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Atenolol

Generic Name
Atenolol
Brand Names
Tenoretic, Tenormin
Drug Type
Small Molecule
Chemical Formula
C14H22N2O3
CAS Number
29122-68-7
Unique Ingredient Identifier
50VV3VW0TI

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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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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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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Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
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