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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/11/01 | Not Applicable | Completed | |||
2024/07/17 | Not Applicable | Recruiting | All India Institute of Medical Sciences, Bhubaneswar | ||
2021/11/03 | Phase 4 | UNKNOWN | Center for Vascular Pathology, Moscow | ||
2021/06/18 | Phase 4 | Recruiting | Shanghai Jiao Tong University School of Medicine | ||
2021/06/04 | Phase 4 | Recruiting | Damanhour Teaching Hospital | ||
2021/05/27 | Phase 2 | Active, not recruiting | Sundeep Khosla, M.D. | ||
2021/02/16 | N/A | Recruiting | |||
2020/01/13 | Not Applicable | UNKNOWN | Onassis Cardiac Surgery Centre | ||
2018/07/06 | Phase 2 | Withdrawn | |||
2017/08/10 | Early Phase 1 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Golden State Medical Supply, Inc. | 60429-026 | ORAL | 100 mg in 1 1 | 8/7/2023 | |
State of Florida DOH Central Pharmacy | 53808-0344 | ORAL | 100 mg in 1 1 | 5/24/2010 | |
RedPharm Drug, Inc. | 67296-1732 | ORAL | 50 mg in 1 1 | 1/14/2021 | |
NuCare Pharmaceuticals,Inc. | 68071-4527 | ORAL | 50 mg in 1 1 | 3/15/2021 | |
direct rx | 72189-146 | ORAL | 25 mg in 1 1 | 6/28/2023 | |
Central Texas Community Health Centers | 76413-140 | ORAL | 25 mg in 1 1 | 12/14/2016 | |
State of Florida DOH Central Pharmacy | 53808-1012 | ORAL | 50 mg in 1 1 | 12/7/2014 | |
Bryant Ranch Prepack | 71335-0954 | ORAL | 50 mg in 1 1 | 5/26/2023 | |
Aidarex Pharmaceuticals LLC | 33261-942 | ORAL | 50 mg in 1 1 | 11/22/2013 | |
Blenheim Pharmacal, Inc. | 10544-031 | ORAL | 50 mg in 1 1 | 3/12/2015 |
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 |
---|---|---|---|---|---|
ATENOLOL TABLET 50 mg | SIN08753P | TABLET, FILM COATED | 50 mg | 6/20/1996 | |
PRENOLOL TABLET 100 mg | SIN10278P | TABLET, FILM COATED | 100 mg | 10/14/1998 | |
TENORMIN TABLET 25 mg | SIN08669P | TABLET, FILM COATED | 25 mg | 4/19/1996 | |
TENOL-100 TABLET 100mg | SIN07662P | TABLET, FILM COATED | 100 mg | 3/10/1994 | |
VASCOTEN 50 TABLET 50 mg | SIN07161P | TABLET | 50 mg | 10/8/1992 | |
NORMATEN TABLET 100 mg | SIN10391P | TABLET, FILM COATED | 100 mg | 11/6/1998 | |
TENOL TABLET 50 mg | SIN07538P | TABLET | 50 mg | 11/1/1993 | |
PRENOLOL 50 TABLET 50 mg | SIN10277P | TABLET, FILM COATED | 50 mg | 10/14/1998 | |
NORMATEN TABLET 50 mg | SIN07584P | TABLET, FILM COATED | 50 mg | 12/21/1993 | |
ATENOLOL TABLET 100 mg | SIN08755P | TABLET, FILM COATED | 100 mg | 6/20/1996 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
ATENOLOL 100 STADA TAB 100MG | N/A | N/A | N/A | 7/14/1994 | |
TOTAMOL TAB 50MG | N/A | N/A | N/A | 3/23/1999 | |
ATENOLOL TABLETS BP 50MG | N/A | N/A | N/A | 10/27/2020 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
TENSIG atenolol 50mg tablet blister pack | 147638 | Medicine | A | 3/31/2008 | |
NATOR Atenolol 25 mg film coated tablets bottle | 197752 | Medicine | A | 9/13/2013 | |
ATENOLOL-WGR atenolol 50mg tablet bottle | 333001 | Medicine | A | 4/21/2020 | |
NOTEN atenolol 50mg tablet blister pack | 46250 | Medicine | A | 10/5/1993 | |
NATOR Atenolol 50 mg film coated tablets bottle | 197754 | Medicine | A | 9/13/2013 | |
Atenolol Tablets 100 mg - BULK | 401178 | Medicine | A | 12/16/2022 | |
Atenolol-AFT atenolol 50 mg/10 mL oral solution bottle | 184745 | Medicine | A | 8/3/2012 | |
ATENOLOL GH Atenolol 50 mg film coated tablets blister pack | 298440 | Medicine | A | 4/12/2018 | |
ATEN Atenolol 25 mg film coated tablets bottle | 197715 | Medicine | A | 9/13/2013 | |
IPCA-ATENOLOL Atenolol 100 mg film coated tablets blister pack | 197711 | Medicine | A | 9/13/2013 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
NU-ATENOL TAB 50MG | nu-pharm inc | 00886114 | Tablet - Oral | 50 MG | 12/31/1990 |
AA-ATENIDONE | aa pharma inc | 02248764 | Tablet - Oral | 100 MG | 8/12/2004 |
FTP-ATENOLOL | ftp-pharmacal inc. | 02238569 | Tablet - Oral | 50 MG | 10/9/1998 |
MAR-ATENOLOL | marcan pharmaceuticals inc | 02371995 | Tablet - Oral | 100 MG | 10/22/2012 |
TEVA-ATENOLOL | teva canada limited | 01912054 | Tablet - Oral | 100 MG | 12/31/1991 |
TEVA-ATENOLOL | teva canada limited | 02171805 | Tablet - Oral | 100 MG | 12/31/1995 |
NTP-ATENOLOL/CHLORTHALIDONE | teva canada limited | 02348233 | Tablet - Oral | 50 MG | N/A |
PENTA-ATENOLOL - 50MG | pentapharm ltd. | 02229585 | Tablet - Oral | 50 MG | N/A |
MYLAN-ATENOLOL | Mylan Pharmaceuticals ULC | 02146894 | Tablet - Oral | 50 MG | 12/31/1995 |
ATENOLOL TABLETS, BP | fc pharma inc. | 02239749 | Tablet - Oral | 50 MG | 6/15/1999 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
ATENOLOL CINFA 100 mg COMPRIMIDOS EFG | Laboratorios Cinfa S.A. | 63146 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
ATENOLOL AUROVITAS 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Aurovitas Spain, S.A.U. | 84416 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
ATENOLOL RATIOPHARM 100 mg COMPRIMIDOS RECUBIERTOS EFG | Teva Pharma S.L.U. | 58255 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
ATENOLOL COMBIX 100 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Laboratorios Combix S.L.U. | 89528 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
KALTEN | Teofarma S.R.L. | 57632 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
ATENOLOL ALTER 100 mg COMPRIMIDOS EFG | Laboratorios Alter S.A. | 57397 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
TENORETIC 100 mg/25 mg COMPRIMIDOS | Atnahs Pharma Netherlands Bv. | 56382 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
ATENOLOL AUROVITAS 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Aurovitas Spain, S.A.U. | 84415 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
ATENOLOL ARISTO 50 mg EFG | Aristo Pharma Iberia S.L. | 62926 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
ATENOLOL TARBIS 50 mg COMPRIMIDOS EFG | Tarbis Farma S.L. | 68229 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
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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