HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use STRATTERA safely and effectively. See full prescribing information for STRATTERA.
STRATTERA ® (atomoxetine) CAPSULES for Oral Use
Initial U.S. Approval: 2002
WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Increased risk of suicidal ideation in children or adolescents (5.1)
No suicides occurred in clinical trials (5.1)
Patients started on therapy should be monitored closely (5.1)
RECENT MAJOR CHANGES

None.

INDICATIONS AND USAGE

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)

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). (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)

CONTRAINDICATIONS

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 eva luation. (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)
Emergent Psychotic or Manic Symptoms – Consider discontinuing treatment if such new symptoms occur. (5.5)
Bipolar Disorder – Screen patients to avoid possible induction of a mixed/manic episode. (5.6)
Aggressive behavior or ho