About Cleviprex®Cleviprex (clevidipine butyrate) injectable emulsion

Cleviprex is the latest-generation intravenous (IV) dihydropyridine calcium channel blocker, and is indicated for the reduction of blood pressure (BP) when oral therapy is not feasible or not desirable. With its rapid onset and offset of effect and ultrashort half-life, Cleviprex can be titrated for predictable BP control. Unlike many current antihypertensive treatments that are metabolized by the kidney or liver,Cleviprex is metabolized by esterases in the blood and extravascular tissues1 and does not accumulate in the body.

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.

Cleviprex side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:
feeling like you might pass out;slow heart rate;urinating less than usual or not at all;
drowsiness, confusion, mood changes, increased thirst, loss of appetite, vomiting;
feeling short of breath, even with mild exertion;swelling, rapid weight gain; or chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.
Less serious Cleviprex side effects may include：headache; ormild nausea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

        美国FDA批准The Medicines Company公司的丁酸氯维地平静脉注射用乳剂(clevidipine butyrate，Cleviprex)上市，用于降低不宜口服治疗或口服治疗无效的高血压。
       本品系一新颖的静脉抗高血压药品，代表了目前治疗药品的1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。新近临床实践发现，控制血压紧急升高和降低不良反应出现的危险性间 存在着重要的相关性。
　 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。
　　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。本品最先在美 国获准上市是基于其对1 406例治疗和手术患者6项Ⅲ期临床研究的结果。所有Ⅲ期临床研究均符合其主要终点指标。本品可引起全身性低血压和反射性心动过速，其最常见的不良反应 （>2%）：头痛，恶心和呕吐。

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详细处方信息以本药内容附件PDF文件（2009122212032932.pdf）的“原文Priscribing Information”为准
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