g, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema. epinephrine injection, usp auto-injector is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.

ts of epinephrine if there is such inadvertent administration. do not inject into buttock. injection into the buttock may not provide effective treatment of anaphylaxis. advise the patient to go immediately to the nearest emergency room for further treatment of anaphylaxis. additionally, injection into the buttock has been associated with the development of clostridial infections (gas gangrene). cleansing with alcohol does not kill bacterial spores, and therefore, does not lower the risk. do not inject into digits, hands or feet. since epinephrine is a strong vasoconstrictor, accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area. advise the patient to go immediately to the nearest emergency room and to inform the healthcare provider in the emergency room of the location of the accidental injection. treatment of such inadvertent administration should consist of vasodilation, in addition to further appropriate treatment of anaphylaxis [see adverse reactions (6)]. hold leg firmly during injection. lacerations, bent needles, and embedded needles have been reported when epinephrine has been injected into the thigh of young children who are uncooperative and kick or move during an injection. to minimize the risk of injection related injury when administering epinephrine injection, usp auto-injector to young children, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection. 5.3 serious infections at the injection site rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection. while cleansing with alcohol may reduce presence of bacteria on the skin, alcohol cleansing does not kill clostridium spores. to decrease the risk of clostridium infection, do not inject epinephrine injection, usp auto-injector into the buttock [see warnings and precautions (5.2)]. advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site. 5.4 allergic reactions associated with sulfite 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 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. 5.5 disease interactions some patients may be at greater risk for developing adverse reactions after epinephrine administration. despite these concerns, it should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation. therefore, patients with these conditions, and/or any other person who might be in a position to administer epinephrine injection, usp auto-injector to a patient experiencing anaphylaxis should be carefully instructed in regard to the circumstances under which epinephrine should be used. patients with heart disease epinephrine should be administered with caution to patients who have heart disease, including patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. in such patients, or in patients who are on drugs that may sensitize the heart to arrhythmias, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias [see drug interactions (7) and adverse reactions (6)]. other patients and diseases epinephrine should be administered with caution to patients with hyperthyroidism, diabetes, elderly individuals, and pregnant women. patients with parkinson's disease may notice a temporary worsening of symptoms.

, usp auto-injector are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary. the prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated. with severe persistent anaphylaxis, repeat injections with an additional epinephrine injection, usp auto-injector may be necessary. more than two sequential doses of epinephrine should only be administered under direct medical supervision [see warnings & precautions (5.1)]. the epinephrine solution in the viewing window of epinephrine injection, usp auto-injector should be inspected visually for particulate matter and discoloration. epinephrine is light sensitive and should be stored in the outer case provided to protect it from light [see how supplied/storage & handling (16.2)].

rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see warnings & precautions (5.5)]. angina may occur in patients with coronary artery disease [see warnings & precautions (5.5)]. accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see warnings & precautions (5.2)]. adverse events experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury. lacerations, bent needles, and embedded needles have been reported when epinephrine injection, usp auto-injector has been injected into the thigh of young children who are uncooperative and kick or move during an injection [see warnings & precautions (5.2)]. injection into the buttock has resulted in cases of gas gangrene [see warnings & precautions (5.2)]. rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by clostridia (gas gangrene), have been reported following epinephrine injection in the thigh [see warnings & precautions (5.3)]. rare cases of stress cardiomyopathy have been reported in patients treated with epinephrine.

e of 0.5 mg/kg/day for 4 days). these effects were not seen in mice at approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). 8.3 nursing mothers it is not known whether epinephrine is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when epinephrine injection, usp auto-injector is administered to a nursing woman. 8.4 pediatric use epinephrine injection, usp auto-injector may be administered to pediatric patients at a dosage appropriate to body weight [see dosage and administration (2)]. clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. since the dose of epinephrine delivered from epinephrine injection, usp auto-injector is fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary. 8.5 geriatric use clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. however, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. therefore, epinephrine injection, usp auto-injector should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [see warnings & precautions (5.5) and overdosage (10)].

°c (59° to 86°f) [see usp controlled room temperature]. do not refrigerate. before using, check to make sure the solution in the auto-injector is clear and colorless. replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particles.