us, rashes, urticaria or angioedema. epipen and epipen jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.

uch 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 clostridial infections (gas gangrene). cleansing with alcohol does not kill bacterial spores, and therefore, does not lower this 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 epipen and epipen jr have 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 epipen 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 epipen 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 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. 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 epipen or epipen jr 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.

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 epipen or epipen jr may be necessary. more than two sequential doses of epinephrine should only be administered under direct medical supervision [see warnings and precautions (5.1)]. the epinephrine solution in the clear window of the epipen auto-injector should be inspected visually for particulate matter and discoloration. epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light [see how supplied/storage and handling (16.2)].

)]. rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see warnings and precautions (5.5)]. angina may occur in patients with coronary artery disease [see warnings and precautions (5.5)]. rare cases of stress cardiomyopathy have been reported in patients treated with epinephrine. accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see warnings and 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 epipen has been injected into the thigh of young children who are uncooperative and kick or move during the injection [see warnings and precautions (5.2)]. injection into the buttock has resulted in cases of gas gangrene [see warnings and 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, including epipen, in the thigh [see warnings and precautions (5.3)].

d to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate. the prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries. management of anaphylaxis during pregnancy is similar to management in the general population. epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in pregnant and non-pregnant patients. in conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. data animal data in an embryofetal development study with rabbits dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including gastroschisis and embryonic lethality) at doses approximately 40 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days). in an embryofetal development study with mice dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including embryonic lethality) at doses approximately 8 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days). these effects were not seen in mice at approximately 4 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). in an embryofetal development study with hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine was shown to be teratogenic at doses approximately 7 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day). 8.2 lactation risk summary there is no information on the presence of epinephrine in human milk, the effects on breastfed infants, or the effects on milk production. epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in breastfeeding and non-breastfeeding patients. 8.4 pediatric use epipen or epipen jr may be administered to pediatric patients at a dosage appropriate to body weight [see dosage & 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 doses of epinephrine delivered from epipen and epipen jr are 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, epipen should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [see warnings and precautions (5.5), overdosage (10)].

ip to clip two carrier tubes together. rx only 16.2 storage and handling protect from light. epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light. store at 20° to 25°c (68° to 77°f); excursions permitted to 15° to 30°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.