MedPath

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.

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

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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