PERFOROMIST® (formoterol fumarate) Inhalation Solution is indicated
for the long-term, twice-daily (morning and evening) administration in the maintenance
treatment of bronchoconstriction in patients with chronic obstructive pulmonary
disease (COPD), including chronic bronchitis and emphysema.
- It is not indicated to treat acute deteriorations of COPD
- It is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST
Inhalation Solution in asthma has not been established.
Long-acting beta2-adrenergic agonists (LABA) increase the risk of
asthma-related death. Data from a large placebo-controlled US study that compared
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 is considered a class
effect of LABA, including formoterol, the active ingredient in PERFOROMIST Inhalation
The safety and efficacy of PERFOROMIST in patients with asthma have not been established.
All LABA, including PERFOROMIST, are contraindicated in patients with asthma without
use of a long-term asthma control medication.
Important Safety Information
PERFOROMIST Inhalation Solution like other LABAs is contraindicated in patients
with asthma without use of a long term asthma control medication.
PERFOROMIST Inhalation Solution should not be initiated in patients with acutely
deteriorating COPD, which may be a life-threatening condition. PERFOROMIST Inhalation
Solution should not be used for the relief of acute symptoms, i.e., as rescue therapy
for the treatment of acute episodes of bronchospasm.
As with other inhaled beta2-agonists, PERFOROMIST Inhalation Solution
can produce paradoxical bronchospasm that may be life-threatening. If paradoxical
bronchospasm occurs, PERFOROMIST Inhalation Solution should be discontinued immediately
and alternative therapy instituted.
PERFOROMIST Inhalation Solution should not be used more often, at higher doses than
recommended, or in conjunction with other inhaled, long-acting beta2-agonists,
as an overdose may result. Clinically significant cardiovascular effects and fatalities
have been reported in association with excessive use of inhaled sympathomimetic
PERFOROMIST Inhalation Solution should be used with caution in patients with cardiovascular
disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension;
in patients with convulsive disorders or thyrotoxicosis; and in patients who are
unusually responsive to sympathomimetic amines.
PERFOROMIST Inhalation Solution, like other beta2-agonists, can produce
a clinically significant cardiovascular effect in some patients as measured by increases
in pulse rate, systolic and/or diastolic blood pressure, and/or symptoms.
PERFOROMIST Inhalation Solution, like other sympathomimetic amines, should be used
with caution. Doses of the related beta2-agonist albuterol, when administered
intravenously, have been reported to aggravate preexisting diabetes mellitus and
Beta agonist medications may produce significant hypokalemia in some patients, which
has the potential to produce adverse cardiovascular effects. The decrease in serum
potassium is usually transient, not requiring supplementation.
Immediate hypersensitivity reactions may occur after administration of PERFOROMIST
Inhalation Solution, as demonstrated by cases of anaphylactic reactions, urticaria,
angioedema, rash, and bronchospasm.
PERFOROMIST Inhalation Solution, as with other beta2-agonists, should
be used with extreme caution in patients being treated with 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 potentiated by
Beta-blockers and formoterol fumarate may inhibit the effect of each other when
administered concurrently. Therefore, patients with COPD should not normally be
treated with beta-blockers except under certain circumstances e.g., as prophylaxis
after myocardial infarction, there may be no acceptable alternatives to the use
of beta-blockers in patients with COPD.
Concomitant treatment with Xanthine derivatives, steroids, or diuretics may potentiate
any hypokalemic effect of adrenergic agonists. The EKG changes and/or hypokalemia
that may result from the administration of non-potassium sparing diuretics (such
as loop or thiazide diuretics) can be acutely worsened by beta-agonists, so caution
is advised in the co-administration.
You are encouraged to report negative side effects of prescription drugs to the
or call 1-800-FDA-1088.