atomoxetine hydrochloride

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Related to atomoxetine hydrochloride: Strattera

atomoxetine hydrochloride


Pharmacologic class: Selective norepinephrine reuptake inhibitor

Therapeutic class: Central nervous system agent

Pregnancy risk category C

FDA Box Warning

• Drug may increase risk of suicidal ideation in children or adolescents with attention deficit hyperactivity disorder (ADHD). Risk must be balanced with clinical need. Observe patient closely for clinical worsening, suicidality, and unusual behavior changes when therapy begins. Advise family to observe patient closely and communicate with prescriber as needed.

• Drug is approved for ADHD in pediatric and adult patients. It's not approved for major depressive disorder.


Unclear. May block norepinephrine reuptake at neuronal synapse.


Capsules: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg

Indications and dosages

Acute treatment of ADHD

Children and adolescents weighing 70 kg (154 lb) or less: Initially, total daily dose of approximately 0.5 mg/kg P.O.; increase after minimum of 3 days to target total daily dose of approximately 1.2 mg/kg given either as single daily dose in morning or as evenly divided doses in morning and late afternoon or early evening. Total daily dosage in children and adolescents shouldn't exceed 1.4 mg/kg or 100 mg, whichever is less.

Children, adolescents, and adults weighing more than 70 kg (154 lb): Initially, total daily dose of 40 mg P.O.; increase after minimum of 3 days to target total daily dose of approximately 80 mg given either as single daily dose in morning or as evenly divided doses in morning and late afternoon or early evening. After 2 to 4 additional weeks, dosage may be increased to maximum of 100 mg in patients who haven't achieved optimal response. Maximum recommended total daily dosage is 100 mg.

Maintenance and extended treatment of ADHD

Children ages 6 to 15: In general, continue dosage at which patient experienced continuous response.

Dosage adjustment

• Hepatic impairment

• Concurrent use of potent CYP2D6 inhibitors (such as fluoxetine, paroxetine, quinidine) in children weighing less than 70 kg (154 lb)


• Hypersensitivity to drug

• Closed-angle glaucoma, pheochromocytoma or history of pheochromocytoma, severe CV disorders

• MAO inhibitor use within past 14 days


Use cautiously in:

• hypotension; impaired renal, cerebrovascular, hepatic, or endocrine function

• serious cardiac structural or heart rhythm abnormalities, cardiomyopathy (use not recommended)

• patients whose underlying medical conditions could be worsened by increased heart rate or blood pressure

• pregnant or breastfeeding patients

• children younger than age 6.


• Give as a single dose in morning, or give half of total daily dose in morning and other half in late afternoon or early evening.

• Check patient's baseline pulse and blood pressure.

Don't give to patient who has taken MAO inhibitors within past 14 days.

Adverse reactions

CNS: aggression, insomnia, dizziness, drowsiness, headache, irritability, crying, mood swings, fatigue, rigors, cerebrovascular accident, suicidal ideation

CV: orthostatic hypotension, palpitations, tachycardia, Raynaud's phenomenon, MI, sudden death

EENT: rhinorrhea, sinusitis

GI: nausea, vomiting, constipation, upper abdominal pain, flatulence, dyspepsia, dry mouth

GU: urinary retention, urinary hesitancy, dysmenorrhea, erectile problems, ejaculation failure, impotence, prostatitis, priapism

Hepatic: severe liver injury

Musculoskeletal: muscle pain

Respiratory: cough

Skin: dermatitis, sweating

Other: fever, hot flashes, growth retardation (in children), decreased appetite, weight loss, hypersensitivity reactions (including angioedema)


Drug-drug. Albuterol: increased cardiovascular effects

MAO inhibitors: hyperthermia, myoclonus, rapid changes in vital signs

Potent CYP2D6 inhibitors: increased atomoxetine effects in children weighing less than 70 kg (154 lb)

Vasopressors: hypertensive crisis

Drug-diagnostic tests. Liver enzymes: elevated levels

Patient monitoring

Monitor liver function tests closely; discontinue drug, and don't restart if liver enzymes are elevated or jaundice occurs.

• Monitor growth in children.

• Assess for weight loss.

• Check blood pressure and pulse, especially after dosage changes.

Monitor for changes in mood, sleep patterns, and behavior (especially aggressive behavior or hostility) and consider discontinuing drug if psychotic or manic symptoms occur.

• Evaluate for urinary hesitancy or urinary retention and sexual dysfunction.

• Provide dietary counseling. Refer patient to dietitian if adverse GI effects significantly limit food intake.

Patient teaching

Instruct patient to immediately report difficulty breathing, swelling of lips or throat, itching, dark urine, yellowing of skin or eyes, right upper quadrant tenderness, or flulike symptoms.

Instruct patient or caregiver to immediately report depression or suicidal thoughts.

• To minimize insomnia, advise patient to establish effective bedtime routine and to take drug in single morning dose or in divided half-doses in morning and late afternoon or early evening.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• Advise patient to minimize GI upset by eating small, frequent servings of food and drinking plenty of fluids.

• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved
References in periodicals archive ?
Atomoxetine hydrochloride capsules, Sun Pharma Global
Atomoxetine hydrochloride capsules, Mylan Pharmaceuticals
Annual US sales for these strengths of branded and generic atomoxetine hydrochloride capsules is estimated at over USD530m (EUR415m), Sun Pharma said.