ATOMOXETINE

brands

Class

• Neuroscience-based Nomenclature: norepinephrine reuptake inhibitor (N-RI)
• Selective norepinephrine reuptake inhibitor (NRI)

ATOMOXETINE commonly prescribed for

(Bold for FDA approved)

How ATOMOXETINE works

• Boosts neurotransmitter norepinephrine and may also increase dopamine in prefrontal cortex

• Blocks norepinephrine reuptake pumps, also known as norepinephrine transporters

• Presumably this increases noradrenergic neurotransmission

• Since dopamine is inactivated bynorepinephrine reuptake in frontal cortex, which largely lacks dopamine transporters, atomoxetine can also increase dopamine neurotransmission in this part of the brain

How long until ATOMOXETINE works

• Onset of therapeutic actions in ADHD can be seen as early as the first day of dosing

• Therapeutic actions may continue to improve for 8–12 weeks

• If it is not working within 6–8 weeks, it may not work at all

Notable Side Effects

• Sedation, fatigue (particularly in children)

• Decreased appetite

• Rare priapism

• Increased heart rate (6–9 beats/minute)

• Increased blood pressure (2–4 mmHg)

• Insomnia, dizziness, anxiety, agitation, aggression, irritability

• Dry mouth, constipation, nausea, vomiting, abdominal pain, dyspepsia

• Urinary hesitancy, urinary retention (oldermen)

• Dysmenorrhea, sweating

• Sexual dysfunction (men: decreased libido, erectile disturbance, impotence, ejaculatory dysfunction, abnormal orgasm; women: decreased libido, abnormal orgasm)

Life Threatening Side Effects

• Increased heart rate and hypertension

• Orthostatic hypotension

• Severe liver damage (rare)

• Hypomania and, theoretically, rare induction of mania

• Rare activation of suicidal ideation and behavior (suicidality) (short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo beyond age 24)

weight gain

unusual

sedation

not usual

What to do about ATOMOXETINE side effects

• Wait

• Wait

• Wait

• Lower the dose

• If giving once daily, can change to split dose twice daily

• If atomoxetine is sedating, take at night to reduce daytime drowsiness

• In a few weeks, switch or add other drugs

usual dosage range

• 0.5–1.2 mg/kg/day in children up to 70 kg; 40–100 mg/day in adults

Dosage Forms

• Capsule 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg

long term use

• Safe

habit forming

• No

Renal Impairment

• Dose adjustment not generally necessary

Hepatic Impairment

• For patients with moderate liver impairment, dose should be reduced to 50% of normal dose

• For patients with severe liver impairment, dose should be reduced to 25% of normal dose

Cardiac Impairment

• Use with caution because atomoxetine can increase heart rate and blood pressure

• Do not use in patients with structural cardiac abnormalities

Elderly

• Some patients may tolerate lower doses better

• Reduction in the risk of suicidality with antidepressants compared to placebo in adults age 65 and older

Children and Adolescents

• Approved to treat ADHD in children over age 6

• Recommended target dose is 1.2 mg/kg per day

• Do not use in children with structural cardiac abnormalities or other serious cardiac problems

• Carefully weigh the risks and benefits of pharmacological treatment against the risks and benefits of nontreatment and make sure to document this in the patient’s chart

• Monitor patients face-to-face regularly, particularly during the first several weeks of treatment

• Use with caution, observing for activation of known or unknown bipolar disorder and/ or suicidal ideation, and inform parents or guardians of this risk so they can help observe child or adolescent patients

Pregnancy

• Effective June 30, 2015, the FDA requires changes to the content and format of pregnancy and lactation information in prescription drug labels, including the elimination of the pregnancy letter categories; the Pregnancy and Lactation Labeling Rule (PLLR or final rule) applies only to prescription drugs and will be phased in gradually for drugs approved on or after June 30, 2001

• Controlled studies have not been conducted in pregnant women

• Some animal studies have shown adverse effects

• Use in women of childbearing potential requires weighing potential benefits to the mother against potential risks to the fetus

• For women of childbearing potential, atomoxetine should generally be discontinued before anticipated pregnancies

Breast Feeding

• Unknown if atomoxetine is secreted in human breast milk, but all psychotropics are assumed to be secreted in breast milk

• Recommend either to discontinue drug or bottle feed