Overview
Atenolol is a cardioselective beta-blocker used in a variety of cardiovascular conditions. Sir James Black, a Scottish pharmacologist, pioneered the use of beta-blockers for the management of angina pectoris in 1958 for which he received the Nobel Prize. Beta-blockers quickly became popular in clinical use and where subsequently investigated for use in myocardial infarction, arrhythmias, and hypertension during the 1960s. Later they continued to be investigated for use in heart failure throughout the 1970-1980s. Atenolol itself was developed early on in this history by Alvogen Malta under the trade name Tenormin and received FDA approval in September, 1981. Despite being one of the most widely prescribed beta blockers, evidence suggests atenolol may not significantly reduce mortality, and only modestly reduce the risk of cardiovascular disease in patients with hypertension. A Cochrane review of patients being treated for primary hypertension shows that atenolol shows a risk ratio of 0.88 for cardiovascular disease risk and a risk ratio of 0.99 for mortality. Similar results have been found in other meta-analyses. A meta-analysis of over 145,000 patients showed the risk of stroke in patients taking atenolol may depend on the age of the patient. The use of atenolol may need to be based on more patient factors than hypertension alone.
Indication
Indicated for: 1) Management of hypertension alone and in combination with other antihypertensives. 2) Management of angina pectoris associated with coronary atherosclerosis. 3) Management of acute myocardial infarction in hemodynamically stable patients with a heart rate greater than 50 beats per minutes and a systolic blood pressure above 100 mmHg. Off-label uses include: 1) Secondary prevention of myocardial infarction. 2) Management of heart failure. 3) Management of atrial fibrillation. 4) Management of supraventricular tachycardia. 5) Management of ventricular arrythmias such as congenital long-QT and arrhythmogenic right ventricular cardiomyopathy. 6) Management of symptomatic thyrotoxicosis in combination with methimazole. 7) Prophylaxis of migraine headaches. 8) Management of alcohol withdrawal.
Associated Conditions
- Alcohol Withdrawal Syndrome
- Angina Pectoris
- Atrial Fibrillation
- Heart Failure
- Hypertension
- Migraine
- Myocardial Infarction
- Refractory Hypertension
- Secondary prevention Myocardial infarction
- Supra-ventricular Tachyarrhythmias
- Thyrotoxicosis
- Ventricular Tachyarrhythmias
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2017/08/10 | Phase 4 | Completed | |||
2017/08/02 | Phase 3 | UNKNOWN | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2017/05/10 | Early Phase 1 | UNKNOWN | Centro Neurológico de Pesquisa e Reabiitação, Brazil | ||
2017/04/10 | Early Phase 1 | UNKNOWN | University of Tennessee Graduate School of Medicine | ||
2017/03/17 | Phase 3 | Terminated | |||
2017/03/06 | Phase 1 | Terminated | |||
2015/12/07 | Phase 2 | UNKNOWN | Xintong Pharmacy Company | ||
2015/09/25 | Phase 2 | Suspended | |||
2015/09/11 | Phase 4 | Completed | |||
2015/06/24 | Phase 1 | Terminated |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aidarex Pharmaceuticals LLC | 53217-201 | ORAL | 50 mg in 1 1 | 3/1/2017 | |
| direct rx | 72189-135 | ORAL | 50 mg in 1 1 | 6/28/2023 | |
| Physicians Total Care, Inc. | 54868-2683 | ORAL | 50 mg in 1 1 | 7/9/2010 | |
| NuCare Pharmaceuticals,Inc. | 68071-4766 | ORAL | 50 mg in 1 1 | 2/17/2021 | |
| Aphena Pharma Solutions - Tennessee, LLC | 67544-161 | ORAL | 25 mg in 1 1 | 4/17/2019 | |
| Mylan Institutional Inc. | 51079-684 | ORAL | 50 mg in 1 1 | 12/27/2023 | |
| Mutual Pharmaceutical Company, Inc. | 53489-530 | ORAL | 100 mg in 1 1 | 9/1/2011 | |
| Proficient Rx LP | 71205-096 | ORAL | 25 mg in 1 1 | 12/1/2018 | |
| Blenheim Pharmacal, Inc. | 10544-167 | ORAL | 25 mg in 1 1 | 2/27/2015 | |
| Blenheim Pharmacal, Inc. | 10544-586 | ORAL | 50 mg in 1 1 | 2/27/2015 |
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 |
|---|---|---|---|---|---|
| UROSIN FILM COATED TABLET 50 mg | SIN12330P | TABLET, FILM COATED | 50 mg | 6/23/2003 | |
| APO-ATENOL TABLET 100 MG BP | SIN03631P | TABLET | 100 mg | 7/26/1989 | |
| APO-ATENOL TABLET 50 mg | SIN03630P | TABLET | 50 mg | 7/26/1989 | |
| TENOLOL TABLET 100 mg | SIN02344P | TABLET, FILM COATED | 100 mg | 10/17/1988 | |
| ATENOLOL TABLET 50 mg | SIN07697P | TABLET, FILM COATED | 50 mg | 4/18/1994 | |
| UROSIN FILM COATED TABLET 100 mg | SIN10116P | TABLET, FILM COATED | 100 mg | 9/25/1998 | |
| TENORMIN TABLET 50 mg | SIN00348P | TABLET, FILM COATED | 50 mg | 4/22/1988 | |
| BETA - NICARDIA CAPSULE | SIN12389P | CAPSULE | 50 mg | 8/14/2003 | |
| NIFETEX-TR CAPSULE | SIN07439P | CAPSULE | 50 mg | 5/24/1993 |
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 |
|---|---|---|---|---|---|
| TENELOL Atenolol 25 mg film coated tablets bottle | 197725 | Medicine | A | 9/13/2013 | |
| IPCA-ATENOLOL Atenolol 25 mg film coated tablets blister pack | 197702 | Medicine | A | 9/17/2013 | |
| Atenolol 50 mg tablet bottle | 333362 | Medicine | A | 4/6/2020 | |
| ATEN Atenolol 50 mg film coated tablets bottle | 197717 | Medicine | A | 9/13/2013 | |
| NATOR Atenolol 100 mg film coated tablets bottle | 197756 | Medicine | A | 9/13/2013 | |
| ATENOLOL SANDOZ atenolol 50mg tablet blister pack | 101462 | Medicine | A | 8/27/2004 | |
| PHARMACOR ATENOLOL 50 | 143388 | Medicine | A | 11/22/2007 | |
| LOTENOL Atenolol 50 mg film coated tablets bottle | 197748 | Medicine | A | 9/13/2013 | |
| NATOR Atenolol 50 mg film coated tablets blister pack | 197753 | Medicine | A | 9/13/2013 | |
| APX-ATENOLOL atenolol 50mg tablet blister pack | 332998 | Medicine | A | 4/21/2020 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ATENOLOL | meliapharm inc | 02351358 | Tablet - Oral | 50 MG | 4/8/2011 |
| AVA-ATENOLOL | avanstra inc | 02360969 | Tablet - Oral | 25 MG | 9/15/2011 |
| MAR-ATENOLOL | marcan pharmaceuticals inc | 02371979 | Tablet - Oral | 25 MG | 10/22/2012 |
| MINT-ATENOL | mint pharmaceuticals inc | 02368048 | Tablet - Oral | 100 MG | 6/13/2011 |
| DOM-ATENOLOL - 100MG | dominion pharmacal | 02229468 | Tablet - Oral | 100 MG | 10/17/1996 |
| ATENOLOL | sivem pharmaceuticals ulc | 02238316 | Tablet - Oral | 50 MG | 9/3/1999 |
| SANDOZ ATENOLOL | 02231733 | Tablet - Oral | 100 MG | 6/7/2000 | |
| AG-ATENOLOL | angita pharma inc. | 02369192 | Tablet - Oral | 100 MG | 7/18/2018 |
| APO-ATENOL TAB 100MG | 00773697 | Tablet - Oral | 100 MG | 12/31/1988 | |
| PENTA-ATENOLOL - 100MG | pentapharm ltd. | 02229586 | Tablet - Oral | 100 MG | N/A |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ATENOLOL CINFA 50 mg COMPRIMIDOS EFG | Laboratorios Cinfa S.A. | 63147 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| TENORMIN 50 mg COMPRIMIDOS | Atnahs Pharma Netherlands Bv. | 56967 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| ATENOLOL / CLORTALIDONA DARI PHARMA 100 MG/25 MG COMPRIMIDOS | Dari Pharma S.L. | 56661 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| NEATENOL DIU 100mg/5mg COMPRIMIDOS | Meda Pharma S.L. | 56535 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ATENOLOL SANDOZ 50 mg COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Sandoz Farmaceutica S.A. | 62449 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| BLOKIUM 100 mg COMPRIMIDOS | 55529 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| ATENOLOL NORMON 100 mg COMPRIMIDOS RECUBIERTOS EFG | Laboratorios Normon S.A. | 61493 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| BLOKIUM-DIU 100 mg/25 mg COMPRIMIDOS | 56665 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| TENORMIN 0,5 mg/ml SOLUCION INYECTABLE | Atnahs Pharma Netherlands Bv. | 56777 | SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized |
| ATENOLOL COMBIX 50 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Laboratorios Combix S.L.U. | 89529 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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