The return of Primatene Mist to pharmacy shelves in 2018 was a significant development for individuals with mild, intermittent asthma seeking an over-the-counter treatment option. However, the reformulated product is not identical to the version that was discontinued in 2011. The primary drivers for the change were environmental regulations, which necessitated a complete overhaul of the device and its formulation. This guide breaks down the key distinctions between the old and new inhalers.
The Driving Force: A Change in Propellant
The most critical change between the two versions of Primatene Mist is the propellant used to deliver the medication. This shift was a direct result of international environmental protocols.
Why the Original Inhaler Was Removed
The original Primatene Mist, sold before 2011, used chlorofluorocarbon (CFC) propellants. CFCs were found to deplete the Earth's ozone layer, leading to the Montreal Protocol, an international treaty aimed at phasing out ozone-depleting substances. The United States' Clean Air Act of 1990 further solidified this effort, leading to the eventual removal of all CFC-based inhalers from the market, including Primatene Mist.
The Environmentally Friendly Alternative
The new Primatene Mist uses hydrofluoroalkane (HFA) propellants, which do not harm the ozone layer. This is the same type of propellant used in many modern prescription inhalers, like those containing albuterol. The switch to HFA was necessary for the product to receive FDA approval for reintroduction.
Comparing the Devices: Old vs. New
Beyond the propellant, the physical design and functional requirements of the inhaler device have been completely redesigned for the new version. Consumers familiar with the old product must read the instructions carefully to use the new one correctly.
Key Device Differences
- The new inhaler features a metal canister, replacing the older version's glass container.
- It includes a built-in spray indicator to show how many administrations remain, a feature not present on the old model.
- The new device requires specific actions to be performed for proper use.
New Usage Instructions
The new Primatene Mist requires a specific set of instructions that must be followed for the device to work properly and deliver an accurate amount of medication. These steps were not required for the original product.
To use the new inhaler correctly, consumers must:
- Activate the inhaler with a series of sprays before the first use.
- Shake the inhaler before every administration.
- Spray one puff into the air before each inhalation.
- Clean the inhaler's mouthpiece with water after each day of use.
Administration and Age Indication Differences
Though both versions use epinephrine, the way the medication is delivered and the target age group have changed.
Administration
The new Primatene Mist delivers a specific amount of epinephrine per spray (0.125 mg) compared to the old CFC version (0.220 mg). However, a more efficient delivery system means the current administration amount provides comparable bronchodilator efficacy. The maximum recommended daily administration is also different:
- Old Version (CFC): May be administered at certain intervals, not to exceed a specific number of administrations per day.
- New Version (HFA): May be administered at certain intervals, not to exceed a specific number of administrations per day.
Age Indication
The approved age range for the new Primatene Mist is different. The FDA approved the reformulated product only for individuals 12 years of age and older. The older version was indicated for use by children as young as 4.
Comparison Table: Old vs. New Primatene Mist
| Feature | Old Primatene Mist (CFC) | New Primatene Mist (HFA) |
|---|---|---|
| Propellant | Chlorofluorocarbons (CFC) | Hydrofluoroalkane (HFA) |
| Canister Material | Glass | Pressurized Metal |
| Active Ingredient | Epinephrine | Epinephrine |
| Epinephrine Amount/Spray | 0.220 mg | 0.125 mg |
| Device Features | Basic, no spray indicator | Includes built-in spray indicator |
| Usage Requirements | Basic instructions | Priming, shaking before each use, daily cleaning |
| Maximum Daily Administration | Specific limitation per 24 hours | Specific limitation per 24 hours |
| Age Indication | 4 years and older | 12 years and older |
| Market Dates | Discontinued 2011 | Approved 2018 |
The Active Ingredient: Epinephrine
Both the old and new Primatene Mist rely on the same active ingredient: epinephrine. Epinephrine is a bronchodilator that works by relaxing the muscles in the airways, making it easier to breathe. It is important to note that epinephrine is intended for temporary relief of mild, intermittent asthma symptoms, not as a replacement for prescription maintenance medication. Patients with more severe or persistent asthma should always consult a doctor for a proper treatment plan. For additional information on the drug facts for the current version, see the FDA website.
Conclusion: A Safer and Redesigned Option
In short, the difference between the old and new Primatene Mist is significant and goes far beyond a simple repackaging. The new version is a modern, environmentally conscious medication with an entirely redesigned delivery system. While it contains the same active ingredient, its use requires careful attention to the updated instructions regarding priming, shaking, and cleaning. The changes in administration protocols and age indication also underscore the importance of understanding the new product's limitations. Former users of the CFC version should thoroughly review the current product's labeling to ensure correct and safe use.
