(Please see Prescribing Information, including Boxed Warning, about increased risk of tendinitis and tendon rupture and exacerbation of muscle weakness in patients with myasthenia gravis.)
(Please see Prescribing Information, including Boxed Warning, about increased risk of tendinitis and tendon rupture and exacerbation of muscle weakness in patients with myasthenia gravis.)
(Before prescribing FORADIL AEROLIZER, please read the Prescribing Information, including the Boxed Warning about asthma-related death. The Medication Guide also is available.)
PROVENTIL HFA Inhalation Aerosol is indicated 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.
IMPORTANT SAFETY INFORMATION FOR PROVENTIL HFA
PROVENTIL HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other PROVENTIL HFA components.
PROVENTIL HFA Inhalation Aerosol can produce paradoxical bronchospasm, which may be life threatening. Discontinue PROVENTIL HFA and institute alternative therapy if paradoxical bronchospasm occurs.
Need for more doses of PROVENTIL HFA than usual may be a marker of deterioration of asthma and requires re-evaluation of the patient and treatment regimen.
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; therefore, it should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
PROVENTIL 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. Large doses of intravenous albuterol have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis.
As with other beta-agonists, albuterol may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects.
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.
Immediate hypersensitivity reactions may occur after administration of PROVENTIL HFA, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
Use of beta-adrenergic-receptor blocking agents may block bronchodilatory effects of beta-agonists and produce severe bronchospasm in asthmatic patients. Patients with asthma should not normally be treated with beta-blockers.
Caution is advised in the coadministration of beta agonists with nonpotassium-sparing diuretics. It is also advised to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.
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.
The most common adverse events with PROVENTIL HFA (vs. placebo) reported with a >3% incidence in a clinical trial were: upper respiratory tract infection 21% (vs. 18%), rhinitis 16% (vs. 14%), nausea 10% (vs. 5%), vomiting 7% (vs. 3%), nervousness 7% (vs. 3%), tremor 7% (vs. 2%), tachycardia 7% (vs. <1%), fever 6% (vs. 5%), respiratory disorder 6% (vs. 5%), inhalation site sensation 6% (vs. 2%), allergic reaction/symptoms 6% (vs. <1%), inhalation taste sensation 4% (vs. 3%), back pain 4% (vs. 3%), and urinary tract infection 3% (vs. 2%).
