20 mcg
Placebo
n
(%)
n
(%)
Total Patients
123
(100)
114
(100)
Diarrhea
6
(4.9)
4
(3.5)
Nausea
6
(4.9)
3
(2.6)
Nasopharyngitis
4
(3.3)
2
(1.8)
Dry Mouth
4
(3.3)
2
(1.8)
Vomiting
3
(2.4)
2
(1.8)
Dizziness
3
(2.4)
1
(0.9)
Insomnia
3
(2.4)
0
0
Patients treated with PERFOROMIST Inhalation Solution 20 mcg twice daily in the 52-week open-label trial did not experience an increase in specific clinically significant adverse events above the number expected based on the medical condition and age of the patients.
6.3 Postmarketing ExperienceThe following adverse reactions have been reported during post-approval use of PERFOROMIST Inhalation Solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Anaphylactic reactions, urticaria, angioedema (presenting as face, lip, tongue, eye, pharyngeal, or mouth edema), rash, and bronchospasm
7 DRUG INTERACTIONS
7.1 Adrenergic DrugsIf additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of formoterol may be potentiated [see WARNINGS AND PRECAUTIONS (5.3, 5.5, 5.6, 5.7)].
7.2 Xanthine Derivatives, Steroids, or DiureticsConcomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists [see WARNINGS AND PRECAUTIONS (5.7)].
7.3 Non-potassium Sparing DiureticsThe ECG 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, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics.
7.4 MAO Inhibitors, Tricyclic Antidepressants, QTc Prolonging DrugsFormoterol, as with other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias
7.5 Beta-blockersBeta-adrenergic receptor antagonists (beta-blockers) and formoterol may inhibit the effect of each other when administered concurrently. Beta-blockers not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, 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 COP |
