Atomoxetine

Atomoxetine capsule is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1 ) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsule is 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) [see Clinical Studies ( 14 )]. …

• 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)
• Acute Treatment Dosing of children and adolescents up to 70 kg body weight - Atomoxetine capsules should be initiated at a total daily dose of approximately 0.5 mg/kg and increased after a minimum of 3 days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening
• No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day [see Clinical Studies ]
• The total daily dose in children and adolescents should not exceed 1.4 mg/kg or 100 mg, whichever is less
• Dosing of children and adolescents over 70 kg body weight and adults - Atomoxetine capsules should be initiated at a total daily dose of 40 mg and increased after a minimum of 3 days to a target total daily dose of approximately 80 mg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening
• After 2 to 4 additional weeks, the dose may be increased to a maximum of 100 mg in patients who have not achieved an optimal response. …

Each capsule contains atomoxetine hydrochloride equivalent to 10 mg (white opaque/white opaque), 18 mg (yellow/white opaque), 25 mg (opaque blue/white opaque) , 40 mg (blue opaque/blue opaque), 60 mg (blue opaque/yellow), 80 mg (brown opaque/white opaque), or 100 mg (brown opaque/brown opaque) of atomoxetine. …

• Anyone considering the use of atomoxetine in a child or adolescent must balance the potential risks with the clinical need [see Boxed Warning and Warnings and Precautions ]
• The pharmacokinetics of atomoxetine in children and adolescents are similar to those
• In adults
• The safety, efficacy, and pharmacokinetics of atomoxetine
• In pediatric patients less than 6 years of age have not been evaluated
• A study was conducted in young rats to evaluate the effects of atomoxetine on growth and neurobehavioral and sexual development. …

The safety, efficacy and pharmacokinetics of atomoxetine in geriatric patients have not been evaluated.

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• General Information Physicians should instruct their patients to read the Medication Guide before starting therapy with atomoxetine and to reread it each time the prescription is renewed
• Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with atomoxetine and should counsel them in its appropriate use
• The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. …

• Hypersensitivity to atomoxetine or other constituents of product. ( 4.1 ) • Atomoxetine capsules use within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations. ( 4.2 , 7.1 ) • Narrow Angle Glaucoma. ( 4.3 ) • Pheochromocytoma or history of pheochromocytoma.( 4.4 ) • Severe Cardiovascular Disorders that might deteriorate with clinically important increases in HR and BP. …

• Monoamine Oxidase Inhibitors. ( 4.2 , 7.1 ) • CYP2D6 Inhibitors - Concomitant use may increase atomoxetine steady-state plasma concentrations in EMs. ( 7.2 ) • Antihypertensive Drugs and Pressor Agents – Possible effects on blood pressure. ( 7.3 ) • Albuterol (or other beta 2 agonists) - Action of albuterol on cardiovascular system can be potentiated. …

• Suicidal Ideation – Monitor for suicidality, clinical worsening, and unusual changes in behavior. ( 5.1 ) • Severe Liver Injury – Should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. ( 5.2 ) • 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. …

Most common adverse reactions (≥5% and at least twice the incidence of placebo patients) • Child and Adolescent Clinical Trials – Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. ( 6.1 ) • Adult Clinical Trials – Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Atomoxetine was administered to 5382 children or adolescent patients with ADHD and 1007 adults with ADHD in clinical studies. …

8.1 Pregnancy: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including atomoxetine, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/. …

10.1 Human Experience There is limited clinical trial experience with atomoxetine overdose. During postmarketing, there have been fatalities reported involving a mixed ingestion overdose of atomoxetine and at least one other drug. There have been no reports of death involving overdose of atomoxetine alone, including intentional overdoses at amounts up to 1400 mg. In some cases of overdose involving atomoxetine, seizures have been reported. …

9.1 Controlled Substance Atomoxetine is not a controlled substance. 9.2 Abuse In a randomized, double-blind, placebo-controlled, abuse-potential study in adults comparing effects of atomoxetine and placebo, atomoxetine was not associated with a pattern of response that suggested stimulant or euphoriant properties. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.