Atomoxetine, a Novel Treatment for Attention-Deficit-Hyperactivity Disorder

Alisa K. Christman, Pharm.D.; Joli D. Fermo, Pharm.D.; John S. Markowitz, Pharm.D.


Pharmacotherapy. 2004;24(8) 

In This Article

Special Populations

Pharmacokinetic studies to evaluate the concentration of atomoxetine in extensive metabolizers showed a 2-fold increased AUC in patients with moderate hepatic insufficiency (based on Child-Pugh class B) and a 4-fold increased AUC in patients with severe hepatic insufficiency (based on Child-Pugh class C) compared with healthy subjects. A reduction in the initial and target doses by 50% and 25% of the normal dose for patients who have moderate hepatic insufficiency and for those with severe hepatic insufficiency, respectively, is recommended.[16,17]

In extensive metabolizers with end-stage renal disease, the extent of systemic exposure of atomoxetine was 65% higher than that of healthy subjects. However, a clinically significant difference was not noted when doses were decreased on a mg/kg basis. Therefore, no dosing adjustments are recommended for extensive metabolizers who have mild, moderate, or end-stage renal disease when using the normal dosing regimen.[16]

No formal studies are available that evaluate atomoxetine treatment in children younger than 6 years. The pharmacokinetic values of atomoxetine in children 6 years and older have been found to be similar to that of adults. Efficacy beyond 9 weeks of therapy and safety beyond 1 year of therapy have not been studied.

No formal studies are available that evaluate the safety and efficacy of atomoxetine in patients older than 65 years.

Atomoxetine is classified as pregnancy category C. In rabbit studies, a dose of 100 mg/kg, approximately 23 times the maximum human dose on a mg/m2 basis, produced a decrease in live fetuses and an increase in resorption in one of three studies. In these studies, the no-effect dose observed was 30 mg/kg.[16]

No adequate, well-controlled studies are available that evaluate atomoxetine therapy in pregnant women. Therefore, treatment with atomoxetine should be recommended only when the benefits outweigh the risks of treatment. The effect of atomoxetine on labor and delivery in humans is not known.

Atomoxetine and/or its metabolites were found to be excreted in the milk of rats. No studies are available that evaluate the amount of atomoxetine or its metabolites in the milk of nursing women. Therefore, the risks versus the benefits should be considered if atomoxetine is to be used for the treatment of ADHD in nursing women.[16]