From the Guidelines
An unopened ampule of epinephrine does not have a specified expiration date in the provided evidence, but it is crucial to follow the manufacturer's guidelines and storage instructions to maintain its potency. When considering the storage and handling of epinephrine, it is essential to note that epinephrine auto-injectors expire after 1 year, as stated in the guidelines for the diagnosis and management of food allergy in the United States 1. However, this information is specific to auto-injectors and not directly applicable to ampules.
- Key factors influencing the expiration date of epinephrine include storage conditions, such as room temperature, and protection from light and moisture.
- The exact expiration date for an unopened ampule of epinephrine should be determined by the manufacturer's guidelines, which are typically printed on the packaging.
- It is vital to regularly check the expiration dates of epinephrine supplies and ensure that the medication is stored properly to maintain its effectiveness.
- In clinical practice, it is recommended to follow the manufacturer's instructions for storage and handling of epinephrine ampules to ensure patient safety and optimal treatment outcomes.
From the FDA Drug Label
16 HOW SUPPLIED/STORAGE & HANDLING
EPINEPHRINE INJECTION, USP 1mg/mL 1:1000 VIAL is supplied in the following dosage forms ... Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Epinephrine is light sensitive. Protect from light and freezing. Inspect visually for particulate matter and discoloration prior to administration. Do not use the solution if it is colored or cloudy, or if it contains particulate matter.
The FDA drug label does not answer the question.
From the Research
Expiration of Unopened Ampule of Epinephrine
- The expiration date of an unopened ampule of epinephrine is not directly addressed in the provided studies.
- However, a study on expired epinephrine 2 found that epinephrine injections remain sterile and retain their active ingredient's content for more than 30 months past expiration.
- This study analyzed six parenteral epinephrine prefilled syringes with an expiration date of January 1,2012, which were stored in a climate-controlled setting and tested 30 months after expiration.
- The results showed that the content of epinephrine present in the original sample remained unchanged compared to the control, with no statistical difference in the UHPLC-MS and NMR signal amplitudes between the control and the expired samples.
- No chemical degradation byproducts were detected using NMR, and there was no growth of any bacteria or fungus.
Storage and Handling
- The study 2 stored the epinephrine syringes in a climate-controlled setting, which may have contributed to the stability of the epinephrine.
- It is essential to follow proper storage and handling procedures for epinephrine to maintain its potency and sterility.