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warnings
WARNINGS EPINEPHRINE Contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic rather than in non-asthmatic people. Use with caution in the following: Elderly; those with cardiovascular disease, hypertension, diabetes, or hyperthyroidism; in psychoneurotic individuals; bronchial asthma and emphysema with degenerative heart disease. Cardiovascular effects: Inadvertently induced high arterial blood pressure may result in angina pectoris (especially when coronary insufficiency is present), or aortic rupture. Epinephrine may induce potentially serious cardiac arrhythmias in patients not suffering from heart disease and patients with organic heart disease or who are receiving drugs that sensitize the myocardium. With Epinephrine, a paradoxical but transient lowering of blood pressure, bradycardia and apnea may occur immediately after injection. Cerebrovascular hemorrhage: Overdosage or inadvertent I.V. injection of epinephrine may cause cerebrovascular hemorrhage resulting from the sharp rise in the blood pressure. Pulmonary edema: Fatalities may also result from pulmonary edema because of the peripheral constriction and cardiac stimulation produced.
ADVERSE REACTIONS Transient and minor: Anxiety, headache, fear, and palpitations often occur with therapeutic doses, especially in hyperthyroid and hypertensive individuals. Cardiac arrhythmias and excessive rise in blood pressure may occur with therapeutic doses or inadvertent overdosage. Local: Repeated local injections can result in necrosis at sites of injection from vascular constriction. Systemic: Cerebral hemorrhage; hemiplegia; subarachnoid hemorrhage; anginal pain in patients with angina pectoris; anxiety; restlessness; throbbing headache; tremor; weakness; dizziness; pallor; respiratory difficulty; palpitation; apprehensiveness; sweating; nausea; vomiting. “Epinephrine-fastness” can occur with prolonged use. To report SUSPECTED ADVERSE REACTIONS, Contact BPI Labs, LLC at (727) 471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch