Primatene® MIST FAQs

What is Primatene® MIST?
Primatene® MIST is the only FDA-approved, over-the-counter asthma inhaler for temporary relief of mild symptoms of intermittent asthma.
What symptoms can Primatene® MIST relieve?
Primatene® MIST is indicated for temporary relief of mild symptoms of intermittent asthma, which include wheezing, tightness of chest, and shortness of breath.
How often can I use Primatene® MIST?
Each dose is 1 to 2 inhalations. The maximum daily dose of Primatene® MIST is 8 inhalations in 24 hours. You should wait at least 4 hours between doses. Please see your doctor if you have more than 2 asthma attacks in a week.
Who is Primatene® MIST intended for?
Primatene® MIST is intended for adults and children ages 12 and older who have intermittent asthma. Consumers should consult with their doctors or pharmacists to assess whether this product is appropriate for them.
Why is Primatene® MIST labeled to relieve symptoms of intermittent asthma only for ages 12 and older?
The capability of Primatene® MIST to treat mild symptoms of intermittent asthma in those under age 12 has not been adequately studied.
Is Primatene® MIST safe for children to use?
Primatene® MIST is only approved for use in children ages 12 and over.
Who should not use Primatene® MIST?
For complete guidance, read the Drug Facts Label on the back of the Primatene® MIST package.
Why was Primatene® MIST discontinued several years ago?
The discontinuation of Primatene® MIST was not due to any safety or efficacy concerns. The original Primatene® MIST contained chlorofluorocarbon (CFC) as its propellant, which is considered an ozone-depleting substance. The product was removed from the market in December 2011 due to the phase out of this ozone-depleting CFC propellant under the Montreal Protocol, an important international environmental treaty. The new Primatene® MIST is a CFC-free metered dose inhaler (MDI) that uses epinephrine as its active ingredient, which is the same active ingredient that was used in the original Primatene® MIST.
What is the difference between the new and old Primatene® MIST?
The new Primatene® MIST uses our patented inhalation delivery system that does not contain CFCs; we have added a built-in spray indicator that shows how many sprays of asthma medicine you have left in the container. We have also redesigned the inhaler by replacing the glass container with a pressurized metal canister. The new Primatene® MIST functions differently than the original, so be sure to read the Consumer Information Insert for detailed directions on how to correctly use your new Primatene® MIST metered dose inhaler.
Were there any clinical trials done prior to the approval of Primatene® MIST?
Yes. In order for Primatene® MIST to be an FDA approved product, many clinical trials were conducted to support the safety and efficacy of Primatene® MIST. The various phase I through phase III clinical trials performed include: dose-ranging studies, pharmacokinetic (PK) and safety studies at high doses, long-term safety and efficacy studies, as well as extensive label comprehension and human factors studies with over 3,000 participants.
How often should the mouthpiece be cleaned? What should be used to clean the mouthpiece?
To prevent clogging, the Primatene® MIST mouthpiece should be washed with water after each day of use. We do not recommend rinsing the mouthpiece with alcohol or placing in the dishwasher. Please follow the washing instructions included with the product or at our website (click here for instructions).
Does regular use of Primatene® MIST negatively impact your lungs?
There is no evidence that indicates negative effects on the lungs from Primatene® MIST when used as instructed. It should be noted that Primatene® MIST is specifically indicated for the temporary relief of mild symptoms of intermittent asthma. If consumers are not better in 20 minutes after use or if symptoms get worse, the drug labeling directs consumers to immediately see a doctor or call 911.
Why is there a decrease in the amount of Epinephrine in each spray to 0.125 mg from the previous version of 0.220 mg? Is it less effective than the version?
Based on clinical studies, Primatene® MIST demonstrated significant bronchodilator efficacy at the dose strength of 0.125 mg, which is comparable to the original Primatene® MIST CFC at 0.220 mg. This indicates that the new Primatene® MIST has a more efficient delivery system that allows it to achieve a similar improvement in asthma symptoms as was previously achieved with the original Primatene® MIST CFC while utilizing a lower dosage of epinephrine.
My asthma symptoms are not improving–should I take more doses of Primatene® MIST?
No. As stated on the label, because asthma may be life threatening, see a doctor or call 911 if you are not better in 20 minutes, get worse, need more than 8 inhalations in 24 hours, or have more than 2 asthma attacks in a week. These may be signs that your asthma is getting worse.
Does Primatene® MIST relieve symptoms of an acute or severe asthma attack?
No. Primatene® MIST is only approved for temporary relief of mild symptoms of intermittent asthma. It is not a replacement for prescription asthma treatments and should not be used as a treatment for severe asthma symptoms.
Does taking Primatene Mist cause excessive cardiac stimulation?
As described in the Drug Facts labeling for Primatene® MIST, when using this product, your blood pressure or heart rate may temporarily go up. This could increase your risk of heart attack or stroke, which may cause death. Please see the Drug Facts labeling for further warnings about the risks of heart attack or stroke, as well as things to avoid when using this product. When properly following instructions, using this product is very unlikely to cause excessive cardiac stimulation. The company performed extensive clinical trials with Primatene® MIST, and provided the data to the Food and Drug Administration (FDA). The clinical data was thoroughly reviewed by the FDA, which approved the product as safe and effective. The clinical data that was reviewed by the FDA demonstrates very low incidences of cardiac-related adverse events. Incidences of cardiac events, including tachycardia (heart rate increase), were non-serious and not clinically significant. An increase in heart rate is a common symptom from all bronchodilator drugs, including prescription asthma inhalers. These symptoms typically disappear in a short period of time. The active ingredient in Primatene® MIST is epinephrine, which only enters the blood circulation in a very low concentration for a short period of time and should not cause excessive cardiac stimulation if used as directed.
Will I develop an addiction to Primatene® MIST?
No. Primatene® MIST is not addictive and is safe to use as directed. Primatene® MIST should only be used as directed and consumers should read the Drug Facts Label on the back of the Primatene® MIST package prior to usage.
What are the ingredients in Primatene® MIST?
Active Ingredient: Epinephrine 0.125 mg
Inactive Ingredients: Dehydrated alcohol (1%), hydrofluoroalkane (HFA 134a), polysorbate 80, thymol
Does taking Primatene® MIST cause high blood pressure?
As described in the Drug Facts labeling for Primatene® MIST, when using this product, your blood pressure or heart rate may temporarily increase. These risks may increase if you have a history of high blood pressure or heart disease or take this product more frequently or more than the recommended dose. In addition, clinical trials of Primatene® MIST HFA did not demonstrate significant increases in blood pressure, when using the product correctly. In a 6-month long term safety study performed on 373 patients at the labeled maximum daily dose (8 inhalations per day), the changes in systolic/diastolic blood pressure of Primatene® MIST HFA were non-significant and similar to those found for a placebo.
Is Primatene® MIST safe to take with other medications?
Primatene® MIST can be used with most prescription and non-prescription medications. However, you should not use Primatene® MIST if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. As with all medications, consumers should read the Drug Facts Label on the back of the Primatene® MIST package prior to usage and consult with their doctors or pharmacists to decide whether Primatene® MIST is appropriate for them. You should also ask a doctor or pharmacist before use if you are taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions, and/or are taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain).
Is there any historical data available related to the mortality rate for the previously marketed Primatene® MIST?
The FDA Adverse Event Reporting System (FAERS) database from 1997-2012 found 41 death reports, which corresponds to an incidence rate of only 0.6 cases per one million units distributed. No clear associations were found linking the deaths to the previously marketed Primatene® MIST.
image of page for checklist

Primatene® MIST Drug Facts

See complete information about what this product contains, what symptoms of asthma it is used to treat, warnings, safety information, and more.