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warnings
WARNINGS Fatalities have been reported following excessive use of Alupent ® (metaproterenol sulfate USP) as with other sympathomimetic inhalation preparations, and the exact cause is unknown. Cardiac arrest was noted in several cases. Alupent, like other beta adrenergic agonists, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or ECG changes. As with other beta adrenergic aerosols, Alupent can produce paradoxical bronchospasm (which can be life threatening). If it occurs, the preparation should be discontinued immediately and alternative therapy instituted. Alupent should not be used more often than prescribed. Patients should be advised to contact their physician in the event that they do not respond to their usual dose of a sympathomimetic amine aerosol.
ADVERSE REACTIONS Adverse reactions are similar to those noted with other sympathomimetic agents. The most frequent adverse reaction to Alupent ® (metaproterenol sulfate USP) administered by metered-dose inhaler among 251 patients in 90-day controlled clinical trials was nervousness. This was reported in 6.8% of patients. Less frequent adverse experiences, occurring in 1-4% of patients were headache, dizziness, palpitations, gastrointestinal distress, tremor, throat irritation, nausea, vomiting, cough and asthma exacerbation. Tachycardia occurred in less than 1% of patients.