Indicated for in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life threatening.

Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of PROVENTIL HFA Inhalation Aerosol than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

PROVENTIL HFA Inhalation Aerosol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. PROVENTIL HFA Inhalation Aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.

Patients with asthma should not normally be treated with beta-blockers.

The ECG changes and/or hypokalemia which may result from the administration of non-potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded.

PROVENTIL HFA Inhalation Aerosol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the cardiovascular system may be potentiated.

Albuterol has not been approved for the management of preterm labor.

There are no adequate and well-controlled studies of PROVENTIL HFA Inhalation Aerosol or  albuterol sulfate in pregnant women. Animal studies: teratogenic including cleft palate formation,cranioschisis, and limb defects.

Because of the potential for tumorigenicity shown for albuterol in animal studies and lack of experience with the use of PROVENTIL HFA Inhalation Aerosol by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Hyperkalemia. GoToSource

• Chronic lung disease in preterm infants. GoToSource

• Whooping cough (pertussis). GoToSource

• Use in patients under 4 years of age. GoToSource 

• Use with glatiramer acetate in patients with multiple sclerosis. GoToSource

Paradoxical bronchospasm. GoToSource

Postural hypotension (drop in blood pressure due to change in body position). GoToSource

Metabolic acidosis (body produces too much acid). GoToSource

Tremors and tachycardia (rapid heart rate). GoToSource

Lawsuits filed for heart attacks.