Epinephrine (Page 4 of 7)

PATIENT INFORMATION and INSTRUCTIONS FOR USE

Epinephrine Injection [/eh-puh-neh-fruhn/], USP Auto-Injector 0.3 mg
one dose of 0.3 mg epinephrine, USP 0.3 mg/0.3 mL

Epinephrine Injection [/eh-puh-neh-fruhn/], USP Auto-Injector 0.15 mgone dose of 0.15 mg epinephrine, USP 0.15 mg/0.3 mL

Authorized generic for EpiPen® and EpiPen Jr® Auto-Injectors

For allergic emergencies (anaphylaxis)

PATIENT INFORMATION

Read this Patient Information leaflet carefully before using the epinephrine injection, USP auto-injector and each time you get a refill. There may be new information. Anyone who may be able to administer the epinephrine injection, USP auto-injector, should know how to use it before you have an allergic emergency.

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Epinephrine Injection, USP Auto-Injector?

1.
Epinephrine injection, USP auto-injector is a single-dose automatic injection devices (auto-injectors) that contains epinephrine. Epinephrine is a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life threatening and, can happen within minutes. If untreated, anaphylaxis can lead to death. This allergic emergency can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or 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)
2.
Always carry 2 epinephrine injection, USP auto-injectors with you because sometimes a single dose of epinephrine may not be enough to treat a serious allergic reaction before seeking medical care. You also need to always carry 2 auto-injectors with you if the first auto-injector is activated before the dose can be given. A device that has been activated by accident cannot be used in an allergic emergency (anaphylaxis).
Note: The epinephrine injection, USP auto-injector has been activated when the blue safety top is removed and a “pop” is heard, the orange needle end of the auto-injector is extended, or the medicine viewing window is blocked.
You may not know when anaphylaxis will happen. Talk to your healthcare provider if you need more auto-injectors to keep at work, school, or other locations. If you use 1 epinephrine injection, USP auto-injector to treat an emergency allergic reaction, be sure to replace it so you always carry 2 auto-injectors. Tell your family members, caregivers, and others where you keep your epinephrine injection, USP auto-injectors. Make sure they know 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 even if you have used the epinephrine injection, USP auto-injector. You can use a second epinephrine injection, USP auto-injector if symptoms continue or come back or if the first auto-injector is activated before the dose can be given. For this reason, you should carry 2 epinephrine injection, USP auto-injectors with you at all times. If you need more than 2 doses for an allergic emergency, they must be given by a healthcare provider.

What are epinephrine injection, USP auto-injectors?

Epinephrine injection, USP auto-injectors are disposable, prefilled auto-injectors used to treat life-threatening, allergic emergencies in people who are at risk for or have a history of serious allergic emergencies. Each device contains one dose of epinephrine.
Epinephrine injection, USP auto-injectors are for immediate administration by you or your caregiver. They do not take the place of emergency medical care. You should get emergency help right away after using your epinephrine injection, USP auto-injector.
Epinephrine injection, USP auto-injectors are for people who have been prescribed this medicine by their healthcare provider.
The epinephrine injection, USP auto-injector (0.3 mg) is for people who weigh 66 pounds or more (30 kilograms or more).
The epinephrine injection, USP auto-injector (0.15 mg) is for people 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 your epinephrine injection, USP auto-injector, tell your healthcare provider about all your medical conditions. Your healthcare provider may give you more instructions about when and how to use epinephrine injection, USP auto-injector if you have the following:

heart problems or high blood pressure
diabetes
thyroid problems
asthma
a history of depression
Parkinson’s disease

You may also receive more instructions if you:

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 about all of your known allergies.

Especially tell your healthcare 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. Other medicines may affect how epinephrine injection, USP auto-injector works.

Know the medicines you take. Keep a list of all your medicines, including over-the-counter medicines, vitamins and herbal supplements 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 the epinephrine injection, USP auto-injector?

Use your single-dose 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 come back while you wait for emergency help or if the first auto-injector is activated before the dose can be given. If you need more than 2 doses of epinephrine for a single anaphylaxis episode, more doses must be administered by a healthcare provider.
Epinephrine injection, USP auto-injector should be injected into the middle of your outer thigh (upper leg). It can be injected through your clothing if needed. Do not inject into a vein or into the buttocks, fingers, toes, hands or feet.
Read and make sure you understand the Instructions for Use at the end of this Patient Information leaflet to learn the right way to use the epinephrine injection, USP auto-injector.
Your healthcare provider will show you how to safely use the epinephrine injection, USP auto-injector.
It is very important that you hold the epinephrine injection, USP auto-injector down firmly on the middle of the outer thigh (upper leg) for at least 3 full seconds. If you do not hold it in place long enough, the epinephrine injection, USP auto-injector might not have time to deliver the correct dose of medicine.
Caution: Never put your thumb, fingers or hand over the orange needle end. Never press or push the orange needle end with your thumb, fingers or hand. The needle comes out of the orange needle end. Accidental injection into fingers, hands or feet may cause a loss of blood flow to these areas. If an accidental injection happens, go immediately to the nearest emergency room.
Warning: Do not flip the blue safety top off using a thumb or by pulling it sideways, or by bending and twisting the blue safety top. This may cause the device to activate by accident: a “pop” is heard, the orange needle end is extended and the medicine viewing window is blocked. A device that has been activated by accident cannot be used in an emergency. If this happens, replace it with a new epinephrine injection, USP auto-injector.
When you are ready to inject, pull the blue safety top straight up and away from the auto-injector.
Your epinephrine injection, USP auto-injector may come in a package with a gray trainer and separate Trainer Instructions for Use. The gray trainer contains no medicine and no needle. Keep the trainer and the real epinephrine injection, USP auto-injector away from young children. The real epinephrine injection, USP auto-injector and trainer are not toys. For young children, use of the trainer and the real epinephrine injection, USP auto-injector should be supervised by an adult. Regularly practice with your gray trainer in non-emergency situations to make sure you can safely use the real epinephrine injection, USP auto-injector in an emergency. Always carry your 2 real epinephrine injection, USP auto-injectors with you in case of an allergic emergency. Additional training information is available at www.epipen.com.
Do not drop the protective case or epinephrine injection, USP auto-injector. If the protective case or auto-injector is dropped, check for damage and leakage. If damage or leakage is noticed or suspected, throw away (dispose of) the epinephrine injection, USP auto-injector and protective case and replace it.

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

Epinephrine injection, USP auto-injectors 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 the epinephrine injection, USP auto-injector into your:
o
veins
o
buttocks
o
fingers, toes, hands or feet

If you accidentally inject epinephrine injection, USP auto-injector into any place other than the middle of your outer thigh, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection.

Rarely, people who have used the epinephrine injection, USP auto-injector may get 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 see any of the following at an injection site:
o
redness that does not go away
o
swelling
o
tenderness
o
the area feels warm to the touch
Cuts on the skin, bent needles and needles that remain in the skin after the injection can happen when young children kick or move during an injection. If you inject a young child with an epinephrine injection, USP auto-injector, hold their leg firmly in place before and during the 3 second injection to prevent injuries. Follow the Instructions for Use at the end of this Patient Information leaflet. Ask your healthcare provider to show you how to:
1.
Hold the young child firmly in place (restrain).
2.
With one hand, grip the auto-injector with the orange needle end pointing down.
3.
With the other hand, pull the blue safety top straight up and away from the auto-injector.
If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use your epinephrine injection, USP auto-injector. Talk to your healthcare provider about all your medical conditions.

Common side effects of epinephrine injection, USP auto-injectors include:

fast, 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 the epinephrine injection, USP auto-injector. For more information, ask your healthcare provider or pharmacist.

Call your doctor 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-injectors?

Store epinephrine injection, USP auto-injectors at room temperature between 68°F to 77°F (20°C to 25°C).
Keep this medicine out of the sight and reach of young children.
Keep protective case in the outer carton to protect from light. When exposed to air or light epinephrine changes quickly to a pinkish or brown color and should not be used.
Do not expose to extreme cold or heat. For example, do not store in your vehicle’s glove box or trunk. Do not store in the refrigerator or freezer.
Examine the contents in the medicine viewing window of your epinephrine injection, USP auto-injector regularly. The medicine should be clear. If the medicine is discolored (pinkish or brown color) or contains solid particles, replace the auto-injector.
Always keep your 2 epinephrine injection, USP auto-injectors in the protective cases to prevent damage to the device. The protective case is not waterproof.
The blue safety top helps to prevent accidental injection. Keep the blue safety top in place until you need to use the epinephrine injection, USP auto-injector. After the auto-injector is used, throw away the blue safety top as this may pose a choking hazard for small children.

Disposing of an Expired, Unused or Used Epinephrine Injection, USP Auto-Injector

Your epinephrine injection, USP auto-injector has an expiration date. Replace the pack of auto-injectors before the expiration date. Throw away (dispose of) expired, unwanted, or unused epinephrine injection, USP auto-injectors in an FDA-cleared sharps disposal container right away after use. Do not throw away the epinephrine injection, USP auto-injectors in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

Made of heavy-duty plastic,
Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
Upright and stable during use,
Leak-resistant, and
Properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal

Visit the FDA’s website (https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know) for more information about how to throw away unused, unwanted or expired medicines.

After using your epinephrine injection, USP auto-injector in an allergic emergency, get emergency medical help right away. Take your used epinephrine injection, USP auto-injector with you to give to your healthcare provider for disposal.

General information about the safe and effective use of epinephrine injection, USP auto-injectors.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use the epinephrine injection, USP auto-injector for a condition for which it was not prescribed. Do not give your epinephrine injection, USP auto-injector to other people.

This Patient Information leaflet summarizes the most important information about the epinephrine injection, USP auto-injectors. 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-injectors that is written for health professionals.

What are the ingredients in epinephrine injection, USP auto-injectors?

Active Ingredients: epinephrine

Inactive Ingredients: sodium chloride, sodium metabisulfite, hydrochloric acid, and water

Important Information

The epinephrine injection, USP auto-injector, 0.3 mg has a yellow colored label.
The epinephrine injection, USP auto-injector, 0.15 mg has a green colored label.
Your epinephrine injection, USP auto-injector is designed to work through clothing.
When receiving an epinephrine injection, USP auto-injector and before you need to use the epinephrine injection, USP auto-injector, remove the auto-injector from the protective case and check the auto-injector to make sure the blue safety top is not raised (see Figure D in the Instructions for Use). If the blue safety top is raised, the auto-injector should not be used because the device could activate by accident. Do not try to push the blue safety top back down. Put the auto-injector back in the protective case and replace it with a new epinephrine injection, USP auto-injector.
Choking hazard: The blue safety top is a small part that may become a choking hazard for children. Throw away the blue safety top immediately after using epinephrine injection, USP auto-injector.
It is very important that you hold the epinephrine injection, USP auto-injector down firmly on the middle of the outer thigh (upper leg) for at least 3 full seconds. If you do not hold it in place long enough, the epinephrine injection, USP auto-injector might not deliver the correct dose of medicine.
If an accidental injection happens, get emergency medical help right away.
Do not place patient information or any other foreign objects in the protective case with the epinephrine injection, USP auto-injector, as this may prevent you from removing the auto-injector for use.
Each epinephrine injection, USP auto-injector can be used only 1 time (single-use). The auto-injectors deliver a fixed dose of epinephrine and cannot be reused. Do not try to reuse epinephrine injection, USP auto-injector after the device has been activated. It is normal for most of the medicine to remain in the auto-injector after the dose is injected. The correct dose has been administered if the orange needle end is extended to cover the needle and the medicine viewing window is blocked.
Incorrect Use and Correct Use of Epinephrine Injection, USP Auto-Injector

Incorrect Use

Correct Use andImportant Reminders

Storage outside the protective case or storage of the epinephrine injection, USP auto-injector in extreme cold or heat.

Always keep your epinephrine injection, USP auto-injector stored in the protective case and at room temperature. Keep protective case in the outer carton to protect from light. Wrong storage may stop the epinephrine injection, USP auto-injector from working. If the device has been in extreme cold or heat, the epinephrine injection, USP auto-injector should be replaced.

Failing to remove the auto-injector from the protective case before use.

The epinephrine injection, USP auto-injector must be removed from the protective case it comes in before use.

Failing to remove the blue safety top before use.

Remove the blue safety top before use. Epinephrine injection, USP auto-injector will not activate with the blue safety top in place.

Activating the auto-injector upside down which will cause an injection into the hand.

The needle exits from the orange end of the epinephrine injection, USP auto-injector, which should be in contact with the outer thigh (upper leg) at a 90˚ angle (perpendicular) to the thigh before and during activation. The orange needle end will extend to cover the needle after activation. If you can still see the needle, do not try to reuse the auto-injector.

Failing to apply enough force to activate the epinephrine injection, USP auto-injector.

Epinephrine injection, USP auto-injector should be administered by swinging and pushing the auto-injector firmly against the outer thigh. Epinephrine injection, USP auto-injectors make a distinct pop sound when pushed against the thigh. The pop sound signals that the injection has started. The correct dose has been administered if the orange needle end is extended and the window is blocked.

Administering at an injection site other than the outer thigh.

Administer epinephrine injection, USP auto-injector in the outer thigh only.

Failing to hold the auto-injector in place for a full 3 seconds.

Hold the epinephrine injection, USP auto-injector in place for a full 3 seconds following activation (count slowly 1, 2, 3).

For more information and video instructions on the use of epinephrine injection, USP auto-injectors, go to www.epipen.com or call 1-800-395-3376.

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