Classifications: psychotherapeutic agent, miscellaneous; Therapeutic: adhd agent
Pregnancy Category: C
10 mg, 18 mg, 25 mg, 40 mg, 60 mg capsules
Exact mechanism of action is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine
transporter, resulting in norepinephrine reuptake inhibition.
Improved attentiveness, ability to follow through on tasks with less distraction and forgetfulness, and diminished hyperactivity.
Treatment of attention deficit/hyperactivity disorder (ADHD) in adults and children.
Hypersensitive to atomoxetine or any of its constituents; concomitant use or use within 2 wk of MAOIs; narrow angle glaucoma;
jaundice; suicidal ideation; pregnancy (category C).
Severe liver injury may progress to liver failure or death in a small percentage of patients. Hypertension, tachycardia,
cardiovascular or cerebrovascular disease; any condition that predisposes to hypotension; urinary retention or urinary hesitancy;
concomitant use of CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine), albuterol or other beta-2 agonists, vasopressor drugs; history of bipolar disorder. Safety and efficacy in children <6 y and the older adult have
not been established; lactation.
Route & Dosage
Adult: PO Start with 40 mg in morning. May increase after 3 d to target dose of 80 mg/d given either once in the morning or divided
morning and late afternoon/early evening. May increase to max of 100 mg/d if needed.
Child/Adolescent: PO <70 kg, start with 0.5 mg/kg/d. May increase after 3 d to target dose of 1.2 mg/kg/d. Administer once daily in morning or divide
dose and give morning and late afternoon/early evening. Max dose is 1.4 mg/kg or 100 mg, whichever is less. >70 kg, the max total daily dose is 100 mg.
Child-Pugh Class B: Initial and target doses should be reduced to 50% of the normal dose.
Child-Pugh Class C: Initial dose and target doses should be reduced to 25% of normal.
- Note that total daily dose in children and adolescents is based on weight. Determine that ordered dose is appropriate for
weight prior to administration of drug.
- Note manufacturer recommends dosage adjustments with concomitant administration of strong CYP2D6 inhibitors (e.g., paroxetine,
fluoxetine, quinidine). Consult physician.
- Store at 15°30° C (59°86° F).
Adverse Effects (≥1%)Body as a Whole:
Flu-like syndrome, flushing, fatigue
, fever, rigors. CNS:
somnolence, crying, tearfulness, irritability, mood swings, insomnia, depression
, tremor, early morning awakenings, paresthesias, abnormal dreams, decreased libido, sleep disorder, suicidal ideation. CV:
Increased blood pressure, sinus tachycardia, palpitations. GI: Upper abdominal pain, constipation
, dyspepsia, vomiting, decreased appetite,
anorexia, dry mouth, diarrhea, flatulence, severe liver injury (rare). Endocrine:
Hot flushes. Metabolic:
Weight loss. Hepatic:
Arthralgia, myalgia. Respiratory: Cough,
rhinorrhea, nasal congestion, sinusitis
Dermatitis, pruritus, increased sweating. Special Senses:
Urinary hesitation/retention, dysmenorrhea, ejaculation dysfunction, impotence, delayed onset of menses, irregular menstruation,
may potentiate cardiovascular effects of atomoxetine; fluoxetine, paroxetine, quinidine
may increase atomoxetine levels and toxicity; maois
may precipitate a hypertensive crisis; may attenuate effects of antihypertensive agents
Well absorbed from GI tract. Peak:
12 h. Metabolism:
In liver by CYP2D6. Elimination:
Primarily in urine. Half-Life:
Assessment & Drug Effects
- Evaluate for continuing therapeutic effectiveness especially with long-term use.
- Monitor children and adolescents for behavior changes that may indicate suicidal ideation.
- Monitor cardiovascular status especially with preexisting hypertension.
- Monitor HR and BP at baseline, following a dose increase, and periodically while on therapy.
- Lab tests: Periodic LFTs.
- Report increased aggression and irritability as these may indicate a need to discontinue the drug.
Patient & Family Education
- Instruct patients on S&S of liver toxicity.
- Report any of the following to physician: chest pains or palpitations, urinary retention or difficulty initiating voiding
urine, appetite loss and weight loss, or insomnia.
- Make position changes slowly if you experience dizziness with arising from a lying or sitting position.
- Do not drive or engage in potentially hazardous activities until reaction to the drug is known.