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.
Background
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 |
---|---|---|---|---|---|
2008/07/29 | Phase 3 | Completed | |||
2008/06/02 | Phase 4 | Completed | |||
2008/04/30 | Phase 4 | Completed | |||
2008/04/21 | Phase 4 | Completed | |||
2008/04/02 | Phase 2 | UNKNOWN | |||
2008/02/28 | Not Applicable | Terminated | |||
2008/01/15 | Phase 2 | Completed | |||
2007/12/28 | Phase 3 | Terminated | |||
2007/09/27 | Phase 4 | Completed | |||
2007/09/14 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
PD-Rx Pharmaceuticals, Inc. | 55289-993 | ORAL | 50 mg in 1 1 | 9/22/2023 | |
State of Florida DOH Central Pharmacy | 53808-0345 | ORAL | 100 mg in 1 1 | 5/24/2010 | |
Major Pharmaceuticals | 0904-7187 | ORAL | 25 mg in 1 1 | 11/8/2021 | |
St. Mary's Medical Park Pharmacy | 60760-256 | ORAL | 25 mg in 1 1 | 1/2/2020 | |
Northwind Pharmaceuticals | 51655-736 | ORAL | 100 mg in 1 1 | 1/1/2023 | |
A-S Medication Solutions | 50090-3411 | ORAL | 25 mg in 1 1 | 9/30/2015 | |
NuCare Pharmaceuticals,Inc. | 68071-3830 | ORAL | 50 mg in 1 1 | 4/18/2025 | |
Apotheca Inc. | 12634-605 | ORAL | 100 mg in 1 1 | 7/6/2016 | |
Golden State Medical Supply, Inc. | 60429-025 | ORAL | 50 mg in 1 1 | 8/7/2023 | |
Northwind Pharmaceuticals, LLC | 51655-491 | ORAL | 25 mg in 1 1 | 1/25/2023 |
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 |
---|---|---|---|---|---|
Atenolol Tablets | 国药准字H51022108 | 化学药品 | 片剂 | 1/22/2020 | |
Atenolol Tablets | 国药准字H22021175 | 化学药品 | 片剂 | 7/24/2020 | |
Atenolol Tablets | 国药准字H32025197 | 化学药品 | 片剂 | 8/24/2020 | |
Atenolol Tablets | 国药准字H11020385 | 化学药品 | 片剂 | 8/19/2020 | |
Atenolol Tablets | 国药准字H13022257 | 化学药品 | 片剂 | 8/27/2024 | |
Atenolol Tablets | 国药准字H31020404 | 化学药品 | 片剂 | 8/13/2024 | |
Atenolol Tablets | 国药准字H45020538 | 化学药品 | 片剂 | 8/13/2020 | |
Atenolol Tablets | 国药准字H23020111 | 化学药品 | 片剂 | 5/18/2020 | |
Atenolol Tablets | 国药准字H37022713 | 化学药品 | 片剂 | 2/17/2025 | |
Atenolol Tablets | 国药准字H11020399 | 化学药品 | 片剂 | 8/27/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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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 100 mg film coated tablets bottle | 197744 | Medicine | A | 9/13/2013 | |
TENELOL Atenolol 50 mg film coated tablets bottle | 197742 | Medicine | A | 9/13/2013 | |
Tanor Atenolol 50 mg film coated tablets bottle | 197766 | Medicine | A | 9/13/2013 | |
Atenolol Tablets 100 mg (BULK) | 400611 | Medicine | A | 12/5/2022 | |
LOTENOL Atenolol 100 mg film coated tablets bottle | 197750 | Medicine | A | 9/13/2013 | |
ATEN Atenolol 100 mg film coated tablets blister pack | 197718 | Medicine | A | 9/13/2013 | |
LOTENOL Atenolol 100 mg film coated tablets blister pack | 197749 | Medicine | A | 9/13/2013 | |
Tanor Atenolol 100 mg film coated tablets blister pack | 197767 | Medicine | A | 9/13/2013 | |
Atenolol 100 mg tablet bottle | 333361 | Medicine | A | 4/6/2020 | |
NOTEN atenolol 50 mg tablet bulk pack | 306815 | Medicine | A | 10/3/2018 |