OVERDOSAGE
The expected signs and symptoms with overdosage of SEREVENT DISKUS 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., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Overdosage with SEREVENT DISKUS may be expected to result in exaggeration of the pharmacologic adverse effects associated with beta-adrenoceptor agonists, including tachycardia and/or arrhythmia, tremor, headache, and muscle cramps. Overdosage with SEREVENT DISKUS can lead to clinically significant prolongation of the QTc interval, which can produce ventricular arrhythmias. Other signs of overdosage may include hypokalemia and hyperglycemia.
As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of SEREVENT DISKUS.
Treatment consists of discontinuation of SEREVENT DISKUS together with appropriate symptomatic 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 SEREVENT DISKUS. Cardiac monitoring is recommended in cases of overdosage.
No deaths were seen in rats at an inhalation dose of 2.9 mg/kg (approximately 240 times the maximum recommended daily inhalation dose in adults and approximately 110 times the maximum recommended daily inhalation dose in children on a mg/m2 basis) and in dogs at an inhalation dose of 0.7 mg/kg (approximately 190 times the maximum recommended daily inhalation dose in adults and approximately 90 times the maximum recommended daily inhalation dose in children on a mg/m2 basis). By the oral route, no deaths occurred in mice at 150 mg/kg (approximately 6,100 times the maximum recommended daily inhalation dose in adults and approximately 2,900 times the maximum recommended daily inhalation dose in children on a mg/m2 basis) and in rats at 1,000 mg/kg (approximately 81,000 times the maximum recommended daily inhalation dose in adults and approximately 38,000 times the maximum recommended daily inhalation dose in children on a mg/m2 basis).
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