DILTIAZEM HCI injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diltiazem Hydrochloride Injection or Diltiazem Hydrochloride for Injection are 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. In addition, Diltiazem Hydrochloride Injection is indicated for: 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 or diltiazem hydrochloride for 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 hydrochloride 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 hydrochloride 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. Injectable forms of diltiazem are 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 injectable forms of diltiazem. As such, the initial use of injectable forms of diltiazem 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 injectable forms of diltiazem. To Use Vial in ADD-Vantage® Flexible Diluent Container To Open: Peel overwrap at corner and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. To Assemble Vial and Flexible Diluent Container: (Use Aseptic Technique) Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap. (SEE FIGURE 2.) NOTE: Do not access vial with syringe. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the tie membrane, then pull back to remove the cover. (SEE FIGURE 3.) Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove. (SEE FIGURE 4.) Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. Label appropriately. To Reconstitute the Drug: Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.) Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. Mix container contents thoroughly and use within the specified time. Preparation for Administration: (Use Aseptic Technique) Confirm the activation and admixture of vial contents. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. Close flow control clamp of administration set. Remove cover from outlet port at bottom of container. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger. Squeeze and release drip chamber to establish proper fluid level in chamber. Open flow control clamp and clear air from set. Close clamp. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. Regulate rate of administration with flow control clamp. WARNING: Do not use flexible containers in series connections. Compatibility: Diltiazem hydrochloride injection and diltiazem hydrochloride for injection were tested for compatibility with three commonly used intravenous fluids at a maximal concentration of 1 mg diltiazem hydrochloride per milliliter. Diltiazem hydrochloride injection and diltiazem hydrochloride for injection were found to be physically compatible and chemically stable in the following parenteral solutions for at least 24 hours when stored in glass (diltiazem hydrochloride injection only) or polyvinylchloride (PVC) bags at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] or under refrigeration 2° to 8°C (36° to 46°F). dextrose (5%) injection USP sodium chloride (0.9%) injection USP dextrose (5%) and sodium chloride (0.45%) injection USP Physical Incompatibilities: Because of potential physical incompatibilities, it is recommended that diltiazem hydrochloride injection or diltiazem hydrochloride for injection not be mixed with any other drugs in the same container. If possible, it is recommended that diltiazem hydrochloride injection or diltiazem hydrochloride for injection not be co-infused in the same intravenous line. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Diltiazem hydrochloride injection. Physical incompatibilities (precipitate formation or cloudiness) were observed when diltiazem hydrochloride injection was infused in the same intravenous line with the following drugs: acetazolamide, acyclovir, aminophylline, ampicillin, ampicillin sodium/sulbactam sodium, cefamandole, cefoperazone, diazepam, furosemide, hydrocortisone sodium succinate, insulin, (regular: 100 units/mL), methylprednisolone sodium succinate, mezlocillin, nafcillin, phenytoin, rifampin, and sodium bicarbonate. Diltiazem hydrochloride for injection. Physical incompatibilities (precipitate formation or cloudiness) were observed when diltiazem hydrochloride for injection at a concentration of 1 mg/mL diluted in normal saline was infused in the same intravenous line with the following drugs: acetazolamide, acyclovir, cefoperazone sodium, diazepam, furosemide, phenytoin and rifampin. NOTE: Diltiazem hydrochloride for injection at a concentration of 1 mg/mL diluted in normal saline was infused in the same intravenous line and was found to be compatible with the following drugs: aminophylline, ampicillin sodium, ampicillin sodium/sulbactam sodium, cefamandole, hydrocortisone sodium succinate, regular insulin (100 units/mL), methylprednisolone sodium succinate, mezlocillin sodium, nafcillin sodium and sodium bicarbonate. Transition to Further Antiarrhythmic Therapy. 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 injection. These antiarrhythmic agents were intravenous or oral digoxin, Class 1 antiarrhythmics (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.

Product summary:

Diltiazem Hydrochloride Injection is supplied in single-dose Fliptop vials as follows: DILTIAZEM HCI FOR INJECTION is supplied in the following dosage forms. NDC 51662-1457-1 DILTIAZEM HCI FOR INJECTION EQUIVALENT TO 100mg DILTIAZEM HCI ADD-VANTAGE VIAL NDC 51662-1457-2 DILTIAZEM HCI FOR INJECTION EQUIVALENT TO 100mg DILTIAZEM HCI ADD-VANTAGE VIAL, 1 VIAL PER POUCH NDC 51662-1457-3 DILTIAZEM HCI FOR INJECTION EQUIVALENT TO 100mg DILTIAZEM HCI ADD-VANTAGE VIAL, 1 VIAL PER POUCH, 10 POUCHES PER CASE HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 DILTIAZEM HYDROCHLORIDE INJECTION IS TO BE STORED UNDER REFRIGERATION 2 TO 8°C (36 TO 46°F). DO NOT FREEZE. MAY BE STORED AT ROOM TEMPERATURE FOR UP TO 1 MONTH. DESTROY AFTER 1 MONTH AT ROOM TEMPERATURE. SINGLE-DOSE VIALS. DISCARD UNUSED PORTION. Diltiazem Hydrochloride for Injection for continuous infusion is supplied in single-dose ADD-Vantage vials as follows: DILTIAZEM HYDROCHLORIDE FOR INJECTION IS TO BE STORED AT 20° TO 25°C (68° TO 77°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] DO NOT FREEZE. RECONSTITUTED MATERIAL IS STABLE FOR 24 HOURS AT CONTROLLED ROOM TEMPERATURE OR REFRIGERATED 2° to 8°C (36° to 46°F). SINGLE-DOSE VIAL.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DILTIAZEM HCI- DILTIAZEM HCI INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
DILTIAZEM HCI FOR INJECTION EQUIVALENT TO 100MG DILTIAZEM HCI ADD-
VANTAGE VIAL
SPL UNCLASSIFIED
Single-Dose Fliptop Vial
Diltiazem Hydrochloride for Injection
Single-Dose ADD-Vantage® Vial
For Continuous Intravenous Infusion
Not For Bolus
RX Only
DESCRIPTION
Diltiazem hydrochloride is a calcium ion cellular influx inhibitor
(slow channel blocker or
calcium channel antagonist). Chemically, diltiazem hydrochloride is
1,5-benzothiazepin-
4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,
3-dihydro-2-(4-methoxyphenyl)-,
monohydrochloride,(+)-cis-. The chemical structure is:
Diltiazem hydrochloride is a white to off-white crystalline powder
with a bitter taste. It is
soluble in water, methanol, and chloroform. It has a molecular weight
of 450.98.
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.
25-mg, 5-mL vial-each sterile vial contains 25 mg diltiazem
hydrochloride, 3.75 mg citric
acid USP, 3.25 mg sodium citrate dihydrate USP, 250 mg sorbitol NF and
water for
injection USP up to 5 mL. Sodium hydroxide or hydrochloric acid is
used for pH
adjustment.
50-mg, 10-mL vial-each sterile vial contains 50 mg diltiazem
hydrochloride, 7.5 mg citric
acid USP, 6.5 mg sodium citrate dihydrate USP, 500 mg sorbitol NF and
water for
injection USP up to 10 mL. Sodium hydroxide or hydrochloric acid is
used for pH
adjustment.
Diltiazem hydrochloride for injection is an off-white lyophilized
powder and, after
reconstitution in an infusion bag, produces a clear, colorless,
sterile, nonpyrogenic
solution.
Diltiazem hydrochloride for injection for continuous intravenous
infusion is available in
ADD-Vantage Vials. The vial contains lyophilized powder comprised of
diltiazem
hydrochloride 100 mg and mannitol USP 75 mg for reconstitu