Ephedrine Sulfate
Injection · Intravenous, Oral
Uses
Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. Ephedrine Sulfate Injection, USP, is an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. (1)
Dosage and administration
Treatment of hypotension developing during anesthesia: Bolus intravenous injection: 5 to 10 mg as needed, not to exceed 50 mg. Dilute before use. See Full Prescribing Information for instructions on administration and preparation for injection. (2) 2.1 General Dosage and Administration Instructions Ephedrine sulfate injection must be diluted before administration to achieve the desired concentration as an intravenous bolus or intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is colored or cloudy, or if it contains particulate matter. 2.2 Dosing for the Treatment of Clinically Important Hypotension in the Setting of Anesthesia The recommended dosage for the treatment of clinically important hypotension in the setting of anesthesia is an initial dose of 5 to 10 mg administered by intravenous bolus. Administer additional boluses as needed, not to exceed a total dosage of 50 mg. Adjust dosage according to the blood pressure goal (i.e., titrate to effect). 2.3 Preparation of a 5 mg/mL Solution for Bolus Intravenous Administration For bolus intravenous administration, prepare a solution containing a final concentration of 5 mg/mL of ephedrine sulfate injection. Withdraw 50 mg (1 mL of 50 mg/mL) of ephedrine sulfate injection and dilute with 9 mL of 5% Dextrose Injection or Sodium Chloride Injection. Withdraw an appropriate dose of the 5 mg/mL solution prior to bolus intravenous administration.
Dosage forms and strengths
Ephedrine sulfate injection is available as a single-dose 1 mL vial that contains 50 mg/mL ephedrine sulfate, equivalent to 38 mg ephedrine base. Injection: 50 mg/mL ephedrine sulfate in single-dose vial (3)
Contraindications
None None (4)
Warnings and precautions
• Pr e ssor Effect with Concomitant Oxytocic Drugs : Pressor effect of sympathomimetic pressor amines is potentiated ( 5.1)
• T ach y ph y l a x i s and Tolerance : Repeated administration of ephedrine may cause tachyphylaxis ( 5.2) 5.1 Pressor Effect with Concomitant Oxytocic Drugs Serious postpartum hypertension has been described in patients who received both a vasopressor (i.e., methoxamine, phenylephrine, ephedrine) and an oxytocic (i.e., methylergonovine, ergonovine) [ see Drug Interactions (7) ]. Some of these patients experienced a stroke. Carefully monitor the blood pressure of individuals who have received both ephedrine and an oxytocic. 5.2 Tolerance and Tachyphylaxis Data indicate that repeated administration of ephedrine can result in tachyphylaxis. Clinicians treating anesthesia-induced hypotension with ephedrine sulfate injection should be aware of the possibility of tachyphylaxis and should be prepared with an alternative pressor to mitigate unacceptable responsiveness. 5.3 Risk of Hypertension When Used Prophylactically When used to prevent hypotension, ephedrine has been associated with an increased incidence of hypertension compared with when ephedrine is used to treat hypotension.
Side effects
The following adverse reactions associated with the use of ephedrine sulfate were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Gastrointestinal disorders : Nausea, vomiting C ardiac disorders : Tachycardia, palpitations (thumping heart), reactive hypertension, bradycardia, ventricular ectopics, R-R variability N e rvous system disorders : Dizziness Psychiatric disorders : Restlessness For medical advice about adverse reactions, contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. (6) To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug interactions
7 DRUG INTERACTIONS I nteractions that Augment the Pressor Effect Oxytocin and oxytocic drugs C linical Impact: Serious postpartum hypertension has been described in patients who received both a vasopressor (i.e., methoxamine, phenylephrine, ephedrine) and an oxytocic (i.e., methylergonovine, ergonovine). Some of these patients experienced a stroke. I ntervention: Carefully monitor the blood pressure of individuals who have received both ephedrine and an oxytocic. Clonidine, propofol, monoamine oxidase inhibitors (MAOIs), atropine C linical Impact: These drugs augment the pressor effect of ephedrine. I ntervention: Carefully monitor the blood pressure of individuals who have received both ephedrine and any of these drugs. I nteractions that Antagonize the Pressor Effect C linical Impact: These drugs antagonize the pressor effect of ephedrine. I ntervention: Carefully monitor the blood pressure of individuals who have received both ephedrine and any of these drugs. Examples: α-adrenergic antagonists, β-adrenergic receptor antagonists, reserpine, quinidine, mephentermine Other Drug Interactions G u anethidine C linical Impact: Ephedrine may inhibit the neuron blockage produced by guanethidine, resulting in loss of antihypertensive effectiveness. I ntervention: Clinician should monitor patient for blood pressor response and adjust the dosage or choice of pressor accordingly. Rocuronium C linical Impact: Ephedrine may reduce the onset time of neuromuscular blockade when used for intubation with rocuronium if administered simultaneously with anesthetic induction. I ntervention: Be aware of this potential interaction. No treatment or other interventions are needed. Ep idural anesthesia C linical Impact: Ephedrine may decrease the efficacy of epidural blockade by hastening the regression of sensory analgesia. I ntervention: Monitor and treat the patient according to clinical practice. Th e ophylline C linical Impact: Concomitant use of ephedrine may increase the frequency of nausea, nervousness, and insomnia. I ntervention: Monitor patient for worsening symptoms and manage symptoms according to clinical practice. Cardiac glycosides C linical Impact: Giving ephedrine with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias. I ntervention: Carefully monitor patients on cardiac glycosides who are also administered ephedrine.
• I nt e r a ctio n s t ha t Augment the Pressor Effect : clonidine, oxytocin and oxytocic drugs, propofol, monoamine oxidase inhibitors (MAOIs), and atropine. Monitor blood pressure. (7)
• I nt e r acti o n s that Antagonize the Pressor Effect : Antagonistic effects with α-adrenergic antagonists, β-adrenergic antagonists, reserpine, quinidine, mephentermine. Monitor blood pressure. (7)
• G uan e t h i d in e : Ephedrine may inhibit the neuron blockage produced by guanethidine, resulting in loss of antihypertensive effectiveness. Monitor blood pressure and adjust the dosage of pressor accordingly. (7)
• R o cu roni u m : Ephedrine may reduce the onset time of neuromuscular blockade when used for intubation with rocuronium if administered simultaneously with anesthetic induction. Be aware of this potential interaction. No treatment or other interventions are needed. (7)
• Epidural anesthesia : Ephedrine may decrease the efficacy of epidural blockade by hastening the regression of sensory analgesia. Monitor and treat the patient according to clinical practice. (7)
• T h e o ph yll in e : Concomitant use of ephedrine may increase the frequency of nausea, nervousness, and insomnia. Monitor patient for worsening symptoms and manage symptoms according to clinical practice. (7)
• Ca rd i a c glycosides : Giving ephedrine with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias. Carefully monitor patients on cardiac glycosides who are also administered ephedrine. (7)
Use in specific populations
8.1 Pregnancy R isk Summary Limited published data on the use of ephedrine sulfate are insufficient to determine a drug associated risk of major birth defects or miscarriage. However, there are clinical considerations [ see Clinical Considerations ] . Animal reproduction studies have not been conducted with ephedrine sulfate. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. C linical Considerations Fetal/Neonatal adverse reactions Cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. These reports describe umbilical artery pH of ≤7.2 at the time of delivery [ see Clinical Pharmacology 12.3 ] . Monitoring of the newborn for signs and symptoms of metabolic acidosis may be required. Monitoring of infant’s acid-base status is warranted to ensure that an episode of acidosis is acute and reversible . 8.2 Lactation R isk Summary Limited published literature reports that ephedrine is present in human milk. However, no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ephedrine sulfate injection and any potential adverse effects on the breastfed child from ephedrine sulfate injection or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of ephedrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Renal Impairment Ephedrine and its metabolite are excreted in urine. In patients with renal impairment, excretion of ephedrine is likely to be affected with a corresponding increase in elimination half-life, which will lead to slow elimination of ephedrine and consequently prolonged pharmacological effect and potentially adverse reactions. Monitor patients with renal impairment carefully after the initial bolus dose for adverse events.
Pregnancy
8.1 Pregnancy R isk Summary Limited published data on the use of ephedrine sulfate are insufficient to determine a drug associated risk of major birth defects or miscarriage. However, there are clinical considerations [ see Clinical Considerations ] . Animal reproduction studies have not been conducted with ephedrine sulfate. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. C linical Considerations Fetal/Neonatal adverse reactions Cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. These reports describe umbilical artery pH of ≤7.2 at the time of delivery [ see Clinical Pharmacology 12.3 ] . Monitoring of the newborn for signs and symptoms of metabolic acidosis may be required. Monitoring of infant’s acid-base status is warranted to ensure that an episode of acidosis is acute and reversible .
Pediatric use
8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Geriatric use
8.5 Geriatric Use Clinical studies of ephedrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Overdosage
Overdose of ephedrine can cause a rapid rise in blood pressure. In the case of an overdose, careful monitoring of blood pressure is recommended. If blood pressure continues to rise to an unacceptable level, parenteral antihypertensive agents can be administered at the discretion of the clinician.
Description
Ephedrine sulfate is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine sulfate injection, USP is a clear, colorless, sterile solution for intravenous injection. Each mL contains ephedrine sulfate 50 mg in water for injection as a single-dose product. The pH range is 4.5 to 7.0. The drug product must be diluted before intravenous administration. The chemical name of ephedrine sulfate is (1R,2S)-(-)-2-methylamine-1-phenylpropan-1-ol sulfate (2:1) (salt). Its molecular weight is 428.54. The structural formula is: Ephedrine sulfate darkens on exposure to light. It is freely soluble in water and ethanol, very slightly soluble in chloroform, and practically insoluble in ether. This is an image of the Chemical structure for Ephedrine Sulfate.
Mechanism of action
12.1 Mechanism of Action Ephedrine sulfate is a sympathomimetic amine that directly acts as an agonist at α- and ß adrenergic receptors and indirectly causes the release of norepinephrine from sympathetic neurons. Pressor effects by direct alpha- and beta-adrenergic receptor activation are mediated by increases in arterial pressures, cardiac output, and peripheral resistance. Indirect adrenergic stimulation is caused by norepinephrine release from sympathetic nerves.
How supplied
Ephedrine Sulfate Injection, USP, 50 mg/mL, is supplied as follows: NDC S tre n gth How Supplied 42023-216-83 50 mg/mL 1 mL clear glass vial; for single use (supplied in packages of 25) Vial stoppers are not manufactured with natural rubber latex. Store ephedrine sulfate injection, 50 mg/mL, at 20° to 25°C (68° to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature.] Protect from light. Store in carton until time of use. For single use only. Discard unused portion.
Label text from the FDA structured product label by Par Health USA, LLC (revised Jan 21, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Ephedrine Sulfate in 33 products
Ephedrine Sulfate NDC products (33)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 70121-1637 | Ephedrine Sulfate 50 mg/mL Injection | Amneal Pharmaceuticals LLC | ANDA |
| 36000-336 | Ephedrine Sulfate 50 mg/mL Injection | Baxter Healthcare Corporation | ANDA |
| 65145-158 | Ephedrine Sulfate 50 mg/mL Injection | Caplin Steriles Limited | ANDA |
| 72572-150 | Ephedrine Sulfate 50 mg/mL Injection | Civica, Inc. | ANDA |
| 43598-725 | Ephedrine Sulfate 50 mg/mL Injection | Dr. Reddy's Laboratories, Inc. | ANDA |
| 55150-373 | Ephedrine Sulfate 50 mg/mL Injection | Eugia US LLC | ANDA |
| 65219-548 | Ephedrine Sulfate 5 mg/mL Injection | Fresenius Kabi USA, LLC | ANDA |
| 65219-546 | Ephedrine Sulfate 5 mg/mL Injection | Fresenius Kabi USA, LLC | ANDA |
| 65219-257 | Ephedrine Sulfate 50 mg/mL Injection | Fresenius Kabi USA, LLC | ANDA |
| 68083-610 | Ephedrine Sulfate 5 mg/mL Injection | Gland Pharma Limited | ANDA |
| 68083-495 | Ephedrine Sulfate 50 mg/mL Injection | Gland Pharma Limited | ANDA |
| 0641-6236 | Ephedrine Sulfate 5 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0641-6238 | Ephedrine Sulfate 50 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 70756-611 | Ephedrine Sulfate 50 mg/mL Injection | Lifestar Pharma LLC | ANDA |
| 71872-7378 | Ephedrine Sulfate 50 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7336 | Ephedrine Sulfate 50 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7257 | Ephedrine Sulfate 50 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7269 | Ephedrine Sulfate 50 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7276 | Ephedrine Sulfate 50 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7302 | Ephedrine Sulfate 50 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 16714-037 | Ephedrine Sulfate 50 mg/mL Injection | NorthStar Rx LLC | ANDA |
| 72603-203 | Ephedrine Sulfate 50 mg/mL Injection | NorthStar RxLLC | ANDA |
| 84549-611 | Ephedrine Sulfate 50 mg/mL Injection | ProPharma Distribution | ANDA |
| 70518-4433 | Ephedrine Sulfate 50 mg/mL Injection | REMEDYREPACK INC. | ANDA |
| 25021-836 | Ephedrine Sulfate 50 mg/mL Injection, Solution | Sagent Pharmaceuticals | ANDA |
| 0781-3269 | Ephedrine Sulfate 50 mg/mL Injection | Sandoz Inc | ANDA |
| 70069-819 | Ephedrine Sulfate 50 mg/mL Injection | Somerset Therapeutics, LLC | ANDA |
| 70700-249 | Ephedrine Sulfate 50 mg/mL Injection | Xiromed, LLC | ANDA |
| 51662-1325 | Ephedrine Sulfate 50 mg/mL Injection, Solution | HF Acquisition Co LLC, DBA HealthFirst | NDA |
| 42023-216 | Ephedrine Sulfate 50 mg/mL Injection, Solution | Par Health USA, LLC | NDA |
| 42023-243 | Ephedrine Sulfate 5 mg/mL Injection | Par Health USA, LLC | NDA |
| 69842-922 | Ephedrine Sulfate 25 mg/1 Tablet, Film Coated | CVS Pharmacy, Inc | OTC MONOGRAPH DRUG |
| 0363-5789 | Ephedrine Sulfate 25 mg/1 Tablet, Film Coated | Walgreen Company | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Ephedrine Sulfate used for?
Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. Ephedrine Sulfate Injection, USP, is an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. (1)
What are the side effects of Ephedrine Sulfate?
The following adverse reactions associated with the use of ephedrine sulfate were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Gastrointestinal disorders : Nausea, vomiting C ardiac disorders : Tachycardia,… See the full label for the complete list.
Who makes Ephedrine Sulfate?
Ephedrine Sulfate is listed by 23 labelers in the FDA NDC directory, including Amneal Pharmaceuticals LLC, Baxter Healthcare Corporation, Caplin Steriles Limited, Civica, Inc..