Overview
Isoprenaline is a non-selective beta adrenergic receptor agonist indicated to treat heart block, Adams-Stokes attacks, bronchospasm in anesthesia, cadiac arrest, hypovolemic shocks, septic shock, hypoperfusion, congestive hear failure, and cardiogenic shock. Isoprenaline research in the 1940s found that this isopropyl analog of epinephrine dilated the bronchi, as well as raising the heart rate and cardiac output, without vasoconstriction. The US patent from 1943 states that this compound had a wider therapeutic index and a stronger action than adrenaline. Isoprenaline was granted FDA approval on 19 February 1948.
Background
Isoprenaline is a non-selective beta adrenergic receptor agonist indicated to treat heart block, Adams-Stokes attacks, bronchospasm in anesthesia, cadiac arrest, hypovolemic shocks, septic shock, hypoperfusion, congestive hear failure, and cardiogenic shock. Isoprenaline research in the 1940s found that this isopropyl analog of epinephrine dilated the bronchi, as well as raising the heart rate and cardiac output, without vasoconstriction. The US patent from 1943 states that this compound had a wider therapeutic index and a stronger action than adrenaline. Isoprenaline was granted FDA approval on 19 February 1948.
Indication
Isoprenaline is indicated to treat mild or transient episodes of heart block not requiring electric shock or pacemakers, serious episodes of heart block and Adams-Stokes attacks not caused by ventricular tachycardia or fibrillation, and bronchospasm during anesthesia. Isoprenaline is also indicated for cases of cardiac arrest until preferable treatments like electric shock and pacemakers are available. Isoprenaline is also indicated as an adjunct therapy to fluid and electrolyte replacement therapy in hypovolemic shock, septic shock, hypoperfusion, congestive heart failure, and cardiogenic shock.
Associated Conditions
- Adams-Stokes attacks
- Bradycardia
- Bronchospasm
- Cardiac Arrest
- Cardiac electrical storm
- Congestive Heart Failure (CHF)
- Hypoperfusion
- Septic Shock
- Serious Heart Block
- Shock, Cardiogenic
- Shock, Hypovolemic
- Short QT syndrome
- Syncope
- Torsades de Pointes
- Transient Heart Block
- Ventricular Arrhythmia
- Beta blocker overdose
- Mild Heart Block
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/10/16 | Early Phase 1 | Recruiting | |||
2024/07/25 | Early Phase 1 | Recruiting | |||
2025/02/03 | Phase 3 | Withdrawn | |||
2023/08/18 | Phase 4 | Suspended | |||
2022/02/02 | Early Phase 1 | Recruiting | |||
2017/01/26 | Phase 2 | Completed | |||
2017/01/12 | Not Applicable | Active, not recruiting | |||
2016/04/04 | Not Applicable | Completed | |||
2016/03/31 | Not Applicable | ENROLLING_BY_INVITATION | |||
2016/02/04 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
KVK-Tech, Inc. | 10702-364 | INTRAVENOUS | 0.2 mg in 1 mL | 9/12/2023 | |
Nexus Pharmaceuticals Inc | 14789-015 | INTRAMUSCULAR, INTRAVENOUS | 0.2 mg in 1 mL | 3/31/2023 | |
Eugia US LLC | 55150-316 | INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRACARDIAC | 0.2 mg in 1 mL | 2/27/2024 | |
Amring Pharmaceuticals Inc. | 69918-735 | INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRACARDIAC | 0.2 mg in 1 mL | 5/28/2021 | |
Armas Pharmaceuticals Inc. | 72485-113 | INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR, INTRACARDIAC | 0.2 mg in 1 mL | 8/9/2021 | |
Amphastar Pharmaceuticals, Inc. | 0548-9502 | INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRACARDIAC | 0.2 mg in 1 mL | 7/16/2018 | |
STI Pharma LLC | 54879-039 | INTRACARDIAC, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 1 mg in 5 mL | 10/4/2022 | |
Nexus Pharmaceuticals Inc | 14789-011 | INTRAMUSCULAR, INTRAVENOUS | 0.2 mg in 1 mL | 3/31/2023 | |
Amneal Pharmaceuticals LLC | 70121-1604 | INTRAVENOUS | 0.2 mg in 1 mL | 2/22/2023 | |
Amphastar Pharmaceuticals, Inc. | 0548-9501 | INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRACARDIAC | 0.2 mg in 1 mL | 7/16/2018 |
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 |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Isoprenaline Hydrochloride Tablets | 国药准字H11021929 | 化学药品 | 片剂 | 12/11/2020 | |
Isoprenaline Hydrochloride Injection | 国药准字H20244337 | 化学药品 | 注射剂 | 6/28/2024 | |
Isoprenaline Hydrochloride Injection | 国药准字H31021344 | 化学药品 | 注射剂 | 4/13/2020 | |
Isoprenaline Hydrochloride Injection | 国药准字H20244012 | 化学药品 | 注射剂 | 6/11/2024 | |
Isoprenaline Hydrochloride Injection | 国药准字H20249512 | 化学药品 | 注射剂 | 12/1/2024 | |
Isoprenaline Hydrochloride Injection | 国药准字H20244011 | 化学药品 | 注射剂 | 6/11/2024 | |
Isoprenaline Hydrochloride Injection | 国药准字H50020020 | 化学药品 | 注射剂 | 9/23/2020 | |
Isoprenaline Hydrochloride Aerosol | 国药准字H44020226 | 化学药品 | 气雾剂 | 4/3/2020 | |
Isoprenaline Hydrochloride Aerosol | 国药准字H37023560 | 化学药品 | 气雾剂 | 2/3/2021 | |
Isoprenaline Hydrochloride Aerosol | 国药准字H31021141 | 化学药品 | 气雾剂 | 11/3/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |