VENTOLIN HFA(albuterol sulfate HFA inhalation aerosol)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ventolin hfa safely and effectively. See full prescribing information for ventolin hfa.
ventolin hfa (albuterol sulfate)  aerosol, metered for respiratory (inhalation) use
Initial U.S. Approval: 1981
RECENT MAJOR CHANGES
Pediatric Use (8.4) 3/2008
INDICATIONS AND USAGE
VENTOLIN HFA is a beta2-adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease (1.1)
Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2)
DOSAGE AND ADMINISTRATION
FOR ORAL INHALATION ONLY.
Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours. For some patients, 1 inhalation every 4 hours may be sufficient. (2.1)
Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise. (2.2)
Priming information: Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray. (2.3)
Cleaning nformation: At least once a week, wash the actuator with warm water and let it air-dry completely. (2.3)
DOSAGE FORMS AND STRENGTHS
Inhalation aerosol: 108 mcg albuterol sulfate (90 mcg albuterol base) from mouthpiece per actuation. Supplied in 18-g canister containing 200 actuations. (3)
CONTRAINDICATIONS
Hypersensitivity to albuterol sulfate or any of the ingredients of VENTOLIN HFA. (4)
WARNINGS AND PRECAUTIONS
Paradoxical bronchospasm may occur and should be treated immediately with alternative therapy. (5.1)
Need for more doses of VENTOLIN HFA than usual may be a sign of deterioration of asthma and requires reeva luation of treatment. (5.2)
Cardiovascular effects may occur with beta-adrenergic agonists use. Consider discontinuation of VENTOLIN HFA if these effects occur. Use with caution in patients with underlying cardiovascular disorders. (5.4)
Immediate hypersensitivity reactions may occur. Discontinue VENTOLIN HFA if immediate hypersensitivity reactions occur. (5.6)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥3%) are throat irritation, viral respiratory infections, upper respiratory inflammation, cough, and musculoskeletal pain. (6)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
Beta-blockers: May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. Patients with asthma should not normally be treated with beta-blockers. (7.1)
Diuretics: Electrocardiographic changes and/or hypokalemia associated with diuretics may worsen with concomitant beta-agonists. Consider monitoring potassium levels. (7.2)
Monoamine oxidase inhibitors (MAOs) or tricyclic antidepressants: May potentiate effect of albuterol on the vascular system. Consider alternative therapy in patients taking MAOs or tricyclic antidepressants. (7.4)
Revised: March 2008
VNT:2PI
See 17 for PATIENT COUNSELING INFORMATION and FDA-appr