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4. Do Not Use SEREVENT Inhalation Aerosol as a Substitute for Oral or Inhaled Corticosteroids: The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids. There are no data demonstrating that SEREVENT Inhalation Aerosol has a clinical anti-inflammatory effect and could be expected to take the place of corticosteroids. Patients who already require oral or inhaled corticosteroids for treatment of asthma should be continued on this type of treatment even if they feel better as a result of initiating SEREVENT Inhalation Aerosol. Any change in corticosteroid dosage should be made ONLY after clinical evaluation (see PRECAUTIONS: Information for Patients). 5. Do Not Exceed Recommended Dosage: Text Continues Below
As with other inhaled beta2-adrenergic drugs, SEREVENT Inhalation Aerosol should not be used more often or at higher doses than recommended. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Large doses of inhaled or oral salmeterol (12 to 20 times the recommended dose) have been associated with clinically significant prolongation of the QTc interval, which has the potential for producing ventricular arrhythmias.
6. Paradoxical Bronchospasm: SEREVENT Inhalation Aerosol can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, SEREVENT Inhalation Aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial. 7. Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of SEREVENT Inhalation Aerosol, as demonstrated by rare cases of urticaria, angioedema, rash, and bronchospasm. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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