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PERFOROMIST Inhalation Solution is a treatment for chronic obstructive pulmonary disease (COPD). You take PERFOROMIST Inhalation Solution by nebulizer 2 times each day: in the morning and again at night.1 If you take it every day, chances are, you'll notice that you're breathing easier more of the time.1-3
There is an increased risk of asthma-related death with long-acting beta2-agonists, the class of drugs to which PERFOROMIST Inhalation Solution belongs. PERFOROMIST Inhalation Solution is not indicated for asthma or in deteriorating COPD. PERFOROMIST Inhalation Solution should not be used to treat acute symptoms, which should be treated with an inhaled short-acting beta2-agonist.
Recent treatments have helped people with COPD, including chronic bronchitis and emphysema (pronounced em fizz EE ma). They can breathe easier and lead more active lives. But how you live your life depends as much on you as on your medicine. It's about taking control. It's about being determined. It's about making the best choices for you.
The more you know about your condition, as well as your medicines, the better choices you can make. Are you eating well? Are you staying as active as you can? Are you staying involved with friends and family? Have you discussed medication options with your doctor?
Maintenance Treatment of COPD. PERFOROMIST Inhalation Solution is approved for the long-term, twice-daily (morning and evening) use in the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.
Important Safety Information
WARNING: INCREASED RISK OF ASTHMA-RELATED DEATH
PERFOROMIST Inhalation Solution belongs to a class of medications known as long-acting beta2-adrenergic agonists or LABAs. Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Data from a large placebo-controlled US study comparing the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta2-adrenergic agonist), the active ingredient in PERFOROMIST Inhalation Solution.
Important Limitations of Use
PERFOROMIST Inhalation Solution should not be used in patients with rapidly worsening COPD, which may be a life-threatening condition.
PERFOROMIST Inhalation Solution is not indicated to treat asthma.
Warnings and Precautions
PERFOROMIST Inhalation Solution should not used for the relief of sudden symptoms, i.e., as rescue therapy for bronchospasm (wheezing or coughing). Sudden symptoms should be treated with a fast-acting rescue inhaler.
Excessive Use of PERFOROMIST Inhalation Solution and Use With Other Long-Acting Beta-Agonists PERFOROMIST Inhalation Solution should not be used more often, or at higher doses than recommended, or with other inhaled, long-acting beta2-agonists, at the same time because of the risk of an overdose. Serious heart effects and fatalities have been reported with too high doses of inhaled adrenaline-like drugs.
As with other inhaled beta2-agonists, PERFOROMIST Inhalation Solution can produce paradoxical bronchospasm (unexpected tightening of breathing tubes) that may be life threatening. If paradoxical bronchospasm occurs, PERFOROMIST Inhalation Solution should be immediately stopped and a different therapy started.
PERFOROMIST Inhalation Solution, like other beta2-agonists, can produce serious heart-related effects in some patients as measured by higher pulse rate and higher blood pressure.
PERFOROMIST Inhalation Solution should be used with caution in patients with heart disease, especially coronary insufficiency, cardiac arrhythmias, and high blood pressure in patients with convulsive disorders or thyrotoxicosis and in patients who are unusually responsive to adrenaline-like drugs.
PERFOROMIST Inhalation Solution, like other adrenaline-like drugs, should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to adrenaline-like drugs. Doses of the related beta2-agonist albuterol, when administered intravenously, have been reported to worsen preexisting diabetes.
MAO Inhibitors, Tricyclic Antidepressants and QTc Prolonging Drugs
PERFOROMIST Inhalation Solution, like other beta2-agonists, should be used with extreme caution in patients being treated with certain antidepressants (monoamine oxidase inhibitors, tricyclic antidepressants), or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be increased by these agents.