INDICATIONS AND USAGE Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

WARNINGS Paradoxical Bronchospasm Albuterol tablets can produce paradoxical bronchospasm, which may be life threatening.

If paradoxical bronchospasm occurs, albuterol tablets should be discontinued immediately and alternative therapy instituted.

Cardiovascular Effects Albuterol tablets, 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 tablets 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 tablets, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

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 tablets 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.

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.

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.

Albuterol, like other beta-adrenergic agonists, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes.

Rarely, erythema multiforme and Stevens-Johnson syndrome have been associated with the administration of oral albuterol sulfate in children.

ADVERSE REACTIONS In clinical trials, the most frequent adverse reactions to albuterol tablets were: Percent Incidence of Adverse Reactions Reaction Percent Incidence Central nervous system Nervousness 20% Tremor 20% Headache 7% Sleeplessness 2% Weakness 2% Dizziness 2% Drowsiness <1% Restlessness <1% Irritability <1% Cardiovascular Tachycardia 5% Palpitations 5% Chest discomfort <1% Flushing <1% Musculoskeletal Muscle cramps 3% Gastrointestinal Nausea 2% Genitourinary Difficulty in micturition <1% Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of albuterol.

In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, unusual taste, and drying or irritation of the oropharynx.

The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with albuterol tablets.

In selected cases, however, dosage may be reduced temporarily; after the reaction has subsided, dosage should be increased in small increments to the optimal dosage.