Microsoft word - 153460 epipen and epipen jr_api.doc

EpiPen®
Unidose 0.3 mg epinephrine auto-injector EpiPen® Jr
Unidose 0.15 mg epinephrine auto-injector
Control number: 153460
Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION.3
SUMMARY PRODUCT INFORMATION .3 INDICATIONS AND CLINICAL USE.3 CONTRAINDICATIONS .6 WARNINGS AND PRECAUTIONS.6 ADVERSE REACTIONS.8 DRUG INTERACTIONS .9 DOSAGE AND ADMINISTRATION .10 OVERDOSAGE .11 STORAGE AND STABILITY.12 DOSAGE FORMS, COMPOSITION AND PACKAGING .12 PART II: SCIENTIFIC INFORMATION .13
PART III: CONSUMER INFORMATION.15
EpiPen®
EpiPen® Jr
PART I: HEALTH PROFESSIONAL INFORMATION

SUMMARY PRODUCT INFORMATION
Dosage Form / Strength
Nonmedicinal Ingredients
Administration
Syringe, 1:2000
Unidose 0.15 mg epinephrine
auto-injector

INDICATIONS AND CLINICAL USE
EpiPen® (0.3 mL Epinephrine Injection, USP, 1:1000) and EpiPen® Jr (0.3 mL Epinephrine Injection, USP, 1:2000) are indicated for the emergency treatment of anaphylactic reactions in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Selection of the appropriate dosage strength is determined according to patient body weight (see DOSAGE AND ADMINISTRATION section). EpiPen® and EpiPen® Jr are intended for immediate self-administration for the emergency treatment of severe allergic reactions (Type I), including anaphylaxis associated with:  foods (e.g., peanuts, tree nuts, shellfish, fish, milk, eggs, and wheat)  stinging insects (e.g., Order Hymenoptera, including bees, wasps, hornets, yellow jackets, and fire ants) and biting insects (e.g., mosquitoes and black flies)  idiopathic anaphylaxis  exercise-induced anaphylaxis Epinephrine is the drug of choice for the emergency treatment of severe allergic reactions. The strong vasoconstrictor action of epinephrine, through its effect on alpha adrenergic receptors, quickly counteracts vasodilation and increased vascular permeability which can lead to loss of intravascular fluid volume and hypotension during anaphylactic reactions. EpiPen® and EpiPen® Jr are designed as emergency supportive therapy only and not as a
replacement or substitute for subsequent medical or hospital care, nor are they intended to
supplant insect venom hyposensitization.
Clinical Signs and Symptoms of Anaphylaxis
Anaphylaxis is a serious, acute, allergic reaction that may cause death1. It has a sudden onset
and generally lasts less than 24 hours. Because anaphylaxis is a generalized reaction, a wide
variety of clinical signs and symptoms may be observed.
One to 2% of the general population are estimated to be at risk for anaphylaxis from food
allergies and insect stings, with a lower reported prevalence for drugs and latex. People with
asthma are at particular risk.
Symptoms of anaphylaxis may include:
Oral: pruritus of lips, tongue, and palate, edema of lips and tongue; metallic taste in the mouth.

Cutaneous: flushing, pruritus, urticaria, angioedema, morbilliform rash, and pilor erecti.
Gastrointestinal: nausea, abdominal pain, vomiting, and diarrhea.
Respiratory:
Laryngeal: pruritus and “tightness” in the throat, dysphagia, dysphonia, hoarseness, wheezing,
and cough:
Nasal: nasal pruritus, congestion, rhinorrhea, sneezing, and sensation of itching in the external
auditory canals.
Cardiovascular: feeling of faintness, syncope, chest pain, dysrhythmia, hypotension. Note:
Hypotension is a sign of anaphylaxis. Patients should be treated in the early stages of
anaphylaxis to prevent hypotension from developing.

Other: periorbital pruritus, erythema and edema, conjunctival erythema, and tearing; lower back
pain and uterine contractions in women; aura of “doom.”

The severity of previous anaphylactic reactions does not determine the severity of future
reactions, and subsequent reactions could be the same, better, or worse. The severity may depend
on the degree of sensitivity, the dose of allergen, and other factors.
Research shows that fatalities from anaphylaxis are often associated with failure to use
epinephrine or a delay in the use of epinephrine treatment.
Epinephrine should be administered as early as possible after the onset of symptoms of a severe
allergic response. Patients requiring epinephrine will not always have predictable reactions.
Adequate warning signs are not always present before serious reactions occur.
It is recommended that epinephrine be given at the start of any reaction associated with a known
or suspected allergen contact. In patients with a history of severe cardiovascular collapse on
exposure to an allergen, the physician may advise that epinephrine be administered immediately
after exposure to that allergen, and before any reaction has begun.
Epinephrine may prove to be life saving when used as directed immediately following exposure
to an allergen.
In most patients, epinephrine is effective after 1 injection. However, symptoms may recur and
further injections may be required to control the reaction. Epinephrine can be re-injected every 5
to 15 minutes until there is resolution of the anaphylaxis or signs of adrenaline excess (such as
palpitations, tremor, uncomfortable apprehension and anxiety).
All individuals receiving emergency epinephrine must be immediately transported to hospital,
ideally by ambulance, for evaluation and observation. Repeat attacks have occurred hours later
without additional exposure to the offending allergen.2-4 Therefore, it is recommended that a patient suffering from an anaphylactic reaction be observed in an emergency facility for an appropriate period because of the possibility of either a “biphasic” reaction (a second reaction) or a prolonged reaction.4 At least a four hour period of observation is advised, although this time may vary. The attending physician will take into consideration such factors as the severity of the reaction, the patient’s response and history and the distance from the hospital to the patient’s home. Anaphylactic reactions typically follow a uniphasic course; however, 20% will be biphasic in nature. The second phase usually occurs after an asymptomatic period of 1 to 8 hours, but may occur up to 38 hours (mean 10 hours) after the initial reaction. About one third of the second-phase reactions are more severe, one third are as severe, and one third are less severe. The second-phase reactions can occur even following administration of corticosteroids. Following treatment of anaphylaxis, the patient must stay within close proximity to a
hospital or where he or she can call 911 for the next 48 hours.

Protracted anaphylaxis, which is frequently associated with profound hypotension and
sometimes lasts longer than 24 hours, is minimally responsive to aggressive therapy, and has a
poor prognosis.
CONTRAINDICATIONS
There are no absolute contraindications to the use of epinephrine in a life-threatening allergic
situation.
WARNINGS AND PRECAUTIONS
General
Patients with a history of anaphylaxis are at risk for subsequent episodes and even death. All
patients who have had one or more episodes of anaphylaxis should have injectable epinephrine
with them or with their parent or caregiver at all times, and should wear some form of medical
identification bracelet or necklace.
Following the resolution of an anaphylactic episode and discharge from hospital, the patient
should immediately obtain and fill a new EpiPen® or EpiPen® Jr auto-injector prescription.
Epinephrine injection (1:1000 and 1:2000) is not intended as a substitute for medical attention or
hospital care. In conjunction with the administration of epinephrine, the patient should seek
appropriate medical care.
Antihistamines and asthma medications must not be used as first line treatment for an
anaphylactic reaction.5

Accidental injection into the hands or feet may result in loss of blood flow to the affected areas
and should be avoided. If there is an accidental injection into these areas, the patient must go
immediately to the nearest emergency room for treatment. Epinephrine should only be injected
into the anterolateral aspect of the thigh. Every effort should be made to avoid possible
inadvertent intravascular administration through appropriate selection of an injection site such as
the thigh. Do not inject into the buttock. Large doses or accidental intravenous injection of
epinephrine may result in cerebral hemorrhage due to a sharp rise in blood pressure. Rapidly
acting vasodilators can counteract the marked pressor effects of epinephrine.
The presence of a condition listed below is not a contraindication to epinephrine administration
in an acute, life-threatening situation. Therefore, patients with these conditions, or any other
person who might be in a position to administer epinephrine to a patient with these conditions
experiencing anaphylaxis, should be instructed about the circumstances under which epinephrine
should be used:
Cardiovascular
Epinephrine use should be avoided in patients with cardiogenic, traumatic, or hemorrhagic
shock; cardiac dilation; and/or cerebral arteriosclerosis.
Epinephrine should be used with caution in patients with cardiac arrhythmias, coronary artery or
organic heart disease, hypertension, or in patients who are on medications that may sensitize the
heart to arrhythmias, e.g., digitalis, diuretics, or anti-arrhythmics. In such patients, epinephrine
may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias.
Patients with hypertension or hyperthyroidism are prone to more severe or persistent effects.
Endocrine and Metabolism
Patients with diabetes may develop increased blood glucose levels following epinephrine
administration.
Neurologic
Epinephrine use should be avoided in patients with organic brain damage.
Patients with Parkinson’s disease may notice a temporary worsening of symptoms after treatment
with epinephrine.
Ophthalmologic
Epinephrine use should be avoided in patients with narrow-angle glaucoma.
Respiratory
There is a significantly increased risk of respiratory symptoms in patients with concomitant
asthma, especially if poorly controlled. These patients are at increased risk of death from
anaphylaxis.
Fatalities may also occur from pulmonary edema resulting from peripheral constriction and
cardiac stimulation.
Sensitivity
This product contains sodium metabisulfite, a substance which may cause allergic-type reactions
including anaphylactic symptoms or mild to severe asthmatic episodes in certain susceptible
persons.
Nevertheless, epinephrine is the drug of choice for serious allergic reactions and 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.
Reproduction
No studies have been conducted to determine epinephrine’s potential effect on fertility.
Special Populations
Geriatrics (>65 years of age):
Elderly patients with hypertension, coronary artery disease or cardiac arrythmias are particularly
at risk for epinephrine overdose. More careful monitoring and avoidance of epinephrine
overdose is recommended for these patients.

Pediatrics (patients 15-30 kg):
There are no data to suggest a difference in safety or effectiveness of epinephrine between adults
and children in this weight group.
See DOSAGE AND ADMINISTRATION section for dosage requirements based on weight.
Pregnancy:

Although there are no adequate and well-controlled studies in pregnant women, epinephrine should
be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
ADVERSE REACTIONS
Adverse Drug Reaction Overview
Adverse reactions of epinephrine include transient, moderate anxiety; feelings of over
stimulation; apprehensiveness; restlessness; tremor; weakness; shakiness; dizziness; sweating;
tachycardia; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties.
Ventricular arrhythmias may follow administration of epinephrine. While these symptoms occur
in some patients treated with epinephrine, they are likely to be more pronounced in patients with
hypertension or hyperthyroidism. These signs and symptoms usually subside rapidly, especially
with bed rest.
Some patients may be at greater risk of developing adverse reactions after epinephrine
administration. These include elderly individuals, pregnant women, and patients with diabetes.
Patients with coronary artery disease are prone to more severe or persistent effects, and may
experience angina.
Excessive doses cause acute hypertension. Rapid rises in blood pressure have produced cerebral
hemorrhage, particularly in elderly patients with cardiovascular disease.
Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients
with underlying cardiac disease or those receiving certain drugs (see DRUG
INTERACTIONS).
The potential for epinephrine to produce these types of adverse reactions does not contraindicate
its use in an acute life-threatening allergic reaction.
DRUG INTERACTIONS
Overview
There are no known contraindications to the use of epinephrine in a life-threatening allergic
reaction.
Drug-Drug Interactions
Epinephrine should be used with caution in patients who are on medications that may sensitize
the heart to arrhythmias, e.g., digitalis, diuretics, or anti-arrhythmics. In such patients,
epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular
arrhythmias.
Caution is advised in patients receiving cardiac glycosides or diuretics, since these agents may
sensitize the myocardium to beta-adrenergic stimulation and make cardiac arrhythmias more
likely.
The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase
inhibitors, sodium levothyroxine, 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. Anaphylaxis may be made worse by beta
blockers because these drugs decrease the effectiveness of epinephrine.
The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha-
adrenergic blocking drugs, such as phentolamine.
Phenothiazines may also reverse the pressor effects of epinephrine.
Deaths have been reported in asthmatic patients treated with epinephrine following the use of
isoproterenol, orciprenaline, salbutamol, and long acting beta agonists.
Drug-Lifestyle Interactions
Cocaine sensitizes the heart to catecholamines (as does uncontrolled hyperthyroidism), and
epinephrine use in these patients should be cautious.
DOSAGE AND ADMINISTRATION
Dosing Considerations
Dosage in any specific patient should be based on body weight. A physician who prescribes
EpiPen® or EpiPen® Jr should take appropriate steps to ensure that the patient thoroughly
understands the indications and use of the device. The physician should review with the patient,
in detail, the CONSUMER INFORMATION section and operation of the auto-injector.
EpiPen® and EpiPen® Jr contain 2 mL of solution but deliver a single dose of 0.3 mL only, with
1.7 mL remaining in the unit after use.
Inject only into the anterolateral aspect of the thigh.

Recommended Dose and Dosage Adjustment
EpiPen®:
EpiPen® delivers a dose of 0.3 mg in 0.3 mL of 1:1000 dilution of epinephrine injection, USP.
EpiPen® is intended for adults and children who weigh 30 kg or more.
EpiPen® Jr:
EpiPen® Jr delivers a dose of 0.15 mg in 0.3 mL of 1:2000 dilution of epinephrine injection,
USP. EpiPen® Jr is intended for children who weigh between 15 kg and 30 kg.
Since the dose of epinephrine delivered from EpiPen® Jr is fixed at 0.15 mg, the physician can
consider other forms of injectable epinephrine if doses lower than 0.15 mg are felt to be
necessary (e.g., for children weighing less than 15 kg).
Administration
Patients with a history of severe allergic reactions should be instructed about the circumstances
under which epinephrine should be used (see INDICATIONS AND CLINICAL USE section).
The patient’s physician or pharmacist should review the package insert in detail with the patient
or caregiver to ensure that he/she understands the indications and use of EpiPen® or EpiPen® Jr.
Actual demonstration of the injection technique by a physician or a pharmacist is recommended.
A training device for patient instruction purposes is also available.
EpiPen® and EpiPen® Jr are intended for intramuscular use in the anterolateral aspect of
the thigh, through clothing if necessary. Do not inject into the buttock.
OVERDOSAGE

Epinephrine is rapidly inactivated in the body, and treatment following overdose with
epinephrine is primarily supportive. If necessary, pressor effects may be counteracted by rapidly
acting vasodilators or alpha-adrenergic blocking drugs. If prolonged hypotension follows such
measures, it may be necessary to administer another pressor drug.
Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result
in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage sometimes also
results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure.
Suitable corrective measures must be taken in such situations. Epinephrine overdosage can also
cause transient bradycardia followed by tachycardia, and these may be accompanied by
potentially fatal cardiac arrhythmias. Treatment of arrhythmias consists of administration of a
beta-adrenergic blocking drug such as propranolol.
If an epinephrine overdose induces pulmonary edema that interferes with respiration, treatment
consists of a rapidly acting alpha-adrenergic blocking drug and/or intermittent positive-pressure
respiration.
Premature ventricular contractions may appear within 1 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.
ACTION AND CLINICAL PHARMACOLOGY
Epinephrine acts on both alpha- and beta-adrenergic receptors. Through its action on alpha-
adrenergic receptors, epinephrine counters the vasodilation and high vascular permeability that
occurs during an anaphylactic reaction that can lead to loss of intravascular fluid volume and
hypotension. Through its action on beta-adrenergic receptors, epinephrine causes bronchial
smooth muscle relaxation that helps alleviate bronchospasm, wheezing, and dyspnea that may
occur during anaphylaxis.
Epinephrine also helps to alleviate pruritus, urticaria, and angioedema, and may be effective in
relieving gastrointestinal and genitourinary symptoms of anaphylaxis because of its relaxant
effects on the smooth muscle of the stomach, intestine, and urinary bladder. Epinephrine
contracts the smooth muscle of the uterus.
Epinephrine, when given intramuscularly or subcutaneously, has a rapid onset and short duration
of action.


STORAGE AND STABILITY
Always store EpiPen® or EpiPen® Jr in the carrier tube with the blue safety release on until you
need to use it. Store at 25°C (77°F); EXCURSIONS PERMITTED TO 15° - 30°C (59 ° - 86°F).
Do not refrigerate. Protect from light. Periodically check to make sure the solution in the
auto-injector is not brown in color. Replace if it is discolored or contains a precipitate.
DOSAGE FORMS, COMPOSITION AND PACKAGING
EpiPen® and EpiPen® Jr are designed to be compact and easy to carry, and to provide emergency
treatment when medical care is not immediately available.
Highly sensitive individuals should have epinephrine injectable products readily available at all
times.

EpiPen®
Each auto-injector contains: 2 mL epinephrine injection 1:1000 and is designed to deliver a
single dose of epinephrine 0.3 mg in 0.3 mL.
Nonmedicinal ingredients: Each mL contains: sodium chloride 6 mg, sodium metabisulfite
1.67 mg and hydrochloric acid to adjust pH. Contains no latex.

EpiPen® Jr
Each auto-injector contains: 2 mL epinephrine injection 1: 2000 and is designed to deliver a
single dose of epinephrine 0.15 mg in 0.3 mL.
Nonmedicinal ingredients: Each mL contains: sodium chloride 6 mg, sodium metabisulfite
1.67 mg and hydrochloric acid to adjust pH. Contains no latex.
PART II: SCIENTIFIC INFORMATION

PHARMACEUTICAL INFORMATION
Drug Substance
Proper
Chemical name: 1-(3,4-dihydroxyphenyl)-2-(methylamino)ethanol Physicochemical properties: Epinephrine is a sympathomimetic catecholamine. Its naturally occurring l-isomer, which is twenty times as active as the d-isomer, is obtained in pure form by separation from the synthetically produced racemate. REPRODUCTION
Teratogenic Effects. Pregnancy Category C
Epinephrine has been shown to have adverse developmental effects in rabbits at a subcutaneous
dose of 1.2 mg/kg (approximately 30 times the maximum recommended daily subcutaneous or
intramuscular dose on a mg/m2 basis), in mice at a subcutaneous dose of 1 mg/kg (approximately
7 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2
basis), and in hamsters at a subcutaneous dose of 0.5 mg/kg (approximately 5 times the
maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis).
These effects were not seen in mice at a subcutaneous dose of 0.5 mg/kg (approximately 3 times
the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis).
REFERENCES

1. Sampson H. et al. Second Symposium on the Definition and Management of Anaphylaxis: Summary Report – Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network Symposium. Journal of Allergy and Clinical Immunology 2006: 117(2) 391-397. 2. Stark BJ, Sullivan TJ. Biphasic and protracted anaphylaxis. Journal of Allergy and 3. Lieberman P. Biphasic Anaphylaxis (Review) Allergy and Clinical Immunology International – Journal of the World Allergy Organization 2004;16:241-248. 4. Sampson HA. Anaphylaxis and Emergency Treatment. Pediatrics 2003;111;1601-1608 5. Allen, M. et al. (2005) Anaphylaxis in Schools and Other Settings, Hamilton, Ontario: Canadian Society of Allergy and Clinical Immunology. IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
EpiPen®
Sterile epinephrine injection USP
 Anxiety or an overwhelming sense of doom Unidose 0.3 mg epinephrine auto-injector
EpiPen® Jr
Sterile epinephrine injection USP
What it does:
Unidose 0.15 mg epinephrine auto-injector
EpiPen® and EpiPen® Jr contain epinephrine, which is the
medication that helps to decrease your body’s allergic reaction. This leaflet is Part III of a three-part “Prescribing
Information” document published when EpiPen®, EpiPen® Jr.
 Relaxing the muscles in your airways so you can breathe were approved for sale in Canada and is designed specifically
for Consumers. This leaflet is a summary and will not tell you
 Helping to reverse the rapid and dangerous decrease in blood everything about EpiPen®, EpiPen® Jr. Contact your doctor
or pharmacist if you have any questions about the drug.
 Relaxing the muscles in your stomach, intestines, and bladder ABOUT THIS MEDICATION
What the medicinal ingredient is:
Epinephrine.
What the medication is used for:
What the nonmedicinal ingredients are:
EpiPen® and EpiPen® Jr are indicated for the emergency treatment
Hydrochloric acid, sodium chloride, sodium metabisulfite, and of anaphylaxis and are intended for people determined to be at risk for serious allergic reactions and for people with a history of What dosage forms it comes in:
EpiPen®: Unidose 0.3 mg epinephrine auto-injector EpiPen® and EpiPen® Jr should be used immediately to treat
yourself or your child when experiencing a severe allergic EpiPen® Jr: Unidose 0.15 mg epinephrine auto-injector reaction. This is emergency treatment. It does not replace seeing a EpiPen® and EpiPen® Jr come in disposable, prefilled automatic
Anaphylaxis is the term for a severe, life-threatening allergic reaction that some people have to foods (like peanuts and shellfish), insect stings, certain medicines, latex, or other allergens. WARNINGS AND PRECAUTIONS
These reactions can also be triggered by exercise or even by unknown causes. A severe allergic reaction occurs when a person If you have had one or more episodes of anaphylaxis you (or is exposed to an allergen (an allergy-causing substance). When the your parent or caregiver) should carry EpiPen® or EpiPen® Jr at
allergen enters the body it triggers the releases of chemicals that all times. You should also wear some form of medical Those who are considered to be at a higher risk of anaphylaxis EpiPen® and EpiPen® Jr are not intended as a substitute for
medical attention or hospital care. After you use EpiPen®, or
EpiPen® Jr always seek medical care immediately.
 who have previously experienced allergic reactions or BEFORE you obtain EpiPen® or EpiPen® Jr, talk to your doctor
or pharmacist about all of your medical conditions, especially if
Anaphylaxis affects multiple body systems: skin, upper and lower
respiratory system, intestinal tract, heart and blood vessels.
The most common warning symptoms of anaphylaxis are:
 Hives and swelling
Typical symptoms of anaphylaxis include:
 Swelling of the throat, lips, tongue, or the area around the eyes
 Difficulty breathing or swallowing
 Metallic taste or itching in the mouth
 Generalized flushing, itching, or redness of the skin
 Stomach cramps, nausea, vomiting, or diarrhea
 Increased heart rate
 heart disease, irregular heartbeat, or high blood pressure required. If symptoms persist while awaiting transport to the
hospital, administer another dose of EpiPen® or EpiPen® Jr.
Usual dose:
EpiPen®, (0.3 mg) should be used for adults and children
weighing 30 kg or more. EpiPen® Jr (0.15 mg) should be used for
children weighing between 15 kg to 30 kg. For children weighing  An allergy to any of the ingredients in this medication  Also notify your doctor and pharmacist if you are pregnant or Directions for Use
EpiPen® or EpiPen® Jr remains the essential treatment for
anaphylaxis even if you have the above conditions.  Remove EpiPen® or EpiPen® Jr from carrier tube before use
 Never put thumb, fingers or hand over orange tip EpiPen® or EpiPen® Jr should not be injected into the hands or
 Never press or push orange tip with thumb, fingers, or hand feet as this may result in the loss of blood flow to the affected
 The injection needle comes out of orange tip areas. If you accidentally inject into these areas, go
 Do not remove blue safety cap until ready to use immediately to the nearest emergency room for treatment
 Remove blue safety cap by pulling straight up (Do not bend or twist off the blue safety cap) INTERACTIONS WITH THIS MEDICATION

To Take Epipen® or Epipen® Jr out of the Carrier Tube
Drugs that may interact with EpiPen® or EpiPen® Jr include:

1. Flip open the cap on the carrier tube. The cap is yellow on Heart rhythm medicine, such as digoxin or quinidine (another EpiPen®, green on EpiPen® Jr.
 Diuretic medicines ("water pills")  MAO inhibitors (MAOI), such as selegilline, isocarboxazid,  Tricyclic antidepressants, such as amitriptyline, doxepin,  Antihistamines, such as chlorpheniramine, tripelennamine, or Beta-adrenergic blocking drugs, such as propranolol 2. Tip the carrier tube and slide EpiPen® or EpiPen® Jr out of
 Alpha-adrenergic blocking drugs, such as phentolamine  Ergot alkaloids and phenothiazines
 Isoproterenol, orciprenaline, salbutamol and LABAs
 Thyroid medications (e.g. sodium levothyroxine)
 Cocaine

PROPER USE OF THIS MEDICATION
If you have been told by your doctor that you are at risk for an To Use Epipen® or Epipen® Jr
anaphylactic reaction, carry your EpiPen® or EpiPen® Jr with you
1. Grasp EpiPen® or EpiPen® Jr with the orange tip pointing
downward, form a fist around the unit (orange tip down), IMPORTANT NOTE: Anaphylaxis can result in death if not
remove blue safety cap by pulling straight up. (Do not bend treated immediately. Talk to your doctor about the warning
or twist off the blue safety cap.) signs and symptoms of anaphylaxis and when to use EpiPen®
or EpiPen® Jr. In addition, if you experience any of the
symptoms of anaphylaxis listed in the “ABOUT THIS
MEDICATION” section, you should administer EpiPen® or
EpiPen® Jr IMMEDIATELY and then seek immediate
transport to hospital, ideally by ambulance, where you will
remain under observation and receive additional treatment, as
IMPORTANT: PLEASE READ
2. Swing and push orange tip firmly into outer thigh so it After you use EpiPen® or EpiPen® Jr always seek appropriate “clicks” AND HOLD on thigh for several seconds. Inject even medical care. EpiPen® or EpiPen® Jr does not replace seeing a through clothing if necessary. Do not inject EpiPen® or
EpiPen® Jr into your hands, feet, or buttock.
The following side effects may occur after using EpiPen® or EpiPen® Jr. SERIOUS SIDE EFFECTS
Symptom / effect

3. Remove EpiPen® or EpiPen® Jr from the thigh. Massage the
injected area if desired. Note: The orange needle cover
automatically extends to cover the injection needle when EpiPen® or EpiPen® Jr is removed from the thigh.
Angina (chest pain) or stroke (symptoms may include blurred vision, difficulty speaking, headache, dizziness, weakness)
Other potential side effects include:

5. Seek medical attention immediately even if the severe allergy symptoms seem to have subsided. Because the effects of epinephrine can wear off and there is a chance of a second reaction, it is important that you seek medical assistance or
go to the emergency room immediately after using EpiPen®
or EpiPen® Jr.
6. Even if you have sought medical help, you must stay
This is not a complete list of side effects.
within close proximity to a hospital or where you can
easily call 911 for the next 48 hours.
It is important that you seek medical assistance or go to the
emergency room immediately after using EpiPen® or EpiPen®
The used EpiPen® or EpiPen® Jr with extended orange needle
cover will not fit back into the carrier. Give any used EpiPen® or
EpiPen® Jr to emergency responders or emergency room
HOW TO STORE IT
Overdose:
 Keep your EpiPen® or EpiPen® Jr at room temperature. Do

Too much epinephrine can cause dangerously high blood pressure,
 Do not expose your EpiPen® or EpiPen ® Jr to direct sunlight.
Do not keep your EpiPen® or EpiPen® Jr in a vehicle during
If you take more than the recommended dose, or inject the EpiPen®
 Always keep your EpiPen® or EpiPen ® Jr in the carrier tube
or EpiPen® Jr anywhere other than your thigh, go to the nearest
emergency room for treatment.
with the blue safety cap on until you need to use it.  Occasionally inspect your EpiPen® or EpiPen® Jr solution
through the viewing window. Replace your EpiPen® or
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
EpiPen® Jr if it is discolored or contains solid particles
(precipitate) or if there are any signs of leakage. The solution EpiPen® and EpiPen® Jr are intended to be used immediately to treat yourself or your child when suffering from a severe allergic  Discard if there are any signs of damage to the carrier or the EpiPen® or EpiPen® Jr.
 Do not attempt to take the EpiPen® or EpiPen® Jr apart.
 Replace your EpiPen® or EpiPen® Jr before the expiration
21046, U.S.A. Distributed in Canada by Pfizer Canada Inc.,  Talk to your pharmacist or physician about how to properly dispose of your expired EpiPen® or EpiPen® Jr.
 Do not place this Consumer Information or any other objects EpiPen®, EpiPen® Jr are registered trademarks of Mylan, Inc.
in the carrier tube with your EpiPen® or EpiPen® Jr, as this
licensed exclusively to its wholly-owned affiliate Dey Pharma, may prevent you from removing your EpiPen® or EpiPen® Jr,
L.P. of Napa, California, USA; sub-licensee, Pfizer Canada Inc., REPORTING SUSPECTED SIDE EFFECTS To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance: By toll-free telephone: 866-234-2345 By toll-free fax: 866-678-6789 Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca By regular mail: Canada Vigilance National Office Marketed Health Products Safety and Effectiveness Information Bureau Marketed Health Products Directorate Health Products and Food Branch Health Canada Tunney’s Pasture, AL 0701C Ottawa ON K1A 0K9 NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice. EXPIRATION REMINDER SERVICE

Patients may also register the expiration date of their EpiPen®,
EpiPen® Jr at www.EpiPen.ca. Shortly before this emergency care
product expires patients will be notified by E-mail or text message
that the product is nearing expiry and should be replaced.
MORE INFORMATION

This document plus the full product monograph, prepared for
health professionals can be found at: www.EpiPen.ca or by
contacting Pfizer Canada Inc. 1-877-EPIPEN 1 (1-877-374-7361).
This leaflet was prepared by Dey Pharma, L.P.
Manufactured for Dey Pharma, L.P., Napa, California 94558,
U.S.A. by Meridian Medical Technologies®, Inc., Columbia, MD

Source: http://files.ru.prom.st/227665_epipenpme15346013mar2012.pdf