Atomoxetine

Atomoxetine is a selective norepinephrine reuptake inhibitor (NRI) used for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6 years and older), adolescents, and adults. It is a non-stimulant medication that does not have the addiction potential of stimulant drugs.

Atomoxetine works by increasing the level of norepinephrine in the brain. Norepinephrine is a neurotransmitter that helps regulate attention, alertness, and impulse control. This medication helps control ADHD symptoms such as inattention, hyperactivity, and impulsivity.

Common side effects include headache, nausea, decreased appetite, abdominal pain, fatigue, and somnolence. In adults, constipation, dry mouth, and dizziness may occur.

• Attention-Deficit/Hyperactivity Disorder (ADHD) in pediatric patients (ages 6 and older), adolescents, and adults

Atomoxetine is a selective norepinephrine reuptake inhibitor (NRI). It inhibits the pre-synaptic norepinephrine transporter, increasing norepinephrine levels in the synaptic cleft. It has weak affinity for the dopamine transporter and no significant affinity for other neurotransmitter receptors or transporters.

Atomoxetine increases norepinephrine activity in cortical and limbic areas in patients with ADHD. It improves the balance of dopamine and norepinephrine in the prefrontal cortex, which enhances attention, memory, and impulse control. Unlike stimulants, it does not directly block the dopamine transporter, resulting in lower addiction potential.

Atomoxetine inhibits the pre-synaptic norepinephrine transporter, increasing norepinephrine levels in the synaptic cleft. Norepinephrine helps regulate dopamine and norepinephrine activity in the prefrontal cortex, which improves attention, impulse control, and cognitive function. This leads to improvement in the core symptoms of ADHD.

Children & Adolescents (6 years+) - ADHD:

• Body weight ≤70 kg: Initial dose 40 mg/day (once daily or divided into 2 doses). May increase to 80 mg/day after at least 7 days. May increase to 100 mg/day after 2-4 weeks if needed.
• Body weight >70 kg: Initial dose 40 mg/day (once daily or divided into 2 doses). May increase to 80 mg/day after at least 7 days. May increase to 100 mg/day after 2-4 weeks if needed.

Adults - ADHD:

• Initial dose: 40 mg/day (once daily or divided into 2 doses). May increase to 80 mg/day after at least 7 days. May increase to 100 mg/day after 2-4 weeks if needed.
• Doses above 80 mg/day are not recommended in adults.

Hepatic Impairment:

• Moderate impairment (Child-Pugh Class B): Reduce dose by 50%.
• Severe impairment (Child-Pugh Class C): Reduce dose by 75%.

Renal Impairment: Dose adjustment may be needed in ESRD patients.

Take this medicine in the dose and duration as advised by your doctor. Swallow the capsule whole - do not open, chew, or crush. May be taken with or without food, but take at a fixed time. Usually taken once daily in the morning.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.

Common Adverse Reactions in Children & Adolescents (≥5% and at least twice placebo):

• Nausea
• Vomiting
• Fatigue
• Decreased appetite
• Abdominal pain
• Somnolence

Common Adverse Reactions in Adults:

• Constipation
• Dry mouth
• Nausea
• Decreased appetite
• Dizziness
• Urinary hesitation
• Erectile dysfunction

Serious Adverse Reactions:

• Suicidal ideation in children and adolescents (0.4% of patients)
• Severe liver damage (rare)
• Increased heart rate and blood pressure
• Psychotic or manic symptoms (rare)

Serious Precautions:

• Suicide risk: Atomoxetine increases the risk of suicidal ideation in children and adolescents. Close monitoring is required during initiation and dose changes.
• Liver damage: Inform your doctor immediately if you experience signs of liver problems (itching, right upper abdominal pain, dark urine, yellow skin/eyes).
• Cardiac risk: Caution in patients with heart problems, heart defects, or high blood pressure.
• Psychiatric symptoms: Inform your doctor if you develop new psychotic or manic symptoms.
• Driving and machinery: Do not drive or operate hazardous machinery until you know how atomoxetine affects you.
• Growth and weight monitoring: Monitor height and weight in children during treatment.
• Do not stop suddenly: Do not stop taking the medication without talking to your doctor first.

• Hypersensitivity to atomoxetine or any component
• Concomitant use with or within 14 days of discontinuing MAO inhibitors
• Angle-closure glaucoma
• Severe heart problems that may be affected by increased heart rate or blood pressure

• MAO Inhibitors: Do not use atomoxetine within 14 days of starting or stopping an MAOI
• CYP2D6 Inhibitors (e.g., paroxetine, fluoxetine, quinidine): May increase atomoxetine levels; dose adjustment may be needed
• Antihypertensive and pressor agents: Possible effects on blood pressure
• Albuterol (or other beta2 agonists): Cardiovascular effects may be potentiated

[UNSAFE] It is unsafe to consume alcohol with Atomoxetine. Alcohol may increase the risk of drowsiness and dizziness.

[CONSULT YOUR DOCTOR] Insufficient safety data on atomoxetine use during pregnancy (Category C). Animal studies have shown fetal risk. Use only if potential benefit justifies the risk.

[CONSULT YOUR DOCTOR] It is unknown whether atomoxetine is excreted in human milk. Caution is advised due to potential risk to the infant.

Safety and efficacy have not been established in patients under 6 years of age. Dosing table for 6-17 years is provided above.

Dose adjustment may be needed for elderly patients.

Hepatic Impairment: Moderate impairment (Child-Pugh Class B): reduce dose by 50%; severe impairment (Child-Pugh Class C): reduce dose by 75%.

Renal Impairment: Dose adjustment may be needed in ESRD patients.

There is no specific antidote for atomoxetine overdose. Symptomatic and supportive treatment is recommended. Overdose may cause nausea, vomiting, somnolence, dizziness, and tachycardia.

Store below 30°C, away from light and moisture. Keep out of reach of children.

Atomoxetine hydrochloride (C₁₇H₂₁NO · HCl)