EpiPen® Auto-Injectors contain 2 ml. Epinephrine
Injection for emergency intramuscularly use. Each EpiPen®
Auto-injector delivers a single dose of 0.3 mg
epinephrine form Epinephrine Injection, USP, 1: 1000
(0.3 ml. ) in a sterile solution. Each EpiPen® Jr.
Auto-Injector delivers a dose of 0.15 mg epinephrine
from Epinephrine Injection, USP, 1:2000 (0.3mL) in a
sterile solution. Each 0.3 ml. also contains 1.8 mg
sodium chloride, 0.5 mg sodium metabisulfite,
hydrochloric acid to adjust pH, and Water for Injection.
The pH range is 2.5-5.0.
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 1 ) 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.
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® Auto-Injector is indented for immediate self
administration by a person with a history of an
EpiPen® is also indicated for temporary emergency
treatment of severe life threatening asthma attacks.
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, urticaria or
angioedema. The EpiPen® is designed as emergency
supportive therapy only and is not a replacement or
substitute for immediate medical or hospital care.
There are no absolute contraindications to the use of
epinephrine in a life-threatening situation.
Epinephrine is light sensitive and should be
stored in the tube provided. Store at room temperature
(15 -30°C/59 -86°F). Do not refrigerate. Before using,
check to make sure solution in Auto-Injector is not
discolored. Replace the Auto-Injector if the solution
is discolored or contains a precipitate. Avoid possible
inadvertent intravascular administration. Select an
appropriate injection site such as the thigh.
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
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 of
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
Accidental injection into the hands or
feet may result in loss of blood flow to the affected
area 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® should ONLY be injected into the anterolateral
aspect of the thigh.
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
guanidine, 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
oxidize inhibitors. Hyperthyroid individuals,
individuals with cardiovascular disease, hypertension or
diabetes, elderly individuals, pregnant women, and
children under 30 kg (66 lbs.) body weight may be
theoretically at greater risk of developing adverse
reactions after epinephrine administration.
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.
IMPAIRMENT OF FERTILITY:
Studies of epinephrine in animals to evaluate the
carcinogenic and mutagenic potential or the effect on
fertility have not been conducted.
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.
Epinephrine may be given safely to children at a dosage
appropriate to body weight (see Dosage and
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
Over dosage 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
Usual epinephrine adult dose for allergic emergencies is
0.3 mg. For pediatric use, the appropriate dosage may be
0.15 mg or 0.30 mg depending upon the body weight of the
patient. 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. With
severe persistent anaphylaxis, repeat injections with an
additional EpiPen® may be necessary.
PO Box 13307, Kanata,
Ontario, Canada, K2K 1X5
Tel: (613) 831-7733,
FAX (613) 831-7738
Manufactured for DEY
Laboratories by Meridian Medical Technologies, Columbia,
MD. 20146. US Patent No. 3,882,863, and 4,031,893, and