Atomoxetine Hydrochloride

What it is and how it works

Mechanism of Action The precise mechanism by which atomoxetine produces its therapeutic effects in Attention-Deficit/Hyperactivity Disorder (ADHD) is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter, as determined in ex vivo uptake and neurotransmitter depletion studies.

Indications

Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) . Diagnostic Considerations A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home.

Dosage and administration (summary)

Initial, Target and Maximum Daily Dose (Acute and Maintenance/Extended Treatment) Body Weight Initial Daily Dose Target Total Daily Dose Maximum Total Daily Dose Children and adolescents up to 70 kg 0.5 mg/kg 1.2 mg/kg 1.4 mg/kg Children and adolescents over 70 kg and adults 40 mg 80 mg 100 mg Dosing adjustment – Hepatic Impairment, Strong CYP2D6 Inhibitor, and in patients known to be CYP2D6 poor metabolizers (PMs).

Contraindications

Hypersensitivity to atomoxetine or other constituents of product. Atomoxetine capsules use within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations. (4.2 , 7.1) Narrow Angle Glaucoma. Pheochromocytoma or history of pheochromocytoma. Severe Cardiovascular Disorders that might deteriorate with clinically important increases in HR and BP.

Warnings and precautions

Suicidal Ideation – Monitor for suicidality, clinical worsening, and unusual changes in behavior. Severe Liver Injury – Should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. Serious Cardiovascular Events – Sudden death, stroke and myocardial infarction have been reported in association with atomoxetine treatment. Patients should have a careful history and physical exam to assess for presence of cardiovascular disease.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including atomoxetine, during pregnancy.

Storage and supply

How Supplied Atomoxetine Capsules USP, 25 mg* are blue opaque/off-white opaque, size ‘4’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘F’ on blue opaque cap & ‘43’ on off-white opaque body with black ink.

Source: Atomoxetine (Atomoxetine) — US FDA prescribing information, 2026-06-25, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.