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). 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. 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.

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

are breastfeeding or plan to breastfeed

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 healthcare provider if you take certain asthma medicines.

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.

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

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.

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.

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

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.

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 Amneal Pharmaceuticals LLC at 877-835-5472, option 1 or email DrugSafety@amneal.com. Please click here for full Prescribing Information including the Patient Information Leaflet.

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.

Indication: The 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.