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atomoxetine (Strattera)

Tradename: Strattera (atomoxetine HCL) (NOT a DEA controlled substance). FDA clears 1st generic 2017 [6] Indications: - attention deficit hyperactivity disorder (ADHD) Contraindications: 1) not recommended in patients with narrow-angle glaucoma 2) use with caution in patients with hypertension, tachycardia or cardiovascular disease Dosage: 1) QD-BID dosing, up to 150 mg/day, 120 mg single dose 2) when switching to atomoxetine from another agent, NO need to taper discontinued agent) Capsules: 10, 18, 25, 40, 60 mg Pharmacokinetics: 1) absorption minimally affected by food 2) absolute bioavailability 63%-94% (poor metabolizers) 4) volume of distribution 0.85 L/kg 5) 98% plasma protein bound, mainly albumin 6) metabolized by cyt P450 2D6 7) major metabolite is 4-OH atomoxetine a) glucoronidated & eliminated in the bile b) pharmacologically active, but does not achieve significant plasma levels 8) elimination 1/2life of 5 hours Monitor: - liver function tests at 1st sign/symptom of liver dysfunction Adverse effects: 1) not common (< 5%) a) GI upset (constipation, dyspepsia) c) dizziness d) mood swings 2) decreased appetite 8% 3) may slow growth 4) mydriasis [2] 5) allergic reactions have been reported -> angioneurotic edema, urticaria, rash [2] 6) hypertension (mean systolic BP increase 3 mm Hg, adult) 7) orthostatic hypotension (1%) 8) urinary hesitancy (3%) & urinary retention (3%) 9) hepatitis several months after initial dose (2 cases) [3] 10) increased risk of suicidal ideation in children, adolescents [4] Overdose: 1) supportive care 2) no deaths reported Drug interactions: 1) drugs that inhibit cyt P450 2D6 may increase levels of atomoxetine (paroxetine, fluoxetine, quinidine ...) 2) atomoxetine potentiates heart rate & blood pressure increase induced by albuterol Laboratory: - atomoxetine in serum/plasma Mechanism of action: - blocks reuptake of norepinephrine

Interactions

drug adverse effects (more general classes)

General

psychotropic agent

Database Correlations

PUBCHEM correlations

References

  1. Prescriber's Letter 10(1):1 2003
  2. http://www.strattera.com http://pi.lilly.com/us/strattera-pi.pdf
  3. Prescriber's Letter 12(2): 2005 New Warning for Strattera Detail-Document#: 210205 (subscription needed) http://www.prescribersletter.com http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01335.html
  4. FDA MedWatch http://www.fda.gov/medwatch/safety/2005/safety05.htm#Strattera - Prescriber's Letter 12(9): 2005 Detail-Document#: 211111 (subscription needed) http://www.prescribersletter.com
  5. Prescriber's Letter 17(7): 2010 Recommended Lab Monitoring for Common Medications Liver Function Test Scheduling Detail-Document#: 260704 (subscription needed) http://www.prescribersletter.com
  6. Brooks M FDA Clears First Generic Versions of Strattera for ADHD. Medscape - May 30, 2017. http://www.medscape.com/viewarticle/880860 - FDA News Release. May 30, 2017 FDA approves first generic Strattera for the treatment of ADHD. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm561096.htm