Overview
A beta-1 agonist catecholamine that has cardiac stimulant action without evoking vasoconstriction or tachycardia. It is proposed as a cardiotonic after myocardial infarction or open heart surgery.
Background
A beta-1 agonist catecholamine that has cardiac stimulant action without evoking vasoconstriction or tachycardia. It is proposed as a cardiotonic after myocardial infarction or open heart surgery.
Indication
Indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures.
Associated Conditions
- Cardiac Decompensation
- Coronary Artery Disease (CAD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/03 | Not Applicable | Recruiting | University of Hamburg-Eppendorf | ||
2024/06/17 | Not Applicable | Recruiting | First Affiliated Hospital of Zhejiang University | ||
2024/03/19 | Phase 1 | Recruiting | Steen Hvitfeldt Poulsen | ||
2024/01/18 | Early Phase 1 | Not yet recruiting | Sichuan University | ||
2023/08/21 | Not Applicable | Not yet recruiting | |||
2023/07/19 | Phase 2 | Not yet recruiting | Federal University of São Paulo | ||
2023/07/13 | Not Applicable | Recruiting | Shanghai Zhongshan Hospital | ||
2023/04/04 | Not Applicable | Recruiting | |||
2022/10/26 | Phase 3 | Recruiting | The Young Investigator Group of Cardiovascular Research | ||
2022/10/20 | Not Applicable | Recruiting | Shanghai Zhongshan Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-4562 | INTRAVENOUS | 400 mg in 100 mL | 3/27/2019 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1337 | INTRAVENOUS | 12.5 mg in 1 mL | 2/19/2024 | |
| Physicians Total Care, Inc. | 54868-5777 | INTRAVENOUS | 400 mg in 100 mL | 1/25/2011 | |
| Hospira, Inc. | 0409-2344 | INTRAVENOUS | 12.5 mg in 1 mL | 11/26/2019 | |
| Hospira, Inc. | 0409-2347 | INTRAVENOUS | 200 mg in 100 mL | 11/3/2021 | |
| Hainan Poly Pharm. Co., Ltd. | 14335-171 | INTRAVENOUS | 12.5 mg in 1 mL | 1/2/2023 | |
| HF Acquisition Co. LLC, DBA HealthFirst | 51662-1664 | INTRAVENOUS | 100 mg in 100 mL | 5/1/2025 | |
| Baxter Healthcare Corporation | 0338-1077 | INTRAVENOUS | 400 mg in 100 mL | 9/8/2023 | |
| Slate Run Pharmaceuticals | 70436-203 | INTRAVENOUS | 250 mg in 20 mL | 2/28/2023 | |
| Baxter Healthcare Corporation | 0338-1073 | INTRAVENOUS | 100 mg in 100 mL | 9/8/2023 |
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 |
|---|---|---|---|---|---|
| DOBUTAMINE INJECTION 12.5 mg/ml | SIN08702P | INJECTION | 12.5 mg/ml | 2/5/1996 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Dobutamine Hydrochloride and Glucose Injection | 国药准字H20040145 | 化学药品 | 注射剂(注射液) | 8/24/2020 | |
| Dobutamine Hydrochloride and Glucose Injection | 国药准字H20030897 | 化学药品 | 注射剂 | 8/11/2020 | |
| Dobutamine Hydrochloride and Glucose Injection | 国药准字H20030898 | 化学药品 | 注射剂 | 8/11/2020 | |
| Dobutamine Hydrochloride and Glucose Injection | 国药准字H20030899 | 化学药品 | 注射剂 | 8/11/2020 | |
| Dobutamine Hydrochloride and Glucose Injection | 国药准字H20031044 | 化学药品 | 注射剂 | 9/3/2021 | |
| Dobutamine Hydrochloride for Injection | 国药准字H20020134 | 化学药品 | 注射剂 | 8/21/2020 | |
| Dobutamine Hydrochloride for Injection | 国药准字H20030923 | 化学药品 | 注射剂 | 8/21/2020 | |
| Dobutamine Hydrochloride for Injection | 国药准字H20020133 | 化学药品 | 注射剂 | 8/21/2020 | |
| Dobutamine Hydrochloride for Injection | 国药准字H20040383 | 化学药品 | 注射剂(注射用无菌粉末) | 4/30/2021 | |
| Dobutamine Hydrochloride Injection | 国药准字H42021933 | 化学药品 | 注射剂 | 8/27/2020 |
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 |
|---|---|---|---|---|---|
| DBL DOBUTAMINE 250mg/20mL (as hydrochloride) injection | 46451 | Medicine | A | 11/30/1993 | |
| Dobutamine-Claris dobutamine (as hydrochloride) 250 mg/ 20 mL concentrated solution for injection ampoule | 212837 | Medicine | A | 7/11/2014 | |
| DOBUTREX Dobutamine 250mg/20mL injection solution | 42993 | Medicine | A | 3/9/1993 | |
| Hospira Dobutamine Hydrochloride Injection 250 mg/20 mL vial | 388810 | Medicine | A | 5/23/2022 | |
| Hospira Dobutamine 12.5 mg/mL Sterile Concentrate 250 mg/20 mL vial | 136674 | Medicine | A | 3/27/2007 | |
| DOBUTREX 250mg powder for injection | 14628 | Medicine | A | 9/5/1991 |