Strattera

(atomoxetine) 

 

 

 

 Full Prescribing Information 

 DailyMed Drug Information 

 

 

 

 

 Forms/Strengths 

 

  Capsules: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg 

 

 

 Dosing 

 

 Age: ≥ 6 

 Onset: ~ 60 min 

 Considerations: Take the first dose on awakening. Additional doses may be given at intervals of 4-6 hours.  

 Initial Dose: 

 

 ≤70 kg: 0.5 mg/kg/day (1 or 2 divided doses) 

 >70 kg: 40 mg daily 

 

 

 Titration: 

 

 ≤70 kg: After at least 3 days at the initial dose, increase to approximately 1.2 mg/kg/day. 

 >70 kg: After at least 3 days at 40 mg/day, increase to 80 mg/day. If no improvement after 2-4 weeks, may increase up to 100 mg/day. 

 

 

 Max Dose: 

 

 ≤70 kg: lesser of 1.4 mg/kg/day or 100 mg/day 

 >70 kg: 100 mg/day 

 

 

 

 

 Quick Facts 

 

 Selective norepinephrine reuptake inhibitor; increases synaptic NE and indirectly boosts dopamine in the prefrontal cortex 

 Non-stimulant ADHD option; improves focus, attention, and impulse control 

 Oral capsule; weight-based, typically once-daily dosing 

 Common side effects: decreased appetite, nausea, dry mouth, fatigue, mood swings 

 Monitor for suicidal ideation in pediatric patients; consider liver function checks 

 

 

 Indications 

 

   ADHD (ICD-10: F90.0) 

 

 

 Off-Label Uses 

 

 Coexisting Anxiety or Tic Disorders : Used off-label in patients with ADHD who may have anxiety or tic disorders, as an alternative to stimulants. 

 Oppositional Defiant Disorder (ODD) : May help reduce irritability and impulsiveness when comorbid with ADHD. 

 Autism Spectrum Disorder (ASD)-associated ADHD symptoms : Sometimes considered when stimulants are not tolerated. 

 Substance Use Disorder in ADHD patients : Considered when stimulant misuse is a concern. 

 

 

 How to Take 

 

 Take once or twice daily , with the first dose in the morning ; if a second dose is needed, take it in the late afternoon. 

 Can be taken with or without food ; taking with food may help reduce nausea. 

 Swallow the capsule whole ; do not crush, chew, or open. 

 If a dose is missed , take it as soon as possible unless it is close to the next dose—do not double up. 

 Do not abruptly stop taking; consult a healthcare provider before discontinuation.   

 

 

 Side Effects 

 

   Common: Somnolence, gastrointestinal symptoms, decreased appetite. 

 Serious: Increased heart rate and blood pressure, suicidal thoughts (black box warning), rare cases of hepatitis 

 

 

 Monitoring / Labs 

 

 Cardiovascular : Baseline and routine monitoring of heart rate and blood pressure. 

 Growth in Pediatrics : Regular monitoring of height and weight to detect growth suppression. 

 Psychiatric Symptoms : Observe for mood changes, anxiety, or psychosis. 

 Abuse Potential : Monitor for misuse or diversion. 

 

 

 Education 

 

 

 When to Call the Doctor: 

 

 Severe mood changes, aggression, or suicidal thoughts . 

 Symptoms of liver dysfunction (yellowing of the skin/eyes, dark urine, persistent nausea). 

 Unusual bruising or bleeding. 

 Severe dizziness, fainting, or difficulty urinating. 

 Chest pain, rapid heartbeat, shortness of breath ( cardiovascular concerns ). 

 

 

 

 Safety Tips: 

 

 Monitor blood pressure and heart rate , as Strattera may cause increases. 

 Use caution in patients with a history of depression, bipolar disorder, or suicidal thoughts . 

 Avoid alcohol , as it may increase drowsiness and liver toxicity risk. 

 May cause drowsiness ; use caution when driving or operating heavy machinery. 

 Tapering may be needed when discontinuing to prevent withdrawal effects. 

 

 

 

 Parent Tips for Pediatric Patients: 

 

 Monitor for behavioral changes, increased agitation, or suicidal thoughts , particularly in the first few weeks. 

 May cause drowsiness or fatigue —observe how the child responds to the medication. 

 Encourage hydration and balanced meals to minimize side effects. 

 If taken for ADHD , track progress with teachers and caregivers to assess effectiveness. 

 

 

 

 

 Additional Information 

 

 

 Contraindications: 

 

 Hypersensitivity to atomoxetine or formulation components. 

 Use within 14 days of MAOI therapy (risk of hypertensive crisis). 

 Severe cardiovascular disease , including history of stroke or arrhythmia. 

 Narrow-angle glaucoma . 

 

 

 

 Pregnancy: 

 

 Category C ; use only if benefits outweigh risks. 

 Limited human data; animal studies suggest potential fetal harm. 

 

 

 

 Lactation: 

 

 Unknown if excreted in breast milk ; use with caution. 

 

 

 

 Drug Interactions: 

 

 CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) may increase atomoxetine levels. 

 Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk . 

 Albuterol and other stimulants may enhance cardiovascular side effects. 

 Antihypertensive medications may lead to excessive blood pressure lowering.