While no diagnostic criteria can provide 100% sensitivity and specificity, there are certain criteria that are likely to capture more than 95% of anaphylaxis cases. Because more than 80% of anaphylaxis cases include skin symptoms, it has been judged that at least 80% of anaphylactic reactions should be identified by Criterion 1.2
When a patient fulfills any of one of these criteria, anaphylaxis is highly likely and epinephrine should be administered immediately.2
Criterion 1: Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both (for example, generalized hives, pruritus or flushing, swollen lips-tongue-uvula) AND AT LEAST ONE OF THE FOLLOWING:
Criterion 2: Two or more of the following that occur rapidly after exposure to a likely allergen for that patient (minutes to several hours):
Criterion 3: Reduced BP after exposure to a known allergen for that patient (minutes to several hours)
In patients with a known allergic history and possible exposure, Criterion 2 would provide ample evidence of an anaphylactic reaction. Criterion 3 should identify the rare patients who experience an acute hypotensive episode after exposure to a known allergen.2
Source: Sampson HA, et al. J Allergy Clin Immunol. 2006;117:391-397.
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Epinephrine auto-injector is indicated in the emergency treatment of severe allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g., triatoma, mosquitos), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as anaphylaxis to unknown substances (idiopathic anaphylaxis) or exercise-induced anaphylaxis.
Epinephrine auto-injector is intended for immediate administration in patients with a history of anaphylactic reactions. Selection of the appropriate dosage strength is determined according to patient body weight by a physician as described in the dosage and administration section of the prescribing information. 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, pruritus, rashes, urticaria, or angioedema. Epinephrine auto-injector is designed as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.
Epinephrine auto-injector should only be injected into the anterolateral aspect of the thigh. Accidental injection into the hands or feet may result in loss of blood flow to the affected area and should be avoided. DO NOT INJECT INTO BUTTOCK. If there is an accidental injection into these areas advise the patient to inform the healthcare provider of the accidental injection when he/she goes to the nearest emergency room for further treatment of anaphylaxis.
Avoid possible inadvertent intravascular administration. Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to a sharp rise in blood pressure. DO NOT INJECT INTRAVENOUSLY. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration.
Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium bisulfite, 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, even if the patient is sulfite-sensitive.
Epinephrine should be administered with caution to patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In patients with coronary insufficiency or ischemic heart disease, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. It should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation.
Epinephrine is light sensitive and should be stored in the carrying-case provided. Store at room temperature (20°-25°C/68°-77°F) with excursions permitted to 15°-30°C (59°-86°F). Do not refrigerate; protect from freezing. Patients should periodically check the solution in epinephrine auto-injector for any discoloration and/or precipitates. If the solution is discolored or contains a precipitate, the patient should replace their epinephrine auto-injector.
Epinephrine auto-injector is a patient (or caregiver) actuated product that contains 1.1 mL of epinephrine injection, USP (1 mg/mL), of which one dose can be delivered by auto-injection. THE REMAINING VOLUME THAT IS LEFT AFTER THIS FIXED DOSE CANNOT BE FURTHER ADMINISTERED AND SHOULD BE DISCARDED WITH THE DEVICE AS OUTLINED IN THE PATIENT INFORMATION LEAFLET.
Adverse reactions to epinephrine include transient, moderate 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. Large doses of epinephrine can cause acute hypertension. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs. Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Angina may occur in patients with coronary artery disease. The potential for epinephrine to produce these types of adverse reactions does not contraindicate its use in an acute, life-threatening allergic reaction.
IN ALL CASES, THE PHYSICIAN SHOULD INSTRUCT THE PATIENT AND/OR ANY OTHER PERSON WHO MIGHT BE IN A POSITION TO ADMINISTER THE EPINEPHRINE, IN THE PROPER USE OF epinephrine auto-injector.
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