The expected signs and symptoms with overdosage of FORADIL AEROLIZER are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms listed under ADVERSE REACTIONS, e.g., angina, hypertension or hypotension, tachycardia, with rates up to 200 beats/min., arrhythmias, nervousness, headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, and insomnia. Metabolic acidosis may also occur. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an overdose of FORADIL AEROLIZER.

Treatment of overdosage consists of discontinuation of FORADIL AEROLIZER together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of FORADIL AEROLIZER. Cardiac monitoring is recommended in cases of overdosage.

The minimum acute lethal inhalation dose of formoterol fumarate in rats is 156 mg/kg (approximately 53,000 and 25,000 times the maximum recommended daily inhalation dose in adults and children, respectively, on a mg/m² basis). The median lethal oral doses in Chinese hamsters, rats, and mice provide even higher multiples of the maximum recommended daily inhalation dose in humans.

FORADIL (formoterol fumarate) is contraindicated in patients with a history of hypersensitivity to formoterol fumarate or to any components of this product.

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