusual changes of behavior, especially during the first few months of treatment or at times of dose change 1.
• Warnings also exist for preexisting cardiovascular diseases/significant cardiac abnormalities, emergent psychotic or manic symptoms, bipolar disorder, aggressive behavior or hostility, possible allergic reactions, effects on urine outflow and growth, and priapism in children, adolescents, and adults 1.

From the FDA Drug Label

Atomoxetine capsules should be initiated at a total daily dose of approximately 0.5 mg/kg and increased after a minimum of 3 days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. Dosing of children and adolescents over 70 kg body weight and adults - Atomoxetine capsules should be initiated at a total daily dose of 40 mg and increased after a minimum of 3 days to a target total daily dose of approximately 80 mg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening After 2 to 4 additional weeks, the dose may be increased to a maximum of 100 mg in patients who have not achieved an optimal response.

The recommended dose titration schedule for atomoxetine (Strattera) is as follows:

• For children and adolescents up to 70 kg body weight:
  • Initiate at 0.5 mg/kg/day
  • Increase to 1.2 mg/kg/day after a minimum of 3 days
• For children and adolescents over 70 kg body weight and adults:
  • Initiate at 40 mg/day
  • Increase to 80 mg/day after a minimum of 3 days
  • May increase to 100 mg/day after 2 to 4 additional weeks if optimal response is not achieved 2

From the Research

Atomoxetine Dose Titration

• The recommended dose titration schedule for atomoxetine (Strattera) is not explicitly stated in the provided studies, but the efficacy and safety of different dosing regimens are discussed 3, 4, 5, 6.
• A study published in 2001 found that atomoxetine was effective in reducing ADHD symptoms in children and adolescents, with a graded dose-response observed at doses of 0.5 mg/kg/day, 1.2 mg/kg/day, and 1.8 mg/kg/day 4.
• Another study published in 2004 found that once-daily atomoxetine treatment was effective in children with ADHD, with significant reductions in symptoms observed during the evening and morning hours 6.
• A pilot study published in 2007 found that a stepwise cross-titration from methylphenidate or amphetamine to atomoxetine was well-tolerated and effective in improving ADHD symptoms in children and adolescents 5.
• The clinical pharmacokinetics of atomoxetine are influenced by the activity of cytochrome P450 2D6, with poor metabolizers having higher plasma concentrations and longer half-lives compared to extensive metabolizers 7.

Dosing Regimens

• The studies suggest that atomoxetine can be administered once daily or in divided doses, with a target dose of 1.2 mg/kg/day or 1.8 mg/kg/day 4, 6.
• The dose titration schedule may need to be adjusted based on individual patient response and tolerability, with careful monitoring of adverse events and efficacy 3, 5.
• The use of atomoxetine in patients with hepatic insufficiency or those taking CYP2D6 inhibitors may require dose adjustments due to changes in pharmacokinetics 7.