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Basic Drug Info
Drug Name:Diltiazem Hydrochloride
Manufacturer:Bedford Laboratories
Other Info:Manufactured by:                                          Manufactured for:Ben Venue Laboratories, Inc.                     Bedford Laboratories™Bedford, OH 44146                                      Bedford, OH 44146May 2005                                                       Div-DLTP01



Clinical Trials:


Indications and Usage

Diltiazem hydrochloride injection is indicated for the following:Atrial Fibrillation or Atrial Flutter.

Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter.

It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome.Paroxysmal Supraventricular Tachycardia.

Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm.

This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome.

Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection.The use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium.For either indication and particularly when employing continuous intravenous infusion, the setting should include continuous monitoring of the ECG and frequent measurement of blood pressure.

A defibrillator and emergency equipment should be readily available.In domestic controlled trials in patients with atrial fibrillation or atrial flutter, bolus administration of diltiazem hydrochloride injection was effective in reducing heart rate by at least 20% in 95% of patients.

Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm.

Following administration of one or two intravenous bolus doses of diltiazem injection, response usually occurs within 3 minutes and maximal heart rate reduction generally occurs in 2 to 7 minutes.

Heart rate reduction may last from 1 to 3 hours.

If hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours.A 24-hour continuous infusion of diltiazem injection in the treatment of atrial fibrillation or atrial flutter maintained at least a 20% heart rate reduction during the infusion in 83% of patients.Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours).

Hypotension, if it occurs, may be similarly persistent.

In the controlled clinical trials, 3.2% of patients required some form of intervention (typically, use of intravenous fluids or the Trendelenburg position) for blood pressure support following diltiazem hydrochloride injection.

In domestic controlled trials, bolus administration of diltiazem hydrochloride injection was effective in converting PSVT to normal sinus rhythm in 88% of patients within 3 minutes of the first or second bolus dose.

Symptoms associated with the arrhythmia were improved in conjunction with decreased heart rate or conversion to normal sinus rhythm following administration of diltiazem hydrochloride injection.
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 --

Paroxysmal supraventricular tachycardia -- An episodic form of supraventricular tachycardia, with abrupt onset and termination.

Atrioventricular Nodal Reentry Tachycardia -- Abnormally rapid heartbeats caused by reentry of atrial impulse into the dual (fast and slow) pathways of ATRIOVENTRICULAR NODE. The common type involves a blocked atrial impulse in the slow pathway which reenters the fast pathway in a retrograde direction and simultaneously conducts to the atria and the ventricles leading to rapid HEART RATE of 150-250 beats per minute.

Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

cardiac arrhythmia -- any variation from the normal rhythm or rate of the heart beat.

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 supraventricular 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

Cardiac Conduction.

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 Drug Interactions).

If high-degree AV block occurs in sinus rhythm, intravenous diltiazem should be discontinued and appropriate supportive measures instituted (see OVERDOSAGE).Congestive Heart Failure.

Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function and in patients with a compromised myocardium, such as severe CHF, acute MI, and hypertrophic cardiomyopathy, have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt).

Administration of oral diltiazem in patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission is contraindicated.

Experience with the use of diltiazem hydrochloride injection in patients with impaired ventricular function is limited.

Caution should be exercised when using the drug in such patients.Hypotension.

Decreases in blood pressure associated with diltiazem hydrochloride injection therapy may occasionally result in symptomatic hypotension (3.2%).

The use of intravenous diltiazem for control of ventricular response in patients with supraventricular arrhythmias should be undertaken with caution when the patient is compromised hemodynamically.

In addition, caution should be used in patients taking other drugs that decrease peripheral resistance, intravascular volume, myocardial contractility or conduction.Acute Hepatic Injury.

In rare instances, significant elevations in enzymes such as alkaline phosphatase, LDH, SGOT, SGPT, and other phenomena consistent with acute hepatic injury have been noted following oral diltiazem.

Therefore, the potential for acute hepatic injury exists following administration of intravenous diltiazem.Ventricular Premature Beats (VPBs).

VPBs may be present on conversion of PSVT to sinus rhythm with diltiazem hydrochloride injection.

These VPBs are transient, are typically considered to be benign, and appear to have no clinical significance.

Similar ventricular complexes have been noted during cardioversion, other pharmacologic therapy, and during spontaneous conversion of PSVT to sinus rhythm.
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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