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SEREVENT INHALATION AEROSOL SHOULD NOT BE USED TO TREAT ACUTE SYMPTOMS. It is crucial to inform patients of this and prescribe an inhaled, short-acting beta2-agonist for this purpose as well as warn them that increasing inhaled beta2-agonist use is a signal of deteriorating asthma. SEREVENT INHALATION AEROSOL IS NOT A SUBSTITUTE FOR INHALED OR ORAL CORTICOSTEROIDS. Text Continues Below
Corticosteroids should not be stopped or reduced when SEREVENT Inhalation Aerosol is initiated. (See PRECAUTIONS: Information for Patients and the PATIENT'S INSTRUCTIONS FOR USE accompanying the product.) 1. Do Not Introduce SEREVENT Inhalation Aerosol as a Treatment for Acutely Deteriorating Asthma SEREVENT Inhalation Aerosol is intended for the maintenance treatment of asthma (see INDICATIONS AND USAGE) and should not be introduced in acutely deteriorating asthma, which is a potentially life-threatening condition. There are no data demonstrating that SEREVENT Inhalation Aerosol provides greater efficacy than or additional efficacy to inhaled, short-acting beta2-agonists in patients with worsening asthma. Serious acute respiratory events, including fatalities, have been reported both in the United States and worldwide in patients receiving SEREVENT Inhalation Aerosol. In most cases, these have occurred in patients with severe asthma (e.g., patients with a history of corticosteroid dependence, low pulmonary function, intubation, mechanical ventilation, frequent hospitalizations, or previous life-threatening acute asthma exacerbations) and/or in some patients in whom asthma has been acutely deteriorating (e.g., unresponsive to usual medications; increasing need for inhaled, short-acting beta2-agonists; increasing need for systemic corticosteroids; significant increase in symptoms; recent emergency room visits; sudden or progressive deterioration in pulmonary function). However, they have occurred in a few patients with less severe asthma as well. It was not possible from these reports to determine whether SEREVENT Inhalation Aerosol contributed to these events or simply failed to relieve the deteriorating asthma. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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