Pacira医药公司在美国上市EXPAREL，这是一种注射用脂质体布比卡因。
XPAREL用于外科手术部位手术后的止痛。
这种药物结合了布比卡因和DepoFoam，通过释放技术将药物释放控制在一个理想的时间内。
Pacira公司总裁兼CEO Dave Srack说：“对美国每年数以百万计的接受外科手术的患者来说，推出这种单剂量非阿片类止痛药，能够很好的辅助医疗器械来治疗手术后的疼痛
EXPAREL®
EXPAREL is a local analgesic that utilizes bupivacaine in combination with the proven product delivery platform, DepoFoam®. A single intraoperative injection given at the close of surgery delivers postsurgical pain control with reduced opioid requirements† for up to 72 hours,*1 making it a potentially suitable choice for patients who need effective pain management in the first few days after surgery,* when pain is at its worst.2
See how EXPAREL is manufactured at the Pacira Science Center Campus.
A non-opioid analgesic should be considered in populations where the use of opioids is most problematic, including:
Elderly patients‡
Obese patients
Sleep apneic patients3
The safety of EXPAREL has been eva luated in 21 clinical trials which include over 1300 subjects in the safety database. EXPAREL administered locally into the surgical site was eva luated in 10 randomized, double-blind clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 mg to 532 mg of EXPAREL.1
EXPAREL is indicated for administration into the surgical site to produce postsurgical analgesia.1
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age.
Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL.
Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations.
In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting.
For more information regarding EXPAREL, please visit the Pacira press release archives or www.EXPAREL.com.
http://www.exparel.com/index.shtml |
