Pronunciation:

ep-i-NEF-rin

Brand Names:

• Adrenaclick
• Adrenalin
• Adrenalin Chloride
• Auvi-Q
• Epipen
• Epipen Jr
• Symjepi
• Twinject

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Anaphylaxis Agent

Pharmacologic—

Sympathomimetic

Chemical—

Alkylarylamine

Uses of This Medicine:

Epinephrine injection is used for emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substances. It is also used to treat anaphylaxis caused by unknown substances or triggered by exercise.

Epinephrine injection is also used to increase blood pressure in adult patients with hypotension (low blood pressure) and septic shock.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of epinephrine injection in children. However, safety and efficacy have not been established in children weighing less than 15 kilograms (kg) using Symjepi™ and in children using Adrenalin® to treat low blood pressure with septic shock.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Auvi-Q® injection in the elderly. However, elderly patients are more likely to have unwanted effects, which may require caution in patients receiving this medicine.

Appropriate studies have not been performed on the relationship of age to the effects of Adrenalin®, Epipen®, or Symjepi™ in the elderly. However, elderly patients are more sensitive to the effects of this medicine and more likely to have unwanted effects, which may require caution in patients receiving this medicine.

No information is available on the relationship of age to the effects of epinephrine injection in geriatric patients. However, elderly patients are more likely to have age-related heart disease which may require caution in patients receiving epinephrine injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dihydroergotamine
• Isocarboxazid
• Linezolid
• Phenelzine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Benperidol
• Bromperidol
• Bucindolol
• Carteolol
• Carvedilol
• Clomipramine
• Desipramine
• Dextroamphetamine
• Dibenzepin
• Digoxin
• Dilevalol
• Dixyrazine
• Doxepin
• Droperidol
• Entacapone
• Ergonovine
• Fexofenadine
• Fluphenazine
• Furazolidone
• Haloperidol
• Halothane
• Imipramine
• Iobenguane I 123
• Iproniazid
• Levalbuterol
• Levobunolol
• Lisdexamfetamine
• Lofepramine
• Loxapine
• Melitracen
• Melperone
• Methdilazine
• Methotrimeprazine
• Methylene Blue
• Methylergonovine
• Metipranolol
• Metopimazine
• Milnacipran
• Moperone
• Nadolol
• Nialamide
• Nortriptyline
• Opicapone
• Opipramol
• Oxprenolol
• Penbutolol
• Perazine
• Periciazine
• Perphenazine
• Pindolol
• Pipamperone
• Piperazine
• Pipotiazine
• Practolol
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propiomazine
• Propranolol
• Protriptyline
• Rasagiline
• Safinamide
• Selegiline
• Sotalol
• Terfenadine
• Tertatolol
• Thiethylperazine
• Thioproperazine
• Thioridazine
• Tianeptine
• Timolol
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimipramine
• Zavegepant

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Labetalol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina pectoris (severe chest pain) or
• Asthma or
• Blood vessel problems or
• Depression, history of or
• Diabetes or
• Heart attack or
• Heart disease (eg, cardiomyopathy, coronary artery disease, organic heart disease) or
• Heart rhythm problems (eg, arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Kidney disease or
• Parkinson's disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

A nurse or other trained health professional will give you this medicine in a medical facility to treat hypotension with septic shock. It is given through a needle placed into one of your veins.

If you are using this medicine at home, make sure you or any of your family members understand exactly how to give them. Also, tell your doctor if you or your caregiver has severe arthritis of the hands. If you have any questions about this, check with your doctor.

This medicine is injected under the skin or into the muscle of your outer thigh only. Do not inject this medicine into a vein, into the muscle of your buttocks, or into your fingers, toes, hands, or feet. To do so, may increase the chance of having serious side effects.

This medicine comes with patient information and instructions leaflet. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor or pharmacist if you have any questions.

This medicine comes in 3 forms:an autoinjector syringe and needle kit, a prefilled syringe, or a vial. This contains the correct dose of medicine your doctor has prescribed.

This medicine comes with an autoinjector trainer and a separate trainer instructions for use. Be sure to practice first with your autoinjector trainer before an allergy emergency happens to make sure you are ready to use the real Auvi-Q®, Adrenaclick®, EpiPen®, or EpiPen Jr® autoinjector in an actual emergency. The autoinjector trainer has a grey color (for Auvi-Q®, EpiPen® or EpiPen Jr®) or beige color (for Adrenaclick®) and does not contain any medicine or needle.

Inspect the autoinjector from time to time before needing it to ensure the blue safety release (EpiPen® or EpiPen Jr®) is not raised and that the autoinjector can be easily remove from the carrier tube.

Do not remove the blue safety release (EpiPen® or EpiPen Jr®), the gray end caps (Adrenaclick®), or the red safety guard (Auvi-Q®) on the autoinjector until you are ready to use it. Do not put your thumb, fingers, or hand over the black base (Auvi-Q®), orange (EpiPen® or EpiPen Jr®), or red (Adrenaclick®) tip of the autoinjector or over the needle of the Symjepi® prefilled syringe. This is to avoid an accidental injection.

If you are about to use the autoinjector, pull up straight the blue safety release (EpiPen® or EpiPen Jr®) with one hand and hold the pen with the other hand. Do not flip the blue safety release off using the thumb or by pulling it sideways, or by bending and twisting it. This may activate the device by accident (a "click is heard, the orange needle is extended, and the window is blocked), making it unusable in case of an emergency. Push the needle end (orange end of the autoinjector) firmly against the outer thigh until it "clicks". This signals that the injection has started. The autoinjector needs to stay in place for a minimum of 3 seconds following activation.

If you use the Symjepi™ prefilled syringe:

• Do not remove the needle cap until you are ready to use it.
• Slowly inject the syringe into the thigh while sitting down.
• Push the plunger all the way down until you hear a "clicking" sound. Hold it for 2 seconds.
• Remove the syringe and massage the area for 10 seconds.
• Call your medical provider right away after injection.
• You may inject the medicine through your clothing, if you need to.

You may need to use more than one injection if your allergic reaction does not get better after the first shot. If more than 2 injections are needed for 1 reaction, however, those should be given only under medical supervision.

If you are using the epinephrine injection in a child, make sure to hold his leg firmly in place and limit movement before and during an injection.

Carry this medicine with you at all times for emergency use in case you have a severe allergic reaction.

Check the injection kits regularly to make sure that the liquid has not changed its color. It should be clear and colorless. Do not use this medicine if the liquid has changed its color (pinkish or brown in color), has become cloudy, or if there are particles in it.

Do not reuse the remaining portion of the medicine that is left in the autoinjector, prefilled syringe, or vial. Throw away the autoinjector, prefilled syringe, or vial after you have used it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):
  • For allergic reactions:
    • Adrenaclick®, Auvi-q®, Epipen®, Epipen Jr®, Twinject®:
      • Adults and children weighing 30 kilograms (kg) or more—0.3 milligram (mg) injected under the skin or into the muscle of your thigh.
      • Children weighing 15 to 30 kg—0.15 mg injected under the skin or into the muscle of your thigh.
      • Children weighing 7.5 to 15 kg—0.1 mg injected under the skin or into the muscle of your thigh.
      • Children weighing less than 7.5 kg—Use and dose must be determined by your doctor.
    • Adrenalin®:
      • Adults and children weighing 30 kilograms (kg) or more—0.3 to 0.5 milligram (mg) injected under the skin or into the muscle of your thigh. You may repeat the injection every 5 to 10 minutes as needed.
      • Children weighing less than 30 kg—Dose is based on body weight and must be determined by your doctor. The dose is 0.01 mg per kg of body weight injected under the skin or into the muscle of your thigh. You may repeat the injection every 5 to 10 minutes as needed. However, the dose is usually not more than 0.3 mg per injection.
    • Symjepi™:
      • Adults and children weighing 30 kilograms (kg) or more—0.3 milligrams (mg) injected under the skin or into the muscle of your thigh.
      • Children weighing 15 to 30 kg—0.15 mg injected under the skin or into the muscle of your thigh.
      • Children weighing less than 15 kg—Use and dose must be determined by your doctor.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the injection kits at room temperature, away from heat, moisture, and direct light. Do not store the medicine in the refrigerator or freezer, or into your vehicle's glove box.

Keep the autoinjector or prefilled syringe in its carrier tube or case to protect from damage. However, this tube or case is not waterproof. If you accidentally drop it, check for damage or leakage.

Throw away expired, unwanted, or unused EpiPen® or EpiPen Jr® in an FDA-cleared sharps container. Do not throw it away in the trash bin.

Precautions While Using This Medicine:

Anaphylaxis is a life-threatening reaction and requires immediate medical attention. Check with your doctor right away, or go to an emergency room as soon as possible, even if you feel better after using this medicine.

Tell your doctor if you develop symptoms of an infection (eg, redness that does not go away, swelling, warmth, or tenderness) at the injection site.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Do not inject this medicine into your buttocks. Epinephrine may not work as well and may cause gas gangrene. Check with your doctor or go to the hospital emergency room right away to get additional treatment.

Do not inject this medicine into your hands or feet. There is already less blood flow to the hands and feet, and epinephrine could make that worse and cause damage to these tissues. If you accidentally inject epinephrine into your hands or feet, check with your doctor or go to the hospital emergency room right away.

This medicine may worsen the condition of patients with heart disease or heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain. You might also feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat.

This medicine may cause pulmonary edema (fluid in the lungs). Check with your doctor right away if you have chest pain, difficult, fast, or noisy breathing, blue lips and fingernails, pale skin, increased sweating, coughing that sometimes produces a pink frothy sputum, or swelling in the legs and ankles.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Abnormal or decreased touch sensation

anxiety

arm, back, or jaw pain

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

blurred vision

chest pain, tightness, heaviness, or discomfort

cold, pale, or bluish color of the skin of the fingers or toes

confusion

difficulty in speaking

dizziness

double vision

fainting

fast, slow, irregular, pounding, or racing heartbeat or pulse

headache

inability to move the arms, legs, or facial muscles

inability to speak

nausea

numbness, tingling, or pain in the fingers

paleness of the skin

pounding in the ears

restlessness

shakiness in the legs, arms, hands, or feet

slow speech

sweating

trembling or shaking of the hands or feet

trouble breathing

unusual tiredness or weakness

vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

coldness of the skin

confusion

decreased awareness or responsiveness

decreased urine output

depression

drowsiness

hostility

irritability

lightheadedness

loss of consciousness

muscle twitching

rapid weight gain

rapid, deep breathing

seizures

severe sleepiness

stomach cramps

swelling of the face, ankles, or hands

unusual drowsiness, dullness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.