Strattera

[atomoxetine HCl]

Overdosage & Contraindications
CONTRAINDICATIONS

Hypersensitivity

STRATTERA is contraindicated in patients known to be hypersensitive to atomoxetine or other constituents of the product (see WARNINGS).

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Monoamine Oxidase Inhibitors (MAOI)

STRATTERA should not be taken with an MAOI, or within 2 weeks after discontinuing an MAOI. Treatment with an MAOI should not be initiated within 2 weeks after discontinuing STRATTERA. With other drugs that affect brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) when taken in combination with an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Such reactions may occur when these drugs are given concurrently or in close proximity.

Narrow Angle Glaucoma

In clinical trials, STRATTERA use was associated with an increased risk of mydriasis and therefore its use is not recommended in patients with narrow angle glaucoma.

OVERDOSAGE

Human Experience

There is limited clinical trial experience with STRATTERA overdose and no fatalities were observed. During postmarketing, there have been reports of acute and chronic overdoses of STRATTERA. No fatal overdoses of STRATTERA alone have been reported.

The most commonly reported symptoms accompanying acute and chronic overdoses were somnolence, agitation, hyperactivity, abnormal behavior, and gastrointestinal symptoms. Signs and symptoms consistent with sympathetic nervous system activation (e. g., mydriasis, tachycardia, dry mouth) have also been observed.

Management of Overdose

An airway should be established. Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures. Gastric lavage may be indicated if performed soon after ingestion. Activated charcoal may be useful in limiting absorption. Because atomoxetine is highly protein-bound, dialysis is not likely to be useful in the treatment of overdose.