0.39-4.88 – not statistically significant]).

The physician who elects to use Atomoxetine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient Atomoxetine capsules may be taken with or without food.Atomoxetine capsules can be discontinued without being tapered.Atomoxetine capsules are not intended to be opened, they should be taken whole The safety of single doses over 120 mg and total daily doses above 150 mg have not been systematically evaluated.In children and adolescents over 70 kg body weight and adults administered strong CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine, Atomoxetine should be initiated at 40 mg/day and only increased to the usual target dose of 80 mg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated.Each capsule contains Atomoxetine hydrochloride, USP equivalent to 10 mg (Opaque White, Opaque White), 18 mg (Opaque Gold, Opaque White), 25 mg (Opaque Blue, Opaque White), 40 mg (Opaque Blue, Opaque Blue), 60 mg (Opaque Blue, Opaque Gold), 80 mg (Opaque Orange, Opaque White), or 100 mg (Opaque Orange, Opaque Orange) of Atomoxetine.Atomoxetine capsules are contraindicated in patients known to be hypersensitive to Atomoxetine or other constituents of the product Atomoxetine should not be taken with an MAOI, or within 2 weeks after discontinuing an MAOI. Such monitoring should include daily observation by families and caregivers.Atomoxetine should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted.Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart ProblemsAssessing Cardiovascular Status in Patients being Treated with AtomoxetineFigure 1: Mean Weight and Height Percentiles Over Time for Patients with Three Years of Atomoxetine TreatmentReasons for discontinuation of treatment due to adverse reactions in child and adolescent clinical trialsCommonly observed adverse reactions in acute child and adolescent, placebo-controlled trialsTable 2: Common Treatment-Emergent Adverse Reactions Associated with the Use of Atomoxetine in Acute (up to 18 weeks) Child and Adolescent TrialsGeneral Disorders and Administration Site ConditionsTable 3: Common Treatment-Emergent Adverse Reactions Associated with the Use of Atomoxetine in Acute (up to 18 weeks) Child and Adolescent TrialsPercentage of Patients Reporting Reaction from BID TrialsPercentage of Patients Reporting Reaction from QD TrialsReasons for discontinuation of treatment due to adverse reactions in acute adult placebo-controlled trialsCommonly observed adverse reactions in acute adult placebo-controlled trialsTable 4: Common Treatment-Emergent Adverse Reactions Associated with the Use of Atomoxetine in Acute (up to 25 weeks) Adult TrialsGeneral Disorders and Administration Site ConditionsGeneral disorders and administration site conditionsTics in patients with ADHD and comorbid Tourette’s DisorderAnxiety in patients with ADHD and comorbid Anxiety DisordersWhat is the most important information I should know about Atomoxetine capsules?The following have been reported with use of Atomoxetine:Suicidal thoughts and actions in children and teenagers:Children and teenagers sometimes think about suicide, and many report trying to kill themselves. In 2 identical, 10-week, randomized, double-blind, placebo-controlled acute treatment studies (Study 5, N=280; Study 6, N=256), patients received either Atomoxetine or placebo.

In rats dosed prior to mating and during organogenesis a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at a dose approximately 5 times the MRHD on a mg/m The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

Physicians should instruct their patients to read the Medication Guide before starting therapy with Atomoxetine capsules 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.

Atomoxetine should be used with caution in any condition that may predispose patients to hypotension, or conditions associated with abrupt heart rate or blood pressure changes.Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by Atomoxetine at usual doses. Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. In some cases of overdose involving Atomoxetine, seizures have been reported. Atomoxetine is not approved for major depressive disorder.Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of Atomoxetine in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving Atomoxetine compared to placebo. You may report side effects to FDA at 1-800-FDA-1088.Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. 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.