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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
2017/08/10
Early Phase 1
Withdrawn
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
Atenolol Tablets
国药准字H41022257
化学药品
片剂
8/14/2020
Atenolol Tablets
国药准字H53020938
化学药品
片剂
6/8/2020
Atenolol Tablets
国药准字H22023171
化学药品
片剂
5/22/2020
Atenolol Tablets
国药准字H32024399
化学药品
片剂
5/11/2020
Atenolol Tablets
国药准字H51022107
化学药品
片剂
12/2/2019
Atenolol Tablets
国药准字H62020532
化学药品
片剂
6/16/2020
Atenolol Tablets
国药准字H32025097
化学药品
片剂
7/7/2020
Atenolol Tablets
国药准字H35020578
化学药品
片剂
7/18/2022
Atenolol Tablets
国药准字H37022714
化学药品
片剂
2/17/2025
Atenolol Tablets
国药准字H11021434
化学药品
片剂(糖衣)
9/1/2020

PPB Drug Approvals

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