Company:

The Medicines Company

Calcium channel blocker (dihydropyridine)

Clevidipine butyrate emulsion 0.5mg/mL; soln for IV infusion; contains lipids 0.2g/mL (soybean oil, egg phospholipids).

To reduce blood pressure when oral therapy is not feasible or desirable.

Clevidipine is a calcium channel blocker formulated in an oil-in-water emulsion for IV infusion. Other drugs in this class include amlodipine, felodipine, nifedipine, and nisoldipine. In vivo studies indicate that this drug reduces mean arterial blood pressure by reducing vascular resistance. It does not affect cardiac filling pressure (pre-load).

Upon infusion, it is rapidly distributed and metabolized, with a terminal half-life of about 15 minutes, and it begins to lower the BP within about 2–4 minutes. An increase in heart rate may occur in response to the vasodilation. Clevidipine does not offer any protection against the effects of sudden beta-blocker withdrawal and is not recommended in this setting.

Two double-blind, randomized, placebo-controlled studies were conducted with patients undergoing coronary artery bypass grafting. One study included pre-op patients with mean BP of 178/77mmHg, and the other included post-op patients with a mean BP of 150/71. In both studies, BP was lowered within 2–4 minutes of starting the cleviprex infusion.

A randomized, placebo-controlled study was conducted in 61 patients with mild-to-moderate essential hypertension (mean baseline BP 151/86mmHg). Subjects were randomized to placebo or cleviprex at several infusion rates ranging from 2–16mg/hr. Systolic BP effect was related to the concentration of clevidipine butyrate given, it plateaued at higher measured concentrations, with the maximal effect about 25% of baseline BP.

In an open label study in 126 patients with severe hypertension, BP was reduced within 5mins and reached a plateau between 15 and 20mins after starting a 2mg/hr infusion.

≥18yrs: Individualize; titrate. Give by IV infusion. Initially 1–2mg/hr; double dose at 90-second intervals until BP approaches goal, then titrate slower (adjust at 5–10minute 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.

≤18yrs: not recommended.

Egg or soy allergy. Defective lipid metabolism (eg, pathologic hyperlipemia, lipoid nephrosis, acute pancreatitis with hyperlipidemia). Severe artery stenosis.

Monitor BP and pulse during infusion and until stabilized. Heart failure (monitor). Pheochromocytoma. Monitor for rebound hypertension for at least 8hrs after stopping infusion (if not given other antihypertensives after prolonged infusion). Labor & delivery. Pregnancy (Cat.C). Nursing mothers.

Headache, nausea, vomiting; hypotension, reflex tachycardia (slow infusion if occurs, do not use beta-blocker); rare: myocardial infarction, cardiac arrest, syncope, dyspnea.

Single-use vials—50mL, 100mL

9/19/08