Maxair Autohaler
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Questions & Answers
Side Effects & Adverse Reactions
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.
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.
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.
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
MAXAIR AUTOHALER is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with reversible bronchospasm including asthma. It may be used with or without concurrent theophylline and/or corticosteroid therapy.
History
There is currently no drug history available for this drug.
Other Information
The active component of MAXAIR AUTOHALER (pirbuterol acetate) is (R,S)α6-{[(1,1-dimethylethyl)amino]methyl}-3-hydroxy-2,6-pyridinedimethanol monoacetate salt, a beta-2 adrenergic bronchodilator, having the following chemical structure:
Pirbuterol acetate is a white, crystalline racemic mixture of two optically active isomers. It is a powder, freely soluble in water, with a molecular weight of 300.3 and empirical formula of C12H20N2O3•C2H4O2.
MAXAIR AUTOHALER is a pressurized metered-dose aerosol unit for oral inhalation. It provides a fine-particle suspension of pirbuterol acetate in the propellant mixture of trichloromonofluoromethane and dichlorodifluoromethane, with sorbitan trioleate. Each actuation delivers 253 mcg of pirbuterol (as pirbuterol acetate) from the valve and 200 mcg of pirbuterol (as pirbuterol acetate) from the mouthpiece. The unit is breath-actuated such that the medication is delivered automatically during inspiration without the need for the patient to coordinate actuation with inspiration. Each 14.0 g canister provides 400 inhalations and each 2.8 g canister provides 80 inhalations.
As with all aerosol medications, it is recommended to prime (test) MAXAIR AUTOHALER before using for the first time. MAXAIR AUTOHALER should also be primed if it has not been used in 48 hours. As described in the priming procedure, use the test fire slide to release two priming sprays into the air away from yourself and other people. (See "Patient's Instructions For Use" portion of this package insert.)
Sources
Maxair Autohaler Manufacturers
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Medicis Pharmaceutical Corp
![Maxair Autohaler (Pirbuterol Acetate) Inhalant [Medicis Pharmaceutical Corp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Maxair Autohaler | Medicis Pharmaceutical Corp
The usual dose for adults and children 12 years and older is two inhalations (400 mcg) repeated every 4–6 hours. One inhalation (200 mcg) repeated every 4–6 hours may be sufficient for some patients.
A total daily dose of 12 inhalations should not be exceeded.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma which would require reassessment of therapy.
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Graceway Pharmaceuticals, Llc
Maxair Autohaler | Graceway Pharmaceuticals, Llc
The usual dose for adults and children 12 years and older is two inhalations (400 mcg) repeated every 4-6 hours. One inhalation (200 mcg) repeated every 4-6 hours may be sufficient for some patients.
A total daily dose of 12 inhalations should not be exceeded.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma which would require reassessment of therapy.
![Maxair Autohaler (Pirbuterol Acetate) Inhalant [Graceway Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7588b164-f4e8-4e1e-a305-2d775d2def7a&name=image-01.jpg)
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