"The US Food and Drug Administration has approved AstraZeneca's Symbicort inhalation aerosol (80/4.5 mcg) for children aged 6 to 12 years with asthma that is not well controlled with an inhaled corticosteroid, the company has announced.
The following rates of adverse reactions to pirbuterol are based on single- and multiple-dose clinical trials involving 761 patients, 400 of whom received multiple doses (mean duration of treatment was 2.5 months and maximum was 19 months).
The following were the adverse reactions reported more frequently than 1 in 100 patients:
CNS: nervousness (6.9%), tremor (6.0%), headache (2.0%), dizziness (1.2%).
Respiratory: cough (1.2%).
Gastrointestinal: nausea (1.7%).
The following adverse reactions occurred less frequently than 1 in 100 patients and there may be a causal relationship with pirbuterol:
Ear, Nose and Throat: smell/taste changes, sore throat.
Other adverse reactions were reported with a frequency of less than 1 in 100 patients but a causal relationship between pirbuterol and the reaction could not be determined: migraine, productive cough, wheezing, and dermatitis.
The following rates of adverse reactions during three-month controlled clinical trials involving 310 patients are noted. The table does not include mild reactions.
PERCENT OF PATIENTS WITH MODERATE TO SEVERE ADVERSE REACTIONS
|Central Nervous System|
Electrocardiograms: Electrocardiograms, obtained during a randomized, double-blind, crossover study in 57 patients, showed no observations or findings considered clinically significant, or related to drug administration. Most electrocardiographic observations, obtained during a randomized, double-blind, cross-over study in 40 patients, were judged not clinically significant or related to drug administration. One patient was noted to have some changes on the one hour postdose electrocardiogram consisting of ST and T wave abnormality suggesting possible inferior ischemia. This abnormality was not observed on the predose or the six hours postdose ECG. A treadmill was subsequently performed and all the findings were normal.
Read the Maxair (pirbuterol) Side Effects Center for a complete guide to possible side effects
Other short-acting beta adrenergic aerosol bronchodilators should not be used concomitantly with MAXAIR (pirbuterol) AUTOHALER because they may have additive effects.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: Pirbuterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of pirbuterol on the vascular system may be potentiated.
Beta Blockers: Beta adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as MAXAIR (pirbuterol) AUTOHALER, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma 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 tothe use ofbeta adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta blockers could be considered, although they should be administered with caution.
Diuretics:The 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 coadministration of beta-agonists with non-potassium sparing diuretics.
Read the Maxair Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 11/24/2008
Additional Maxair Information
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