Instructions for Administration
Maintain aseptic technique while handling Cleviprex. Cleviprex is a single-use parenteral product. Do not use if contamination is suspected. Once the stopper is punctured, use within 12 hours and discard any unused portion.
Cleviprex is supplied in sterile, pre-mixed, ready-to-use 50 mL or 100 mL vials. Invert vial gently several times before use to ensure uniformity of the emulsion prior to administration. Inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit. Administer Cleviprex using an infusion device allowing calibrated infusion rates. Commercially available standard plastic cannulae may be used to administer the infusion.Administer Cleviprex by a central line or a peripheral line.
Cleviprex should not be administered in the same line as other medications.
Cleviprex should not be diluted, but it can be administered with the following:
Water for Injection, USP
Sodium Chloride (0.9%) Injection, USP
Dextrose (5%) Injection, USP
Dextrose (5%) in Sodium Chloride (0.9%) Injection, USP
Dextrose (5%) in Ringers Lactate Injection, USP
Lactated Ringers Injection, USP
10% amino acid
Dosage Forms and Strengths
Cleviprex is a sterile, milky white injectable emulsion for intravenous use, available in the following two configurations:
50 mL single use vial with 0.5 mg/mL clevidipine
100 mL single use vial with 0.5 mg/mL clevidipine
Contraindications
Known Allergy
Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products.
Defective Lipid Metabolism
Cleviprex is contraindicated in patients with defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia.
Severe Aortic Stenosis
Cleviprex is contraindicated in patients with severe aortic stenosis because afterload reduction can be expected to reduce myocardial oxygen delivery.
Warnings and Precautions
Need for Aseptic Technique
Use aseptic technique and discard any unused product within 12 hours of stopper puncture [see Dosage and Administration (2.3)].
Hypotension and Reflex Tachycardia
Cleviprex may produce systemic hypotension and reflex tachycardia. If either occurs, decrease the dose of Cleviprex. There is limited experience with short-duration therapy with beta-blockers as a treatment for Cleviprex-induced tachycardia. Beta-blocker use for this purpose is not recommended.
Lipid Intake
Cleviprex contains approximately 0.2 g of lipid per mL (2.0 kcal). Lipid intake restrictions may be necessary for patients with significant disorders of lipid metabolism. For these patients, a reduction in the quantity of concurrently administered lipids may be necessary to compensate for the amount of lipid infused as part of the Cleviprex formulation.
Negative Inotropy
Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.
Beta-Blocker Withdrawal
Cleviprex is not a beta-blocker, does not reduce heart rate, and gives no protection against the effects of abrupt beta-blocker withdrawal. Beta-blockers should be w