Atomoxetine (Brand Names in India: Strattera, Attentrol, Axepta, Atomoxet)

1. Generic Name

Atomoxetine Hydrochloride

2. Brand Names

• Strattera (Lupin)
• Attentrol (Intas Pharmaceuticals)
• Axepta (Sun Pharmaceuticals)
• Atomoxet (Cipla Limited)

3. Pharmaceutical Formulation

• Capsules: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg

4. Therapeutic Classification

Norepinephrine Reuptake Inhibitor (NRI)

5. Indications

Atomoxetine is indicated for:

• Attention Deficit Hyperactivity Disorder (ADHD): Adults and children ≥6 years.

6. Mechanism of Action

Atomoxetine selectively inhibits the presynaptic norepinephrine transporter, increasing norepinephrine levels in the prefrontal cortex. This improves attention, reduces impulsivity, and enhances executive functioning.

7. Dosage and Administration

Children and Adolescents (≥6 years):

• Initial Dose: 0.5 mg/kg/day.
• Target Dose: 1.2 mg/kg/day (maximum of 100 mg/day).

Adults:

• Initial Dose: 40 mg/day.
• Target Dose: 80 mg/day (maximum of 100 mg/day).

Administration:

• Can be taken with or without food.
• Once-daily or divided doses (morning and late afternoon).

8. Onset of Action

Important Note:
Atomoxetine typically requires 2 to 4 weeks to show therapeutic effects, with full benefits often seen by 6 to 8 weeks. Patient adherence is crucial for optimal outcomes.

9. Contraindications

• Hypersensitivity to atomoxetine or its excipients.
• Severe cardiovascular disorders (e.g., symptomatic cardiac arrhythmias, severe hypertension).
• Narrow-angle glaucoma.
• Concurrent use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuation.

10. Warnings and Precautions

• Suicidality: Increased risk in children and adolescents; monitor closely.
• Liver Injury: Rare but serious; monitor liver function tests if symptoms occur.
• Cardiovascular Effects: Monitor blood pressure and heart rate regularly.
• Psychiatric Effects: May exacerbate anxiety, agitation, or tics.
• Growth Retardation: Monitor growth in children and adolescents.

11. Side Effects

Common:

• Dry mouth, nausea, decreased appetite
• Insomnia, fatigue, dizziness
• Increased blood pressure and heart rate

Serious:

• Severe liver injury (e.g., jaundice, elevated transaminases)
• Suicidal thoughts and behaviors
• Severe allergic reactions

12. Drug Interactions

• MAOIs: Risk of hypertensive crisis; contraindicated.
• Albuterol: Risk of tachycardia and increased blood pressure.
• CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine): Increased atomoxetine plasma levels; dose adjustment may be needed.
• Pressor agents (e.g., phenylephrine): Enhanced cardiovascular effects.

13. Overdose Management

Symptoms: Tachycardia, hypertension, dry mouth, agitation, gastrointestinal symptoms.
Treatment: Symptomatic and supportive care, including cardiac monitoring.

14. Pharmacokinetics

• Absorption: Rapid, peak plasma concentration within 1-2 hours.
• Distribution: Protein binding ~98%.
• Metabolism: Hepatically metabolized via CYP2D6.
• Elimination: Half-life ~5 hours in extensive metabolizers and ~24 hours in poor metabolizers.

15. Storage and Handling

Store at a temperature below 30°C, protected from light and moisture. Keep out of reach of children.

16. Packaging

Available in blister packs of 10, 20, or 30 capsules.

17. Manufacturer Information

• Strattera: Lupin
• Attentrol: Intas Pharmaceuticals
• Axepta: Sun Pharmaceuticals
• Atomoxet: Cipla Limited