Posted from: Tuesday, December 11, 2018 - 05:01 PM - Present

New Formulation of Primatene Mist Approved for OTC Use

November 7, 2018 – The U.S. FDA has approved a new formulation of Primatene® Mist (epinephrine inhalation aerosol bronchodilator suspension), manufactured by Amphastar Pharmaceuticals. The product is approved for over-the-counter use to provide temporary relief for symptoms of mild, intermittent asthma in patients who are at least 12 years of age.

Primatene Mist has been off the U.S. market since 2011 due to the presence of chlorofluorocarbon (CFC) propellants in its previous formula. Epinephrine inhalers containing CFCs were phased out of the market because of the damage CFCs can do to the Earth’s ozone layer. The newly approved formulation uses hydrofluoroalkane (HFA) propellants instead of CFCs. HFAs are used in prescription inhalers as well.

The materials of the Primatene Mist inhaler have been improved as well. While it was previously sold in glass containers, it will now be available in metal metered-dose inhalers with a mouthpiece and dose counter. Consumers should familiarize themselves with the instructions for proper use that are included in the product packaging, as the new inhaler functions differently than the previous design.

Recommended dosing is one spray to start. If symptoms do not improve after one minute, patients can use a second spray. They should then wait at least four hours before using another dose.

Patients should see a doctor right away if their asthma symptoms do not improve within 20 minutes of using Primatene Mist, or if the asthma gets worse. Patients should also see a doctor as soon as possible if they need more than eight inhalations in a 24-hour period, or have more than two asthma attacks in seven days. The FDA has provided guidance on the proper use of Primatene Mist at:

Amphastar Pharmaceuticals plans to launch the product in early 2019. Each inhaler will contain 160 metered sprays that deliver 0.125mg of medication per spray.

Last Updated Thursday, November 14, 2019 - 04:06 PM.