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 | Phase 4 | Completed |
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 |
---|---|---|---|---|---|
Atenolol Injection | 国药准字H20090220 | 化学药品 | 注射剂 | 7/8/2019 | |
Atenolol Injection | 国药准字H20183263 | 化学药品 | 注射剂 | 7/6/2023 | |
Atenolol Injection | 国药准字H20183389 | 化学药品 | 注射剂 | 8/23/2023 | |
Atenolol Tablets | 国药准字H20249783 | 化学药品 | 片剂 | 12/25/2024 | |
Atenolol Tablets | 国药准字H20249782 | 化学药品 | 片剂 | 12/25/2024 | |
Atenolol Tablets | 国药准字H20063435 | 化学药品 | 片剂 | 5/14/2020 | |
Atenolol Tablets | 国药准字H12020259 | 化学药品 | 片剂 | 7/20/2020 | |
Atenolol Tablets | 国药准字H44021430 | 化学药品 | 片剂 | 8/27/2024 | |
Atenolol Tablets | 国药准字H31020403 | 化学药品 | 片剂 | 12/31/2019 | |
Atenolol Tablets | 国药准字H23021130 | 化学药品 | 片剂 | 4/16/2020 |
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 |
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