CARDIZEM^® (diltiazem hydrochloride) is a calcium ion 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. CARDIZEM Injectable (diltiazem hydrochloride injection) is a clear, colorless, sterile, nonpyrogenic solution. It has a pH range of 3.7 to 4.1.

CARDIZEM Injectable is for direct intravenous bolus injection and continuous intravenous infusion. 25-mg, 5-mL vialeach sterile vial contains 25 mg diltiazem hydrochloride, 3.75 mg citric acid USP, 3.25 mg sodium citrate dihydrate USP, 357 mg sorbitol solution USP, and water for injection USP up to 5 mL. Sodium hydroxide or hydrochloric acid is used for pH adjustment.

50-mg, 10-mL vialeach sterile vial contains 50 mg diltiazem hydrochloride, 7.5 mg citric acid USP, 6.5 mg sodium citrate dihydrate USP, 714 mg sorbitol solution USP, and water for injection USP up to 10 mL. Sodium hydroxide or hydrochloric acid is used for pH adjustment.

CARDIZEM Lyo-Ject Syringe (diltiazem hydrochloride) after reconstitution contains a clear, colorless, sterile, nonpyrogenic solution. It has a pH range of 4.0 to 7.0. CARDIZEM Lyo-Ject Syringe after reconstitution is for direct intravenous bolus injection and continuous intravenous infusion.

CARDIZEM Lyo-Ject Syringe 25-mg syringe is available in a dual chamber, disposable syringe. Chamber 1 contains lyophilized powder comprised of diltiazem hydrochloride 25 mg and mannitol USP 37.5 mg. Chamber 2 contains sterile diluent composed of 5 mL water for injection with 0.5% benzyl alcohol NF, and 0.6% sodium chloride USP. CARDIZEM Monovial (diltiazem hydrochloride for injection), after reconstitution in an infusion bag, produces a clear, colorless, sterile, nonpyrogenic solution.

CARDIZEM Monovial for continuous intravenous infusion is available in a glass vial with transfer needle set. The vial contains lyophilized powder comprised of diltiazem hydrochloride 100 mg and mannitol USP 75 mg.

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