Breathe more easily for more of your day
PERFOROMIST + Spiriva®
If you take Spiriva® and feel you might need more control for your symptoms of COPD, ask your doctor about adding PERFOROMIST Solution.
A few examples of worsening COPD:
- Breathlessness that affects your activities
- Waking up at night with symptoms
- Increased use of rescue medications like albuterol
- Emergency doctor’s office or emergency room visits
A recent clinical study showed that PERFOROMIST™ Solution in combination with Spiriva® worked better than Spiriva® used alone.3
Spiriva® HandiHaler® (tiotropium bromide inhalation powder) is indicated for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Spiriva® HandiHaler® is not indicated for the initial treatment of acute episodes of bronchospasm, ie, rescue therapy.
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- Patient Medication Guide
Please see full Prescribing Information, including Boxed Warning.
Approved Use
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. [See WARNINGS AND PRECAUTIONS.]
Important Limitations of Use
Deteriorating COPD
PERFOROMIST Inhalation Solution should not be used in patients with rapidly worsening COPD, which may be a life-threatening condition.
Asthma
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.
Paradoxical Bronchospasm
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.
Cardiovascular Effects
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.
Coexisting Conditions
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.
Drug Interactions
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.
Adverse Events
PERFOROMIST Inhalation Solution was studied in a 12-week, double-blind, placebo- and active-controlled trial (123 subjects treated with PERFOROMIST Inhalation Solution) and a 52-week, active-controlled trial (463 subjects treated with PERFOROMIST Inhalation Solution). The most common adverse events reported in patients taking PERFOROMIST Inhalation Solution, and occurring more frequently than in patients taking placebo, were diarrhea (5%), nausea (5%), nasopharyngitis (3%), dry mouth (3%), dizziness (2%), and insomnia (2%).
This Web site provides useful information about chronic obstructive pulmonary disease (COPD) and the maintenance treatment of COPD with PERFOROMIST (formoterol fumarate) Inhalation Solution. Please consult with your healthcare practitioner, who is your best source for diagnosing COPD and recommending appropriate treatment.
© 2008 Dey, L.P., Napa, CA. All rights reserved. This Web site is intended for United States of America (U.S.A.) residents only and is subject to all applicable U.S.A. laws.
PERFOROMIST is a registered trademark of Dey, L.P. DEY® is a registered trademark of Dey, L.P. U.S. Patent Nos. 6,814,953 and 6,667,344.