Overview
Ephedrine was first described in western literature in 1888, as a naturally occurring component of the ephedra plant, along with pseudoephedrine. Ephedrine acts as both a direct and indirect sympathomimetic. It is an alpha- and beta-adrenergic receptor agonist; however, it also causes the indirect release of norepinephrine from sympathetic neurons, inhibiting norepinephrine reuptake and displacing more norepinephrine from storage vesicles. Ephedrine is used for its vasoconstrictive, positive chronotropic, and positive inotropic effects. Ephedrine and phenylephrine are still used to treat hypotension, but their use in other indications has decreased due to the development of more selective adrenergic agonists. Ephedrine was granted a type 7 FDA Approval on 29 April 2016.
Background
Ephedrine was first described in western literature in 1888, as a naturally occurring component of the ephedra plant, along with pseudoephedrine. Ephedrine acts as both a direct and indirect sympathomimetic. It is an alpha- and beta-adrenergic receptor agonist; however, it also causes the indirect release of norepinephrine from sympathetic neurons, inhibiting norepinephrine reuptake and displacing more norepinephrine from storage vesicles. Ephedrine is used for its vasoconstrictive, positive chronotropic, and positive inotropic effects. Ephedrine and phenylephrine are still used to treat hypotension, but their use in other indications has decreased due to the development of more selective adrenergic agonists. Ephedrine was granted a type 7 FDA Approval on 29 April 2016.
Indication
Ephedrine intravenous injections are indicated to treat hypotension under anesthesia, ephedrine injections by multiple routes are indicated to treat allergic conditions such as bronchial asthma, ephedrine nasal spray is and OTC medication used as a decongestant.
Associated Conditions
- Allergic Reaction
- Bronchial Asthma
- Common Cold
- Cough
- Depression
- Fever
- General Anesthesia Induced Hypotension
- Headache
- Joint Pain
- Myasthenia Gravis
- Narcolepsy
- Nasal Congestion
- Rhinorrhoea
- Sore Throat
- Dry cough
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/24 | Phase 1 | Completed | |||
2025/04/10 | Phase 4 | Not yet recruiting | mehmet özkılıç | ||
2025/02/25 | N/A | Not yet recruiting | |||
2025/01/22 | N/A | Active, not recruiting | |||
2024/12/19 | N/A | Active, not recruiting | Centre of Postgraduate Medical Education | ||
2024/11/08 | Phase 4 | Recruiting | Matias Vested | ||
2024/10/31 | Phase 4 | Completed | |||
2024/07/12 | Not Applicable | Recruiting | |||
2024/03/25 | Phase 2 | Recruiting | Kasr El Aini Hospital | ||
2024/02/29 | Not Applicable | Recruiting | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Civica, Inc. | 72572-150 | INTRAVENOUS | 50 mg in 1 mL | 8/17/2020 | |
| Gland Pharma Limited | 68083-495 | INTRAVENOUS | 50 mg in 1 mL | 1/12/2022 | |
| Nexus Pharmaceuticals, LLC | 14789-252 | INTRAVENOUS | 5 mg in 1 mL | 2/14/2024 | |
| Dr. Reddy's Laboratories, Inc. | 43598-725 | INTRAVENOUS | 50 mg in 1 mL | 12/24/2018 | |
| Civica, Inc. | 72572-151 | INTRAVENOUS | 50 mg in 1 mL | 12/30/2023 | |
| Medical Purchasing Solutions, LLC | 71872-7276 | INTRAVENOUS | 50 mg in 1 mL | 5/3/2023 | |
| Exela Pharma Sciences, LLC | 51754-4250 | INTRAVENOUS | 5 mg in 1 mL | 11/27/2020 | |
| Par Pharmaceutical, Inc. | 42023-243 | INTRAVENOUS | 5 mg in 1 mL | 1/30/2024 | |
| Hikma Pharmaceuticals USA Inc. | 0641-6238 | INTRAVENOUS | 50 mg in 1 mL | 9/24/2020 | |
| Par Pharmaceutical, Inc. | 42023-233 | INTRAVENOUS | 500 mg in 10 mL | 8/14/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| EPHEDRINE AGUETTANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 30 MG/ 10 ML | SIN16846P | INJECTION, SOLUTION | 30 mg/ 10 ml | 8/25/2023 | |
| SUNSEDYL FORTE COUGH LINCTUS | SIN07750P | ELIXIR | 7.2 mg/5 ml | 6/21/1994 | |
| EPHEDRINE AGUETTANT SOLUTION FOR INJECTION 30MG/ML | SIN15912P | INJECTION, SOLUTION | 30mg/ml | 3/17/2020 | |
| DBL EPHEDRINE SULFATE INJECTION 30 mg/ml | SIN02734P | INJECTION | 30 mg/ml | 5/6/1989 | |
| DHASEDYL SYRUP | SIN06928P | SYRUP | 6 mg/5 ml | 4/13/1992 | |
| DIPRODIN ELIXIR | SIN07830P | ELIXIR | 6 mg/5 ml | 9/1/1994 | |
| MARTINDALE PHARMA EPHEDRINE HYDROCHLORIDE SOLUTION FOR INJECTION 30MG/ML | SIN15678P | INJECTION, SOLUTION | 30 mg/ml | 5/3/2019 | |
| EPHEDRINE NASAL DROPS BPC | SIN04850P | SOLUTION | 0.5% w/v | 6/28/1990 | |
| PROMEDYL-B LINCTUS | SIN02838P | ELIXIR | 7.2 mg/5 ml | 5/22/1989 | |
| SUNSEDYL COUGH LINCTUS | SIN03490P | ELIXIR | 7.2 mg/5 ml | 6/26/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ephedrine Hydrochloride Syrup | 国药准字H44023543 | 化学药品 | 糖浆剂 | 4/3/2020 | |
| Ephedrine Hydrochloride Syrup | 国药准字H44022912 | 化学药品 | 糖浆剂 | 3/4/2020 | |
| Ephedrine Hydrochloride Syrup | 国药准字H44023171 | 化学药品 | 糖浆剂 | 2/19/2020 | |
| Ephedrine Hydrochloride Syrup | 国药准字H45021530 | 化学药品 | 糖浆剂 | 8/27/2020 | |
| Ephedrine Hydrochloride Injection | 国药准字H52020828 | 化学药品 | 注射剂 | 4/11/2022 | |
| Ephedrine Hydrochloride Injection | 国药准字H41022051 | 化学药品 | 注射剂 | 5/6/2020 | |
| Ephedrine Hydrochloride Injection | 国药准字H44022502 | 化学药品 | 注射剂 | 2/19/2020 | |
| Ephedrine Hydrochloride Injection | 国药准字H41022708 | 化学药品 | 注射剂 | 4/15/2025 | |
| Ephedrine Hydrochloride Injection | 国药准字H41020326 | 化学药品 | 注射剂 | 7/18/2022 | |
| Ephedrine Hydrochloride Injection | 国药准字H41021826 | 化学药品 | 注射剂 | 8/11/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PROSEDYL COUGH SYRUP | N/A | N/A | N/A | 8/20/1985 | |
| MOTRACK COUGH SYRUP | N/A | N/A | N/A | 9/14/2010 | |
| NEW MARSEDYL-DM ELIXIR | N/A | N/A | N/A | 8/11/2015 | |
| NICE PHENDYL-B LINCTUS | N/A | neochem pharmaceutical laboratories ltd. | N/A | N/A | 7/15/1982 |
| MERSIDYL SYRUP | N/A | N/A | N/A | 2/25/1986 | |
| COCLEAN SYRUP | N/A | N/A | N/A | 6/15/2001 | |
| COFFTIER COUGH SYRUP | N/A | N/A | N/A | 2/15/2008 | |
| MARSEDYL ELIXIR | N/A | N/A | N/A | 2/25/1984 | |
| PFC COUGH SYRUP CM FORMULA | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 7/9/2010 |
| PACTOREX SYRUP | N/A | N/A | N/A | 4/20/1979 |