Generic Name and Formulations:
Clevidipine butyrate emulsion 0.5mg/mL; soln for IV infusion; contains lipids 0.2g/mL (soybean oil, egg phospholipids).
Company:
The Medicines Company
Indications for CLEVIPREX:
To reduce blood pressure when oral therapy is not feasible or desirable.
Adult Dose for CLEVIPREX:
≥18yrs: Individualize; titrate. Give by IV infusion. Initially 1–2mg/hr; double dose at 90sec intervals until BP approaches goal, then titrate slower (adjust at 5–10min intervals). Dose increases of 1–2mg/hr results in systolic BP lowering of about 2–4mmHg. Maintenance: 4–6mg/hr; usual max 16–32mg/hr. Do not exceed 1000mL (21mg/hr for 24hrs) due to lipid load. Switch to oral therapy when indicated.
Children's Dose for CLEVIPREX:
<18yrs: not recommended.
Pharmacological Class:
Calcium channel blocker (dihydropyridine).
Contraindications:
Egg or soy allergy. Defective lipid metabolism (eg, pathologic hyperlipemia, lipoid nephrosis, acute pancreatitis with hyperlipidemia). Severe aortic stenosis.
Warnings/Precautions:
Maintain aseptic technique. Monitor BP and pulse during infusion and until stabilized. Heart failure (monitor). Monitor for rebound hypertension for at least 8hrs after stopping infusion (if not given other antihypertensives after prolonged infusion). Avoid abrupt cessation of any β-blocker treatment. Pheochromocytoma. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.
Adverse Reactions:
Headache, nausea, vomiting; hypotension, reflex tachycardia (slow infusion if occurs, do not use beta-blocker); rare: myocardial infarction, cardiac arrest, syncope, dyspnea.
How Supplied:
Single-use vials—50mL, 100mL
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Cleviprex® (clevidipine) Injectable Emulsion is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
Important Safety Information
Cleviprex® (clevidipine) Injectable Emulsion is contraindicated in patients with:
Allergies to soybeans, soy products, eggs, or egg products;
Defective lipid metabolism seen in conditions such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and
Severe aortic stenosis.
Cleviprex is intended for intravenous use. Use aseptic technique and discard any unused product within 12 hours of stopper puncture.
Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. 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.
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.
Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.
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 withdrawn only after a gradual reduction in dose.
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.
There is no information to guide use of Cleviprex in treating hypertension associated with pheochromocytoma.
Most common adverse reactions for Cleviprex (>2%) are headache, nausea, and vomiting.
Please see full Prescribing Information for Cleviprex.
