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Basic Drug Info
Drug Name:Diltiazem Hydrochloride
Manufacturer:Baxter Healthcare Corporation
Other Info:

Transition to other antiarrhythmic agents following administration of diltiazem hydrochloride injection is generally safe.

However, reference should be made to the respective agent manufacturer’s package insert for information relative to dosage and administration.In controlled clinical trials, therapy with antiarrhythmic agents to maintain reduced heart rate in atrial fibrillation or atrial flutter or for prophylaxis of PSVT was generally started within 3 hours after bolus administration of diltiazem hydrochloride. These antiarrhythmic agents were intravenous or oral digoxin, Class 1 antiarrthythmics (e.g., quinidine, procainamide), calcium channel blockers, and oral beta-blockers.Experience in the use of antiarrhythmic agents following maintenance infusion of diltiazem hydrochloride injection is limited. Patients should be dosed on an individual basis and reference should be made to the respective manufacturer’s package insert for information relative to dosage and administration.



Clinical Trials:


Indications and Usage
Diltiazem Hydrochloride Injection is indicated for the following:
Contraindications

Diltiazem hydrochloride injection is contraindicated in:Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker.Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker.Patients with severe hypotension or cardiogenic shock.Patients who have demonstrated hypersensitivity to the drug.Intravenous diltiazem and intravenous beta-blockers should not be administered together or in close proximity (within a few hours).Patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in WPW syndrome or short PR syndrome.

As with other agents which slow AV nodal conduction and do not prolong the refractoriness of the accessory pathway (e.g., verapamil, digoxin), in rare instances patients in atrial fibrillation or atrial flutter associated with an accessory bypass tract may experience a potentially life-threatening increase in heart rate accompanied by hypotension when treated with diltiazem hydrochloride injection.

As such, the initial use of diltiazem hydrochloride injection should be, if possible, in a setting where monitoring and resuscitation capabilities, including DC cardioversion/defibrillation, are present (see OVERDOSAGE).

Once familiarity of the patient’s response is established, use in an office setting may be acceptable.Patients with ventricular tachycardia.

Administration of other calcium channel blockers to patients with wide complex tachycardia (QRS ?0.12 seconds) has resulted in hemodynamic deterioration and ventricular fibrillation.

It is important that an accurate pretreatment diagnosis distinguish wide complex QRS tachycardia of superventricular origin from that of ventricular origin prior to administration of diltiazem hydrochloride injection.
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.

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

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

Atrial Fibrillation -- Abnormal cardiac rhythm that is characterized by rapid, uncoordinated firing of electrical impulses in the upper chambers of the heart (HEART ATRIA). In such case, blood cannot be effectively pumped into the lower chambers of the heart (HEART VENTRICLES). It is caused by abnormal impulse generation.

Atrial Flutter -- Rapid, irregular atrial contractions caused by a block of electrical impulse conduction in the right atrium and a reentrant wave front traveling up the inter-atrial septum and down the right atrial free wall or vice versa. Unlike ATRIAL FIBRILLATION which is caused by abnormal impulse generation, typical atrial flutter is caused by abnormal impulse conduction. As in atrial fibrillation, patients with atrial flutter cannot effectively pump blood into the lower chambers of the heart (HEART VENTRICLES).

Wolff-Parkinson-White Syndrome -- A form of ventricular pre-excitation characterized by a short PR interval and a long QRS interval with a delta wave. In this syndrome, atrial impulse conducts to the HEART VENTRICLES via an accessory pathway located between the wall of the right or left atria and the ventricles, known as the bundle of Kent. The inherited form can be caused by mutation of PRKAG2 gene encoding a gamma-2 regulatory subunit of AMP-activated protein kinase.

SHORT SYNDROME --

Tachycardia, Ventricular -- An abnormally rapid ventricular rhythm usually in excess of 150 beats per minute. It is generated within the ventricle below the BUNDLE OF HIS, either as autonomic impulse formation or reentrant impulse conduction. Depending on the etiology, onset of ventricular tachycardia can be paroxysmal (sudden) or nonparoxysmal, its wide QRS complexes can be uniform or polymorphic, and the ventricular beating may be independent of the atrial beating (AV dissociation).

Ventricular Fibrillation -- A potentially lethal cardiac arrhythmia that is characterized by uncoordinated extremely rapid firing of electrical impulses (400-600/min) in HEART VENTRICLES. Such asynchronous ventricular quivering or fibrillation prevents any effective cardiac output and results in unconsciousness (SYNCOPE). It is one of the major electrocardiographic patterns seen with CARDIAC ARREST.

Warnings

Diltiazem prolongs AV nodal conduction and refractoriness that may rarely result in second- or third-degree AV block in sinus rhythm. Concomitant use of diltiazem with agents known to affect cardiac conduction may result in additive effects (see PRECAUTIONS, Drug Interactions).

If high-degree AV block occurs in sinus rhythm, intravenous diltiazem should be discontinued and appropriate supportive measures instituted (seeOVERDOSAGE).
Branded Drugs
The following US Branded drugs contain Diltiazem Hydrochloride


CARDIZEM CD -- BIOVAIL LABORATORIES INC

CARDIZEM SR -- BIOVAIL LABORATORIES INC

CARTIA XT -- WATSON LABORATORIES INC FLORIDA

DILACOR XR -- WATSON LABORATORIES INC

DILT-CD -- APOTEX INC

DILTZAC -- APOTEX INC ETOBICOKE SITE

TAZTIA XT -- WATSON LABORATORIES INC FLORIDA

TIAZAC -- BIOVAIL CORP INTERNATIONAL

CARDIZEM -- BIOVAIL LABORATORIES INC

CARDIZEM -- BIOVAIL LABORATORIES INTERNATIONAL SRL

CARDIZEM LA -- BIOVAIL LABORATORIES INTERNATIONAL SRL


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