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Basic Drug Info
Drug Name:ATENOLOL
Manufacturer:Genpharm Inc.
Other Info:See WARNINGS – Pregnancy and Fetal Injury.



Clinical Trials:


Indications and Usage

Atenolol Tablets USP are indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality.

Treatment can be initiated as soon as the patient’s clinical condition allows.

(See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta blockade.

As noted above, some subgroups (e.g.

elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.
Acute myocardial infarction --

Contraindications

Atenolol Tablets USP are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure.

(See WARNINGS.)Atenolol is contraindicated in those patients with a history of hypersensitivity to atenolol or any of the drug product’s components.
Sinus bradycardia -- A heart rate of less than 60 beats per minute, with its origin in the sinus node. (NCI)

Heart Block -- Impaired conduction of cardiac impulse that can occur anywhere along the conduction pathway, such as between the SINOATRIAL NODE and the right atrium (SA block) or between atria and ventricles (AV block). Heart blocks can be classified by the duration, frequency, or completeness of conduction block. Reversibility depends on the degree of structural or functional defects.

Cardiogenic shock -- Shock resulting from diminution of cardiac output in heart disease.

Heart failure -- inability of the heart to pump blood at an adequate rate to fill tissue metabolic requirements or the ability to do so only at an elevated filling pressure.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Atenolol can cause fetal harm when administered to a pregnant woman.

Atenolol crosses the placental barrier and appears in cord blood.

Administration of atenolol, starting in the second trimester of pregnancy, has been associated with the birth of infants that are small for gestational age.

No studies have been performed on the use of atenolol in the first trimester and the possibility of fetal injury cannot be excluded.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.Neonates born to mothers who are receiving atenolol at parturition or breast-feeding may be at risk for hypoglycemia and bradycardia.

Caution should be exercised when atenolol is administered during pregnancy or to a woman who is breast-feeding (See PRECAUTIONS, Nursing Mothers).Atenolol has been shown to produce a dose-related increase in embryo/fetal resorptions in rats at doses equal to or greater than 50 mg/kg/day or 25 or more times the maximum recommended human antihypertensive dose*.

Although similar effects were not seen in rabbits, the compound was not evaluated in rabbits at doses above 25 mg/kg/day or 12.5 times the maximum recommended human antihypertensive dose*.*Based on the maximum dose of 100 mg/day in a 50 kg patient.
Branded Drugs
The following US Branded drugs contain ATENOLOL


TENORMIN -- ASTRAZENECA PHARMACEUTICALS LP

TENORMIN -- ASTRAZENECA LP

ATENOLOL AND CHLORTHALIDONE -- IPR PHARMACEUTICALS INC

ATENOLOL AND CHLORTHALIDONE -- MUTUAL PHARMACEUTICAL CO INC

ATENOLOL AND CHLORTHALIDONE -- MYLAN PHARMACEUTICALS INC

ATENOLOL AND CHLORTHALIDONE -- NOSTRUM LABORATORIES INC

ATENOLOL AND CHLORTHALIDONE -- PLIVA INC

ATENOLOL AND CHLORTHALIDONE -- WATSON LABORATORIES INC

TENORETIC 100 -- ASTRAZENECA PHARMACEUTICALS LP

TENORETIC 50 -- ASTRAZENECA PHARMACEUTICALS LP


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