DILTIAZEM (CARDIZEM ®)
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Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]
| ---Final Concentration 1 mg/ml ---
Diltiazem hydrochloride Solution (5 mg/mL)
[125 mg (25 ml)/ 100 ml] [Titrate]
[Total volume = 125 ml]
Diltiazem hydrochloride powder, for solution (100mg vials)
The vials contain sterile diltiazem hydrochloride, USP, 100 mg and mannitol, USP, 75 mg base for reconstitution in the ADD-Vantage®Flexible Diluent Container containing 5% dextrose injection or 0.9% sodium chloride injection.
Note: if the ADD-Vantage®Flexible containers are not available use the following steps:
Stability / Miscellaneous
Diltiazem hydrochloride injection was found to be physically compatible and chemically stable in the following parenteral solutions for at least 24 hours when stored in glass 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
DOSAGE AND ADMINISTRATION
Continuous Intravenous Infusion
Diltiazem shows dose-dependent, non-linear pharmacokinetics. Duration of infusion longer than 24 hours and infusion rates greater than 15 mg/h have not been studied. Therefore, infusion duration exceeding 24 hours and infusion rates exceeding 15 mg/h are not recommended.
Dilution: To prepare diltiazem hydrochloride injection for continuous intravenous infusion aseptically transfer the appropriate quantity (see chart) of diltiazem hydrochloride injection to the desired volume of either Normal Saline, D5W, or D5W/0.45% NaCl. Mix thoroughly. Use within 24 hours. Keep refrigerated until use.
*5 mg/h may be appropriate for some patients.
• dextrose (5%) injection USP
Diltiazem Hydrochloride. Physical incompatibilities (precipitate formation or cloudiness) were observed when diltiazem hydrochloride 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.
Transition to Further Antiarrhythmic Therapy:
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. 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.
DISCARD UNUSED PORTION.
STORE PRODUCT 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.
Revised: June, 2006