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Atenolol

Aurolife Pharma LLC

Atenolol Tablets, USP Rx only


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ATENOLOL DESCRIPTION


1
Atenolol





CLINICAL PHARMACOLOGY


12

Pharmacokinetics and Metabolism




2 DOSAGE AND ADMINISTRATION

Pharmacodynamics






121













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


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 beta1 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 beta1 selectivity is not absolute, the lowest possible dose of atenolol should be used with therapy initiated at 50 mg and a beta2-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.

Anesthesia and Major Surgery




OVERDOSAGE

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 vivoS typhimurium

Animal Toxicology




Usage in Pregnancy




WARNINGS - Pregnancy and Fetal Injury

Nursing Mothers




WARNINGS, Pregnancy and Fetal Injury

Pediatric Use


Geriatric Use

Hypertension and Angina Pectoris Due to Coronary Atherosclerosis


Acute Myocardial Infarction



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%)


*Full dosage was 10 mg and some patients received less than 10 mg but more than 5 mg.
 
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


Aurolife Pharma LLC



Aurobindo Pharma USA, Inc.


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg (1000 Tablet Bottle)


NDC 13107-168-99
Atenolol Tablets, USP
25 mg
Rx only      1000 Tablets
Aurobinod
Atenolol

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 mg (1000 Tablet Bottle)


NDC 13107-169-99
Atenolol Tablets, USP 
50 mg
Rx only      1000 Tablets
Aurobinod
Atenolol

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (1000 Tablet Bottle)


NDC 13107-170-99
Atenolol Tablets, USP
100 mg
Rx only      1000 Tablets
Aurobinod
Atenolol

Atenolol

Atenolol TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:13107-168
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:13107-168-01 100 in 1 BOTTLE
2 NDC:13107-168-99 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078512 2011-06-20


Atenolol

Atenolol TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:13107-169
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:13107-169-01 100 in 1 BOTTLE
2 NDC:13107-169-99 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078512 2011-06-20


Atenolol

Atenolol TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:13107-170
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:13107-170-01 100 in 1 BOTTLE
2 NDC:13107-170-99 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078512 2011-06-20


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Be sure to consult your doctor before taking any medication!
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