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Basic Drug Info
Drug Name:Cardizem
Manufacturer:Biovail Pharmaceuticals, Inc.
Other Info:Prescribing Information as of August 2001® Cardizem is a registered trademark ofBiovail Laboratories IncorporatedManufactured by: Aventis Pharmaceuticals Inc.Kansas City, MO, 64137, USADistributed by: Biovail Pharmaceuticals, Inc.Bridgewater, NJ, 08807, USA50070835



Clinical Trials:


Indications and Usage

CARDIZEM CD is indicated for the treatment of hypertension.

It may be used alone or in combination with other antihypertensive medications.CARDIZEM CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm.
Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

Angina Pectoris -- The symptom of paroxysmal pain consequent to MYOCARDIAL ISCHEMIA usually of distinctive character, location and radiation. It is thought to be provoked by a transient stressful situation during which the oxygen requirements of the MYOCARDIUM exceed that supplied by the CORONARY CIRCULATION.

Coronary Artery Vasospasm -- Spasm of the large- or medium-sized coronary arteries.

Contraindications
CARDIZEM is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.
Sick Sinus Syndrome -- A condition caused by dysfunctions related to the SINOATRIAL NODE including impulse generation (CARDIAC SINUS ARREST) and impulse conduction (SINOATRIAL EXIT BLOCK). It is characterized by persistent BRADYCARDIA, chronic ATRIAL FIBRILLATION, and failure to resume sinus rhythm following CARDIOVERSION. This syndrome can be congenital or acquired, particularly after surgical correction for heart defects.

Complete atrioventricular block -- Complete failure of atrial electrical impulse conduction through the AV node to the ventricles.

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

Acute myocardial infarction --

Warnings

1.

Cardiac Conduction.

CARDIZEM prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome.

This effect may rarely result in abnormally slow heart rates (particularly in patients with sick sinus syndrome) or second- or third-degree AV block (13 of 3290 patients or 0.40%).

Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction.

A patient with Prinzmetal's angina developed periods of asystole (2 to 5 seconds) after a single dose of 60 mg of diltiazem.

(See ADVERSE REACTIONS section.)

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