Source: FDA, National Drug Code (US) Revision Year: 2021
Cleviprex is a sterile, milky-white emulsion containing 0.5 mg/mL of clevidipine suitable for intravenous administration. Clevidipine is a dihydropyridine calcium channel blocker. Chemically, the active substance, clevidipine, is butyroxymethyl methyl 4-(2´,3´-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. It is a racemic mixture with a molecular weight of 456.3 g/mol. Each enantiomer has equipotent antihypertensive activity.
The structure and formula are:
Clevidipine is practically insoluble in water and is formulated in an oil-in-water emulsion. In addition to the active ingredient, clevidipine, Cleviprex contains soybean oil (200 mg/mL), glycerin (22.5 mg/mL), purified egg yolk phospholipids (12 mg/mL), oleic acid (0.3 mg/mL), disodium edetate (0.05 mg/mL), and sodium hydroxide to adjust pH. Cleviprex has a pH of 6.0–8.0 and is a ready-to-use emulsion.
| Dosage Forms and Strengths |
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Cleviprex is a sterile, milky white injectable emulsion for intravenous use, available in the following configurations:
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| How Supplied |
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Cleviprex (clevidipine) injectable emulsion is supplied as a sterile, milky white liquid emulsion product in single-use glass vials at a concentration of 0.5 mg/mL of clevidipine. NDC 10122-610-10: 10 Single Use 50 mL Vials Manufactured by: Fresenius Kabi Austria GmbH, Graz, Austria Marketed by: Chiesi USA, Inc., Cary, NC 27518 |
| Drug | Countries | |
|---|---|---|
| CLEVIPREX | Austria, Spain, France, Netherlands, New Zealand, United States |
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