ST LOUIS (MD Consult) - On June 11, 2009, the US Food and Drug Administration announced the approval of Caldolor, an injectable dosage formulation of ibuprofen. The drug is indicated for the treatment of pain and fever, and it is being promoted as a useful alternative for patients who are unable to take medication orally. 

Caldolor will be available for hospital use only. It is approved to be administered in 400- to 800-mg doses, infused over 30 minutes, every 6 hours for acute pain. To treat fever, the drug is approved in a 400-mg dose administered over 30 minutes, followed by a dose of 400 mg every 4 to 6 hours or 100 to 200 mg every 4 hours, as necessary.

In a clinical trial of 319 women who had undergone an elective abdominal hysterectomy, patients were less likely to request morphine for pain on an as-needed basis when Caldolor was administered. The most common adverse reactions reported in controlled clinical trials were nausea, flatulence, vomiting, and headache.

Caldolor should be used with caution in patients with congestive heart failure and kidney impairment, in patients who are at risk for thrombosis, and in patients with a prior history of ulcers or gastrointestinal bleeding. When administered to such patients, the lowest effective dose should be given for the shortest time period to reduce the risk of serious adverse events. The drug has been associated with hypertension, and with serious skin and allergic reactions.

圣路易斯(MD Consult) ——2009年6月11日，美国食品药品管理局（FDA）宣布批准布洛芬的注射剂型（Caldolor）上市，用于疼痛和发热的治疗，用作无法口服用药患者的替代治疗。

 

Caldolor将仅可在医院内应用，其批准的剂量和用法为：对于急性疼痛，每6小时应用400～800mg，每次30分钟以上输注；对于发热，首剂400 mg，30分钟以上输注，尔后按需每4～6小时给予400 mg或每4小时应用100～200 mg。 

在对包括319例接受择期经腹子宫切除术的女性患者进行的一项临床研究中，当给予Caldolor后，患者更少要求应用吗啡，尽管吗啡是可按需索取的。在这项对照临床试验中出现最多的不良反应是恶心、胃肠气胀、呕吐和头痛。 

以下患者应慎用Caldolor：充血性心力衰竭、肾功能不全、有发生血栓形成风险和有胃肠溃疡或出血史的患者。当这些患者应用Caldolor时，应在尽量短的时间内给予最低有效剂量，以尽可能减少不良事件的发生。有研究证明，此药可引起高血压、严重皮肤和过敏反应。

 

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