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Atomoxetine

Class
Antidepressants
Subclass
Serotonin-norepinephrine reuptake inhibitors
Substance name
Atomoxetine hydrochloride
Brand names
Strattera®
Common formulations
Capsule
Dosage and administration
Adults patients
ADHD
•
Start at: 40 mg PO daily for at least 3 days
•
Maintenance: 80 mg PO daily, in 1-2 divided doses (single daily dose in the morning or evenly divided doses in the morning and late afternoon/early evening)
•
Maximum: 100 mg per day
Consider increasing to 100 mg daily after 2-4 weeks if optimal control is not achieved.
Social anxiety disorder in patients with ADHD • Off-label
•
Start at: 20 mg PO BID for at least 7 days
•
Maintenance: 40 mg PO BID for 13 weeks
•
Maximum: 100 mg per day
Other off-label uses
•
Treatment of orthostatic hypotension (neurogenic)
Indications for use
Labeled indications
Adults
•
Treatment of ADHD
Children
•
Treatment of ADHD
Off-label indications
Adults
•
Treatment of orthostatic hypotension (neurogenic)
•
Treatment of social anxiety disorder in patients with ADHD
Safety risks
Boxed warnings
Suicidal ideation
•
Use extreme caution in pediatric or adolescent patients. Monitor closely for suicidality and unusual changes in behavior.
Contraindications
Hypersensitivity to atomoxetine or its components
Angle-closure glaucoma
Pheochromocytoma
Severe cardiovascular disorders
Concomitant use of MAOIs
•
Do not use atomoxetine with or within 14 days of switching to or from MAOIs.
Warnings and precautions
Aggressive behavior
•
Maintain a high level of suspicion, as atomoxetine has been associated with an increased risk of aggressive behavior an hostility.
Aggressive behavior, hostility
•
Use caution in children and adolescents with ADHD.
Cardiovascular mortality, hypertension, tachycardia
•
Use extreme caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease.
Growth delay
•
Maintain a high level of suspicion, as atomoxetine has been associated with an increased risk of growth delay in pediatric patients. Monitor growth.
Hepatotoxicity
•
Maintain a high level of suspicion, as atomoxetine has been associated with an increased risk of sever liver injury, including rare cases of liver failure. Discontinue atomoxetine if jaundice or laboratory evidence of liver injury occurs.
Increased BP, increased HR
•
Use caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease.
Increased serum atomoxetine levels
•
Use caution in CYP2D6 poor metabolizers or patients taking potent CYP2D6 inhibitors, such as paroxetine, fluoxetine, and quinidine. Initiate atomoxetine at 40 mg daily and increase to 80 mg daily only if symptoms fail to improve after 4 weeks and the initial dose is well tolerated.
Manic or mixed episodes
•
Use caution in patients with bipolar disorder. Screen patients for personal and family history of bipolar disorder, mania, or hypomania before initiating atomoxetine.
Orthostatic hypotension, syncope
•
Maintain a high level of suspicion, as orthostatic hypotension and syncope have been reported with atomoxetine.
Priapism
•
Maintain a high level of suspicion, as atomoxetine has been associated with rare cases of priapism.
Psychosis, mania
•
Maintain a high level of suspicion, as atomoxetine has been associated with an increased risk of psychotic and manic symptoms, including hallucinations, delusional thinking, and mania.
Urinary retention, UTI
•
Maintain a high level of suspicion, as atomoxetine has been associated with an increased risk of urinary retention and hesitancy.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Reduce dose by 50%.
Child-Pugh C (severe)
•
Reduce dose by 75%.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Consider safer alternatives. Evidence of fetal harm in animals. Enroll patients in a dedicated pregnancy outcome monitoring registry.
Breastfeeding
Consider alternative agents that may be safer.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Dry mouth, insomnia, loss of appetite, nausea
Common 1-10%
•
Abdominal pain, blurred vision, tremor, urinary retention, cold extremities, constipation, dizziness, somnolence, erectile dysfunction, dyspepsia, vomiting, nightmares, ejaculation difficulties, hyperhidrosis, fatigue, ↑ thirst, weight loss, dysuria, irritability, palpitations, chills, paresthesia, ↓ libido, sleeping disorder, dysmenorrhea, hot flashes, urinary hesitancy
Unknown frequency
•
Syncope, raynaud's phenomenon, ↑QT interval, lethargy, rhabdomyolysis, hypoesthesia, tics, depression, anxiety, seizure, hair loss
Interactions
Drug(s)
Check Interactions
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