Epinephrine (Page 3 of 3)

16.2 Storage and Handling

Protect from light. Epinephrine is light sensitive and should be stored in the carrying-case provided to protect it from light. Store at room temperature (20° to 25°C (68° to 77°F)); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Do not refrigerate. Before using, check to make sure the solution in the auto-injector is clear and colorless. Replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particles.

17 PATIENT COUNSELING INFORMATION

[see FDA-Approved Patient Labeling (Patient Information and Instructions for Use)]

A healthcare provider should review the patient instructions and operation of epinephrine injection, USP auto-injector, in detail, with the patient or caregiver.

Epinephrine is essential for the treatment of anaphylaxis. Patients who are at risk of or with a history of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens, as well as idiopathic and exercise-induced anaphylaxis, should be carefully instructed about the circumstances under which epinephrine should be used.

Administration and Training

Patients and/or caregivers should be instructed in the appropriate use of epinephrine injection, USP auto-injector. Epinephrine injection, USP auto-injector should be injected into the middle of the outer thigh (through clothing if necessary). Each epinephrine injection, USP auto-injector is a single-use injection. Advise patients to seek immediate medical care in conjunction with administration of epinephrine injection, USP auto-injector.

Complete patient information, including dosage, directions for proper administration and precautions can be found inside each epinephrine injection, USP auto-injector carton. A printed label on the surface of epinephrine injection, USP auto-injector shows instructions for use and a diagram depicting the injection process.

Patients and/or caregivers should be instructed to use the Trainer to familiarize themselves with the use of epinephrine injection, USP auto-injector in an allergic emergency. The Trainer may be used multiple times.

Adverse Reactions

Epinephrine may produce symptoms and signs that include 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 signs and symptoms usually subside rapidly, especially with rest, quiet, and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following epinephrine administration. Patients with Parkinson’s disease may notice a temporary worsening of symptoms [see Warnings and Precautions (5.4)].

Accidental Injection

Advise patients to seek immediate medical care in the case of accidental injection. Since epinephrine is a strong vasoconstrictor when injected into the digits, hands or feet, treatment should be directed at vasodilation if there is such an accidental injection to these areas [see Warnings and Precautions (5.2)].

Storage and Handling

Instruct patients to inspect the epinephrine solution visually through the viewing window periodically. Epinephrine injection, USP auto-injector should be replaced if the epinephrine solution appears discolored (pinkish or brown), cloudy, or contains particles. Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light. Patients should be instructed that epinephrine injection, USP auto-injector must be properly disposed of once the blue caps have been removed or after use [see How Supplied/Storage and Handling (16.2)].

Complete patient information, including dosage, directions for proper administration and precautions are provided inside each epinephrine injection, USP auto-injector carton.

Manufactured for and Distributed by: Lineage Therapeutics Inc., Horsham, PA 19044

© 2014 Lineage Therapeutics Inc., Horsham, PA. All rights reserved. This product and the use thereof is proprietary and protected under one or more of United States Patents 5,358,489; 5,540,664; 5,833,669; 5,665,071; 5,695,472; 7,297,136; 7,905,352; 7,621,891; 7,927,303; 7,931,618; 8,187,224; and/or related patents in countries other than the U.S.

For inquiries call 1-888-894-6528

71006-07

Relabeled By: Preferred Pharmaceuticals Inc.

Patient Information

EPINEPHRINE INJECTION, USP AUTO-INJECTOR (ep-in-eph-rine)

Authorized generic of Adrenaclick®

For allergic emergencies (anaphylaxis)

Read this Patient Information Leaflet carefully before you use the epinephrine injection, USP auto-injector, and each time you get a refill. There may be new information. You, your parent, caregiver, or others who may be in a position to administer 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 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:
1.
trouble breathing
2.
wheezing
3.
hoarseness (changes in the way your voice sounds)
4.
hives (raised reddened rash that may itch)
5.
severe itching
6.
swelling of your face, lips, mouth, or tongue
7.
skin rash, redness, or swelling
8.
fast heartbeat
9.
weak pulse
10.
feeling very anxious
11.
confusion
12.
stomach pain
13.
losing control of urine or bowel movements (incontinence)
14.
diarrhea or stomach cramps
15.
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)
16.
Use epinephrine injection, USP auto-injector right away.
17.
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?

1.
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.
2.
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.
3.
Epinephrine injection, USP auto-injector is for people who have been prescribed this medicine by their healthcare provider.
4.
The epinephrine injection, USP auto-injector 0.3 mg auto-injector is for patients who weigh 66 pounds or more (30 kilograms or more).
5.
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).
6.
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:

1.
have heart problems or high blood pressure
2.
have diabetes
3.
have thyroid problems
4.
have asthma
5.
have a history of depression
6.
have Parkinson’s disease
7.
have any other medical conditions
8.
are pregnant or plan to become pregnant. It is not known if epinephrine will harm your unborn baby.
9.
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 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, 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 medicine you take.

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

1.
Each epinephrine injection, USP auto-injector contains only 1 dose of medicine.
2.
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.
3.
Read the Instructions for Use at the end of this Patient Information Leaflet for information about the right way to use epinephrine injection, USP auto-injector.
4.
Your healthcare provider will show you how to safely use the epinephrine injection, USP auto-injector.
5.
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.
6.
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.
7.
Your epinephrine injection, USP auto-injector comes packaged in a carton containing 1 or 2 epinephrine injection, USP auto-injectors.
8.
You may request a separate Trainer, that comes packaged with Trainer Instructions for Use. 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.
9.
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.

1.
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:
1.
veins
2.
buttocks
3.
fingers, toes, hands or feet.
2.
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.
3.
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:

1.
faster, irregular or “pounding” heartbeat
2.
sweating
3.
headache
4.
weakness
5.
shakiness
6.
paleness
7.
feelings of over excitement, nervousness, or anxiety
8.
dizziness
9.
nausea or vomiting
10.
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?

1.
Store epinephrine injection, USP auto-injector at room temperature between 68° to 77° F (20° to 25° C).
2.
Protect from light.
3.
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.
4.
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.
5.
Always keep your epinephrine injection, USP auto-injector in the carrying case to protect it from damage; however, the carrying case is not waterproof.
6.
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.
7.
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 not 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 1-888-894-6528.

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.

Important Information

1.
The epinephrine injection, USP auto-injector 0.3 mg auto-injector has a yellow colored label.
2.
The epinephrine injection, USP auto-injector 0.15 mg auto-injector has an orange colored label.
3.
The epinephrine injection, USP auto-injector Trainer has a beige color, and contains no medicine and no needle.
4.
Your auto-injector is designed to work through clothing.
5.
The two blue end caps on the epinephrine injection, USP auto-injector help to prevent accidental injection of the device. Do not remove the blue end caps until you are ready to use it.
6.
Only inject into the middle of the outer thigh (upper leg). Never inject into any other part of the body.
7.
Never put your thumb, fingers, or your hand over the red tip. The needle comes out of the red tip.
8.
If an accidental injection happens, get medical help right away.
9.
Do not place patient information or any other foreign objects in carrier with the auto-injector, as this may prevent you from removing the auto-injector for use.

Instructions for Use

EPINEPHRINE INJECTION, USP AUTO-INJECTOR (ep-in-eph-rine)

For allergic emergencies (anaphylaxis)

Read these Instructions for Use carefully before you use epinephrine injection, USP auto-injector. Before you need to use your epinephrine injection, USP auto-injector, make sure your healthcare provider shows you the right way to use it. Parents, caregivers, and others who may be in a position to administer epinephrine injection, USP auto-injector should also understand how to use it well. If you have any questions, ask your healthcare provider.

Your epinephrine injection, USP auto-injector

Injector image 1
(click image for full-size original)
Injector image 2
(click image for full-size original)

STEP 1. Prepare epinephrine injection, USP auto-injector for injection

1.
Remove epinephrine injection, USP auto-injector from its protective carrying case.
2.
Pull off blue end caps ; you will now see a red tip. Grasp the auto-injector in your fist with the red tip pointing downward. See Figure A.

Note:

1.
The needle comes out of the red tip.
2.
To avoid an accidental injection, never put your thumb, fingers, or hand over the red tip. If an accidental injection happens, get medical help right away.
Figure A

STEP 2. Administer epinephrine injection, USP auto-injector

1.
Put the red tip against the middle of the outer thigh (upper leg) at a 90° angle (perpendicular) to the thigh.
2.
Press down hard and hold firmly against the thigh for approximately 10 seconds to deliver the medicine. See Figure B.
Figure B
1.
Only inject into the middle of the outer thigh. Do not inject into any other part of the body.
2.
Remove epinephrine injection, USP auto-injector from the thigh.
3.
Massage the area for 10 seconds.
4.
Check the red tip. The injection is complete and you have received the correct dose of the medicine if you see the needle sticking out of the red tip. If you do not see the needle repeat Step 2.

STEP 3. 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.

STEP 4. After use / Disposal

Carefully cover the needle with the carrying case.

1.
Lay the labeled half of the carrying case cover down on a flat surface. Use one hand to carefully slide the end of the auto-injector, needle first, into the labeled carrying case cover. See Figure C.
Figure C
1.
After the needle is inside the labeled cover, push the unlabeled half of the carrying case cover firmly over the non-needle end of the auto-injector. See Figure D.
Figure D
1.
Take your used epinephrine injection, USP auto-injector with you when you go to see a healthcare provider.
2.
Tell the healthcare provider that you have received an injection of epinephrine. Show the healthcare provider where you received the injection.
3.
Give your used epinephrine injection, USP auto-injector to the healthcare provider for inspection and proper disposal.
4.
Ask for a refill, if needed.

Note:

1.
Epinephrine injection, USP auto-injector is a single-use injectable device that delivers a fixed dose of epinephrine. The auto-injector cannot be reused. 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 you see the needle sticking out of the red tip.
2.
A separate epinephrine injection, USP auto-injector Trainer is available. 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, but always carry your real epinephrine injection, USP auto-injector in case of an allergic emergency.
3.
Do not try to take the epinephrine injection, USP auto-injector apart.

For more information and video instructions on the use of epinephrine injection, USP auto-injector, go to www.epinephrineautoinject.com or call 1-888-894-6528.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

10/2014

© 2014 Lineage Therapeutics Inc., Horsham, PA. All rights reserved.

Manufactured for and Distributed by:
Lineage Therapeutics Inc.
Horsham, PA 19044

71007-07

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL — 0.3 mg CARTON NDC 68788-6376-2
Rx Only
Lineage Therapeutics
epinephrine injection, USP
auto-injector
0.3 mg
For Allergic Emergencies
in patients weighing over 66 lb
For Subcutaneous or Intramuscular Use Only
This carton contains: Two epinephrine auto-injectors

Relabeled By: Preferred Pharmaceuticals Inc.

Epinephrine Injecton, USP 0.3mg
(click image for full-size original)
EPINEPHRINE
epinephrine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-6376(NDC:54505-102)
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPINEPHRINE (EPINEPHRINE) EPINEPHRINE 0.3 mg in 0.3 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
CHLOROBUTANOL
SODIUM BISULFITE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-6376-2 2 CASE in 1 CARTON contains a CASE
1 1 SYRINGE, GLASS in 1 CASE This package is contained within the CARTON (68788-6376-2) and contains a SYRINGE, GLASS
1 0.3 mL in 1 SYRINGE, GLASS This package is contained within a CASE and a CARTON (68788-6376-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020800 04/14/2016
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 RELABEL (68788-6376)

Revised: 04/2016 Preferred Pharmaceuticals Inc.

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