For intramuscular and subcutaneous use
INDICATIONS AND USAGE
Epinephrine injection is for emergency treatment of allergic reactions (Type I), including anaphylaxis.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Do not administer repeated injections of epinephrine at the same site, as the resulting vasoconstriction may cause tissue necrosis.
Do not inject into buttock. Do not inject into digits, hands, or feet.
Serious Infections at the Injection Site:
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia have been reported.
Disease Interactions: Some patients may be at greater risk for developing adverse reactions after systemic epinephrine administration. The presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation. Epinephrine should be administered with caution in patients who have heart
disease and to patients with hyperthyroidism, Parkinson’s disease, diabetes mellitus, pheochromocytoma, elderly individuals, and pregnant women.
Allergic Reactions Associated with Sulfite—This product does not contain sodium bisulfite.
Common adverse reactions to systemically administered epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties.
Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred.
• Sympathomimetic agents: possible additive effects
• Cardiac glycosides, halogenated hydrocarbon anesthetics, or diuretics: observe for development of cardiac arrhythmias
• Tricyclic antidepressants, MAO inhibitors, levothyroxine sodium, and certain antihistamines: potentiate effects of epinephrine
• Beta-adrenergic blocking drugs: antagonize the cardiostimulating and bronchodilating effects of epinephrine
• Alpha-adrenergic blocking drugs: antagonize the vasoconstricting and hypertensive effects of epinephrine
• Ergot alkaloids may reverse the pressor response to epinephrine
USE IN SPECIFIC POPULATIONS
Pregnancy Teratogenic Effects: Pregnancy Category C. Epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery: Use with caution during labor and delivery. Although epinephrine improves maternal hypotension associated with anaphylaxis, it may result in
uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia.
Nursing Mothers: Because many drugs are excreted in human milk, caution should be exercised when epinephrine is administered to a nursing woman.
Pediatric Use: Clinical use data support weight-based dosing for treatment of anaphylaxis in pediatric patients.
Geriatric Use: Consider starting with a lower dose.
Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage. Overdosage may also result in pulmonary edema.
Epinephrine overdosage can also cause transient bradycardia followed by tachycardia and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia. Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block.
Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis due to elevated blood lactic acid levels, and kidney failure. Myocardial ischemia, myocardial infarction and cardiomyopathy have been noted in the literature following overdose of epinephrine.
For additional Safety Information, please see Full Prescribing Information. You are encouraged to report Adverse Drug Events to American Regent Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.