Atomoxetine capsules for treatment of ADHD in children and adults

Atomoxetine capsules are prescription medicine used to treat attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years and older, as well as adults. They are intended as part of a comprehensive ADHD treatment plan that may include psychological, educational, and social interventions.

Atomoxetine capsules are approved for the treatment of ADHD in pediatric patients 6 years of age and older and in adults. The medication is used as an integral part of a total treatment program tailored to individual patient needs.

Atomoxetine hydrochloride

Atomoxetine is a selective norepinephrine reuptake inhibitor (SNRI). It works by increasing norepinephrine levels in the brain, which helps improve attention and reduce impulsivity and hyperactivity in people with ADHD.

Recommended Dosage for ADHD Treatment

Atomoxetine capsules dosing varies by age and weight:

• Pediatric patients < 70 kg: Start at 0.5 mg/kg/day; titrate after at least 3 days to a target dose of 1.2 mg/kg/day; maximum dose is 1.4 mg/kg/day or 100 mg/day, whichever is lower.
• Pediatric patients ≥ 70 kg and adults: Start at 40 mg/day; titrate after at least 3 days to a target dose of 80 mg/day; maximum dose is 100 mg/day.

Doses may be given once daily in the morning or divided twice daily (morning and late afternoon/early evening). Capsules should be taken whole, with or without food.

Special Populations and Dose Adjustments

• Hepatic impairment: Severe impairment (Child-Pugh C): 25% of recommended dose; moderate impairment (Child-Pugh B): 50% of recommended dose; mild impairment (Child-Pugh A): normal dosing.
• CYP2D6 poor metabolizers or patients using strong CYP2D6 inhibitors: A longer titration interval of 4 weeks is recommended if symptoms do not improve and the initial dose is tolerated. Dosing remains the same as standard recommendations.

Additional Instructions

• Screen for bipolar disorder before initiating therapy.
• Allow at least 14 days between stopping or starting monoamine oxidase inhibitors (MAOIs) and atomoxetine.
• If a dose is missed, take as soon as possible but do not exceed the total daily prescribed dose in 24 hours.
• No tapering is required when discontinuing atomoxetine.

• Known hypersensitivity to atomoxetine or any capsule ingredient, including anaphylaxis and angioneurotic edema.
• Use with or within 14 days of stopping a monoamine oxidase inhibitor (MAOI).
• Narrow angle glaucoma.
• Pheochromocytoma or history of pheochromocytoma.
• Severe cardiac or vascular disorders that may worsen with increased blood pressure or heart rate.

Key Warnings and Precautions

• Suicidal thoughts and behavior: Pediatric patients 6 years and older should be closely monitored for suicidal ideation or behavior, especially during the first months or dose changes. Families should be alert and communicate promptly with health care providers. Consider stopping atomoxetine if emergent suicidality occurs.
• Severe liver injury: Discontinue atomoxetine in patients with signs or laboratory evidence of liver damage. Liver damage may occur within 4 months of starting treatment, and symptoms can worsen after stopping the drug.
• Cardiovascular risks: Obtain careful cardiac history and exam prior to use, particularly for structural cardiac abnormalities or serious heart conditions. Atomoxetine is contraindicated in patients with severe cardiac or vascular disorders that may worsen with increased blood pressure or heart rate. Measure heart rate and blood pressure at baseline, after dosage increases, and periodically thereafter.
• Psychiatric symptoms: Monitor carefully for new or worsening psychotic or manic symptoms. Screen for bipolar disorder risk factors before starting treatment. Consider discontinuation if such symptoms develop.
• Aggressiveness and hostility: Monitor for exacerbation or new onset of aggressive behavior or hostility during treatment.
• Urinary effects: Watch for urinary retention or hesitancy, which may occur during treatment.
• Priapism: Seek immediate medical attention if prolonged or painful erection occurs.
• Growth monitoring: Pediatric patients should have growth (height and weight) monitored during therapy.

Common and Serious Side Effects

• Common: Increase in heart rate and blood pressure, urinary hesitation, irritability, insomnia, stomach upset, and dry mouth.
• Serious: Suicidal ideation and behavior in pediatric patients, severe liver injury, hypersensitivity reactions (anaphylaxis, angioneurotic edema, rash, urticaria), psychosis or mania, aggressive behavior, urinary retention, priapism, and cardiovascular events (e.g., sudden death in patients with underlying cardiac abnormalities).

Drug Interactions

• Contraindicated with monoamine oxidase inhibitors (MAOIs). Allow a 14-day washout period before starting or stopping atomoxetine.
• Strong CYP2D6 inhibitors or poor CYP2D6 metabolizers may require longer titration intervals and careful monitoring.