Product Description.:
Par 258
tablet , white , scored , round round
Flat-faced beveled-edge
Alupent? (metaproterenol sulfate USP) Inhalation Aerosol is a bronchodilator administered by oral inhalation. The Alupent Inhalation Aerosol containing 75 mg of metaproterenol sulfate as micronized powder is sufficient medication for 100 inhalations. The Alupent Inhalation Aerosol containing 150 mg of metaproterenol sulfate as micronized powder is sufficient medication for 200 inhalations. Each metered dose delivers through the mouthpiece 0.65 mg of metaproterenol sulfate (each ml contains 15 mg). The inert ingredients are dichlorodifluoromethane, dichlorotetrafluoroethane and trichloromonofluoromethane as propellants, and sorbitan trioleate.
INDICATIONS AND USAGE
Alupent? (metaproterenol sulfate USP) is indicated as a bronchodilator for bronchial asthma and for reversible bronchospasm which may occur in association with bronchitis and emphysema.
CONTRAINDICATIONS
Use in patients with cardiac arrhythmias associated with tachycardia is contraindicated.
Although rare, immediate hypersensitivity reactions can occur. Therefore, Alupent? (metaproterenol sulfate USP) Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to any of its components.
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.
PRECAUTIONS
General
Extreme care must be exercised with respect to the administration of additional sympathomimetic agents.
Since metaproterenol is a sympathomimetic amine, it should be used with caution in patients with cardiovascular disorders, including ischemic heart disease, hypertension or cardiac arrhythmias, in patients with hyperthyroidism or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines or who have convulsive disorders. Significant changes in systolic and diastolic blood pressure could be expected to occur in some patients after use of any beta adrenergic bronchodilator.
Information for Patients
Appropriate care should be exercised when considering the administration of additional sympathomimetic agents. A sufficient interval of time should elapse prior to administration of another sympathomimetic agent.
Drug Interactions
Other beta adrenergic aerosol bronchodilators should not be used concomitantly with Alupent? (metaproterenol sulfate USP) because they may have additive effects. Beta adrenergic agonists should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta adrenergic agonists on the vascular system may be potentiated.
