A Primer on the Newly-Approved OTC Asthma Inhaler

The only FDA-approved over-the-counter (OTC) metered-dose inhaler (MDI), Primatene Mist, is arriving in stores.¹ Primatene Mist is FDA-approved for the temporary relief of mild symptoms of intermittent asthma.² With this new OTC option taking its place in the asthma product landscape, pharmacists can provide crucial therapeutic interventions and education.

What’s New?

Some may remember the old formulation of OTC Primatene Mist that was taken off the market in 2011 because it contained chlorofluorocarbon (CFC) propellants, which are known to deplete the ozone layer. The reformulated version approved by FDA in November 2018 uses hydrofluoroalkane (HFA) propellants permitted under current international and US law and used in prescription-only inhalers such as those containing albuterol and levalbuterol.

While the new HFA propellant Primatene Mist uses the same active bronchodilator ingredient (epinephrine) as the previously available CFC propellant version, there are some important differences. For example, dosing is different between the old and new products. The CFC product was 1 to 2 inhalations every 3 hours, not to exceed 12 inhalations per day. The HFA product has more conservative dosing of 1 to 2 inhalations every 4 hours, not to exceed 8 inhalations per day. The dosing is based on dose ranging trials conducted by the product sponsor.^3,2 The device also has been redesigned. Like other MDIs, the product comes with detailed instructions for use that must be followed for the device to work properly and deliver an accurate dose.

Primatene Mist has unique instructions for shaking and priming before the first use and before each subsequent use. It also must be cleaned after each day of use.

The new version is approved for use in adults and children 12 years of age and older. It is not known if the product works or is safe in children younger than 12 years. By contrast, the old version was approved for ages 4 and older.⁴

FDA analysis of the data, including new information that was developed since Primatene Mist was previously on the market, shows that there are no serious safety concerns when Primatene Mist is used as directed.⁵

Opportunities for Pharmacist Intervention

Pharmacists are uniquely positioned to answer patient and provider questions about this new OTC product. When approached by a patient or caregivers who are considering the product, solicit additional information to tailor recommendations.

• If a patient thinks he or she has asthma, but hasn’t been diagnosed, explain that asthma is a complex medical condition and recommend that he or she first consult a qualified provider for proper diagnosis. Also explain that Primatene Mist can provide short-term relief of mild, intermittent asthma symptoms, but not long-term control.
• Patients currently using prescription inhalers may ask about Primatene Mist. Explain that Primatene Mist is not a replacement for prescription asthma treatments and recommend that they not start or stop asthma medications without talking with their provider. If a patient tells you that his or her regimen is not effectively controlling their asthma symptoms, use the interaction as an opportunity to check how the current inhaler(s) is being used and cleaned. Also recommend that the patient see their doctor to make sure that their asthma regimen is optimized.
• Counsel patients regarding the asthma alert. Even patients with mild asthma can have serious, life-threatening exacerbations. Advise patients to see a doctor immediately if they are not better in 20 minutes after using Primatene, their symptoms get worse, they need more than 8 inhalations in 24 hours, or they have more than two asthma attacks in a week.
• If a parent wants to purchase Primatene Mist for a child, ask for the child’s age and counsel accordingly. Primatene Mist should not be used in children under 12.
• The Drug Facts label instructs patients to ask a doctor or pharmacist if they take certain medications. Primatene Mist should not be used by patients taking a prescription monoamine oxidase inhibitor (MAOI), or for two weeks after stopping an MAOI. Help patients identify whether they take an MAOI and counsel patients who take medications containing pseudoephedrine, ephedrine, caffeine, or phenylephrine.
• Patients with hypertension or heart disease may ask about warnings on the Drug Facts label that using Primatene Mist may increase their risk of heart attack or stroke. Explain that while high doses of epinephrine may lead to tachycardia or hypertension, these effects have not been seen at recommended doses of Primatene Mist.⁴ Strongly encourage patients not to take the product more frequently or exceed the recommended dose.

Counseling patients

When the product arrives in stores, patients may consult with their pharmacist first. Emphasize to patients the importance of reading the Drug Facts thoroughly before selecting the product, and the instructions for use before using it. Become familiar with the Drug Facts label and instructions for use before counseling patients (Table). Both are available in Drugs@FDA (www.fda.gov/DrugsatFDA).

Table:

Counseling Points from the Drug Facts Label and Instructions for Use ²

(in addition to interventions discussed above)

Adults and children 12 years of age and older who have been diagnosed with mild, intermittent asthma: Use for temporary relief of mild symptoms of intermittent asthma such as wheezing, tightness of the chest, and shortness of breath.

Ask a doctor before use if you have: ever been hospitalized for asthma; heart disease; high blood pressure; diabetes; trouble urinating due to an enlarged prostate gland; thyroid disease; seizures; narrow angle glaucoma.

Before first use: Activate the new inhaler by shaking then spraying into the air 4 separate times.

Each dose:

• Remove the red cap (if attached). Shake the inhaler then spray into the air 1 time.
• Exhale completely then place the inhaler in your mouth.
• Inhale deeply while pressing down on top of the inhaler, then continue the deep breath.
• Hold your breath as long as possible, then exhale.
• Wait 1 minute. If symptoms are not relieved, take a second inhalation by repeating the steps above.
• Wait at least 4 hours before using the inhaler again.

See a doctor 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.

Stop use and ask a doctor if your asthma is getting worse; you have difficulty sleeping; you have a rapid heartbeat; or you have tremors, nervousness, or seizure.

After each day of use: Wash the inhaler by running water through the mouthpiece for 30 seconds.

Store at room temperature.

Danielle Molnar, PharmD, BCPS is the with the FDA’s Division of Drug Information.

References

• Amphastar Pharmaceuticals, Inc. Announces Reintroduction of Primatene MIST. http://ir.amphastar.com/news-releases/news-release-details/amphastar-pharmaceuticals-inc-announces-reintroduction [news release]. Amphastar Pharmaceuticals website. Accessed on November 30, 2018.
• US Food and Drug Administration. Primatene Mist NDA #205920 approved labeling from Drugs@FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205920Orig1s000lbl.pdf. Accessed on November 30, 2018.
• US Food and Drug Administration. Primatene Mist NDA #016126 approved labeling from Drugs@FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16126s25lbl.pdf. Accessed on December 7, 2018.
• US Food and Drug Administration. CDER Conversation: Safely Using the Newly Available OTC Asthma Inhaler Primatene Mist. https://www.fda.gov/Drugs/NewsEvents/ucm624994.htm. Accessed on November 30, 2018.
• US Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625338.htm. Accessed on November 30, 2018.