stility should be monitored. (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, 17.5)
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)
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
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)
USE IN SPECIFIC POPULATIONS
Pregnancy/Lactation - Pregnant or nursing women should not use unless potential benefit justifies potential risk to fetus or infant. (8.1, 8.3)
Hepatic Insufficiency - Increased exposure (AUC) to atomoxetine than with normal subjects in EM subjects with moderate (Child-Pugh Class B) (2-fold increase) and severe (Child-Pugh Class C) (4-fold increase). (8.6)
Renal Insufficiency - Higher systemic exposure to atomoxetine than healthy subjects for EM subjects with end stage renal disease - no difference when exposure corrected for mg/kg dose. (8.7)
Patients with Concomitant Illness - Does not worsen tics in patients with ADHD and comorbid Tourette's Disorder. (8.10)
Patients with Concomitant Illness – Does not worsen anxiety in patients with ADHD and comorbid Anxiety Disorders. (8.10)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 5/2017
CLOSE
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS
1 INDICATIONS AND USAGE
1.1 Attention-Deficit/Hyperactivity Disorder (ADHD)
1.2 Diagnostic Considerations
1.3 Need for Comprehensive Treatment Program
2 DOSAGE AND ADMINISTRATION
2.1 Acute Treatment
2.2 Maintenance/Extended Treatment
2.3 General Dosing Information
2.4 Dosing in Specific Populations
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Monoamine Oxidase Inhibitors (MAOI)
4.3 Narrow Angle Glaucoma
4.4 Pheochromocytoma
4.5 Severe Cardiovascular Disorders
5 WARNINGS AND PRECAUTIONS
5.1 Suicidal Ideation
5.2 Severe Liver Injury
5.3 Serious Cardiovascular Events
5.4 Effects on Blood Pressure and Heart Rate
5.5 Emergence of New Psychotic or Manic Symptoms
5.6 Screening Patients for Bipolar Disorder
5.7 Aggressive Behavior or Hostility
5.8 Allergic Events
5.9 Ef
