Suev 10

• Attention-Deficit/Hyperactivity Disorder (ADHD) in pediatric patients (ages 6 and older), adolescents, and adults

Children & Adolescents (6 years+) - ADHD:

• Body weight ≤70 kg: Initial dose 40 mg/day (once daily or divided into 2 doses). May increase to 80 mg/day after at least 7 days. May increase to 100 mg/day after 2-4 weeks if needed.
• Body weight >70 kg: Initial dose 40 mg/day (once daily or divided into 2 doses). May increase to 80 mg/day after at least 7 days. May increase to 100 mg/day after 2-4 weeks if needed.

Adults - ADHD:

• Initial dose: 40 mg/day (once daily or divided into 2 doses). May increase to 80 mg/day after at least 7 days. May increase to 100 mg/day after 2-4 weeks if needed.
• Doses above 80 mg/day are not recommended in adults.

Hepatic Impairment:

• Moderate impairment (Child-Pugh Class B): Reduce dose by 50%.
• Severe impairment (Child-Pugh Class C): Reduce dose by 75%.

Renal Impairment: Dose adjustment may be needed in ESRD patients.

Common Adverse Reactions in Children & Adolescents (≥5% and at least twice placebo):

• Nausea
• Vomiting
• Fatigue
• Decreased appetite
• Abdominal pain
• Somnolence

Common Adverse Reactions in Adults:

• Constipation
• Dry mouth
• Nausea
• Decreased appetite
• Dizziness
• Urinary hesitation
• Erectile dysfunction

Serious Adverse Reactions:

• Suicidal ideation in children and adolescents (0.4% of patients)
• Severe liver damage (rare)
• Increased heart rate and blood pressure
• Psychotic or manic symptoms (rare)

Serious Precautions:

• Suicide risk: Atomoxetine increases the risk of suicidal ideation in children and adolescents. Close monitoring is required during initiation and dose changes.
• Liver damage: Inform your doctor immediately if you experience signs of liver problems (itching, right upper abdominal pain, dark urine, yellow skin/eyes).
• Cardiac risk: Caution in patients with heart problems, heart defects, or high blood pressure.
• Psychiatric symptoms: Inform your doctor if you develop new psychotic or manic symptoms.
• Driving and machinery: Do not drive or operate hazardous machinery until you know how atomoxetine affects you.
• Growth and weight monitoring: Monitor height and weight in children during treatment.
• Do not stop suddenly: Do not stop taking the medication without talking to your doctor first.