Note: The indented statement below is required by the Federal Government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs). This product contains trichloromonofluoromethane and dichlorodifluoromethane, substances which harm the environment by destroying ozone in the upper atmosphere. Your physician has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about alternatives, consult with your physician.
boxed warning
Important Information: Store between 15° and 30°C (59° to 86°F). Failure to use this product within this temperature range may result in improper dosing. For optimal results, the canister should be at room temperature before use. Shake well before using. Caution: Contents of canister under pressure. Do not puncture. Do not use near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Avoid spraying in eyes. Keep out of reach of children. Rx Only Use Maxair Autohaler only as prescribed by your physician. Handle with care. DO NOT USE WITH OTHER CANISTERS OR MOUTHPIECES. For information on the drug, refer to your doctor or pharmacist.
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warnings
WARNINGS Cardiovascular MAXAIR AUTOHALER, like other inhaled beta adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure and/or symptoms. Although such effects are uncommon after administration of MAXAIR AUTOHALER at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, MAXAIR AUTOHALER, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Paradoxical Bronchospasm MAXAIR AUTOHALER can produce paradoxical bronchospasm, which can be life threatening. If paradoxical bronchospasm occurs, MAXAIR AUTOHALER should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial. Use of Anti-Inflammatory Agents The use of beta adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding antiinflammatory agents, e.g., corticosteroids. Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of MAXAIR AUTOHALER than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
ADVERSE REACTIONS 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%). Cardiovascular: palpitations (1.7%), tachycardia (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: CNS: depression, anxiety, confusion, insomnia, weakness, hyperkinesia, syncope. Cardiovascular: hypotension, skipped beats, chest pain. Gastrointestinal: dry mouth, glossitis, abdominal pain/cramps, anorexia, diarrhea, stomatitis, nausea and vomiting. Ear, Nose and Throat: smell/taste changes, sore throat. Dermatological: rash, pruritus. Other: numbness in extremities, alopecia, bruising, fatigue, edema, weight gain, flushing. 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 Reaction Pirbuterol Metaproterenol N=157 N=153 Central Nervous System tremors 1.3% 3.3% nervousness 4.5% 2.6% headache 1.3% 2.0% weakness .0% 1.3% drowsiness .0% 0.7% dizziness 0.6% .0% Cardiovascular palpitations 1.3% 1.3% tachycardia 1.3% 2.0% Respiratory chest pain/tightness 1.3% .0% cough .0% 0.7% Gastrointestinal nausea 1.3% 2.0% diarrhea 1.3% 0.7% dry mouth 1.3% 1.3% vomiting .0% 0.7% Dermatological skin reaction .0% 0.7% rash .0% 1.3% Other bruising 0.6% .0% smell/taste change 0.6% .0% backache .0% 0.7% fatigue .0% 0.7% hoarseness .0% 0.7% nasal congestion .0% 0.7% Electrocardiograms Electrocardiograms, obtained during a randomized, double-blind, cross-over 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.