Glossary

Terms you may want to be familiar with^29-43

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z

A

Acetylcholine: a chemical that contracts the muscles around the airways. ³²

Airways: another term for the bronchial tubes in the lung. ³²

Albuterol: a commonly prescribed bronchodilator for people with COPD. ³²

Anticholinergic: a type of bronchodilator that relaxes the muscles allowing the bronchial tubes to expand. ³²

Asthma: a disease involving temporary spasm of the muscles surrounding the bronchial tubes. Asthma can be reversed by bronchodilators. ³²

B

Beta₂-agonist: a type of bronchodilator that relaxes the muscles allowing the bronchial tubes to expand. ³³

Bronchial tubes: also known as airways, the system of tubes that carry air through the lungs and carbon dioxide out of the lungs. ³²

Bronchodilator: a medication that expands the diameter of the bronchial tubes making breathing easier. ³²

C

Carbon dioxide (CO₂): the waste product of breathing that is exhaled by breathing out. ³²

Chronic bronchitis: one of the 2 conditions included under the definition of COPD. Chronic bronchitis is a permanent inflammation of the bronchial tubes that makes breathing in more difficult. ³²

Combination therapy: taking more than one medicine at a time to help relieve symptoms of COPD. ³⁴

Congestive heart failure: a coronary condition that shares some symptoms with COPD. ³⁵

COPD: Chronic Obstructive Pulmonary Disease, a progressive condition of the lungs that makes breathing more difficult. COPD includes both emphysema and chronic bronchitis. ³⁶

Corticosteroids: medications that reduce inflammation in the airways that carry air to the lungs (bronchial tubes). They also decrease the mucus made by the bronchial tubes and make it easier to breathe. ^32,37

D

Dry powder inhaler (DPI): a mechanism that delivers powdered medication to the lungs. ³⁸

E

Emphysema: one of the conditions included in COPD, emphysema affects the air sacs, making it more difficult to breathe out. ^32,36

Exacerbations: acute periods of illness in people with COPD. Exacerbations can be caused by infections, such as pneumonia. ³⁶

F

FEV: Forced Expiratory Volume, a measurement by a spirometer of the amount of air the lungs can hold. ³⁹

FEV₁: Forced Expiratory Volume in 1 second, a measurement by a spirometer of the amount of air the lungs can hold. ³⁹

FVC: Forced Vital Capacity, a measurement by a spirometer of the amount of air the lungs can hold. ⁴⁰

Formoterol: Formoterol is an inhaled long-acting beta₂-agonist used as a bronchodilator in the treatment of COPD. ³²

G

Glucocorticoid: an inhaled steroid that often helps to reduce inflammation of the bronchial tubes. ⁴¹

I

Inhaler: a device that delivers medication directly to the lungs. ³²

Ipratropium: a commonly prescribed bronchodilator for people with COPD. ³²

M

Metered dose inhaler (MDI): a medication delivery device that provides a specific amount of medication with each use. ⁴²

Methylxanthine: a type of bronchodilator derived from tea and used primarily by those for whom other bronchodilators are not effective. ^{32, 43}

Mucus: secretions produced in the bronchial tubes to remove foreign particles from the lung. ⁴³

N

Nebulizer: a device that turns medications into a fine mist for delivery to the lungs. ³²

O

Oxygen (O₂): the element that energizes the body's chemistry. ³²

P

Paradoxical bronchospasm: a condition which occurs when a medicine prescribed to treat sudden narrowing of the airways, causing coughing or difficulty breathing, has the effect of causing this condition. Paradoxical bronchospasm can be life-threatening. ⁴⁴

Pulmonary function test: a test using a spirometer to measure how well the lungs take air in and breathe carbon dioxide out. ⁴⁵

S

Spirometer: a hand-held device that measures how well the lungs are functioning. ³²

Sputum: mucus that is coughed up from the lungs. ³²

T

Theophylline: a methylxanthine bronchodilator. ³²

Tiotropium: a long-acting anticholinergic bronchodilator used in the management of COPD. ⁴⁶

W

Wheezing: a sound sometimes made by people who have trouble breathing. ³²

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.

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.