Atomoxetine

DEA Class; Rx

Common Brand Names; Strattera

Selective norepinephrine reuptake inhibitor (NRI); lack of abuse potential
Used for attention-deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older
Boxed warning regarding potential for suicidal ideation and need to monitor for changes in mood and behavior; may increase blood pressure and heart rate

Indicated for attention-deficit/hyperactivity disorder (ADHD)

Hypersensitivity

Narrow-angle glaucoma

Administration concomitantly with or within 14 days of monoamine oxidase inhibitor (MAOI) therapy; risk of potentially fatal reaction, including hyperthermia, myoclonus, altered mental status, and neuroleptic malignant syndrome (NMS)-like symptoms

Pheochromocytoma: Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with current or previous pheochromocytoma

Severe cardiovascular disorders where condition would deteriorate because BP increases by 15-20 mm Hg or HR increases by 20 beats/min; risk is greater in poor CYP2D6 metabolizers

Children and adolescents

• Nausea (7-13%)
• Fatigue (6-8%)
• Irritability (6%)
• Dizziness (5%)
• Weight decreased (3%)
• Anorexia (3%)
• Therapeutic response unexpected (2%)
• Rash (2%)
• Constipation (1-2%)
• Mood swings (1-2%)

• Headache (19%)
• Abdominal pain (17-18%)
• Decreased appetite (16%)
• Vomiting (11%)
• Somnolence (11%)

Adults

• Nausea (26%)
• Dry mouth (20%)
• Decreased appetite (16%)
• Insomnia (15%)
• Nausea (7-13%)
• Fatigue (6-8%)
• Irritability (6%)
• Dizziness (5%)
• Weight decreased (3%)
• Anorexia (3%)
• Therapeutic response unexpected (2%)
• Rash (2%)
• Constipation (1-2%)
• Mood swings (1-2%)
• Fatigue (10%)
• Constipation (8%)
• Dizziness (8%)
• Somnolence (8%)
• Erectile dysfunction (8%)
• Abdominal pain (7%)
• Urinary hesitation (6%)
• Irritability (5%)
• Dyspepsia (4%)
• Vomiting (4%)
• Abnormal dreams (4%)
• Ejaculation delayed and/or ejaculation disorder (4%)
• Hyperhidrosis (4%)
• Libido decreased (3%)
• Sleep disorder (3%)
• Chills (3%)
• Palpitations (3%)
• Paresthesia (3%)
• Dysmenorrhea (3%)
• Hot flush (3%)
• Feeling jittery (2%)
• Thirst (2%)
• Weight decreased (2%)
• Dysuria (2%)

Liver injury reported within 120 days of initiation of atomoxetine; patients may present with elevated liver enzymes (>20x ULN) and jaundice with significantly elevated bilirubin levels (>2x ULN), followed by recovery upon discontinuance of atomoxetine

Orthostatic hypotension and syncope reported

Risk of suicidal thoughts in children and adolescents

Small risk of allergic reaction

Use caution in hypertension, tachycardia (see Contraindications)

Sudden deaths, stroke, and myocardial infarction reported in patients with structural cardiac abnormalities or other serious heart problems taking stimulants at usual doses; patients should have a careful history and physical exam to assess for presence of cardiovascular disease; consider not using atomoxetine in adults with clinically significant cardiac abnormalities

Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation

Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients; it may not be possible to determine whether a manic or mixed episode that appears during treatment is due to an adverse reaction to the drug or a patient’s underlying bipolar disorder; before initiating treatment, patients should be adequately screened for risk factors for bipolar disorder such as a personal or family history of mania and depression

Monitor growth of children ages 7 to 10 years during treatment with stimulants; may need to interrupt therapy in patients not growing or gaining weight as expected

Urinary hesitancy or sexual dysfunction may occur

Available published studies use in pregnant females are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

There are no data on presence of atomoxetine or its metabolite in human milk, effects on the breastfed children, or its effects on milk production

Present in animal milk; when a drug is present in animal milk, it is likely that the drug will be present in human milk