FDA label 06bc9168-c27f-1a50-c7cb-9ff0e266ab75

BOXED WARNING {template}

WARNINGS 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 sulfate inhalation solution 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. 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 anti- inflammatory agents, e.g., corticosteroids. Paradoxical Bronchospasm Albuterol sulfate 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 recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new vial. Cardiovascular Effects Albuterol sulfate inhalation solution, like all 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 after administration of albuterol sulfate inhalation solution at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (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 sulfate inhalation solution, like all 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, anaphylaxis, and oropharyngeal edema. Microbial Contamination To avoid microbial contamination, the entire contents of the unit-dose ampule should be administered immediately after the ampule has been opened.

ADVERSE REACTIONS The results of clinical trials with albuterol sulfate inhalation solution in 135 patients showed the following side effects which were considered probably or possibly drug related: Percent Incidence of Adverse Reaction Percent Incidence CENTRAL NERVOUS SYSTEM Tremors 20% Dizziness 7% Nervousness 4% Headache 3% Insomnia 1% GASTROINTESTINAL Nausea 4% Dyspepsia 1% EAR, NOSE, AND THROAT Nasal congestion 1% Pharyngitis <1% CARDIOV ASCULAR Tachycardia 1% Hypertension 1% RESPIRA TOR Y Bronchospasm 8% Cough 4% Bronchitis 4% Wheezing 1% No clinically relevant laboratory abnormalities related to albuterol sulfate inhalation solution were determined in these studies. Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) have also been reported after the use of inhaled albuterol.

<table border="1" cellpadding="0" cellspacing="0" width="50%"> <tbody align="left" valign="middle"> <tr> <td valign="top"> <content styleCode="bold">Reaction</content> </td> <td valign="top"> <content styleCode="bold">Percent Incidence</content> </td> </tr> <tr> <td valign="top"> <content styleCode="bold">CENTRAL NERVOUS SYSTEM</content> </td> <td align="center" valign="top"> </td> </tr> <tr> <td valign="top">Tremors</td> <td align="center" valign="middle">20%</td> </tr> <tr> <td valign="top">Dizziness</td> <td align="center" valign="top">7%</td> </tr> <tr> <td valign="top">Nervousness</td> <td align="center" valign="top">4%</td> </tr> <tr> <td valign="top">Headache</td> <td align="center" valign="top">3%</td> </tr> <tr> <td valign="top">Insomnia</td> <td align="center" valign="top">1%</td> </tr> <tr> <td valign="top"> <content styleCode="bold">GASTROINTESTINAL</content> </td> <td valign="top"> </td> </tr> <tr> <td valign="top">Nausea</td> <td align="center" valign="top">4%</td> </tr> <tr> <td valign="top">Dyspepsia</td> <td align="center" valign="top">1%</td> </tr> <tr> <td valign="top"> <content styleCode="bold">EAR, NOSE, AND </content> <content styleCode="bold">THROAT</content> </td> <td valign="top"> </td> </tr> <tr> <td valign="top">Nasal congestion</td> <td align="center" valign="top">1%</td> </tr> <tr> <td valign="top">Pharyngitis</td> <td align="center" valign="top">&lt;1%</td> </tr> <tr> <td valign="top"> <content styleCode="bold">CARDIOV</content> <content styleCode="bold">ASCULAR</content> </td> <td valign="top"> </td> </tr> <tr> <td valign="top">Tachycardia</td> <td align="center" valign="top">1%</td> </tr> <tr> <td valign="top">Hypertension</td> <td align="center" valign="top">1%</td> </tr> <tr> <td valign="top"> <content styleCode="bold">RESPIRA</content> <content styleCode="bold">TOR</content> <content styleCode="bold">Y</content> </td> <td valign="top"> </td> </tr> <tr> <td valign="top">Bronchospasm</td> <td align="center" valign="top">8%</td> </tr> <tr> <td valign="top">Cough</td> <td align="center" valign="top">4%</td> </tr> <tr> <td valign="top">Bronchitis</td> <td align="center" valign="top">4%</td> </tr> <tr> <td valign="top">Wheezing</td> <td align="center" valign="top">1%</td> </tr> </tbody> </table>