Overview
Carvedilol is a racemic mixture where the S(-) enantiomer is both a beta and alpha-1 adrenoceptor blocker, and the R(+) enantiomer is an alpha-1 adrenoceptor blocker. It is currently used to treat heart failure, left ventricular dysfunction, and hypertension. The dual action of carvedilol is advantageous in combination therapies as moderate doses of 2 drugs have a decreased incidence of adverse effects compared to high dose monotherapy in the treatment of moderate hypertension. Carvedilol was granted FDA approval on 14 September 1995.
Background
Carvedilol is a racemic mixture where the S(-) enantiomer is both a beta and alpha-1 adrenoceptor blocker, and the R(+) enantiomer is an alpha-1 adrenoceptor blocker. It is currently used to treat heart failure, left ventricular dysfunction, and hypertension. The dual action of carvedilol is advantageous in combination therapies as moderate doses of 2 drugs have a decreased incidence of adverse effects compared to high dose monotherapy in the treatment of moderate hypertension. Carvedilol was granted FDA approval on 14 September 1995.
Indication
Carvedilol is indicated to treat mild to severe heart failure, left ventricular dysfunction after myocardial infarction with ventricular ejection fraction ≤40%, or hypertension.
Associated Conditions
- Atrial Fibrillation
- Chronic Stable Angina Pectoris
- Hypertension
- LVEF ≤40% Left ventricular dysfunction
- NYHA Class I or II heart failure
- Chronic heart failure with reduced ejection fraction (NYHA Class III)
- Chronic heart failure with reduced ejection fraction (NYHA Class IV)
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2010/07/02 | Phase 4 | Completed | Takeshi Morimoto | ||
2010/04/14 | Phase 4 | Completed | E-DA Hospital | ||
2010/02/18 | Phase 4 | UNKNOWN | |||
2010/02/08 | Phase 1 | Completed | |||
2010/02/08 | Phase 1 | Completed | |||
2010/01/29 | Phase 4 | Completed | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | ||
2009/11/09 | Phase 2 | Completed | |||
2009/08/25 | Phase 1 | Completed | |||
2009/06/19 | Phase 4 | Completed | |||
2009/03/18 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Unit Dose Services | 70786-0144 | ORAL | 12.5 mg in 1 1 | 4/15/2021 | |
| Advagen Pharma Ltd | 72888-035 | ORAL | 6.25 mg in 1 1 | 8/17/2021 | |
| A-S Medication Solutions | 50090-6742 | ORAL | 6.25 mg in 1 1 | 9/16/2023 | |
| Cardinal Health 107, LLC | 55154-6884 | ORAL | 6.25 mg in 1 1 | 1/3/2023 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-163 | ORAL | 6.25 mg in 1 1 | 8/29/2023 | |
| State of Florida DOH Central Pharmacy | 53808-0221 | ORAL | 25 mg in 1 1 | 6/7/2010 | |
| Sandoz Inc | 0781-5223 | ORAL | 12.5 mg in 1 1 | 10/22/2018 | |
| St. Mary's Medical Park Pharmacy | 60760-233 | ORAL | 6.25 mg in 1 1 | 11/6/2018 | |
| Aurobindo Pharma Limited | 65862-142 | ORAL | 3.125 mg in 1 1 | 8/23/2023 | |
| Bryant Ranch Prepack | 71335-0273 | ORAL | 25 mg in 1 1 | 2/21/2022 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||