Overview
Propranolol is a racemic mixture of 2 enantiomers where the S(-)-enantiomer has approximately 100 times the binding affinity for beta adrenergic receptors. Propranolol is used to treat a number of conditions but most commonly is used for hypertension. Propranolol was granted FDA approval on 13 November 1967.
Indication
Propranolol is indicated to treat hypertension. Propranolol is also indicated to treat angina pectoris due to coronary atherosclerosis, atrial fibrillation, myocardial infarction, migraine, essential tremor, hypertrophic subaortic stenosis, pheochromocytoma, and proliferating infantile hemangioma.
Associated Conditions
- Akathisia caused by antipsychotic use
- Angina Pectoris
- Atrial Fibrillation
- Cardiovascular Mortality
- Essential Tremor
- Gastroesophageal variceal hemorrhage prophylaxis
- Hemangiomas
- Hypertension
- Migraine
- Myocardial Infarction
- Obstructive Hypertrophic Cardiomyopathy
- Performance Anxiety
- Pheochromocytoma
- Proliferating Infantile Hemangioma
- Supraventricular Arrhythmias
- Tachyarrhythmia caused by Digitalis intoxication
- Tachyarrhythmia caused by catecholamine excess
- Thyroid Crisis
- Thyrotoxicosis
- Tremor caused by lithium
- Ventricular Tachycardia (VT)
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2012/01/05 | Early Phase 1 | Completed | |||
2011/10/25 | Phase 4 | Completed | Mikael Lantz | ||
2011/10/14 | Phase 4 | UNKNOWN | |||
2011/05/06 | Phase 2 | UNKNOWN | |||
2011/04/28 | Phase 1 | Withdrawn | |||
2011/03/21 | Not Applicable | UNKNOWN | McGill University Health Centre/Research Institute of the McGill University Health Centre | ||
2011/03/04 | Phase 1 | Completed | |||
2011/02/18 | Not Applicable | UNKNOWN | |||
2011/02/17 | Phase 4 | Recruiting | |||
2011/02/17 | Phase 4 | UNKNOWN |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Northwind Pharmaceuticals | 51655-348 | ORAL | 10 mg in 1 1 | 12/31/2021 | |
| Direct Rx | 61919-488 | ORAL | 60 mg in 1 1 | 4/19/2019 | |
| Zydus Pharmaceuticals USA Inc. | 68382-161 | ORAL | 60 mg in 1 1 | 11/10/2022 | |
| DIRECT RX | 61919-808 | ORAL | 40 mg in 1 1 | 1/21/2020 | |
| Physicians Total Care, Inc. | 54868-0696 | ORAL | 80 mg in 1 1 | 5/26/2010 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-961 | ORAL | 20 mg in 1 1 | 7/19/2014 | |
| State of Florida DOH Central Pharmacy | 53808-0891 | ORAL | 20 mg in 1 1 | 10/18/2014 | |
| Preferred Pharmaceuticals Inc. | 68788-7860 | ORAL | 10 mg in 1 1 | 9/12/2023 | |
| Blenheim Pharmacal, Inc. | 10544-284 | ORAL | 20 mg in 1 1 | 3/17/2015 | |
| Bryant Ranch Prepack | 63629-2277 | ORAL | 20 mg in 1 1 | 11/15/2021 |
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. | |||||
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