Important Safety Information

What is the most important information I should know about epinephrine injection, USP auto-injector?

  1. 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 an 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).
  2. Always carry your epinephrine injection, USP auto-injector with you because you may not know when anaphylaxis may happen. 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.
  3. When you have an allergic emergency (anaphylaxis)
    • 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.

What is epinephrine injection, USP auto-injector?

  • 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.
  • The epinephrine injection, USP auto-injector 0.3 mg auto-injector is for patients who weigh 66 pounds or more (30 kilograms or more).
  • The epinephrine injection, USP auto-injector 0.15 mg auto-injector is for patients who weigh about 33 to 66 pounds (15 to 30 kilograms).
  • It is not known if epinephrine injection, USP auto-injector is safe and effective in children who weigh less than 33 pounds (15 kilograms).

What should I tell my healthcare provider before using epinephrine injection, USP auto-injector?

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
  • have 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. It is not known if epinephrine will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if epinephrine passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Tell your healthcare provider of all known allergies. Especially tell your provider if you take certain asthma medicines. Epinephrine injection, USP auto-injector and other medicines may affect each other, causing side effects. Epinephrine injection, USP auto-injector may affect the way other medicines work, and other medicines may affect how epinephrine injection, USP auto-injector works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Use your epinephrine injection, USP auto-injector for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicines you take.

How should I use epinephrine injection, USP auto-injector?

  • Each 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. 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.
  • Caution: Never put your thumb, fingers, or hand over the red tip. Never press or push the red tip with your thumb, fingers, or hand. The needle comes out of the red tip. Accidental injection into finger, hands, or feet may cause a loss of blood flow to those areas. If this happens, go immediately to the nearest emergency room. Tell the healthcare provider where on your body you received the accidental injection.
  • Your epinephrine injection, USP auto-injector comes packaged in a carton containing 1 or 2 epinephrine injection, USP auto-injectors.
  • You may request a separate Trainer, that comes packaged with instructions. Additional video instructions on the use of epinephrine injection, USP auto-injector are available from www.epinephrineautoinject.com. The epinephrine injection, USP auto-injector Trainer has a beige color. The beige epinephrine injection, USP auto-injector Trainer contains no medicine and no needle. Practice with your epinephrine injection, USP auto-injector Trainer before an allergic emergency happens to make sure you are able to safely use the real epinephrine injection, USP auto-injector in an emergency. Always carry your real epinephrine injection, USP auto-injector with you in case of an allergic emergency.
  • Do not drop the carrying case or epinephrine injection, USP auto-injector. If the carrying case or epinephrine injection, USP auto-injector is dropped, check for damage and leakage. Dispose of the auto-injector and carrying case, and replace if damage or leakage is noticed or suspected.

What are the possible side effects of epinephrine injection, USP auto-injector?

Epinephrine injection, USP auto-injector may cause serious side effects.

  • Epinephrine injection, USP auto-injector should only be injected into the middle of your outer thigh (upper leg). Do not inject epinephrine injection, USP auto-injector 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.

  • Rarely 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
  • Cuts to the skin, bent needles, and needles that remain in the skin after the injection, have happened in young children who do not cooperate and kick or move during an injection. 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. Ask your healthcare provider to show you how to properly hold the leg of a young child during an injection.
  • If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use epinephrine injection, USP auto-injector. Talk to your healthcare provider about all your medical conditions.

Common side effects of epinephrine injection, USP auto-injector include

  • faster, irregular or “pounding” heartbeat
  • sweating
  • headache
  • weakness
  • shakiness
  • paleness
  • feelings of over excitement, nervousness, or anxiety
  • dizziness
  • nausea or vomiting
  • breathing problems

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.

How should I store epinephrine injection, USP auto-injector?

  • Store epinephrine injection, USP auto-injector at room temperature between 68° to 77° F (20° to 25° C).
  • Protect from light.
  • Do not expose to extreme heat or cold. For example do not store in your vehicle’s glove box and do not store in the refrigerator or freezer.
  • Examine the contents in the clear viewing window of your auto-injector periodically. The solution should be clear. If the solution is discolored (pinkish or brown), cloudy or contains solid particles, replace the unit.
  • Always keep your epinephrine injection, USP auto-injector in the carrying case to protect it from damage; however the carrying case is not waterproof.
  • The two blue end caps help to prevent accidental injection. Do not remove the blue end caps until you are ready to use epinephrine injection, USP auto-injector.
  • Your epinephrine injection, USP auto-injector has an expiration date. Replace it before the expiration date. 

Keep epinephrine injection, USP auto-injector and all medicines out of the reach of children.

General information about the safe and effective use of epinephrine injection, USP auto-injector:

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do no use epinephrine injection, USP auto-injector for a condition for which it was not prescribed. Do not give epinephrine injection, USP auto-injector to other people.

This Patient Information Leaflet summarizes the most important information about epinephrine injection, USP auto-injector.

If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about epinephrine injection, USP auto-injector that is written for health professionals.

For more information and video instructions on the use of epinephrine injection, USP auto-injector, go to www.epinephrineautoinject.com or call 1-800-934-6729.

What are the ingredients in epinephrine injection, USP auto-injector?
Active Ingredient: epinephrine
Inactive Ingredients: sodium chloride, chlorobutanol, sodium bisulfite, hydrochloric acid and sodium hydroxide, and water.

PP-EAI-US-0006

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