About ProAir ® HFA with Dose Counter
ProAir ® HFA (albuterol sulfate) Inhalation Aerosol with dose counter is indicated in patients 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. In March 2012, the U.S. Food and Drug Administration approved the addition of the dose counter, an innovation designed to help patients, as well as their caregivers, keep track of the number of doses remaining in the inhaler.
ProAir ® HFA with dose counter supports the FDA’s recommendations for such mechanisms, as a means to track the number of doses remaining. Dose counters reduce the risk of utilizing an inhaler that no longer contains the medication required.
The safety and efficacy of ProAir ® HFA was determined through clinical trials comparing it to a marketed active comparator albuterol HFA inhaler and placebo HFA aerosol. In clinical trials of adults and children with asthma, ProAir ® HFA produced bronchodilator responses greater than those observed with a matched placebo HFA inhalation aerosol and comparable safety and efficacy to the active comparator albuterol HFA inhaler.Important Safety Information If your symptoms become significantly worse when you use ProAir ® HFA, contact your doctor immediately. This may indicate either a worsening of your asthma or a reaction to the medication, which may rarely occur with the first use of a new canister of ProAir ® HFA. Either of these could be life-threatening. What to tell your doctor before using ProAir ® HFA: If you have a heart, blood, or seizure disorder, high blood pressure, diabetes, or an overactive thyroid, be sure to tell your doctor. Also make sure your doctor knows all medications you are taking, especially heart medications and drugs that treat depression, because some medications may interfere with how well your asthma medications work. Do not exceed the recommended dose. Side effects associated with ProAir ® HFA included headache, rapid heartbeat, pain, dizziness, and irritation of the throat and nose. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see full prescribing information at http://www.proairhfa.com/pdf/ProAirPrescribingInformation.pdf. About Teva Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is a world leading generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas. Teva currently employs approximately 46,000 people around the world and reached $18.3 billion in net revenues in 2011.