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The expected signs and symptoms with overdosage of FORADIL CERTIHALER (formoterol fumarate inhalation powder) 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 CERTIHALER.
Treatment of overdosage consists of discontinuation of FORADIL CERTIHALER (formoterol fumarate inhalation powder) 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 CERTIHALER (formoterol fumarate inhalation powder) . Cardiac monitoring is recommended in cases of overdosage.
The minimum lethal inhalation dose of formoterol fumarate in rats is 156 mg/kg (approximately 63,000 and 30,000 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.
Because of the risk of asthma-related death and hospitalization, use of FORADIL CERTIHALER (formoterol fumarate inhalation powder) for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (see WARNINGS – Asthma Related Death). FORADIL (formoterol fumarate) is contraindicated in patients with a history of hypersensitivity to formoterol fumarate or to any components of this product.
Last reviewed on RxList: 6/29/2010
This monograph has been modified to include the generic and brand name in many instances.
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