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epinephrine injection, USP Warnings and Precautions

WARNINGS

Inadvertently induced high arterial blood pressure may result in angina pectoris, aortic rupture or cerebral hemorrhage.

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.

Parenterally administered epinephrine initially may produce constriction of renal blood vessels and decrease urine formation.

Epinephrine is the preferred treatment for serious allergic 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. The presence of a sulfite(s) in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations.


PRECAUTIONS

The solution should be protected from light. Do not use the injection if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

Do not administer unless solution is clear and seal is intact.

Discard unused portion.

Although epinephrine can produce ventricular fibrillation, its actions in restoring electrical activity in asystole and in enhancing defibrillation of the fibrillating ventricle are well documented. The drug, however, should be used with caution in patients with ventricular fibrillation.

In patients with prefibrillatory rhythm, intravenous epinephrine must be used judiciously with extreme caution because of its excitatory action on the heart. Since the myocardium is sensitized to this action of the drug by many anesthetic agents, epinephrine may convert asystole to ventricular fibrillation if used in the treatment of anesthetic cardiac accidents.

Epinephrine should be used cautiously in patients with hyperthyroidism, hypertension and cardiac arrhythmias. All vasopressors should be used cautiously in patients taking monoamine oxidase (MAO) inhibitors.

Epinephrine should not be administered concomitantly with other sympathomimetic drugs (such as isoproterenol) because of possible additive effects and increased toxicity. Combined effects may induce serious cardiac arrhythmias. They may be administered alternately when the preceding effect of other such drug has subsided.

Administration of epinephrine to patients receiving cyclopropane or halogenated hydrocarbon general anesthetics such as halothane which sensitize the myocardium, may induce cardiac arrhythmia. (See CONTRAINDICATIONS). When encountered, such arrhythmias may respond to administration of a beta-adrenergic blocking drug. Epinephrine also should be used cautiously with other drugs (e.g., digitalis, glycosides) that sensitize the myocardium to the actions of sympathomimetic drugs.

Diuretic agents may decrease vascular response to pressor drugs such as epinephrine.

Epinephrine may antagonize the neuron blockade produced by guanethidine resulting in decreased antihypertensive effect and requiring increased dosage of the latter.

Pregnancy Category C. Animal reproduction studies have not been conducted with epinephrine. It is also not known whether epinephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Epinephrine should be given to a pregnant woman only if clearly needed.

Labor and Delivery. Parenteral administration of epinephrine if used to support blood pressure during low or other spinal anesthesia for delivery can cause acceleration of fetal heart rate and should not be used in obstetrics when maternal blood pressure exceeds 130/80. (See CONTRAINDICATIONS).

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