PERFOROMIST® (formoterol fumarate) Inhalation Solution is used for the long-term treatment of chronic obstructive pulmonary disease (COPD) including chronic inflammation of the lungs (bronchitis) and emphysema. It is only to be used with a jet nebulizer and is taken twice daily (morning and evening).
Important Limitations for Use:
IMPORTANT SAFETY INFORMATION
- PERFOROMIST should not be used as a rescue medication
- PERFOROMIST is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma has not been established.
Warnings and Precautions
|WARNING: ASTHMA-RELATED DEATH
PERFOROMIST Inhalation Solution belongs to a class of drugs called long-acting beta2-agonists (LABA). People with asthma who take LABA such as PERFOROMIST Inhalation Solution have an increased risk of death from asthma problems. Do not use PERFOROMIST Inhalation Solution if you have asthma without using a long-term asthma control medicine.
PERFOROMIST Inhalation Solution should not be used instead of rescue inhaler or nebulized medicine for the treatment of acute symptoms. Extra doses of PERFOROMIST Inhalation Solution should not be used for that purpose since overuse can cause serious heart problems, including death. Acute or sudden symptoms should be treated with an inhaled short-acting beta2-agonist.
Seek immediate medical attention if:
Do not use PERFOROMIST Inhalation Solution with other LABA medicines for any reason.
- your symptoms quickly worsen despite recommended doses of PERFOROMIST Inhalation Solution
- PERFOROMIST Inhalation Solution treatment becomes less effective
- you need more inhalations of a short-acting beta2-agonist (rescue inhaler or nebulized medicine) than usual.
The use of PERFOROMIST Inhalation Solution with certain health conditions or with certain medications can cause serious side effects. Tell your health care professional about all of your health conditions, including if you:
- have heart problems
- have high blood pressure
- have diabetes
- have seizures
- have thyroid problems
- have liver problems
- are pregnant or planning to become pregnant. It is not known if PERFOROMIST Inhalation Solution can harm an unborn baby.
- are breastfeeding. It is not known if PERFOROMIST Inhalation Solution passes into breast milk and if it can harm your baby.
It is important to inform your healthcare professional of all prescription or over the counter medications you are taking including: beta-blockers, some antidepressants (tricyclic and MAO inhibitors), steroids, diuretics, xanthine derivatives (e.g. theophylline), as well as vitamins and herbal supplements. PERFOROMIST Inhalation Solution and certain medicines may interact with each other and cause serious side effects.
Immediate allergic reactions may occur after taking PERFOROMIST Inhalation Solution, including anaphylactic reactions, hives, generalized swelling including the airway, rash, and bronchospasm.
The most common side effects reported in patients taking PERFOROMIST Inhalation Solution were diarrhea, nausea, nasopharyngitis, dry mouth, dizziness, and insomnia. Serious side effects may include sudden shortness of breath, serious allergic reactions, chest pain, increased or decreased blood pressure, a fast and irregular heartbeat, low blood potassium, high blood sugar, and high blood acid.
How to Use PERFOROMIST Inhalation Solution
Use PERFOROMIST Inhalation Solution exactly as directed by your health care professional. Do not stop using PERFOROMIST Inhalation Solution or other medicines to control or treat your COPD unless told to do so by your health care professional because your symptoms might get worse. Your health care professional will change your medicines as needed.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.