Overview
Epinephrine, also known as adrenaline, is a hormone and neurotransmitter and produced by the adrenal glands that can also be used as a drug due to its various important functions. Though it has long been used in the treatment of hypersensitivity reactions, epinephrine in the auto-injector form (EpiPen) has been available since 1987 in the USA. Many new products/biosimilars and dosage routes have been approved under various names over the last several decades , , . On August 16, 2018, Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths . Dosage delivery routes for epinephrine include intravenous, inhalation, nebulization, intramuscular injection, and subcutaneous injection. In general, the most common uses of parenteral epinephrine are to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity (anaphylactic or anaphylactoid) reactions to drugs, animal serums and other allergens, and to prolong the action of infiltration anesthetics . In addition to the above functions, epinephrine is the primary drug administered during cardiopulmonary resuscitation (CPR) to reverse cardiac arrest , . It can be used in severe cases of croup .
Indication
Epinephrine injection is indicated in the emergency treatment of type I allergic reactions, including anaphylaxis. It is also used to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Epinephrine's cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes but is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock . Epinephrine is used as a hemostatic agent. It is also used in treating mucosal congestion of hay fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions. Epinephrine injection can be utilized to prolong the action of local anesthetics . In addition to the above, epinephrine is used as an over the counter (OTC) agent for the intermittent symptoms of asthma, such as wheezing, tightness of chest and shortness of breath . It is also used for the maintenance of mydriasis during intraocular surgery .
Associated Conditions
- Anaphylaxis
- Angioneurotic Edema
- Bleeding
- Bronchospasm
- Complete Heart Block
- Hypotension
- Idiopathic Anaphylaxis
- Laryngotracheobronchitis
- Mild Intermittent Asthma
- Nasal Congestion
- Open Angle Glaucoma (OAG)
- Respiratory Distress
- Severe Asthma
- Syncope
- Type I Hypersensitivity
- Urticaria
- Uterine Contractions
- Ventricular Fibrillation
- Resuscitation in cardiac arrest following anesthetic accidents
- Severe hypersensitivity reactions
- Unresponsive Asystole
- Unresponsive Bradycardia
Research Report
Epinephrine (DB00668): A Comprehensive Monograph on its History, Pharmacology, and Clinical Utility
Introduction
Epinephrine, known also by its British Approved Name, Adrenaline, stands as a paramount molecule in both human physiology and clinical medicine. It is an endogenous catecholamine that functions dually as a hormone, synthesized and released by the chromaffin cells of the adrenal medulla, and as a neurotransmitter within select pathways of the central nervous system.[1] This dual role places it at the center of the body's acute stress response, orchestrating the profound physiological shifts colloquially known as the "fight-or-flight" response.[2] The discovery and isolation of this potent substance over a century ago marked a watershed moment in science, effectively launching the field of endocrinology and providing medicine with one of its most powerful and versatile tools.
The therapeutic utility of epinephrine is a direct translation of its physiological functions. It is the cornerstone of emergency treatment for life-threatening conditions, most notably Type I hypersensitivity reactions, including anaphylaxis, where its multifaceted actions are uniquely suited to counteract systemic collapse.[4] Its potent cardiovascular effects are harnessed in the management of cardiac arrest and as a vasopressor agent to combat profound hypotension in septic shock.[2] Furthermore, its applications extend to the emergency management of severe asthma, as an essential adjunct to local anesthetics, and in ophthalmic procedures to control intraocular pressure and induce mydriasis.[4]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/02/05 | Phase 3 | Completed | |||
2020/01/22 | Phase 4 | Completed | |||
2019/12/05 | Not Applicable | Completed | |||
2019/11/06 | Not Applicable | Completed | Federal University of Minas Gerais | ||
2019/11/01 | Early Phase 1 | Withdrawn | |||
2019/10/28 | Phase 4 | UNKNOWN | Beijing Tiantan Hospital | ||
2019/10/18 | Not Applicable | Completed | |||
2019/08/22 | Phase 4 | Completed | |||
2019/07/25 | Phase 3 | Completed | |||
2019/05/24 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mylan Specialty L.P. | 49502-101 | INTRAMUSCULAR | 0.15 mg in 0.3 mL | 8/31/2018 | |
| B. Braun Medical Inc. | 0264-9378 | EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL | 0.005 mg in 1 mL | 12/13/2021 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1381 | INTRACARDIAC, INTRAVENOUS | 0.1 mg in 1 mL | 8/15/2022 | |
| Teva Pharmaceuticals USA, Inc. | 0093-5985 | INTRAMUSCULAR, SUBCUTANEOUS | 0.15 mg in 0.3 mL | 1/31/2021 | |
| Novocol Pharmaceutical of Canada, Inc. | 51004-0550 | SUBCUTANEOUS | 0.02 mg in 1 mL | 12/15/2011 | |
| King Bio Inc. | 57955-9001 | ORAL | 10 [hp_X] in 59 mL | 5/19/2025 | |
| BPI LABS LLC | 54288-155 | INTRAVENOUS, INTRACARDIAC | 0.1 mg in 1 mL | 10/5/2023 | |
| Fresenius Kabi USA, LLC | 63323-468 | INFILTRATION, EPIDURAL, INTRACAUDAL, PERINEURAL | 0.005 mg in 1 mL | 4/30/2023 | |
| Physicians Total Care, Inc. | 54868-4819 | INTRAMUSCULAR | 0.15 mg in 0.3 mL | 5/14/2012 | |
| King Bio Inc. | 57955-0762 | ORAL | 12 [hp_X] in 59 mL | 5/20/2025 |
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| No EMA approvals found for this drug. | |||
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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| E-PILO 4 OPHTHALMIC SOLUTION | 02133202 | Drops - Ophthalmic | 10 MG / ML | 12/31/1995 | |
| EPIPEN | 00509558 | Solution - Intramuscular | 0.3 MG / 0.3 ML | 12/31/1980 | |
| ALL-II | bio active canada ltd. | 02233551 | Liquid - Oral | 6 X | 5/26/1998 |
| ALL- I | bio active canada ltd. | 02233550 | Liquid - Oral | 6 X | 5/26/1998 |
| XYLOCAINE 0.5% W EPINEPHRINE 1:200000 | astrazeneca canada inc | 00228915 | Liquid - Block/Infiltration | 5 MCG / ML | 12/31/1971 |
| FML-TOX | bio active canada ltd. | 02234237 | Liquid - Oral | 12 X | 5/26/1998 |
| SPINAL ANAESTHESIA TRAY | baxter corporation | 02023326 | Liquid - Parenteral (Unspecified)
,
Topical | 1 ML | 12/31/1993 |
| SPINAL ANAESTHESIA TRAY | baxter corporation | 02009080 | Kit - Topical
,
Block/Infiltration | 1 ML / ML | 2/2/1996 |
| RADOPT | terra botanica products ltd. | 02233360 | Liquid - Oral | 6 X | 5/25/1998 |
| MARCAINE | carestream health canada company | 02311887 | Solution - Block/Infiltration | 0.0091 MG / ML | 8/28/2008 |
CIMA AEMPS Drug Approvals
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