pharmacopeia

Mechanism of action

Sourced from openFDA

Epinephrine acts on both alpha (α)- and beta (β)-adrenergic receptors. The mechanism of the rise in blood pressure is 3-fold: a direct myocardial stimulation that increases the strength of ventricular contraction (positive inotropic action), an increased heart rate (positive chronotropic action), and peripheral vasoconstriction.

Indications

Sourced from openFDA
  • Epinephrine is a non-selective alpha and beta adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. ( 1.1 ) 1.1 Hypotension associated with Septic Shock Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

Contraindications

Sourced from openFDA
  • None. None.contraindicated

Dosage & administration

Sourced from openFDA

• Hypotension associated with septic shock ( 2.2 ) : o Dilute epinephrine in dextrose solution prior to infusion. o Infuse epinephrine into a large vein. o Titrate 0.05 mcg/kg/min to 2 mcg/kg/min to achieve desired blood pressure. o Wean gradually. 2.1 General Considerations Inspect 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. Discard any unused portion. 2.2 Hypotension associated with Septic Shock Dilute epinephrine in 5% Dextrose Injection, USP or 5% Dextrose and Sodium Chloride solution. These dextrose containing fluids provide protection against significant loss of potency by oxidation. Administration in saline solution alone is not recommended. If indicated, administer whole blood or plasma separately. Add the entire contents of epinephrine prefilled syringe to 1000 mL of a 5% Dextrose containing solution. Each mL of this dilution contains 1 mcg of epinephrine. Whenever possible, give infusions of epinephrine into a large vein. Avoid using a catheter tie-in technique, because the obstruction to blood flow around the tubing may cause stasis and increased local concentration of the drug. Avoid the veins of the leg in elderly patients or in those suffering from occlusive vascular diseases.

Warnings & precautions

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• Monitor blood pressure frequently. (5.1) • Increases cardiac output and causes peripheral vasoconstriction. (5.2) • May induce cardiac arrhythmias and myocardial ischemia. (5.3) • Avoid extravasation into tissues, which can cause local necrosis. (5.4) • Constricts renal blood vessels which may result in oliguria or renal impairment. (5.5) • Sulfite Warning. (5.6) 5.1 Hypertension Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine. 5.2 Pulmonary Edema Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. 5.3 Cardiac Arrhythmias and Ischemia Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients suffering from coronary artery disease or cardiomyopathy [see Adverse Reactions (6) and Drug Interactions (7.3)] . 5.4 Extravasation and Tissue Necrosis with Intravenous Infusion Avoid extravasation of epinephrine into the tissues, to prevent local necrosis. When Epinephrine Injection is administered intravenously, check the infusion site frequently for free flow. Blanching along the course of the infused vein, sometimes without obvious extravasation, may be attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage.

Adverse reactions

Sourced from openFDA

The following adverse reactions are discussed elsewhere in labeling: • Hypertension [see Warnings and Precautions (5.1)] • Pulmonary Edema [see Warnings and Precautions (5.2)] • Cardiac Arrhythmias and Ischemia [see Warnings and Precautions (5.3)] • Extravassation and Tissue Necrosis with Intravenous Infusion [see Warnings and Precautions (5.4)] • Renal Impairment [see Warnings and Precautions (5.5)] • Allergic Reactions associated with Sulfite [see Warnings and Precautions (5.6)] The following adverse reactions associated with the infusion of epinephrine 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. Cardiovascular disorders: tachycardia, supraventricular tachycardia, ventricular arrhythmias, myocardial ischemia, myocardial infarction, limb ischemia, pulmonary edema Gastrointestinal disorders : Nausea, vomiting General disorders and administrative site conditions : Chest pain, extravasation Metabolic : hypoglycemia, hyperglycemia, insulin resistance, hypokalemia, lactic acidosis Nervous system disorders : Headache, nervousness, paresthesia, tremor, stroke, central nervous system bleeding Psychiatric disorders : Excitability Renal disorders : Renal insufficiency Respiratory : Pulmonary edema, rales Skin and subcutaneous tissue disorders : Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation Most common adverse reactions to systemically administered epine…

Use in specific populations

Sourced from openFDA

• Pregnancy: May lead to fetal harm (8.1) • Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. (8.1, 8.5) 8.1 Pregnancy Risk Summary Limited published data on epinephrine use in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. However, there are risks to the mother and fetus associated with epinephrine use during labor or delivery, and risks due to untreated hypotension associated with septic shock (see Clinical Considerations) . In animal reproduction studies, epinephrine demostrated adverse developmental effects when administed to pregnant rabbits (gastroschisis), mice (teratogenie effects, embryonic lethality, and delayed skeletal ossification), and hamsters (embryonic lethality and delayed skeletal ossification) during organogenesis at doses approximately 15 times, 3 times and 2 times, respectively, the maximum recommended daily intramuscular or subcutaneous dose (see Data). 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.

Pharmacokinetics

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Metabolism
Following intravenous injection, epinephrine is rapidly cleared from the plasma with an effective half-life of < 5 min. A pharmacokinetic steady state following continuous intravenous infusion is achieved within 10-15 min.

Overdosage

Sourced from openFDA

Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Epinephrine overdosage may also cause transient bradycardia followed by tachycardia and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Myocardial ischemia and infarction, cardiomyopathy, extreme pallor and coldness of the skin, metabolic acidosis due to elevated blood lactic acid levels, and renal insufficiency and failure have also been reported. Epinephrine is rapidly inactivated in the body and treatment following overdose is primarily supportive. Treatment of pulmonary edema consists of a rapidly acting alpha-adrenergic blocking drug (such as phentolamine mesylate) and respiratory support.

Approval history

Sourced from openFDA
  • Nov 19, 1948NDANDA006488Fresenius Kabi Usa
  • Oct 3, 1972NDANDA016964Hospira
  • Dec 30, 1981NDANDA018304Fresenius Kabi Usa
  • Dec 22, 1987NDANDA019430Viatris
  • Apr 3, 2000NDANDA020971Deproco
  • May 30, 2003NDANDA020800Impax
  • Feb 26, 2010NDANDA022466Pierrel
  • Aug 10, 2012NDANDA201739Kaleo Inc

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Epinephrine, Injection, .1 mg/1 mL (NDC 0409-4933-01)To be discontinued
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Epinephrine, Injection, .1 mg/1 mL (NDC 0409-4933-10)To be discontinued
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Lidocaine Hydrochloride And Epinephrine, Injection, 1 g/50 mL (2%; 1:100,000) (NDC 0409-3182-03)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Lidocaine Hydrochloride And Epinephrine, Injection, 2.5 g/50 mL (0.5%; 1:200,000) (NDC 0409-3177-01)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated
  • Lidocaine Hydrochloride And Epinephrine, Injection, 200 mg/20 mL (1%; 1:100,000) (NDC 0409-3178-01)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Lidocaine Hydrochloride And Epinephrine, Injection, 300 mg/30 mL (1%; 1:100,000) (NDC 0409-3178-02)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated
  • Lidocaine Hydrochloride And Epinephrine, Injection, 400 mg/20 mL (2%; 1:100,000) (NDC 0409-3182-01)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated
  • Lidocaine Hydrochloride And Epinephrine, Injection, 400 mg/20 mL (2%; 1:200,000) (NDC 0409-3183-01)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated
  • Lidocaine Hydrochloride And Epinephrine, Injection, 450 mg/30 mL (1.5%; 1:200,000) (NDC 0409-3181-01)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated
  • Lidocaine Hydrochloride And Epinephrine, Injection, 500 mg/50 mL (1%; 1:100,000) (NDC 0409-3178-03)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated
  • Lidocaine Hydrochloride and Epinephrine, Injection, 600 mg/30 mL (2%; 1:100,000) (NDC 0409-3182-02)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Lidocaine Hydrochloride And Epinephrine, Injection, 75 mg/5 mL (1.5%; 1:200,000) (NDC 0409-1209-01)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated

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.
109,277 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 Ineffective10,6999.8%
  2. 2Fatigue5,9555.4%
  3. 3Headache5,8965.4%
  4. 4Pain5,8685.4%
  5. 5Nausea5,6455.2%
  6. 6Off Label Use5,3284.9%
  7. 7Dyspnoea5,1274.7%
  8. 8Sinusitis4,2773.9%
  9. 9Pneumonia3,7273.4%
  10. 10Product Dose Omission Issue3,6453.3%
  11. 11Diarrhoea3,5583.3%
  12. 12Vomiting3,5193.2%
  13. 13Dizziness3,3793.1%
  14. 14Pyrexia3,3513.1%
  15. 15Rash3,2082.9%

Literature

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Recent PubMed references pinned to Epinephrine 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 3,501 ClinicalTrials.gov registrations naming Epinephrine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Epinephrine work?
Epinephrine acts on both alpha (α)- and beta (β)-adrenergic receptors. The mechanism of the rise in blood pressure is 3-fold: a direct myocardial stimulation that increases the strength of ventricular contraction (positive inotropic action), an increased heart rate (positive chronotropic action), and peripheral vasoconstriction.
What is Epinephrine used for?
According to FDA labeling, Epinephrine carries indications including: Epinephrine is a non-selective alpha and beta adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. ( 1.1 ) 1.1 Hypotension associated with Septic Shock Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Epinephrine?
Epinephrine is classified as Adrenergic and dopaminergic agents, Alpha- and beta-adrenoreceptor agonists, Local hemostatics, Other agents for local oral treatment, Sympathomimetics in glaucoma therapy, Sympathomimetics, plain, alpha-Adrenergic Agonist, beta-Adrenergic Agonist, Catecholamine, Adrenergic alpha-Agonists, Adrenergic beta-Agonists, Adrenergic beta1-Agonists, Adrenergic beta2-Agonists, Arterial Vasoconstriction, Bronchodilation, Decreased Intraocular Aqueous Secretion, Decreased Uterine Smooth Muscle Contraction or Tone, Hemostasis Alteration, Increased Blood Pressure, Positive Chronotropy, Positive Inotropy, Pupillary Dilation.
What are the brand names for Epinephrine?
Epinephrine is marketed under brand names including Adrenalin, Articadent, Auvi-Q, Citanest Forte, Epipen, Flavalta, Lignospan, Marcaine with Epinephrine.
What are the contraindications for Epinephrine?
Epinephrine labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for epinephrine 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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