• 3M Drug Delivery Systems Launches Redesigned Rescue Inhaler PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol now manufactured with top-mounted dose indicator

    July 25, 2018

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    • ST. PAUL, Minn. – (July 25, 2018) – This spring, 3M Drug Delivery Systems launched an improved version of one of the leading rescue inhalers on the market. Since 1996, more than 150 million PROVENTIL HFA metered dose inhalers have been used by patients around the world. Now, patients will benefit from the added convenience of being able to track the number of doses they have used, so they will know when to order a refill. PROVENTIL HFA Inhalation Aerosol and PROVENTIL HFA Inhalation Aerosol with Dose Indicator are indicated in adults and children 4 years and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

      PROVENTIL HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other PROVENTIL HFA components.
      Beginning in the spring of 2018, PROVENTIL HFA will be manufactured with a top-mounted dose indicator. The dose counter will offer patients peace of mind because they will no longer have to worry about remembering how many times they have used their inhaler, it will be displayed right on top of the device. The new device will also help prevent patients from unknowingly throwing away inhalers that may have doses left in them.

      “For more than 20 years, 3M has been proud to provide patients with one of the best rescue inhalers on the market,” said Keith O’Connor, Global Business Leader, 3M Inhalation Drug Delivery. “This is a product that millions of patients know and trust will work when they need it to. The ability to count the number of doses remaining in their inhalers will further help them manage their asthma.”

      “The inhalation industry continues to be focused on finding innovative ways to make delivery devices more user-friendly,” said Silvia Perez, President, 3M Drug Delivery Systems Division. “At 3M, we are committed to improving the patient experience in a variety of ways. Not only are we improving upon established products that are in the market, like PROVENTIL HFA, we are pushing technological boundaries with new innovations.”

      Additional Selected Safety Information for PROVENTIL HFA (albuterol sulfate)
       

      • PROVENTIL HFA 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 reevaluation of the patient and treatment regimen.
      • PROVENTIL HFA, 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 preexisting 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 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%).

      Proventil HFA is manufactured by 3M and marketed and distributed by Merck. More information about 3M inhalation capabilities is available at https://www.3m.com/3M/en_US/drug-delivery-systems-us/technologies/inhalation/.

      Please see Prescribing Information for PROVENTIL HFA at the following link:
      https://www.merck.com/product/usa/pi_circulars/p/proventil_hfa/proventil_hfa_doseindicator_pi.pdf. (PDF, 240.7 KB)

      The Patient Information is also available at the following link:
      https://www.merck.com/product/usa/pi_circulars/p/proventil_hfa/proventil_hfa_doseindicator_ppi.pdf (PDF, 299.7 KB)

      3M is a trademark of 3M Company. Proventil and Merck are trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.