FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Ephedrine Sulfate Injection, USP is indicated primarily to counteract the hypotensive effects of spinal or other types of nontopical conduction anesthesia. It is also useful as a pressor agent in hypotensive states following sympathectomy, or following overdosage with ganglionic-blocking agents, antiadrenergic agents, veratrum alkaloids or other drugs used for lowering blood pressure in the treatment of arterial hypertension. The drug is sometimes injected to relieve acute bronchospasm, but it is less effective than epinephrine for this purpose.
History
There is currently no drug history available for this drug.
Other Information
Ephedrine Sulfate Injection, USP is a sterile, nonpyrogenic solution containing ephedrine sulfate 50 mg/mL in water for injection. It is administered by subcutaneous, intramuscular or intravenous injection as an adrenergic agent. The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.3 (4.5 to 7.0). The osmolar concentration of the 5% solution is 0.35 mOsmol/mL (calc.).
Ephedrine Sulfate, USP is a sympathomimetic amine chemically designated α-[1-(methylamino) ethyl] benzenemethanol sulfate (2:1)(salt). It has the following structural formula:
Sources
Ephedrine Manufacturers
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Hospira, Inc.
Ephedrine | Hospira, Inc.
Depending on the clinical circumstances, Ephedrine Sulfate Injection may be given subcutaneously, intramuscularly or intravenously.
Usual adult dose: 25 to 50 mg (range 10 to 50 mg) injected subcutaneously or intramuscularly (equivalent to 0.2 to 1.0 mL of 5% solution) is usually adequate to prevent or minimize hypotension secondary to spinal anesthesia. Repeat doses should be governed by blood pressure response or, if used as a bronchodilator, according to the degree of improvement. Absorption (onset of action) by the intramuscular route is more rapid (within 10 to 20 minutes) than by subcutaneous injection. The intravenous route may be used if an immediate effect is desired.
When used during labor, administer only sufficient dosage to maintain blood pressure at or below 130/80.
In acute attacks of asthma, the smallest effective dose should be used (usually 0.25 to 0.5 mL) or as otherwise determined by the patient’s response.
Usual pediatric dose: 750 micrograms per kg of body weight or 25 mg/M2 of body surface injected intravenously or subcutaneously, four times daily or as otherwise determined by the patient’s response.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.
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