You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
IMPORTANT SAFETY INFORMATION
Epinephrine injection, USP auto-injector is intended for immediate administration as emergency supportive
therapy and is not intended as a substitute for immediate medical care. In conjunction with the administration of
epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of
epinephrine should only be administered under direct medical supervision.
Epinephrine injection, USP auto-injector should ONLY be injected into the anterolateral aspect of the thigh. Do not
inject intravenously. Do not inject into buttock. Do not inject into fingers, hands or feet. Instruct caregivers to
hold the child’s leg firmly in place and limit movement prior to and during injection to minimize the risk of injection
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. Arrhythmias, including fatal ventricular fibrillation, have been reported
in patients with underlying cardiac disease or those receiving certain drugs. Patients who receive epinephrine
while concomitantly taking cardiac glycosides, diuretics or anti-arrhythmics should be observed carefully for the
development of cardiac arrhythmias. 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.
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by
Clostridia, have been reported at the injection site following epinephrine injection for anaphylaxis. Advise patients
to seek medical care if they develop signs or symptoms of infection.
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