SPL Set ID: 5749599d-ff2a-42e4-aa72-cd25013feee8

CARDENE I.V. (nicardipine hydrochloride) is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). CARDENE I.V. for intravenous administration contains 20 mg (0.1 mg/mL) of nicardipine hydrochloride per 200 mL in either dextrose or sodium chloride or 40 mg (0.2 mg/mL) of nicardipine hydrochloride per 200 mL in sodium chloride. Nicardipine hydrochloride is a dihydropyridine derivative with IUPAC (International Union of Pure and Applied Chemistry) chemical name (±)-2-(benzyl-methyl amino) ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride and has the following structure: Nicardipine hydrochloride is a greenish-yellow, odorless, crystalline powder that melts at about 169ºC. It is freely soluble in chloroform, methanol, and glacial acetic acid, sparingly soluble in anhydrous ethanol, slightly soluble in n-butanol, water, 0.01 M potassium dihydrogen phosphate, acetone, and dioxane, very slightly soluble in ethyl acetate, and practically insoluble in benzene, ether, and hexane. It has a molecular weight of 515.99. CARDENE I.V. is available as sterile, non-pyrogenic, a clear, pale yellow to yellow color solution, and essentially free from visible particles, in 10 mL single-dose vial for intravenous infusion after dilution. Each mL contains 2.5 mg nicardipine hydrochloride, 1 mg ascorbic acid, 0.525 mg citric acid monohydrate, 0.09 mg sodium hydroxide and 48 mg sorbitol (neosorb PF). Citric acid monohydrate and/or sodium hydroxide may have been added to adjust pH to 3.0 to 4.2. Cardene Structural Formula