EPIPEN® Auto-Injector for Intramuscular Injection of Epinephrine

EPIPEN - epinephrine injection 
EPIPEN JR - epinephrine injection 
Dey Pharma L.P.

----------

EPIPEN®
Auto-Injector for Intramuscular Injection of Epinephrine

PRESCRIBING INFORMATION

(PHARMACIST - PLEASE REMOVE BEFORE DISPENSING)


EPIPEN® 0.3 mg EPINEPHRINE AUTO-INJECTOR

Auto-Injector for Intramuscular Injection of Epinephrine
For the Emergency Treatment of Allergic Reactions (Anaphylaxis)
Delivers a single 0.3 mg intramuscular dose of epinephrine from epinephrine injection, USP, 1:1000 (0.3 mL).

EPIPEN® JR 0.15 mg EPINEPHRINE AUTO-INJECTOR
Auto-Injector for Intramuscular Injection of Epinephrine
For the Emergency Treatment of Allergic Reactions (Anaphylaxis)

Delivers a single 0.15 mg intramuscular dose of epinephrine from epinephrine injection, USP, 1:2000 (0.3 mL).

IMPORTANT INFORMATION

DESCRIPTION

The EpiPen® and Epipen® Jr auto-injectors contain 2 mL epinephrine injection for emergency intramuscular use. Each EpiPen auto-injector 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 delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP, 1:2000 (0.3 mL) in a sterile solution.

For stability purposes, approximately 1.7 mL remains in the auto-injector after activation and cannot be used.

Each 0.3 mL in EpiPen 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 EpiPen Jr 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 B-(3, 4-dihydroxyphenyl)-a-methyl-aminoethanol, with the following structure:

Structure

It deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Epinephrine solutions which show evidence of discoloration should be replaced.

CLINICAL PHARMACOLOGY

Epinephrine is a sympathomimetic drug, acting on both alpha and beta receptors. It is the drug of choice for the emergency treatment of severe allergic reactions (Type I) to insect stings or bites, foods, drugs, and other allergens. It can also be used in the treatment of idiopathic or exercise-induced anaphylaxis. Epinephrine when given subcutaneously or intramuscularly has a rapid onset and short duration of action. The strong vasoconstrictor action of epinephrine through its effect on alpha adrenergic receptors acts quickly to counter vasodilation and increased vascular permeability which can lead to loss of intravascular fluid volume and hypotension during anaphylactic reactions. Epinephrine through its action on beta receptors on bronchial smooth muscle causes bronchial smooth muscle relaxation which alleviates wheezing and dyspnea. Epinephrine also alleviates pruritis, urticaria, and angioedema and may be effective in relieving gastrointestinal and genitourinary symptoms associated with anaphylaxis.

INDICATIONS AND USAGE

Epinephrine is indicated in the emergency treatment of allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise-induced anaphylaxis. The EpiPen and EpiPen Jr auto-injectors are intended for immediate self-administration by a person with a history of an anaphylactic reaction. Such 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, pruritis, rashes, uticaria or angioedema. The EpiPen and EpiPen Jr are designed as emergency supportive therapy only and are not a replacement or substitute for immediate medical or hospital care.

CONTRAINDICATIONS

There are no absolute contraindications to the use of epinephrine in a life-threatening situation.

WARNINGS

Epinephrine is light sensitive and should be stored in the tube provided. Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) (See USP Controlled Room Temperature). Do not refrigerate. Before using, check to make sure the solution in the auto-injector is not discolored. Replace the auto-injector if the solution is discolored or contains a precipitate. Avoid possible inadvertent intravascular administration. EpiPen and EpiPen Jr should only be injected into the anterolateral aspect of the thigh. DO NOT INJECT INTO BUTTOCK.

Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to sharp rise in blood pressure. DO NOT INJECT INTRAVENOUSLY. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine.

Epinephrine is the preferred treatment for serious allergic 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. The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations.

Accidental injection into the hands or feet may result in loss of blood flow to the affectedarea and should be avoided. If there is an accidental injection into these areas, advise the patient to go immediately to the nearest emergency room for treatment. EpiPen and EpiPen Jr should only be injected into the anterolateral aspect of the thigh.

PRECAUTIONS

Epinephrine is essential for the treatment of anaphylaxis. Patients 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 this life-saving medication should be used. It must be clearly determined that the patient is at risk of future anaphylaxis, since the following risks may be associated with epinephrine administration (see Dosage and Administration).

Epinephrine is ordinarily administered with extreme caution to patients who have heart disease. Use of epinephrine with drugs that may sensitize the heart to arrhythmias, e.g., digitalis, mercurial diuretics, or quinidine, ordinarily is not recommended. Anginal pain may be induced by epinephrine in patients with coronary insufficiency.

The effects of epinephrine may be potentiated by tricyclic antidepressants and monoamine oxidase inhibitors.

Some patients may be at greater risk of developing adverse reactions after epinephrine administration. These include: hyperthyroid individuals, individuals with cardiovascular disease, hypertension, or diabetes, elderly individuals, pregnant women, pediatric patients under 30 kg (66 lbs.) body weight using EpiPen, and pediatric patients under 15 kg (33 lbs.) body weight using EpiPen Jr.

Despite these concerns, epinephrine is essential for the treatment of anaphylaxis. 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 this life-saving medication should be used.

CARCINOGENESIS, MUTAGENES IS, IMPAIRMENT OF FERTILITY

Studies of epinephrine in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted. This should not prevent the use of this life-saving medication under the conditions noted underINDICATIONS AND USAGE and as indicated under PRECAUTIONS above.

USAGE IN PREGNANCY

Pregnancy Category C: Epinephrine has been shown to be teratogenic in rats when given in doses about 25 times the human dose. There are no adequate and well-controlled studies in pregnant women. Epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

PEDIATRIC USE

Epinephrine may be given safely to pediatric patients at a dosage appropriate to body weight (see Dosage and Administration).

ADVERSE REACTIONS

Side effects of epinephrine may include palpitations, tachycardia, sweating, nausea and vomiting, respiratory difficulty, pallor, dizziness, weakness, tremor, headache, apprehension, nervousness and anxiety.

Cardiac arrhythmias may follow administration of epinephrine.

OVERDOSAGE

Overdosage or inadvertent intravascular injection of epinephrine may cause cerebral hemorrhage resulting from a sharp rise in blood pressure. Fatalities may also result from pulmonary edema because of peripheral vascular constriction together with cardiac stimulation.

DOSAGE AND ADMINISTRATION

A physician who prescribes EpiPen or EpiPen Jr should take appropriate steps to insure that the patient (or parent) understands the indications and use of this device thoroughly. The physician should review with the patient or any other person who might be in a position to administer EpiPen or EpiPen Jr to a patient experiencing anaphylaxis, in detail, the patient instructions. and operation of the EpiPen or EpiPen Jr auto-injector. Inject the delivered dose of the EpiPen auto-injector (0.3 mL epinephrine injection, USP, 1:1000) or the EpiPen Jr auto injector (0.3 mL epinephrine injection, USP. 1:2000) intramuscularly into the anterolateral aspect of the thigh, through clothing if necessary. See detailed Directions for Use on the accompanying Patient Instructions.

Usual epinephrine adult dose for allergic emergencies is 0.3 mg. For pediatric use, the appropriate dosage may be 0.15 or 0.30 mg depending upon the body weight of the patient. A dosage of 0.01 mg/kg body weight is recommended. EpiPen Jr, which provides a dosage of 0.15 mg, may be more appropriate for patients weighing less than 30 kg. However, the prescribing physician has the option of prescribing more or less than these amounts, based on careful assessment of each individual patient and recognizing the life-threatening nature of the reactions for which this drug is being prescribed. The physician should consider using other forms of injectable epinephrine if doses lower than 0.15 mg are felt to be necessary.

Each EpiPen or EpiPen Jr contains a single dose of epinephrine. With severe persistent anaphylaxis, repeat injections with an additional EpiPen may be necessary.

Parenteral drug products should be periodically inspected visually by the patient for particulate matter or discoloration and should be replaced if these are present.

HOW SUPPLIED

EpiPen® auto-injectors (epinephrine injections, USP, 1:1000, 0.3 mL) are available in individual cartons, NDC 49502-500-01, and as EpiPen 2-Pak® , NDC 49502-500-02, a pack that contains two EpiPen auto-injectors (epinephrine injections, USP, 1:1000, 0.3 mL) and one EpiPen trainer device.

EpiPen® Jr auto-injectors (epinephrine injection, USP, 1:2000, 0.3 mL) are available in individual cartons, NDC 49502-501-01, and as EpiPen Jr 2-Pak® , NDC 49502-501-02, a pack that contains two EpiPen Jr auto-injectors (epinephrine injections, USP, 1:2000, 0.3 mL) and one EpiPen trainer device.

Each EpiPen and EpiPen Jr auto-injector comes in an individual carrying case that provides built-in needle protection after use. EpiPen 2-Pak and EpiPen Jr 2-Pak also include a S-clip to clip two cases together.

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) (See USP Controlled Room Temperature). Contains no latex. Protect from light.

Rx only.

MANUFACTURED FOR DEY®, NAPA, CALIFORNIA 94558, U.S.A.

by Meridian Medical Technologies, Inc., a subsidiary of
King Pharmaceuticals, Inc., Columbia, MD 21046, U.S.A.

7/05 03-500-04

0001297

PATIENT INSERT

PHARMACIST, PLEASE DISPENSE WITH PRODUCT

EPIPEN®
(Epinephrine) Auto-Injector 015/0.3 mg

For allergic emergencies (anaphylaxis)

Amount of epinephrine delivered
EpiPen® = one dose of 0.30 mg epinephrine (USP, 1:1000, 0.3 mL)
EpiPen® Jr = one dose of 0.15 mg epinephrine (USP, 1:2000, 0.3 mL)

NDC 49502-500-01 (EpiPen®)
NDC 49502-500-02 (EpiPen 2-Pak®)
NDC 49502-501-01 (EpiPen® Jr)
NDC 49502-501-02 (EpiPen Jr 2-Pak®)

MANUFACTURED FOR DEY®
NAPA, CA 94558, U.S.A.
by Meridian Medical Technologies, Inc.,
a subsidiary of King Pharmaceuticals, Inc.,
Columbia, MD 21046, U.S.A.
03-535-04 2/06
0001323

IMPORTANT INFORMATION

Please be prepared! Read both sides of this insert before an emergency occurs!

EpiPen®and EpiPen®Jr are disposable, prefilled automatic injection devices for use during allergic emergencies. They contain a single dose of epinephrine which you inject into your outer thigh.
EpiPen® and EpiPen® Jr contain no latex.

It's important that you have this emergency medicine with you at all times. If you need additional units to keep at work, school, etc, please talk to your doctor.

WHEN TO USE

EpiPen® and EpiPen® Jr auto-injectors are used to treat severe allergic reactions (anaphylaxis). You should use this medication only if your doctor has prescribed it for allergic emergencies. Such emergencies may occur from insect stings or bites, foods, drugs, latex, other allergens, exercise-induced anaphylaxis, or unknown causes.

CARE AND STORAGE

Your auto-injector has an expiration date

To dispose of expired units

Expired auto-injectors must be disposed of properly.

To dispose of an expired auto-injector and carrier, take it to your doctor's office or to a hospital for proper disposal.

Examine contents in clear window of auto-injector periodically

DIRECTIONS FOR USE

  1. Unscrew the yellow or green cap off of the EpiPen® or EpiPen® Jr carrying case and remove the EpiPen® or EpiPen® Jr auto-injector from its storage tube.
  2. Grasp unit with the black tip pointing downward.
    Figure
  3. Form fist around the unit (black tip down).
  4. With your other hand, pull off the gray safety release.
    Figure
  5. Hold black tip near outer thigh.
  6. Swing and jab firmly into outer thigh until it clicks so that unit is perpendicular (at a 90° angle) to the thigh. (Auto-injector is designed to work through clothing.)
    Figure
  7. Hold firmly against thigh for approximately 10 seconds. (The injection is now complete. Window on auto-injector will show red.)
  8. Remove unit from thigh and massage injection area for 10 seconds.
  9. Call 911 and seek immediate medical attention.
  10. Carefully place the used auto-injector (without bending the needle), needle-end first, into the storage tube of the carrying case that provides built-in needle protection after use. Then screw the cap of the storage tube back on completely, and take it with you to the hospital emergency room.

Note: Most of the liquid (about 85%) stays in the auto-injector and cannot be reused. However, you have received the correct dose of the medication if the red flag appears in window.

WARNING

  • NEVER put thumb, fingers, or hand over black tip. The needle comes out of black tip. Accidental injection into hands or feet may result in loss of blood flow to these areas.
    If this happens, go immediately to the nearest emergency room.
  • EpiPen® and EpiPen® Jr should be injected only into the outer thigh
    (see “Directions for Use”).
  • Do NOT remove gray safety release until ready to use.

IMMEDIATELY AFTER USE

Join the Free EpiPen®Center for Anaphylactic SupportToday!

Because it's important that you always have an up-to-date EpiPen®or EpiPen®Jr with you at all times, we started an expiration reminder program as part of theEpiPen®Center for Anaphylactic Support™.Every time you purchase a new EpiPen®, be sure to register it with us, and we'll send you reminders so you can have an up-to-date EpiPen®.
This important program is a FREE service!

See other side for more details.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – EpiPen 0.3 mg AUTO-INJECTOR LABEL

NDC 49502-500-01

See other side for instructions

Rx only

After use, most of liquid stays in auto-injector and can't be reused.
Delivers 0.3 mg intramuscular dose of epinephrine from epinephrine injection 1:1000 USP (0.3 mL).
Each 0.3 mL also contains 1.8 mg sodium chloride and 0.5 mg sodium metabisulfite.

EpiPen ® 0.3 mg Epinephrine Auto-Injector for Allergic Emergencies (Anaphylaxis)

REPLACE
IF SOLUTION IS DISCOLORED

STORE AT 25°C (77°F); EXCURSIONS PERMITTED TO 15-30°C (59-86°F)
DO NOT REFRIGERATE. PROTECT FROM LIGHT. CONTAINS NO LATEX.

Dey ® Mfd. For Dey, L.P., Napa, CA 94558 USA by Meridian Medical Technologies , Inc.
Columbia, MD 21046 USA
A subsidiary of King Pharmaceuticals ® , Inc.

EpiPen ® 0.3 mg Epinephrine Auto-Injector

  1. Pull off blue safety release.
  2. Swing and firmly push orange tip against outer thigh so it ‘clicks’ AND HOLD on thigh approx. 10 seconds to deliver drug.
  3. Seek emergency medical attention.
    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – EpiPen 0.3 mg AUTO-INJECTOR LABEL

PACKAGE LABEL – PRINICPAL DISPLAY PANEL – EpiPen Jr 0.15 mg AUTO-INJECTOR LABEL

NDC 49502-501-01

See other side for instructions

Rx only

After use, most of liquid stays in auto-injector and can't be reused.
Delivers 0.15 mg intramuscular dose of epinephrine from epinephrine injection 1:2000 USP (0.3 mL).
Each 0.3 mL also contains 1.8 mg sodium chloride and 0.5 mg sodium metabisulfite.

EpiPen ® Jr
0.15 mg Epinephrine Auto-Injector for Allergic Emergencies (Anaphylaxis)

REPLACE
IF SOLUTION IS DISCOLORED

STORE AT 25°C (77°F); EXCURSIONS PERMITTED TO 15-30°C (59-86°F)
DO NOT REFRIGERATE. PROTECT FROM LIGHT. CONTAINS NO LATEX.

Dey ® Mfd. For Dey, L.P., Napa, CA 94558 USA by Meridian Medical Technologies , Inc.
Columbia, MD 21046 USA
A subsidiary of King Pharmaceuticals ® , Inc.

EpiPen® Jr 0.15 mg Epinephrine Auto-Injector

  1. Pull off blue safety release.
  2. Swing and firmly push orange tip against outer thigh so it ‘clicks’ AND HOLD on thigh approx. 10 seconds to deliver drug.
  3. Seek emergency medical attention.
    PACKAGE LABEL – PRINICPAL DISPLAY PANEL – EpiPen Jr 0.15 mg AUTO-INJECTOR LABEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – EpiPen 0.3 mg CARTON

NDC 49502-500-01

Rx only

New Product Appearance!

For Allergic Emergencies (Anaphylaxis) 0.3 mg each

EpiPen ® (Epinephrine) Auto-Injector 0.3 mg

OPEN IMMEDIATELY
EpiPen ® Center for Anaphylactic Support
FREE MEMBERSHIP – Details Inside

Dey ®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – EpiPen 0.3 mg CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – EpiPen Jr 0.15 mg CARTON

NDC 49502-501-01

Rx only

New Product Appearance!

For Allergic Emergencies (Anaphylaxis) 0.15 mg each

EpiPen ® Jr (Epinephrine) Auto-Injector 0.15 mg

OPEN IMMEDIATELY
EpiPen ® Center for Anaphylactic Support
FREE MEMBERSHIP – Details Inside

Dey ®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – EpiPen Jr 0.15 mg CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – EpiPen 2-Pak 0.3 mg CARTON

NDC 49502-500-02

Rx only.

New Product Appearance!

For Allergic Emergencies (Anaphylaxis) 0.3 mg each

EpiPen 2-Pak ® (Epinephrine) Auto-Injectors 0.3 mg

OPEN IMMEDIATELY
EpiPen ® Center for Anaphylactic Support
FREE MEMBERSHIP – Details Inside

Each carton contains 2 EpiPen ® Auto-Injectors and 1 Trainer.

Dey ®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – EpiPen 2-Pak 0.3 mg CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – EpiPen Jr 2-Pak 0.15 mg CARTON

NDC 49502-501-02

Rx only.

New Product Appearance!

For Allergic Emergencies (Anaphylaxis) 0.15 mg each

EpiPen Jr 2-Pak ® (Epinephrine) Auto-Injectors 0.15 mg

OPEN IMMEDIATELY
EpiPen ® Center for Anaphylactic Support
FREE MEMBERSHIP – Details Inside

Each carton contains 2 EpiPen ® Jr Auto-Injectors and 1 Trainer.

Dey ®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – EpiPen Jr 2-Pak 0.15 mg CARTON

EPIPEN 
epinephrine   injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)49502-500
Route of AdministrationINTRAMUSCULARDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Epinephrine (Epinephrine) Epinephrine0.3 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Chloride 
Sodium Metabisulfite 
Water 
Hydrochloric Acid 
Nitrogen 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
149502-500-011 CONTAINER In 1 CARTONcontains a CONTAINER
11 SYRINGE In 1 CONTAINERThis package is contained within the CARTON (49502-500-01) and contains a SYRINGE, GLASS
10.3 mL In 1 SYRINGE, GLASSThis package is contained within a CONTAINER and a CARTON (49502-500-01)
249502-500-021 CONTAINER In 1 CARTONcontains a CONTAINER
21 SYRINGE In 1 CONTAINERThis package is contained within the CARTON (49502-500-02) and contains a SYRINGE, GLASS
20.3 mL In 1 SYRINGE, GLASSThis package is contained within a CONTAINER and a CARTON (49502-500-02)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01943012/22/1987

EPIPEN JR 
epinephrine   injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)49502-501
Route of AdministrationINTRAMUSCULARDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Epinephrine (Epinephrine) Epinephrine0.15 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Chloride 
Sodium Metabisulfite 
Water 
Hydrochloric Acid 
Nitrogen 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
149502-501-012 CONTAINER In 1 CARTONcontains a CONTAINER
11 SYRINGE In 1 CONTAINERThis package is contained within the CARTON (49502-501-01) and contains a SYRINGE, GLASS
10.3 mL In 1 SYRINGE, GLASSThis package is contained within a CONTAINER and a CARTON (49502-501-01)
249502-501-022 CONTAINER In 1 CARTONcontains a CONTAINER
21 SYRINGE In 1 CONTAINERThis package is contained within the CARTON (49502-501-02) and contains a SYRINGE, GLASS
20.3 mL In 1 SYRINGE, GLASSThis package is contained within a CONTAINER and a CARTON (49502-501-02)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01943012/22/1987

Labeler - Dey Pharma L.P. (194775557)
Registrant - Meridian Medical Technologies, Inc. (167671341)
Establishment
NameAddressID/FEIOperations
Meridian Medical Technologies, Inc.038889234MANUFACTURE, ANALYSIS, STERILIZE
Establishment
NameAddressID/FEIOperations
Meridian Medical Technologies, Inc.167671341MANUFACTURE, LABEL, PACK
Revised: 05/2010Dey Pharma L.P.