Albuterol Sulfate Inhalation Solution

WARNINGS Paradoxical Bronchospasm As with other inhaled beta-adrenergic agonists, Albuterol Inhalation Solution can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, Albuterol Inhalation Solution should be discontinued immediately and alternative therapy instituted. It should be noted 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 bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory 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 Albuterol Inhalation Solution than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and the treatment regimen, giving special consideration of the possible need for anti-inflammatory treatment (e.g., corticosteroids). Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs and with the home use of nebulizers. It is, therefore, essential that the physician instruct the patient in the need for further evaluation, if his/her asthma becomes worse. Cardiovascular Effects Albuterol Inhalation Solution, like other 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 for Albuterol Inhalation Solution 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, Albuterol Inhalation Solution like all other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions may occur after administration of albuterol as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema.

ADVERSE REACTIONS Clinical Trial Experience Adverse events reported in >1% of patients receiving Albuterol Inhalation Solution and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table. Table 1: Adverse Events with an Incidence of >1% of Patients Receiving Albuterol Inhalation Solution and Greater than Placebo (expressed as % of treatment group) 1.25 mg Albuterol Inhalation Solution (N=115) 0.63 mg Albuterol Inhalation Solution (N=117) Placebo (N=117) Asthma Exacerbation 13 11.1 8.5 Otitis Media 4.3 0.9 0 Allergic Reaction 0.9 3.4 1.7 Gastroenteritis 0.9 3.4 0.9 Cold Symptoms 0 3.4 1.7 Flu Syndrome 2.6 2.6 1.7 Lymphadenopathy 2.6 0.9 1.7 Skin/Appendage Infection 1.7 0 0 Urticaria 1.7 0.9 0 Migraine 0.9 1.7 0 Chest Pain 0.9 1.7 0 Bronchitis 0.9 1.7 0.9 Nausea 1.7 0.9 0.9 There was one case of ST segment depression in the 1.25 mg Albuterol Inhalation Solution treatment group. No clinically relevant laboratory abnormalities related to Albuterol Inhalation Solution administration were seen in this study. Post-marketing Experience Metabolic acidosis has been reported after the use of albuterol inhalation solution. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure.

<table border="1" width="100%"><caption>Table 1: Adverse Events with an Incidence of &gt;1% of Patients Receiving Albuterol Inhalation Solution and Greater than Placebo (expressed as % of treatment group)</caption><tbody><tr><td styleCode="Lrule Rrule Toprule Botrule"/><td><content styleCode="bold">1.25 mg Albuterol Inhalation Solution (N=115)</content></td><td><content styleCode="bold">0.63 mg Albuterol Inhalation Solution (N=117)</content></td><td><content styleCode="bold">Placebo (N=117)</content></td></tr><tr><td>Asthma Exacerbation</td><td>13</td><td>11.1</td><td>8.5</td></tr><tr><td>Otitis Media</td><td>4.3</td><td>0.9</td><td>0</td></tr><tr><td>Allergic Reaction</td><td>0.9</td><td>3.4</td><td>1.7</td></tr><tr><td>Gastroenteritis</td><td>0.9</td><td>3.4</td><td>0.9</td></tr><tr><td>Cold Symptoms</td><td>0</td><td>3.4</td><td>1.7</td></tr><tr><td>Flu Syndrome</td><td>2.6</td><td>2.6</td><td>1.7</td></tr><tr><td>Lymphadenopathy</td><td>2.6</td><td>0.9</td><td>1.7</td></tr><tr><td>Skin/Appendage Infection</td><td>1.7</td><td>0</td><td>0</td></tr><tr><td>Urticaria</td><td>1.7</td><td>0.9</td><td>0</td></tr><tr><td>Migraine</td><td>0.9</td><td>1.7</td><td>0</td></tr><tr><td>Chest Pain</td><td>0.9</td><td>1.7</td><td>0</td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule">Bronchitis</td><td>0.9</td><td>1.7</td><td>0.9</td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule">Nausea</td><td>1.7</td><td>0.9</td><td>0.9</td></tr></tbody></table>