Long-term stability of epinephrine dispensed in unsealed syringes for the first-aid treatment of anaphylaxis.

BACKGROUND

When epinephrine autoinjectors are unavailable or unaffordable, patients at risk for anaphylaxis in the community are sometimes provided with an unsealed syringe containing a premeasured epinephrine dose for use in first-aid treatment of anaphylaxis episodes.

OBJECTIVES

To study the stability of epinephrine solution in unsealed syringes under conditions of high ambient temperature, low vs high humidity, and light vs dark.

METHODS

Forty unsealed syringes each containing an epinephrine dose of 0.3 mg (as a 1-mg/mL epinephrine solution) were stored at 38 degrees C for 5 months, with 10 syringes at each of 4 different standardized storage conditions: dark and light at low (15%) humidity and dark and light at high (95%) humidity. Duplicate syringes were removed monthly from each storage environment and analyzed for epinephrine content vs control syringes.

RESULTS

The epinephrine dose, expressed as the percentage remaining of the mean control dose, was below compendial limits (90% to 115% of label claim) by 3 months after storage at 38 degrees C and low humidity and by 4 months after storage at 38 degrees C and high humidity. Light had no significant effect.

CONCLUSION

In hot climates, if an unsealed syringe prefilled with an epinephrine dose is provided for the first-aid treatment of anaphylaxis, it should be replaced every few months on a regular basis with a new syringe containing a fresh dose of epinephrine.