Atenolol description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Home SubjectClassCompaniesIngredientsNames A-Z
Search
Home – Atenolol

Atenolol

Med-Health Pharma, LLC

Atenolol Tablets, USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ATENOLOL DESCRIPTION


1
Atenolol



CLINICAL PHARMACOLOGY


12

Pharmacokinetics and Metabolism



2 DOSAGE AND ADMINISTRATION

Pharmacodynamics





1 21















Atenolol Geriatric Pharmacology

ATENOLOL INDICATIONS AND USAGE


Hypertension



Angina Pectoris Due to Coronary Atherosclerosis



Acute Myocardial Infarction

DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS WARNINGS

ATENOLOL CONTRAINDICATIONS


WARNINGS

WARNINGS


Cardiac Failure





In Patients Without a History of Cardiac Failure

DOSAGE AND ADMNISTRATION.

Cessation of Therapy with Atenolol
 
Patients with coronary artery disease, who are being treated with atenolol, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in angina patients following the abrupt discontinuation of therapy with beta-blockers. The last two complications may occur with or without preceding exacerbation of the angina pectoris. As with other beta-blockers, when discontinuation of atenolol is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. If the angina worsens or acute coronary insufficiency develops, it is recommended that atenolol be promptly reinstituted, at least temporarily. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue atenolol therapy abruptly even in patients treated only for hypertension. (See DOSAGE AND ADMINISTRATION .)
Concomitant Use of Calcium Channel Blockers

PRECAUTIONS

Bronchospastic Diseases

PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS. Because of its relative beta 1 selectivity, however, atenolol may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Since beta 1 selectivity is not absolute, the lowest possible dose of atenolol should be used with therapy initiated at 50 mg and a beta 2-stimulating agent (bronchodilator) should be made available. If dosage must be increased, dividing the dose should be considered in order to achieve lower peak blood levels.

Major Surgery



Diabetes and Hypoglycemia



Thyrotoxicosis

DOSAGE AND ADMINISTRATION

Untreated Pheochromocytoma

Pregnancy and Fetal Injury




PRECAUTIONS, Nursing Mothers



PRECAUTIONS

General




Impaired Renal Function

DOSAGE AND ADMINISTRATION

Drug Interactions




WARNINGS













Carcinogenesis, Mutagenesis, Impairment of Fertility


in vivo S typhimurium



Animal Toxicology



Usage in Pregnancy




WARNINGS - Pregnancy and Fetal Injury

Nursing Mothers




WARNINGS, Pregnancy and Fetal Injury

Pediatric Use


Geriatric Use








CLINICAL PHARMACOLOGY INDICATIONS AND USAGE

ATENOLOL ADVERSE REACTIONS





 
Volunteered
(U.S. Studies)
 Total – Volunteered
 and Elicited
 (Foreign+U.S
. Studies)
Atenolol
(n=164)
%
 Placebo
(n=206)
%
 Atenolol
(n=399)
%
 Placebo
(n=407)
%
 CARDIOVASCULAR
  
 
 
 
     Bradycardia
 3
 0
 3
 0
     Cold Extremities
 0
 0.5
 12
 5
     Postural Hypotension
 2
 1
 4
 5
     Leg Pain
 0
 0.5
 3
 1
 CENTRAL NERVOUS SYSTEM/NEUROMUSCULAR
  
 
 
 
     Dizziness
 4
 1
 13
 6
     Vertigo
 2
 0.5
 2
 0.2
     Lightheadedness
 1
 0
 3
 0.7
     Tiredness
 0.6
 0.5
 26
 13
     Fatigue
 3
 1
 6
 5
     Lethargy
 1
 0
 3
 0.7
     Drowsiness
 0.6
 0
 2
 0.5
     Depression
 0.6
 0.5
 12
 9
     Dreaming
 0
 0
 3
 1
 GASTROINTESTINAL
  
 
 
 
     Diarrhea
 2
 0
 3
 2
     Nausea
 4
 1
 3
 1
 RESPIRATORY (see WARNINGS )
  
 
 
 
     Wheeziness
 0
 0
 3
 3
     Dyspnea
 0.6
 1
 6
 4

Acute Myocardial Infarction




 
Conventional Therapy
Plus Atenolol
(n=244)
 Conventional
Therapy Alone
(n=233)
 Bradycardia
 43
 (18%)
 24
 (10%)
 Hypotension
 60
 (25%)
 34
 (15%)
 Bronchospasm
 3
 (1.2%)
 2
 (0.9%)
 Heart Failure
 46
 (19%)
 56
 (24%)
 Heart Block
 11
 (4.5%)
 10
 (4.3%)
 BBB + Major
     Axis Deviation
 16
 (6.6%)
 28
 (12%)
 Supraventricular Tachycardia
 28
 (11.5%)
 45
 (19%)
     Atrial Fibrillation
 12
 (5%)
 29
 (11%)
     Atrial Flutter
 4
 (1.6%)
 7
 (3%)
 Ventricular Tachycardia
 39
 (16%)
 52
 (22%)
 Cardiac Reinfarction
 0
 (0%)
 6
 (2.6%)
 Total Cardiac Arrests
 4
 (1.6%)
 16
 (6.9%)
 Nonfatal Cardiac Arrests
 4
 (1.6%)
 12
 (5.1%)
 Deaths
 7
 (2.9%)
 16
 (6.9%)
 Cardiogenic Shock
 1
 (0.4%)
 4
 (1.7%)
 Development of Ventricular
     Septal Defect
 0
 (0%)
 2
 (0.9%)
 Development of Mitral
     Regurgitation
 0
 (0%)
 2
 (0.9%)
 Renal Failure
1
 (0.4%)
 0
 (0%)
 Pulmonary Emboli
3
 (1.2%)
 0
 (0%)

Reasons for Reduced Dosage
IV Atenolol
 Reduced Dose
(< 5 mg)*		 Oral Partial Dose
 Hypotension/Bradycardia
 105
 (1.3%)
 1168
 (14.5%)
 Cardiogenic Shock
 4
 (.04%)
 35
 (.44%)
 Reinfarction
 0
 (0%)
 5
 (.06%)
 Cardiac Arrest
 5
 (.06%)
 28
 (.34%)
 Heart Block (> first degree)
 5
 (.06%)
 143
 (1.7%)
 Cardiac Failure
 1
 (.01%)
 233
 (2.9%)
 Arrhythmias
 3
 (.04%)
 22
 (.27%)
 Bronchospasm
 1
 (.01%)
 50
 (.62%)





POTENTIAL ADVERSE EFFECTS



Hematologic:

Allergic:

Central Nervous System:

Gastrointestinal:

Other:

Miscellaneous: DOSAGE AND ADMINISTRATION

OVERDOSAGE
















2



ATENOLOL DOSAGE AND ADMINISTRATION


Hypertension





Angina Pectoris





Acute Myocardial Infarction











Elderly Patients or Patients with Renal Impairment



2


Creatinine Clearance
 (mL/min/1.73 m2)
 Atenolol Elimination
 Half-Life
(h)
 Maximum
Dosage
15-35
 16-27
 50 mg daily
<15
 >27
 25 mg daily







Cessation of Therapy in Patients with Angina Pectoris

HOW SUPPLIED


Atenolol Tablets USP, 25 mg




Atenolol Tablets USP, 50 mg




Atenolol Tablets USP, 100 mg




Store at


Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited








PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg (30 Tablet Bottle)


NDC 51138-096-30
Atenolol

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 mg (30 Tablet Bottle)


NDC 51138-097-30
Atenolol

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (30 Tablet Bottle)


NDC 51138-098-30
Atenolol

Atenolol

Atenolol TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:51138-096(NDC:65862-168)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ATENOLOL ATENOLOL 25 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO
CROSPOVIDONE
POVIDONE K90
cellulose, microcrystalline
SILICON DIOXIDE
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off-white) 6 mm D;21 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51138-096-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078512 2011-01-20


Atenolol

Atenolol TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:51138-097(NDC:65862-169)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ATENOLOL ATENOLOL 50 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO
CROSPOVIDONE
POVIDONE K90
cellulose, microcrystalline
SILICON DIOXIDE
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off-white) 7 mm D;22 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51138-097-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078512 2011-01-20


Atenolol

Atenolol TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:51138-098(NDC:65862-170)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ATENOLOL ATENOLOL 100 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO
CROSPOVIDONE
POVIDONE K90
cellulose, microcrystalline
SILICON DIOXIDE
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off-white) 9 mm D;23 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51138-098-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078512 2011-01-20


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.
Designed by Tank
Developed by KB.MD