DILTIAZEM HYDROCHLORIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

DILTIAZEM HYDROCHLORIDE

Composition:

DILTIAZEM HYDROCHLORIDE 5 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diltiazem Hydrochloride Injection is indicated for the following: 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. 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. 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.

Product summary:

Diltiazem Hydrochloride Injection 5 mg/mL is available in the following:     5 mL Vial (25 mg/vial) packaged in 10s (NDC 0641-9217-10)     10 mL Vial (50 mg/vial) packaged in 10s (NDC 0641-9218-10)     25 mL Vial (125 mg/vial) packaged in 10s (NDC 0641-9219-10) SINGLE-DOSE VIALS. DISCARD UNUSED PORTION. This product, including the packaging components, is free of latex. Store diltiazem hydrochloride injection under refrigeration 2º-8ºC (36º-46ºF). DO NOT FREEZE. May be stored at room temperature for up to 1 month. Destroy after 1 month at room temperature.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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DILTIAZEM HYDROCHLORIDE INJECTION
RX ONLY NOVAPLUS®
DESCRIPTION
DILTIAZEM HYDROCHLORIDE is a calcium ion influx inhibitor (slow
channel blocker or
calcium channel antagonist). Chemically, diltiazem hydrochloride is
(+)-5-[2-
(Dimethylamino)ethyl]-_cis_-2,3-dihydro-3-hydroxy-2-(_p_-methoxyphenyl)-1,5-
benzothiazepin-4(5_H_)-one acetate(ester) monohydrochloride. The
structural formula is:
C
H
N O S• HCl MW: 450.98
Diltiazem hydrochloride is a white to off-white crystalline powder
with a bitter taste. It is
soluble in water, methanol, and chloroform.
Diltiazem hydrochloride injection is a clear, colorless, sterile,
nonpyrogenic solution. It
has a pH range of 3.7 to 4.1.
Diltiazem hydrochloride injection is for direct intravenous bolus
injection and continuous
intravenous infusion.
Each mL contains: 5 mg Diltiazem Hydrochloride, USP, 0.75 mg Citric
Acid Anhydrous,
USP, 0.65 mg Sodium Citrate Dihydrate USP, 50 mg Sorbitol NF, and
Water for Injection,
USP q.s. Sodium Hydroxide or Hydrochloric Acid is used to adjust pH.
CLINICAL PHARMACOLOGY
MECHANISMS OF ACTION
Diltiazem inhibits the influx of calcium (Ca
+) ions during membrane depolarization of
cardiac and vascular smooth muscle. The therapeutic benefits of
diltiazem in
supraventricular tachycardias are related to its ability to slow AV
nodal conduction time
and prolong AV nodal refractoriness. Diltiazem exhibits frequency
(use) dependent
effects on AV nodal conduction such that it may selectively reduce the
heart rate during
tachycardias involving the AV node with little or no effect on normal
AV nodal conduction
22
26
2
4
2
at normal heart rates.
Diltiazem slows the ventricular rate in patients with a rapid
ventricular response during
atrial fibrillation or atrial flutter. Diltiazem converts paroxysmal
supraventricular
tachycardia (PSVT) to normal sinus rhythm by interrupting the reentry
circuit in AV nodal
reentrant tachycardias and reciprocating tachycardias, e