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:
≥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:
<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
【剂型及规格】注射液，25mg/50mL (每毫升含氯维地平0.5mg)；50mg/100mL。
【适应症】抗高血压药。用于降低不宜口服治疗或口服治疗无效的高血压。
【项目简介】
丁酸氯维地平是由英国阿斯利康公司（AstraZeneca）公司研制的第三代新型短效二氢吡啶类钙通道拮抗剂，2008年8月首次在美国上市，商品名Cleviprex。2011年11月本品在欧盟获得批准。本品为注射乳剂，用于治疗不宜口服或口服无效的高血压，也可用于治疗外科手术后急性血压升高。氯维地平为二氢吡啶衍生物，本品2008年8月获FDA批准上市。氯维地平具有高度的血管及心肌选择性，在体内迅速代谢为非活性物质。氯维地平具有很强的降低脉率的活性，对全身血管及肺血管也有扩张效果。
氯维地平是一个二氢吡啶类L-型钙通道阻滞剂，L-型钙通道在动脉平滑肌去极化时调节钙的流入。麻醉大鼠和狗试验表明氯维地平通过减少全身血管阻力降低平均动脉血压。氯维地平不能降低心脏充盈压，证实对静脉容量血管没用影响。在近10年中，尚无静脉注射的抗高血压新药上市。本品是新一代静脉注射用二氢吡啶类钙通道阻滞药，代表了目前治疗高血压药品的一项新进展，为重症监护室医生提供了快速、精确控制血压的新武器。凭藉急救室、手术室和监护室所得数据，本品向医生提供了降血压重要的新观点。本品起效快，作用消除也快，可递增剂量精确地控制血压。与目前许多静脉注射经肾和(或)肝代谢的抗高血压药不同，其在血液和组织中代谢，因而不在体内蓄积。
