Adrenalin Injection

Name: Adrenalin Injection

Uses For Adrenalin

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.

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

Proper Use of epinephrine

This section provides information on the proper use of a number of products that contain epinephrine. It may not be specific to Adrenalin. Please read with care.

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.

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 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. Ask your doctor or pharmacist if you have any questions.

This medicine comes in 2 forms:an autoinjector syringe and needle kit or a prefilled syringe. 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 Adrenaclick®, EpiPen®, or EpiPen Jr® autoinjector in an actual emergency. The autoinjector trainer has a grey color (for EpiPen® or EpiPen Jr®) or beige color (for Adrenaclick®) and does not contain any medicine or needle.

Do not remove the blue safety release (EpiPen® or EpiPen Jr®) or the gray end caps (Adrenaclick®) on the autoinjector until you are ready to use it. Do not put your thumb, fingers, or hand over the 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 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 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 or prefilled syringe. Throw away the autoinjector or prefilled syringe 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:
    • For allergic reactions:
      • Adults and children weighing more than 30 kilograms (kg)—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 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.

Adrenalin Injection Description

Adrenalin® (epinephrine injection, USP) is a clear, colorless, sterile solution containing 1 mg/mL epinephrine, packaged as 1 mL of solution in a single-use clear glass vial or 30 mL of solution in a multiple-dose amber glass vial.  In the 1 mL vial, each 1 mL of Adrenalin® solution contains 1 mg epinephrine, 7.3 mg sodium chloride, 0.457 mg sodium metabisulfite, 1 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, and water for injection.  In the 30 mL vial, each 1 mL of Adrenalin® solution contains 1 mg epinephrine, 6.15 mg sodium chloride, 0.457 mg sodium metabisulfite, 0.920 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, 5.25 mg chlorobutanol as a preservative and water for injection. The pH range is 2.2-5.0.

Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol.

The chemical structure of epinephrine is:

The molecular weight of epinephrine is 183.2.

Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.

Patient Counseling Information

Advise patients or their caregivers about common adverse reactions associated with the use of epinephrine including an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These symptoms and signs usually subside rapidly, especially with rest, quiet and recumbent positioning.

Warn patients with a good response to initial treatment about the possibility of recurrence of symptoms and instruct patients to obtain proper medical attention if symptoms return.

Warn patients with diabetes that they may develop increased blood glucose levels following epinephrine administration.

Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site [see Warnings and Precautions (5.2)].

Distributed by:
Par Pharmaceutical
Chestnut Ridge, NY 10977

Adrenalin® is a registered trademark of Par Sterile Products, LLC (Chestnut Ridge, NY).
Registered Trademark No. 53,934

R08/17

OS159J-01-90-07

3003592G

PRINCIPAL DISPLAY PANEL - 1 mL Vial Label

NDC 42023-159-25
Rx Only

Adrenalin®
(epinephrine
injection, USP)

1 mg/mL

NOT for Ophthalmic Use

1 mL Single-Use Vial

Adrenalin 1 mL vial label

PRINCIPAL DISPLAY PANEL - 30 mL Vial Label

NDC 42023-168-01
Rx Only

Adrenalin®
(epinephrine
injection, USP)

1 mg/mL

(30 mg/30 mL)

For Intramuscular or
Subcutaneous Use

NOT for Ophthalmic Use

30 mL Multiple Dose Vial

Adrenalin 30 mL vial label

ADRENALIN 
epinephrine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42023-159
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPINEPHRINE (EPINEPHRINE) EPINEPHRINE 1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 7.3 mg  in 1 mL
SODIUM METABISULFITE 0.457 mg  in 1 mL
SODIUM HYDROXIDE 1 mg  in 1 mL
TARTARIC ACID 2.25 mg  in 1 mL
EDETATE DISODIUM 0.20 mg  in 1 mL
HYDROCHLORIC ACID  
WATER  
Packaging
# Item Code Package Description
1 NDC:42023-159-25 25 VIAL in 1 CARTON
1 1 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204200 07/01/2013
ADRENALIN 
epinephrine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42023-168
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPINEPHRINE (EPINEPHRINE) EPINEPHRINE 1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 6.15 mg  in 1 mL
SODIUM METABISULFITE 0.457 mg  in 1 mL
SODIUM HYDROXIDE 0.920 mg  in 1 mL
TARTARIC ACID 2.25 mg  in 1 mL
EDETATE DISODIUM 0.20 mg  in 1 mL
CHLOROBUTANOL 5.25 mg  in 1 mL
HYDROCHLORIC ACID  
WATER  
Packaging
# Item Code Package Description
1 NDC:42023-168-01 1 VIAL in 1 CARTON
1 30 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204640 03/01/2014
Labeler - Par Pharmaceutical, Inc. (092733690)
Revised: 08/2017   Par Pharmaceutical, Inc.
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