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Atenolol

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

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 (seeDOSAGE AND ADMINISTRATION).


ATENOLOL DESCRIPTION


Atenolol





CLINICAL PHARMACOLOGY



PHARMACOKINETICS AND METABOLISM


DOSAGE AND ADMINISTRATION

PHARMACODYNAMICS














INDICATIONS & USAGE

Hypertension


Angina Pectoris Due to Coronary Atherosclerosis


Acute Myocardial Infarction
DOSAGE AND ADMINISTRATIONCONTRAINDICATIONSWARNINGS

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 (seeDOSAGE 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




ANIMAL PHARMACOLOGY & OR TOXICOLOGY



PREGNANCY


WARNINGS - Pregnancy and Fetal Injury

NURSING MOTHERS


WARNINGS, Pregnancy and Fetal Injury

PEDIATRIC USE



GERIATRIC USE




CLINICAL PHARMACOLOGYINDICATIONS AND USAGE).
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function.

ATENOLOL ADVERSE REACTIONS




WARNINGS
Acute Myocardial Infarction








POTENTIAL ADVERSE EFFECTS

Hematologic:
Allergic:
Central Nervous System:
Gastrointestinal:
Other:
Miscellaneous:INDICATIONS AND USAGE


OVERDOSAGE












DOSAGE & ADMINISTRATION

Hypertension



Angina Pectoris



Acute Myocardial Infarction






Elderly Patients or Patients with Renal Impairment








Cessation of Therapy in Patients with Angina Pectoris


HOW SUPPLIED

Atenolol Tablets, USP













STORAGE AND HANDLING





PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Atenolol

Atenolol

Atenolol

Atenolol TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-544(NDC:63304-623)
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
MAGNESIUM CARBONATE
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
white 9 mm RE;21 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-544-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077877 2011-09-29


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Be sure to consult your doctor before taking any medication!
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