Recommended Dosage and Treatment Guidelines for Strattera (Atomoxetine) in ADHD
For patients with ADHD, atomoxetine (Strattera) should be dosed at 0.5 mg/kg/day initially, titrated to a target dose of 1.2 mg/kg/day, with a maximum dose of 1.4 mg/kg/day or 100 mg/day (whichever is lower). 1, 2
Dosing Guidelines by Age Group
Children and Adolescents (≤70 kg)
- Initial dose: 0.5 mg/kg/day
- Target dose: 1.2 mg/kg/day
- Maximum dose: 1.4 mg/kg/day
- Dose adjustment every 7-14 days 1, 2
Adolescents (>70 kg) and Adults
- Initial dose: 40 mg/day
- Target dose: 80 mg/day
- Maximum dose: 100 mg/day 2
Administration
- Can be administered as a single daily dose or split into two evenly divided doses 3, 4
- Once-daily dosing improves medication adherence 1
- Can be taken with or without food
Special Populations
Hepatic Impairment
- Dosage adjustment required for patients with hepatic insufficiency 2
- Patients with moderate hepatic impairment: reduce to 50% of normal dose
- Patients with severe hepatic impairment: reduce to 25% of normal dose
CYP2D6 Poor Metabolizers
- Dosage adjustment required for known CYP2D6 poor metabolizers 2
- These patients have greater exposure to and slower elimination of atomoxetine 3
Patients Taking CYP2D6 Inhibitors
- Dosage adjustment required when co-administered with strong CYP2D6 inhibitors (e.g., paroxetine) 2
Treatment Recommendations by Age
Elementary School-Aged Children (6-11 years)
- FDA-approved medications for ADHD, including atomoxetine, are recommended as first-line treatment 5
- Evidence is particularly strong for stimulant medications and sufficient but less strong for atomoxetine 5
- Combining medication with parent/teacher-administered behavior therapy is strongly recommended 5
Adolescents (12-18 years)
- FDA-approved medications for ADHD, including atomoxetine, are strongly recommended with the adolescent's assent 5
- Behavioral interventions are also recommended, preferably in combination with medication 5
Adults
- Atomoxetine is approved for adult ADHD treatment 4
- Same dosing principles apply, with maximum dose of 100 mg/day
Monitoring and Follow-up
Initial Titration
- Titrate doses to achieve maximum benefit with minimum adverse effects 5
- Schedule follow-up within 2-4 weeks after initiation 1
- Monitor vital signs, particularly heart rate and blood pressure 1, 2
- Assess for side effects including insomnia, appetite changes, and mood effects
Long-term Monitoring
- Regular follow-up visits to monitor effectiveness and side effects
- Assess for emerging comorbidities
- Evaluate functional improvement across settings
- Monitor height and weight in pediatric patients 2
Safety Considerations
Cardiovascular Effects
- Monitor for increases in heart rate and blood pressure 2, 3
- Use with caution in patients with hypertension, tachycardia, or cardiovascular disease 2
- Contraindicated in severe cardiovascular disorders 2
Psychiatric Effects
- Black box warning for increased risk of suicidal ideation in children and adolescents 2
- Monitor for emergence of new psychotic or manic symptoms 2
- Screen for bipolar disorder prior to starting treatment 2
Other Important Safety Considerations
- Severe liver injury: discontinue if jaundice or laboratory evidence of liver injury occurs 2
- Potential for allergic reactions 2
- Urinary hesitancy and retention may occur 2
- Priapism requires prompt medical attention 2
Advantages of Atomoxetine
- No abuse potential, making it suitable for patients with history of substance dependence 1
- Not a controlled substance in the US 3, 6
- May be beneficial for patients with comorbid anxiety disorders 1
- Preferred for patients with tic disorders/Tourette's syndrome 1
- Can be effective for both ADHD and depression symptoms 1
Common Side Effects
- Gastrointestinal: dry mouth, nausea, decreased appetite, constipation 3, 4
- Neurological: headache, dizziness, somnolence 3
- Other: sweating, dysuria, sexual problems, palpitations 4
Efficacy Considerations
- In clinical trials, atomoxetine doses of 1.2 mg/kg/day and 1.8 mg/kg/day showed similar efficacy, suggesting 1.2 mg/kg/day is an appropriate target dose for most patients 7
- Atomoxetine is significantly more effective than placebo but may be less effective than extended-release stimulant formulations 3, 6
Atomoxetine provides an important non-stimulant option for ADHD treatment with demonstrated efficacy and generally good tolerability, particularly valuable for patients with substance abuse risk or comorbid anxiety or tics.