You should also know about a few other labeling changes. Here is the information Mylan sent me. You can also find more information on the FDA website:
For epinephrine auto-injectors, including EpiPen® and EpiPen Jr® Auto-Injectors:
Hold patient’s leg and limit movement during administration
Lacerations, bent needles and embedded needles have been reported when epinephrine has been injected into the thigh of young children who are uncooperative and kick or move during an injection. In order to minimize the risk of injection-related injury when administering the epinephrine injection to young children, caregivers are advised to hold the child’s leg firmly in place and limit movement prior to and during injection.
Patients should seek medical care if they develop signs or symptoms of infection at the injection site
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site. While cleansing with alcohol may reduce the presence of bacteria on the skin, it does not kill Clostridium spores. To decrease the risk of Clostridium infection, do not inject into the buttock. Patients should seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site.
For EpiPen® and EpiPen Jr® Auto-Injectors only:
Injection hold time reduced from 10 seconds to 3 seconds
After administration, EpiPen® Auto-Injector should be held firmly in place for 3 seconds prior to removal.
Given the life-threatening nature of anaphylaxis, it is critical that patients and caregivers are trained in the proper use of their prescribed epinephrine auto-injector. If you have any questions, please call Mylan's Customer Service team at 1-800-395-3376.