Epinephrine injection, USP auto-injector contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise or other unknown causes. Symptoms of anaphylaxis may include:
  • trouble breathing
  • wheezing
  • hoarseness (changes in the way your voice sounds)
  • hives (raised reddened rash that may itch)
  • severe itching
  • swelling of your face, lips, mouth, or tongue
  • skin rash, redness, or swelling
  • fast heartbeat
  • weak pulse
  • feeling very anxious
  • confusion
  • stomach pain
  • losing control of urine or bowel movements (incontinence)
  • diarrhea or stomach cramps
  • dizziness, fainting, or “passing out” (unconsciousness)
Talk to your healthcare provider if you need additional units to keep at work, school, or other locations. Tell your family members, caregivers, and others where you keep your epinephrine injection, USP auto-injector and how to use it before you need it. You may be unable to speak in an allergic emergency.
  • Use epinephrine injection, USP auto-injector right away.
  • Get emergency medical help right away. You may need further medical attention. You may need to use a second epinephrine injection, USP auto-injector if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.
  • Epinephrine injection, USP auto-injector is a disposable, prefilled automatic injection device (auto-injector) used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. Each device contains a single dose of epinephrine.
  • Epinephrine injection, USP auto-injector is for immediate self (or caregiver) administration and does not take the place of emergency medical care. You should get emergency medical help right away after using epinephrine injection, USP auto-injector.
  • Epinephrine injection, USP auto-injector is for people who have been prescribed this medicine by their healthcare provider.
Before you use epinephrine injection, USP auto-injector, tell your healthcare provider about all your medical conditions, especially if you:
  • have heart problems or high blood pressure
  • diabetes
  • have thyroid problems
  • have asthma
  • have a history of depression
  • have Parkinson’s disease have any other medical condition
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed
prescriptions and over-the-counter medicines, vitamins and herbal supplements. Tell your healthcare provider of all known allergies. Especially tell your healthcare provider if you take certain asthma medicines.
  • Epinephrine Injection, USP auto-injector contains only 1 dose of medicine.
  • Epinephrine Injection, USP auto-injector should only be injected into the middle of the outer thigh (upper leg). It can be injected through clothing, if needed.
  • Read the Instructions for Use in the Patient Information Leaflet for information about the right way to use epinephrine injection, USP auto-injector.
  • Your healthcare provider will show you how to safely use the epinephrine injection, USP auto-injector.
  • Use epinephrine injection, USP auto-injector exactly as your healthcare provider tells you to use it.

Possible Side Effects Include:

  • faster, irregular or “pounding” heartbeat
  • sweating
  • headache
  • weakness
  • shakiness
  • paleness
  • feelings of over excitement, nervousness, or anxiety
  • dizziness
  • nausea or vomiting
  • nausea or vomiting
These side effects may go away with rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of epinephrine injection, USP auto-injector. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Do Not inject Epinephrine Injection, USP into your veins, buttocks, fingers, toes hands or feet.
  • If you accidently inject epinephrine injection, USP auto-injector into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection.
  • In rare occasions, patients who use epinephrine injection, USP auto-injector may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following at an injection site:
  • redness that does not go away
  • swelling
  • tenderness
  • the area feels warm to the touch
  • If you inject a young child with epinephrine injection, USP auto-injector, hold their leg firmly in place before and during the injection to prevent injuries.
  • Active Ingredient: epinephrine
  • Inactive Ingredients: sodium chloride, chlorobutanol, sodium bisulfite, hydrochloric acid and sodium hydroxide, and water.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS, contact AvKARE Pharmaceuticals LLC at 855-361-3993 or email DrugSafety@avkare.com