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 under INDICATIONS 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).
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