).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 An exposure–response analysis encompassing doses of Atomoxetine (0.5, 1.2 or 1.8 mg/kg/day) or placebo demonstrated Atomoxetine exposure correlates with efficacy as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator administered and scored. Drug Safety and Availability 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. They are supplied as follows:NDC 50268-059-13 (10 capsules per card, 3 cards per carton)Atomoxetine capsules, USP 80 mg* are available for oral administration as hard gelatin capsules with a white opaque body and an orange opaque cap, imprinted “APO AM80” in black ink.Atomoxetine capsules, USP 100 mg* are available for oral administration as hard gelatin capsules with an orange opaque body and an orange opaque cap, imprinted “APO AM100” in black ink.Store Atomoxetine capsules, USP at 20° to 25°C (68° to 77°F) excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Advise the patient to read the FDA-approved patient labeling (Medication Guide). All people who take atomoxetine need to be watched closely. Atomoxetine is used to treat attention-deficit hyperactivity disorder (ADHD) in children, teenagers, and adults. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. 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) 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. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. No suicides occurred in these trialsDosing of children and adolescents up to 70 kg body weightDosing of children and adolescents over 70 kg body weight and adultsDosing adjustment for hepatically impaired patientsDosing adjustment for use with a strong CYP2D6 inhibitor or in patients who are known to be CYP2D6 PMsAll pediatric patients being treated with Atomoxetine should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.Families and caregivers of pediatric patients being treated with Atomoxetine should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Atomoxetine capsules are not intended to be opened. 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.

For more information call AvKARE at 1-855-361-3993 or drugsafety@avkare.com.All registered trademarks in this document are the property of their respective owners.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Prompt medical attention is required in the event of suspected priapism.This growth pattern was generally similar regardless of pubertal status at the time of treatment initiation. You may also report side effects at https://www.fda.gov/medwatch. 0.67-2.64 – not statistically significant]).