Enter drug's generic or brand name below. Results will appear here. Note: all drug related information obtained on this page is provided by RX List.
Using the RX LIST database:
(1) Enter the drug name in the search box below and hit ENTER
(2) The rx list web site will open here with the drug search completed. Next, scroll down the page to locate the link to the drug you are searching for and then click on the link.
EPIPEN®
(epinephrine) Injection, USP
EpiPen (epinephrine injection, USP) 0.3 mg and EpiPen Jr (epinephrine injection, USP) 0.15 mg ar e auto-injectors and combination products containing drug and device components.
Each EpiPen Auto-Injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 1:1000 (0.3 mL) in a sterile solution.
Each EpiPen Jr Auto-Injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 1:2000 (0.3 mL) in a sterile solution.
The EpiPen and EpiPen Jr each contain 2 mL epinephrine solution. Approximately 1.7 mL remains in the auto-injector after activation, but is not available for future use, and should be discarded.
Each 0.3 mL in the EpiPen Auto-Injector contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0.
Each 0.3 mL in the EpiPen Jr Auto-Injector contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0.
Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure:
 |
Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace EpiPen and EpiPen Jr if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles.
Thoroughly review the patient instructions and operation of EpiPen or EpiPen Jr with patients and caregivers prior to use [see PATIENT INFORMATION].
EpiPen and EpiPen Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.
Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema.
EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.
Selection of the appropriate dosage strength (EpiPen 0.3 mg or EpiPen Jr 0.15 mg) is determined according to patient body weight.
Inject EpiPen or EpiPen Jr intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Instruct caregivers of young children who are prescribed an EpiPen or EpiPen Jr and who may be uncooperative and kick or move during an injection to hold the leg firmly in place and limit movement prior to and during an injection [see WARNINGS AND PRECAUTIONS].
Each EpiPen or EpiPen Jr contains a single dose of epinephrine for single-use injection. Since the doses of epinephrine delivered from EpiPen or EpiPen Jr are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.
The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated. With severe persistent anaphylaxis, repeat injections with an additional EpiPen or EpiPen Jr may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see WARNINGS AND PRECAUTIONS].
The epinephrine solution in the clear window of the EpiPen Auto-Injector should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light [see HOW SUPPLIED].
EpiPen Auto-Injectors (epinephrine injections, USP 0.3 mg/0.3 mL) are available as EpiPen 2Pak®, NDC 49502-500-02, a pack that contains two EpiPen Auto-Injectors (epinephrine injections, USP 0.3 mg/0.3 mL) and one EpiPen Auto-Injector trainer device.
EpiPen Jr Auto-Injectors (epinephrine injections, USP 0.15 mg/0.3 mL) are available as EpiPen Jr 2-Pak®, NDC 49502-501-02, a pack that contains two EpiPen Jr Auto-Injectors (epinephrine injections, USP 0.15 mg/0.3 mL) and one EpiPen Auto-Injector trainer device.
EpiPen 2-Pak® and EpiPen Jr 2-Pak® also include an S-clip to clip two carrier tubes together.
Protect from light. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light. Store at 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.
Properly dispose all used, unwanted or expired EpiPen and EpiPen Jr auto-injectors [see PATIENT INFORMATION].
Manufactured by: Meridian Medical Technologies, Inc., Columbia, MD 21046, U.S.A., a Pfizer company. Revised: Jan 2020
Due to the lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below.
Common adverse reactions to systemically administered epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism [see WARNINGS AND PRECAUTIONS].
Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see WARNINGS AND PRECAUTIONS].
Angina may occur in patients with coronary artery disease [see WARNINGS AND PRECAUTIONS].
Rare cases of stress cardiomyopathy have been reported in patients treated with epinephrine.
Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see WARNINGS AND PRECAUTIONS].
Adverse events experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury.
Lacerations, bent needles, and embedded needles have been reported when EpiPen has been injected into the thigh of young children who are uncooperative and kick or move during the injection [see WARNING AND PRECAUTIONS].
Injection into the buttock has resulted in cases of gas gangrene [see WARNINGS AND PRECAUTIONS].
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection, including EpiPen, in the thigh [see WARNINGS AND PRECAUTIONS].
Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see WARNINGS AND PRECAUTIONS].
The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.
The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta- adrenergic blocking drugs, such as propranolol.
The vasoconstricting and hypertensive effects of epinephrine are antagonized by alphaadrenergic blocking drugs, such as phentolamine.
Ergot alkaloids may also reverse the pressor effects of epinephrine.
Included as part of the "PRECAUTIONS" Section
EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy and are not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see INDICATIONS, DOSAGE AND ADMINISTRATION and PATIENT INFORMATION].
EpiPen and EpiPen Jr should only be injected into the anterolateral aspect of the thigh [see DOSAGE AND ADMINISTRATION and PATIENT INFORMATION].
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. Clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection. While cleansing with alcohol may reduce presence of bacteria on the skin, alcohol cleansing does not kill Clostridium spores. To decrease the risk of Clostridium infection, do not inject EpiPen into the buttock [see WARNINGS AND PRECAUTIONS]. 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.
The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations even if the patient is sulfite-sensitive.
Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium metabisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons.
The alternatives to using epinephrine in a life-threatening situation may not be satisfactory.
Some patients may be at greater risk for developing adverse reactions after epinephrine administration. Despite these concerns, it should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation. Therefore, patients with these conditions, and/or any other person who might be in a position to administer EpiPen or EpiPen Jr to a patient experiencing anaphylaxis should be carefully instructed in regard to the circumstances under which epinephrine should be used.
Epinephrine should be administered with caution to patients who have heart disease, including patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In such patients, or in patients who are on drugs that may sensitize the heart to arrhythmias, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias [see DRUG INTERACTIONS and ADVERSE REACTIONS].
Epinephrine should be administered with caution to patients with hyperthyroidism, diabetes, elderly individuals, and pregnant women. Patients with Parkinson’s disease may notice a temporary worsening of symptoms.
[See FDA-Approved Patient Labeling (PATIENT INFORMATION and Instructions for Use).]
A healthcare provider should review the patient instructions and operation of EpiPen and EpiPen Jr 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.
Instruct patients and/or caregivers in the appropriate use of EpiPen and EpiPen Jr. EpiPen should be injected into the middle of the outer thigh (through clothing, if necessary). Each device is a single-use injection. Advise patients to seek immediate medical care in conjunction with administration of EpiPen.
Instruct caregivers to hold the leg of young children firmly in place and limit movement prior to and during injection. Lacerations, bent needles, and embedded needles have been reported when EpiPen and EpiPen Jr have been injected into the thigh of young children who are uncooperative and kick or move during an injection [see WARNINGS AND PRECAUTIONS].
Instruct patients and/or caregivers to throw away the blue safety release immediately after using EpiPen and EpiPen Jr. This small part may pose a choking hazard for children.
Complete patient information, including dosage, directions for proper administration and precautions can be found inside each EpiPen or EpiPen Jr carton. A printed label on the surface of EpiPen shows instructions for use and a diagram depicting the injection process.
Instruct patients and/or caregivers to use and practice with the Trainer to familiarize themselves with the use of EpiPen in an allergic emergency. The Trainer may be used multiple times. A Trainer device is provided in 2-Pak cartons.
Instruct patients and/or caregivers to immediately place the blue safety release back on the Trainer and reset it after practicing. This small part may pose a choking hazard for children.
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].
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 vasodilatation if there is such an accidental injection to these areas [see WARNINGS AND PRECAUTIONS].
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].
Instruct patients to inspect the epinephrine solution visually through the clear window of the auto-injector periodically. Replace EpiPen and EpiPen Jr if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light. The carrier tube is not waterproof. Instruct patients that EpiPen and EpiPen Jr must be used or properly disposed once the blue safety release is removed or after use [see Storage And Handling].
Advise patients and caregivers to promptly dispose of medicines that are no longer needed. Dispose of expired, unwanted, or unused EpiPen and EpiPen Jr auto-injectors in an FDA-cleared sharps container. Instruct patients not to dispose EpiPen or EpiPen Jr in their household trash. Instruct patients that if they do not have a FDA-cleared sharps disposal container, they may use a household container that is made of a heavy-duty plastic, can be closed with a tight-fitting and 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. Inform patients that they can visit the FDA website for additional information on disposal of unused medicines.
Complete patient information, including dosage, directions for proper administration and precautions can be found inside each EpiPen Auto-Injector carton.
Long-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted.
Epinephrine and other catecholamines have been shown to have mutagenic potential in vitro. Epinephrine was positive in the Salmonella bacterial reverse mutation assay, positive in the mouse lymphoma assay, and negative in the in vivo micronucleus assay. Epinephrine is an oxidative mutagen based on the E. coli WP2 Mutoxitest bacterial reverse mutation assay. This should not prevent the use of epinephrine under the conditions noted under INDICATIONS.
The potential for epinephrine to impair reproductive performance has not been evaluated, but epinephrine has been shown to decrease implantation in female rabbits dosed subcutaneously with 1.2 mg/kg/day (40-fold the highest human intramuscular or subcutaneous daily dose) during gestation days 3 to 9.
There are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women. In animal reproductive studies, epinephrine administered by the subcutaneous route to rabbits, mice, and hamsters during the period of organogenesis was teratogenic at doses 7 times and higher than the maximum recommended human intramuscular and subcutaneous dose on a mg/m2 basis. Epinephrine is the first-line medication of choice for the treatment of anaphylaxis during pregnancy in humans. Epinephrine should be used for treatment of anaphylaxis during pregnancy in the same manner as it is used in non-pregnant patients.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Disease-associated maternal and embryo/fetal risk
During pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate. The prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries.
Management of anaphylaxis during pregnancy is similar to management in the general population. Epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in pregnant and non-pregnant patients. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care.
Animal Data
In an embryofetal development study with rabbits dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including gastroschisis and embryonic lethality) at doses approximately 40 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days).
In an embryofetal development study with mice dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including embryonic lethality) at doses approximately 8 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days). These effects were not seen in mice at approximately 4 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days).
In an embryofetal development study with hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine was shown to be teratogenic at doses approximately 7 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day).
There is no information on the presence of epinephrine in human milk, the effects on breastfed infants, or the effects on milk production. Epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in breastfeeding and non-breastfeeding patients.
EpiPen or EpiPen Jr may be administered to pediatric patients at a dosage appropriate to body weight [see DOSAGE AND ADMINISTRATION]. Clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Since the doses of epinephrine delivered from EpiPen and EpiPen Jr are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.
Clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. However, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. Therefore, EpiPen should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [see WARNINGS AND PRECAUTIONS, OVERDOSE].
Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.
Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.
Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.
None
Epinephrine acts on both alpha-and beta-adrenergic receptors.
Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension.
Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing and dyspnea that may occur during anaphylaxis.
Epinephrine also alleviates pruritus, urticaria, and angioedema and may relieve gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder.
When given subcutaneously or intramuscularly, epinephrine has a rapid onset and short duration of action.
Instructions for Use
EPIPEN®
(epinephrine injection, USP)
Auto-Injector 0.3 mg
EpiPen® = one dose of 0.3 mg epinephrine, USP 0.3 mg/0.3 mL
EPIPEN JR®
(epinephrine injection, USP)
Auto-Injector 0.15 mg
EpiPen Jr® = one dose of 0.15 mg epinephrine, USP 0.15 mg/0.3 mL
For allergic emergencies (anaphylaxis)
Patient Information
Read this Patient Information Leaflet carefully before using the EpiPen® or EpiPen Jr® 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 EpiPen or EpiPen Jr 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 the EpiPen and EpiPen Jr?
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 EpiPen or EpiPen Jr and how to use it before you need it. You may be unable to speak in an allergic emergency.
Symptoms of anaphylaxis may include:
What are EpiPen and EpiPen Jr?
What should I tell my healthcare provider before using the EpiPen or EpiPen Jr?
Before you use EpiPen or EpiPen Jr, tell your healthcare provider about all your medical conditions, but especially if you:
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.
EpiPen or EpiPen Jr and other medicines may affect each other, causing side effects. EpiPen or EpiPen Jr may affect the way other medicines work, and other medicines may affect how EpiPen or EpiPen Jr 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 EpiPen or EpiPen Jr for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicines you take.
How should I use EpiPen and EpiPen Jr?
The needle comes out of the orange tip. Accidental injection into finger, hands or feet may cause a loss of blood flow to these areas. If this happens, go immediately to the nearest emergency room. Tell the healthcare provider where on your body you received the accidental injection.
What are the possible side effects of the EpiPen and EpiPen Jr?
EpiPen and EpiPen Jr may cause serious side effects.
If you accidentally inject EpiPen or EpiPen Jr 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.
Common side effects of EpiPen and EpiPen Jr include:
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 EpiPen or EpiPen Jr. 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 EpiPen and EpiPen Jr?
Visit the FDA website (www.fda.gov/drugs/safe-disposal-medicines/disposalunused-medicines-what-you-should-know) for more information about how to throw away (dispose of) unused medicines.
Keep EpiPen and EpiPen Jr and all medicines out of the reach of children.
General information about the safe and effective use of EpiPen and EpiPen Jr
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use the EpiPen or EpiPen Jr for a condition for which it was not prescribed. Do not give your EpiPen or EpiPen Jr to other people.
This Patient Information Leaflet summarizes the most important information about EpiPen and EpiPen Jr. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about EpiPen and EpiPen Jr that is written for health professionals.
For more information and video instructions on the use of EpiPen and EpiPen Jr, go to www.epipen.com or call 1-800-395-3376.
What are the ingredients in EpiPen and EpiPen Jr?
Active Ingredients: Epinephrine
Inactive Ingredients: sodium chloride, sodium metabisulfite, hydrochloric acid, and water
Important Information
Instructions for Use
EPIPEN®
(epinephrine injection, USP)
Auto-Injector 0.3 mg
EpiPen® = one dose of 0.3 mg epinephrine, USP 0.3 mg/0.3 mL
EPIPEN JR®
(epinephrine injection, USP)
Auto-Injector 0.15 mg
EpiPen Jr® = one dose of 0.15 mg epinephrine, USP 0.15 mg/0.3 mL
For allergic emergencies (anaphylaxis)
Read this Instructions for Use carefully before you use EpiPen or EpiPen Jr. Before you need to use your EpiPen or EpiPen Jr, 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 EpiPen or EpiPen Jr Auto-Injector should also understand how to use it as well. If you have any questions, ask your healthcare provider.
Your EpiPen and EpiPen Jr Auto-Injector
 |
A dose of EpiPen or EpiPen Jr requires 3 steps: Prepare, Administer and Get emergency medical help
Step 1. Prepare EpiPen or EpiPen Jr for injection
Remove the EpiPen or EpiPen Jr from the clear carrier tube.
Flip open the yellow cap of your EpiPen or the green cap of your EpiPen Jr carrier tube.
 |
Tip and slide the auto-injector out of the carrier tube.
 |
Grasp the auto-injector in your fist with the orange tip (needle end) pointing downward.
With your other hand, remove the blue safety release by pulling straight up without bending or twisting it.
 |
Important: The blue safety release is a small part that may become a choking hazard for children. Throw away the blue safety release immediately after using EpiPen or EpiPen Jr.
Note:
Step 2. Administer EpiPen or EpiPen Jr
If you are administering EpiPen or EpiPen Jr to a young child, hold the leg firmly in place while administering an injection.
Place the orange tip against the middle of the outer thigh (upper leg) at a right angle (perpendicular) to the thigh.
 |
Swing and push the auto-injector firmly until it ‘clicks’. The click signals that the injection has started.
Hold firmly in place for 3 seconds (count slowly 1,2,3). The injection is now complete.
 |
Remove the auto-injector from the thigh. The orange tip will extend to cover the needle. If the needle is still visible, do not attempt to reuse it.
 |
Massage the injection area for 10 seconds.
 |
Step 3. Get emergency medical help now.
You may need further medical attention. You may need to use a second EpiPen or EpiPen Jr Auto-Injector if symptoms continue or recur.
Note:
EPIPEN®
(epinephrine injection, USP)
Auto-Injector 0.3 mg
EpiPen® = one dose of 0.3 mg epinephrine, USP 0.3 mg/0.3 mL
EPIPEN JR®
(epinephrine injection, USP)
Auto-Injector 0.15 mg
EpiPen Jr® = one dose of 0.15 mg epinephrine, USP 0.15 mg/0.3 mL
MyEpiPen.com
Register your EpiPen or EpiPen Jr Auto-Injector at MyEpiPen.com and find out more about:
Register up to 6 EpiPen or EpiPen Jr Auto-Injectors and receive automatic Refill Reminder Alerts.
For more information about EpiPen or EpiPen Jr Auto-Injectors and proper use of the product, call Mylan at 1-877-446-3679 or visit www.epipen.com.
EpiPen® Trainer
Instructions for Use
EpiPen Trainer Instructions for Use
In an emergency: Do not use the grey Trainer. Use your real yellow EpiPen® or green EpiPen Jr® Auto-Injector.
Important Information
The EpiPen Trainer
Familiarize yourself with this grey Trainer. Practice until you are comfortable using it.
Your grey colored Trainer:
 |
Practice Instructions
 |
 |
 |
Note:
 |
Note: With the real yellow EpiPen or green EpiPen Jr Auto-Injector, the orange tip covers the needle after self-injection to help protect you from accidentally sticking yourself or others.
Practice Session Information
In case of an allergic emergency, use the real yellow EpiPen or green EpiPen Jr Auto-Injector and not the grey Trainer.
Follow instructions above. Repeat as often as needed until you are able to self-inject quickly and correctly.
Reread:
Train others who could help you in an emergency:
For more information about the EpiPen and EpiPen Jr Auto-Injector and the proper use of the products, go to www.epipen.com.
Caution:
Important differences between the Trainer and your real yellow EpiPen or green EpiPen Jr Auto-Injector
 |
 |
| TRAINER (Grey) | EpiPen (Yellow) | EpiPen Jr (Green) | |
| Contains medicine? | No | Yes | Yes |
| Has needle? | No | Yes | Yes |
| Comes in Carrier Tube? | No | Yes | Yes |
| Color of Label? | Grey | Yellow | Green |
| Has expiration date? | No | Yes | Yes |
| Can be reused? | Yes | No (use only one time) | No (use only one time) |
| Okay to remove and replace safety release? | Yes | No (remove just one time before use) | No (remove just one time before use) |
| Pressure needed to hold against thigh? | Moderate | Strong | Strong |
This Trainer Instructions for Use has been approved by the U.S. Food and Drug Administration.
