Nicardipine hydrochloride is available as a 2.5-mg/mL concentrate for injection in 10-mL single-dose vials.3702; 3703 Each mL (Hikma) also contains benzoic acid 0.305 mg and sodium chloride 7.5 mg in water for injection; sodium hydroxide may have been added to adjust the pH.3702 Each mL (American Regent) also contains sorbitol 48 mg, edetate disodium 0.04 mg, citric acid monohydrate 0.525 mg, and sodium hydroxide 0.09 mg in water for injection; additional citric acid and/or sodium hydroxide may have been added to adjust the pH.3703 Each mL (AuroMedics) also contains sorbitol 48 mg, citric acid monohydrate 0.525 mg, and sodium hydroxide 0.09 mg in water for injection; additional citric acid and/or sodium hydroxide may have been added to adjust the pH.3704
Nicardipine hydrochloride also is available as a premixed, iso-osmotic, ready-to-use solution at concentrations of 0.1 and 0.2 mg/mL in bags containing 200 mL.3701; 3702 Each mL of the 0.1-mg/mL premixed solution (Cardene I.V., Chiesi) also contains either dextrose hydrous 48 mg or sodium chloride 8.6 mg, as well as citric acid anhydrous 0.0192 mg, sorbitol 1.92 mg, and hydrochloric acid and/or sodium hydroxide to adjust the pH.3701 Each mL of the 0.2-mg/mL premixed solution (Cardene I.V., Chiesi) also contains sodium chloride 8.3 mg, citric acid anhydrous 0.0384 mg, sorbitol 3.84 mg, and hydrochloric acid and/or sodium hydroxide to adjust the pH.3701 Each mL of the 0.1- and 0.2-mg/mL premixed solutions (Hikma) also contains sodium chloride 9 mg; hydrochloric acid may have been added to adjust the pH.3702
pH
Nicardipine hydrochloride concentrates for injection have a pH of 3.5.3702; 3703; 3704
The premixed infusion solutions (Cardene I.V.) have a pH ranging from 3.7 to 4.7.3701
Trade Name(s)
Cardene I.V.
Nicardipine hydrochloride concentrate for injection is administered by slow continuous intravenous infusion after dilution to a concentration of 0.1 mg/mL.3702; 3703; 3704 The infusion is prepared by adding 10 mL (25 mg) of nicardipine hydrochloride concentrate for injection to 240 mL of compatible infusion solution, yielding 250 mL of a 0.1-mg/mL solution.3702; 3703; 3704
Nicardipine hydrochloride premixed solutions in dextrose or sodium chloride also are administered by slow continuous intravenous infusion.3701; 3702 Further dilution of the premixed solutions is not required.3701; 3702
Nicardipine hydrochloride should be administered through a central vein or a large peripheral vein to reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, extravasation, and the rare occurrence of vascular impairment.3701; 3702; 3703; 3704 If nicardipine hydrochloride is administered via a peripheral vein, the infusion site should be changed every 12 hours to avoid venous irritation.3701; 3702; 3703; 3704 Extreme care should be exercised to avoid intra-arterial administration or extravasation.3701; 3702; 3703; 3704
Intact containers of the clear, colorless to yellow solution should be stored at controlled room temperature and protected from light by storing in the carton until time of use.3701; 3702; 3703; 3704 Manufacturers state that freezing does not adversely affect the product;3702; 3703; 3704 one manufacturer of premixed infusion solutions (Chiesi) states that the drug should be protected from freezing.3701 Exposure to excessive heat and elevated temperatures should be avoided.3701; 3702; 3703; 3704
Light Effects
Deliberate exposure of a 0.1-mg/mL nicardipine hydrochloride solution to daylight resulted in about 8% loss in 7 hours and 21% loss in 14 hours. Protection from light may be considered.2193
Sorption
Nicardipine hydrochloride (Dupont Merck) 50 and 500 mg/L in a variety of infusion solutions in polyvinyl chloride (PVC) containers showed a decline in concentration due to sorption to the plastic. Losses were rapid in Ringers injection, lactated with up to 42% lost in 24 hours. The concentrations were stable in glass containers.1380
Standardize 4 Safety
One or more standardized concentrations for this drug have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. (See Standardize 4 Safety in Users Guide.) Recommendations developed to date through this initiative are available at www.ashp.org/pharmacy-practice/standardize-4-safety-initiative.
Table 1: Standardize 4 Safety Continuous IV Infusion Standard Concentrations for Nicardipine3635; 3636
Patient Population | Concentration Standards | Dosing Units |
---|---|---|
Adults | 0.1 mg/mL 0.2 mg/mL | mg/hour |
Pediatric patients (50 kg) | 0.1 mg/mL 0.2 mg/mL 0.5 mg/mL | mcg/kg/minute (note dosing units differ from concentration units) |
For a list of references cited in the text of this monograph, search the monograph titled References.