Clevidipine is available as a ready-to-use oil-in-water emulsion in 50- and 100-mL single-dose vials.3200 Each mL contains clevidipine 0.5 mg along with soybean oil 200 mg, glycerin 22.5 mg, purified egg yolk phospholipids 12 mg, oleic acid 0.3 mg, and disodium edetate 0.05 mg (0.005%) with sodium hydroxide to adjust the pH.3200
pH
6 to 8.3200
Trade Name(s)
Cleviprex
Clevidipine is administered by intravenous infusion into either a central line or peripheral line using an infusion device that allows calibrated infusion rates.3200
Vials of clevidipine should be inverted gently several times prior to administration to ensure uniformity of the emulsion.3200 Commercially available standard plastic cannulae may be used to administer the infusion.3200
Clevidipine ready-to-use emulsion should not be diluted.3200
Clevidipine is a milky white, oil-in-water emulsion.3200 Intact vials should be stored at 2 to 8°C in the carton to protect from light and should not be frozen.3200 Intact vials may be stored for up to 2 months at controlled room temperature; vials stored at room temperature should be marked with the date of removal from refrigeration and should be discarded 2 months after the date of transfer to room temperature storage or the expiration date, whichever comes first.3200 Once moved to storage at room temperature, vials should not be returned to refrigerated storage.3200
The lipid base of the oil-in-water emulsion supports microbiological growth.3200 The disodium edetate in the formulation retards the growth of microorganisms, but the product can still support growth and is not antimicrobially preserved.3200 Aseptic technique should be maintained during handling.3200
Once the vial stopper is punctured, administration of clevidipine should be completed within 12 hours and any unused portion should be discarded.3200 The emulsion should be visually inspected for particulate matter and discoloration prior to administration.3200
Temperature Effects
Clevidipine should be stored at 2 to 8°C;3200 however, clevidipine (Chiesi) 0.5 mg/mL in intact vials has been reported to be physically and chemically stable after 5 cycles of alternating storage at 5°C for 24 hours followed by 25°C for 24 hours.3334
Freezing Solutions
Clevidipine should not be frozen;3200 however, clevidipine (Chiesi) 0.5 mg/mL in intact vials has been reported to be physically and chemically stable for up to 12 hours at -15°C followed by storage for 24 hours at 5°C.3334
Light Effects
Clevidipine is photosensitive and should be stored protected from light; however protection from light during administration is not required.3200
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 Clevidipine3635
Patient Population | Concentration Standards | Dosing Units |
---|---|---|
Pediatric patients (50 kg) | 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.