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STRATTERA (ATOMOXETINE HCL): OVERDOSAGE

Human Experience

No fatal overdoses occurred in clinical trials. There is limited clinical trial experience with Strattera (Atomoxetine HCl) capsules overdose. During postmarketing, there have been fatalities reported involving a mixed ingestion overdose of Strattera (Atomoxetine Hydrochloride) and at least one other drug. There have been no reports of death involving overdose of this medicine alone, including intentional overdoses at amounts up to 1400 mg. In some cases of overdose involving Strattera (Atomoxetine Hydrochloride) capsules, seizures have been reported. The most commonly reported symptoms accompanying acute and chronic overdoses of Strattera were somnolence, gastrointestinal symptoms, dizziness, tremor, and abnormal behavior. Hyperactivity and agitation have also been reported. Signs and symptoms consistent with mild to moderate sympathetic nervous system activation (e.g., tachycardia, blood pressure increased, mydriasis, dry mouth) have also been observed.

Most events were mild to moderate. Less commonly, there have been reports of QT prolongation and mental changes, including disorientation and hallucinations.

Management of Overdose

Consult with a Certified Poison Control Center for up to date guidance and advice. Because atomoxetine is highly proteinbound, dialysis is not likely to be useful in the treatment of overdose.

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