Safety considerations

EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors-as well as their authorized generics- should only be injected into the anterolateral aspect of the thigh. Do not inject intravenously, into buttock, or into digits, hands, or feet. Instruct caregivers to hold the leg of young children firmly in place and limit movement prior to and during injection to minimize risk of injection-related injury. 

Epinephrine should be used with caution in patients with heart disease, and in patients who are on drugs that may sensitize the heart to arrhythmias, because it may precipitate or aggravate angina pectoris and produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or taking cardiac glycosides, diuretics, or anti-arrhythmics. 

Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions. Common adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.  


There are no absolute contraindications to epinephrine administration for an anaphylactic reaction.1-3

Storing the EpiPen® Auto-Injector and Its Authorized Generic

EpiPen® and EpiPen Jr® Auto-Injectors and Epinephrine Injection, USP should be stored in the carrier tube provided at a temperature of 20-25 °C (68-77 °F); however, temperature excursions between 15-30 ºC (59-86 ºF) are permitted1,2. EpiPen®, EpiPen Jr®, and Epinephrine Injection, USP Auto-Injectors should not be stored in refrigerators or in a vehicle's glove box1,2. EpiPen® Auto-Injectors and their authorized generic auto-injectors should not be exposed to extreme heat or cold and should be protected from light1,2.

Disposing of a used EpiPen® or Epinephrine Injection, USP Auto-Injector

It is important to communicate to your patients that used EpiPen® and Epinephrine Injection, USP Auto-Injectors must be disposed of properly4. They should be taken to a healthcare professional’s office or to a hospital for proper disposal1,2.Also, remind your patients to obtain a replacement for any used EpiPen® Auto-Injector or its authorized generic1,2

How chemically stable is epinephrine?

Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Patients should be instructed to visually inspect the epinephrine solution periodically for particulate matter and discoloration. Patients should also be advised to replace their EpiPen® or EpiPen Jr® or Epinephrine Injection, USP Auto-Injector if the epinephrine solution contains particulate matter or develops a pinkish or brown color, because these changes indicate that the effectiveness of the drug product may have decreased or been affected. It is important to follow recommended storage conditions.1,2

How should EpiPen® Auto-Injector or its authorized generic be carried?

Until EpiPen® or Mylan's Epinephrine Injection, USP Auto-Injectors need to be used, they should be carried in the carrier tube with the blue safety release cap on.1,2

My patient accidentally injected himself/herself with EpiPen® Auto-Injector (or its authorized generic). What should I do?

Because epinephrine is a strong vasoconstrictor, accidental injection into fingers, hands or feet may result in decrease or loss of blood flow to these areas.1,2 The patient should be advised to go immediately to the nearest emergency department and to inform the healthcare professional in the emergency department of the location of the accidental injection.1,2 Patients are also instructed to ask for a refill prescription.1,2

Share This Site

Special Offers

Mylan offers Access and Savings Programs for eligible patients.

There’s only one recommended first line treatment for anaphylaxis.

More Important Safety Information

EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors are intended for immediate administration as emergency supportive therapy only and are not intended as a substitute for immediate medical or hospital care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision.

EpiPen® and EpiPen Jr® should only be injected into the anterolateral aspect of the thigh. Do not inject intravenously, into buttock, or into digits, hands, or feet. Instruct caregivers to hold the leg of young children firmly in place and limit movement prior to and during injection to minimize risk of injection-related injury.

Rare cases of serious skin and soft tissue infections have been reported following epinephrine injection. Advise patients to seek medical care if they develop symptoms of infection such as persistent redness, warmth, swelling, or tenderness at the injection site.

Epinephrine should be used with caution in patients with heart disease, and in patients who are on drugs that may sensitize the heart to arrhythmias, because it may precipitate or aggravate angina pectoris and produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or taking cardiac glycosides, diuretics, or anti-arrhythmics.

Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions. Common adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.

Indications

EpiPen® and EpiPen Jr® Auto-Injectors are indicated in the emergency treatment of Type I allergic reactions, including anaphylaxis, to allergens, idiopathic and exercise-induced anaphylaxis, and in patients with a history or increased risk of anaphylactic reactions. Selection of the appropriate dosage strength is determined according to body weight.

Please see the full Prescribing Information and Patient Information.

For additional information please contact us at 800-395-3376.

References

  1. EpiPen [prescribing & patient information]. Morgantown, WV: Mylan Specialty L.P.; 2017..
  2. Epinephrine Injection, USP [prescribing & patient information]. Morgantown, WV: Mylan Specialty L.P.; 2017.
  3. Simons FE. Anaphylaxis: recent advances in assessment and treatment. J Allergy Clin Immunol. 2009;124(4):625-636.
  4. Jones TS, Coffin PO. Preventing blood-borne infections through pharmacy syringe sales and safe community syringe disposal. J Am Pharm Assoc (Wash). 2002;42(6)(suppl 2):S6-S9.
EpiPen® & EpiPen Jr® (epinephrine injection, USP) Auto-Injectors 0.3/0.15mg

You are now leaving Mylan Specialty's website.

The website you are about to access is not owned or controlled by Mylan Specialty.

MYLAN SPECIALTY ASSUMES NO RESPONSIBILITY FOR, AND MAKES NO REPRESENTATION AS TO THE ACCURACY OF, ANY CONTENT CONTAINED ON THE WEBSITE YOU ARE ABOUT TO ACCESS.

OK

This site is intended for US healthcare professionals.

If you are a patient, please check out our site for patients.