pharmacopeia
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Mechanism of action

Sourced from openFDA

Ephedrine sulfate is a sympathomimetic amine that directly acts as an agonist at α- and β-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.

Adrenergic

Indications

Sourced from openFDA
  • Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. Ephedrine sulfate injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.

Contraindications

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  • None None ( 4 )contraindicated

Dosage & administration

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Should be administered by trained healthcare providers ( 2.1 ) Ephedrine sulfate injection, 50 mg/mL, must be diluted before administration as an intravenous bolus dose. ( 2.1 ) Bolus intravenous injection: 5 mg to 10 mg as needed, not to exceed 50 mg. ( 2.1 ) 2.1 General Dosage and Administration Instructions Ephedrine sulfate injection, 50 mg/mL must be diluted before administration as an intravenous bolus to achieve the desired concentration. Dilute with normal saline or 5% dextrose in water. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 2.2 Dosing for the Treatment of Clinically Important Hypotension in the Setting of Anesthesia Ephedrine sulfate injection should be administered by trained healthcare providers. The recommended dosages 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 Prepare 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 0.9% Sodium Chloride Injection.

Warnings & precautions

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Pressor Effects with Concomitant Use with Oxytocic Drugs : Pressor effect of sympathomimetic pressor amines is potentiated ( 5.1 ) Tachyphylaxis 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.

Adverse reactions

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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 Cardiac disorders: Tachycardia, palpitations (thumping heart), reactive hypertension, bradycardia, ventricular ectopics, R-R variability Nervous system disorders: Dizziness Psychiatric disorders: Restlessness Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary Available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, there are clinical considerations due to underlying conditions (see Clinical Considerations) . In animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (MRHD) of 50 mg/day). No malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the MRHD, respectively [See data] . The estimated background risk of major birth defects and miscarriage for the indicated population are 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 2-4% and 15-20%, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
Publications studying pharmacokinetics of oral administration of (-)-ephedrine support that (-)-ephedrine is metabolized into norephedrine. However, the metabolism pathway is unknown.

Overdosage

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Apr 29, 2016NDANDA208289Exela Pharma
  • Jan 27, 2017NDANDA208943Ph Health
  • Aug 23, 2017ANDAANDA209784Sandoz
  • Oct 23, 2019ANDAANDA212932Amneal
  • Apr 17, 2020NDANDA213407Nexus
  • Aug 4, 2020ANDAANDA209646Fresenius Kabi Usa
  • Oct 3, 2020ANDAANDA212649Dr Reddys
  • Oct 16, 2020NDANDA213994Ph Health

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
641 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective497.6%
  2. 2Hypotension406.2%
  3. 3Cardiac Arrest345.3%
  4. 4Dyspnoea335.1%
  5. 5Nausea294.5%
  6. 6Toxicity To Various Agents294.5%
  7. 7Off Label Use264.1%
  8. 8Overdose243.7%
  9. 9Tachycardia243.7%
  10. 10Drug Abuse233.6%
  11. 11Anaphylactic Reaction213.3%
  12. 12Drug Dependence213.3%
  13. 13Dizziness203.1%
  14. 14Anaphylactic Shock193.0%
  15. 15Blood Pressure Decreased193.0%

Literature

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Recent PubMed references pinned to Ephedrine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 278 ClinicalTrials.gov registrations naming Ephedrine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ephedrine work?
Ephedrine sulfate is a sympathomimetic amine that directly acts as an agonist at α- and β-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.
What is Ephedrine used for?
According to FDA labeling, Ephedrine carries indications including: Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. Ephedrine sulfate injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ephedrine?
Ephedrine is classified as Adrenergic and dopaminergic agents, Alpha- and beta-adrenoreceptor agonists, Sympathomimetics, combinations excl. corticosteroids, Sympathomimetics excl. antiglaucoma preparations, Sympathomimetics, plain, alpha-Adrenergic Agonist, beta-Adrenergic Agonist, Norepinephrine Releasing Agent, Adrenergic Agonists, Adrenergic alpha-Agonists, Adrenergic beta-Agonists, Arterial Vasoconstriction, Bronchodilation, Decreased Nasal and Sinus Secretions, Increased Norepinephrine Activity.
What are the brand names for Ephedrine?
Ephedrine is marketed under brand names including Akovaz, Bronkaid, Bronkaid Max, Emerphed, Primatene with ephedrine, Primatene with ephedrine & guaifenesin, Rezipres.
What are the contraindications for Ephedrine?
Ephedrine labeling lists contraindications including: None None ( 4 ). Always consult the full prescribing information and a clinician.
Note. Data for ephedrine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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