STRATTERA is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1)

DOSAGE AND ADMINISTRATION

Initial, Target and Maximum Daily Dose (2.1)

(Acute and Maintenance/Extended Treatment)

Dosing adjustment — Hepatic Impairment, Strong CYP2D6 Inhibitor, and in patients known to be CYP2D6 poor metabolizers (PMs). (2.4, 12.3)

———————-DOSAGE FORMS AND STRENGTHS———————-

Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. (3, 11, 16)

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 Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.

• Hypersensitivity to atomoxetine or other constituents of product. (4.1)
• STRATTERA 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. (4.5)

WARNINGS AND PRECAUTIONS

• 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. STRATTERA generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to its noradrenergic effects. Consideration should be given to not using STRATTERA in adults with clinically significant cardiac abnormalities. (5.3)
• Emergent Cardiovascular Symptoms – Patients should undergo prompt cardiac evaluation. (5.3)
• Effects on Blood Pressure and Heart Rate – Increase in blood pressure and heart rate; orthostasis and syncope may occur. Use with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease. (5.4)
• Psychotic or Manic Symptoms – Consider discontinuing STRATTERA if such new symptoms occur. (5.5)
• Bipolar Disorder – Screen patients for bipolar disorder. (5.6)
• Aggressive behavior or hostility – Monitor for the appearance or worsening of aggressive behavior or hostility. (5.7)
• Possible allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash. (5.8)
• Effects on Urine Outflow – Urinary hesitancy and retention may occur. (5.9)
• Priapism – Prompt medical attention is required in the event of suspected priapism. (5.10, 17)
• Growth – Height and weight should be monitored in pediatric patients. (5.11)
• Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients known to be CYP2D6 PMs – Dose adjustment of STRATTERA may be necessary. (5.13)

• 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 beta2 agonists) – Action of albuterol on cardiovascular system can be potentiated. (7.4)

There is limited clinical trial experience with STRATTERA overdose. During postmarketing, there have been fatalities reported involving a mixed ingestion overdose of STRATTERA and at least one other drug. There have been no reports of death involving overdose of STRATTERA alone, including intentional overdoses at amounts up to 1400 mg. In some cases of overdose involving STRATTERA, seizures have been reported. The most commonly reported symptoms accompanying acute and chronic overdoses of STRATTERA were gastrointestinal symptoms, somnolence, dizziness, tremor, and abnormal behavior. Hyperactivity and agitation have also been reported. Signs and symptoms consistent with mild to moderate sympathetic nervous system activation (e.g., tachycardia, blood pressure increased, mydriasis, dry mouth) have also been observed. Most events were mild to moderate. Less commonly, there have been reports of QT prolongation and mental changes, including disorientation and hallucinations [see Clinical Pharmacology (12.2)].

Management of Overdose: Consult with a Certified Poison Control Center for up to date guidance and advice. Because atomoxetine is highly protein-bound, dialysis is not likely to be useful in the treatment of overdose.