Ephedrine may cause hypertension resulting in intracranial hemorrhage. Ephedrine may induce anginal pain in patients with coronary insufficiency or ischemic heart disease. The drug also may induce potentially fatal arrhythmias in patients with organic heart disease or who are receiving drugs that sensitize the myocardium. See CONTRAINDICATIONS.

Initially, parenterally administered ephedrine may produce constriction of renal blood vessels and decreased urine formation.

Ephedrine Sulfate Injection, USP is subject to oxidation and should be protected against exposure to light.

Do not administer unless solution is clear and seal is intact. Discard unused portion. Ephedrine should be used cautiously in patients with hyperthyroidism, hypertension, heart disease (including coronary insufficiency, angina pectoris and patients receiving digitalis), cardiac arrhythmias, diabetes or unstable vasomotor system. All vasopressors should be used cautiously in patients taking monoamine oxidase (MAO) inhibitors.

Ephedrine should not be administered concomitantly with other sympathomimetic drugs because of possible additive effects and increased toxicity.

Alpha-adrenergic blocking agents may reduce the vasopressor response to ephedrine by causing vasodilation.

Beta-adrenergic blocking drugs may block the cardiac and bronchodilating effects of ephedrine. Administration of ephedrine to patients receiving anesthesia with cyclopropane or halogenated hydrocarbons such as halothane which sensitize the myocardium, may induce cardiac arrhythmia. (See CONTRAINDICATIONS). Use of a pressor drug with less cardiac stimulating effects should be considered in patients receiving myocardial sensitizing anesthetics. When encountered, such arrhythmias may respond to administration of a beta-adrenergic blocking drug. Ephedrine also should be used cautiously with other drugs (e.g., digitalis glycosides) that sensitize the myocardium to the actions of sympathomimetic agents.

Drugs such as reserpine and methyldopa which reduce the amount of norepinephrine in sympathetic nerve endings may reduce the pressor response to ephedrine. Diuretic agents also may decrease vascular response to pressor drugs such as ephedrine.

Ephedrine may antagonize the neuron blockade produced by guanethidine resulting in decreased anti-hypertensive effect and requiring increased dosage of the latter.

Pregnancy Category C

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

Labor and Delivery

Parenteral administration of ephedrine to maintain 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.

Pediatric Use

The safety and effectiveness of Ephedrine has not been established. Its limited use in pediatric patients has been inadequate to fully define the proper dosage and limitations of use.

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