Ephedrine Sulfate

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Ephedrine Sulfate Recall

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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.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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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.

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History

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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 Sulfate Manufacturers

Andersen Pharma Llc

Ephedrine Sulfate | Andersen Pharma Llc

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.

No Recall
West-ward Pharmaceutical Corp

Ephedrine Sulfate | West-ward Pharmaceutical Corp

Adults and children 12 years of age and over:

Oral dosage is 12.5 to 25 milligrams every 4 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Do not exceed recommended dose unless directed by a doctor.
Children under 12 years of age: Consult a doctor.

No Recall
Sandoz Inc

Ephedrine Sulfate | Sandoz 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.

No Recall
Akorn, Inc.

Ephedrine Sulfate | Akorn, Inc.

ADULTS - The usual parenteral dose is 25 to 50 mg given subcutaneously or intramuscularly. Intravenously, 5 to 25 mg may be administered slowly, repeated in 5 to 10 minutes, if necessary.

CHILDREN - The usual subcutaneous or intramuscular dose is 0.5 mg/kg of body weight or 16.7 mg/square meter of body surface every 4 to 6 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Akorn, Inc.

Ephedrine Sulfate | Akorn, Inc.

ADULTS - The usual parenteral dose is 25 to 50 mg given subcutaneously or intramuscularly. Intravenously, 5 to 25 mg may be administered slowly, repeated in 5 to 10 minutes, if necessary.

CHILDREN - The usual subcutaneous or intramuscular dose is 0.5 mg/kg of body weight or 16.7 mg/square meter of body surface every 4 to 6 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Cardinal Health

Ephedrine Sulfate | Cardinal Health

ADULTS - The usual parenteral dose is 25 to 50 mg given subcutaneously or intramuscularly. Intravenously, 5 to 25 mg may be administered slowly, repeated in 5 to 10 minutes, if necessary.

CHILDREN - The usual subcutaneous or intramuscular dose is 0.5 mg/kg of body weight or 16.7 mg/square meter of body surface every 4 to 6 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Cardinal Health

Ephedrine Sulfate | Cardinal Health

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.

No Recall