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Atenolol

State of Florida DOH Central Pharmacy

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






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

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0658-1 25 mg 30 Tablets in a Blister Pack White to Off-white 65862-168
53808-0900-1 50 mg 30 Tablets in a Blister Pack White to Off-white 65862-169
53808-0660-1 100 mg 30 Tablets in a Blister Pack White to Off-white 65862-170

Store at


Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

Label Image for 25 mg


NDC 53808-0658-1
Atenolol Tablets, USP
25 mg
Rx only           30 Tablets
AUROBINDO
Atenolol

Label Image for 50 mg


NDC 53808-0900-1
Atenolol Tablets, USP
50 mg
Rx only           30 Tablets
AUROBINDO
Atenolol

Label Image for 100 mg


NDC 53808-0660-1
Atenolol Tablets, USP
100 mg
Rx only           30 Tablets
AUROBINDO
Atenolol

Atenolol

Atenolol TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:53808-0658(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:53808-0658-1 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078512 2009-07-01


Atenolol

Atenolol TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:53808-0900(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:53808-0900-1 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078512 2009-07-01


Atenolol

Atenolol TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:53808-0660(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:53808-0660-1 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078512 2009-07-01


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