Albuterol - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Life-threatening paradoxical bronchospasm may occur.

Discontinue Albuterol Sulfate HFA immediately and institute alternative therapy.

Need for more doses of Albuterol Sulfate HFA than usual may be a sign of deterioration of asthma and requires reevaluation of treatment.

Albuterol Sulfate HFA is not a substitute for corticosteroids.

Cardiovascular effects may occur.

Use with caution in patients sensitive to sympathomimetic drugs and patients with cardiovascular or convulsive disorders. ( 5.4 , 5.7 ) Excessive use may be fatal.

Do not exceed recommended dose.

Immediate hypersensitivity reactions may occur.

Discontinue Albuterol Sulfate HFA immediately.

Hypokalemia and changes in blood glucose may occur. ( 5.7 , 5.8 ) 5.1 Paradoxical Bronchospasm Albuterol Sulfate HFA can produce paradoxical bronchospasm, which may be life threatening.

If paradoxical bronchospasm occurs following dosing with Albuterol Sulfate HFA, it should be discontinued immediately and alternative therapy should be instituted.

It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.

5.2 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 HFA than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

5.3 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, to the therapeutic regimen.

5.4 Cardiovascular Effects Albuterol Sulfate HFA, like all other beta 2 -adrenergic agonists, can produce clinically significant cardiovascular effects in some patients such as changes in pulse rate or blood pressure.

If such effects occur, Albuterol Sulfate HFA 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 relevance of these findings is unknown.

Therefore, Albuterol Sulfate HFA, like all other sympathomimetic amines, should be used with caution in patients with underlying cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

5.5 Do Not Exceed Recommended Dose Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma.

The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.

5.6 Hypersensitivity Reactions, including Anaphylaxis Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of Albuterol Sulfate HFA [see Contraindications ] .

5.7 Coexisting Conditions Albuterol Sulfate HFA, like other sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines.