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Clevidipine Butyrate

Cleviprex® is supplied as a sterile, milky white, ready-to-use lipid emulsion that contains clevidipine butyrate, soybean oil, glycerin, purified egg yolk phospholipids, and sodium hydroxide to adjust pH.1 Cleviprex is formulated and administered in a lipid emulsion because clevidipine butyrate is practically insoluble in water.1

Rapidly Metabolized by Tissue and Blood Esterases

  • Cleviprex is rapidly metabolized by hydrolysis of the ester linkage, primarily by esterases in the blood and extravascular tissues, making its elimination unlikely to be affected by hepatic or renal dysfunction1
  • In vitro studies show that Cleviprex and its metabolite, at the concentrations achieved in clinical practice, will not inhibit or induce any cytochrome P450 enzyme1
  • The potential of Cleviprex to interact with other drugs is low1

 

Metabolism in Blood and Extravascular Tissues2

Molecule

Figure adapted from Nordlander M et al. Cardiovasc Drug Rev. 2004;22:227-250.

IMPORTANT SAFETY INFORMATION

Cleviprex is intended for intravenous use. Titrate drug depending on the response of the individual patient to achieve the desired blood pressure reduction. Monitor blood pressure and heart rate continually during infusion, and then until vital signs are stable. Patients who receive prolonged Cleviprex infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped.

Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products; defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and in patients with severe aortic stenosis.

Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully. Cleviprex gives no protection against the effects of abrupt beta-blocker withdrawal.

Most common adverse reactions (> 2%) are headache, nausea, and vomiting.

Cleviprex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Maintain aseptic technique while handling Cleviprex. Cleviprex contains phospholipids and can support microbial growth. Do not use if contamination is suspected. Once the stopper is punctured, use and discard within 4 hours.

Please see full Prescribing Information.

References

  1. Cleviprex™ (clevidipine butyrate) injectable emulsion [prescribing information]. Parsippany, NJ: The Medicines Company; August 1, 2008. Nordlander M, Sjoquist PO, Ericsson H, Ryden L. Pharmacodynamic, pharmacokinetic and clinical effects of clevidipine, an ultrashort-acting calcium antagonist for rapid blood pressure control. Cardiovasc Drug Rev. 2004;22:227-250.
  2. Nordlander M, Sjoquist PO, Ericsson H, Ryden L. Pharmacodynamic, pharmacokinetic and clinical effects of clevidipine, an ultrashort-acting calcium antagonist for rapid blood pressure control. Cardiovasc Drug Rev. 2004;22:227-250.