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7. Patients should be cautioned regarding common adverse cardiovascular effects, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness. 8. In patients receiving SEREVENT Inhalation Aerosol, other inhaled medications should be used only as directed by the physician. 9. When using SEREVENT Inhalation Aerosol to prevent exercise-induced bronchospasm, patients should take the dose at least 30 to 60 minutes before exercise. Text Continues Below
10. Patients who are pregnant or nursing should contact the physician about the use of SEREVENT Inhalation Aerosol. 11. Effective and safe use of SEREVENT Inhalation Aerosol includes an understanding of the way that it should be administered. Drug Interactions Short-Acting Beta2-Agonists: In the two 3-month, repetitive-dose clinical asthma trials (N = 184), the mean daily need for additional beta2-agonist use was 1 to 1½ inhalations/day, but some patients used more. Eight percent (8%) of patients used at least 8 inhalations/day at least on 1 occasion. Six percent (6%) used 9 to 12 inhalations at least once. There were 15 patients (8%) who averaged over 4 inhalations/day. Four (4) of these used an average of 8 to 11 inhalations/day. In these 15 patients there was no observed increase in frequency of cardiovascular adverse events. The safety of concomitant use of more than 8 inhalations/day of short-acting beta2-agonists with SEREVENT Inhalation Aerosol has not been established. In 15 patients who experienced worsening of asthma while receiving SEREVENT Inhalation Aerosol, nebulized albuterol (1 dose in most) led to improvement in FEV1 and no increase in occurrence of cardiovascular adverse events.
Monoamine Oxidase Inhibitors and Tricyclic Antidepressants
Salmeterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of salmeterol on the vascular system may be potentiated by these agents. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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