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当前位置:药品说明书与价格首页 >> 抗肿瘤药 >> 药品目录 >> 辅助药类 >> 止痛剂类 >> 布洛芬静脉注射液(ibuprofen,Caldolor)

布洛芬静脉注射液(ibuprofen,Caldolor)

2011-04-25 18:30:58  作者:新特药房  来源:中国新特药网天津分站  浏览次数:911  文字大小:【】【】【
简介:制造商: 坎伯兰制药公司 药理分类: 类固醇消炎药(丙酸deriv。) 活性成分(补): 布洛芬100mg/mL;为稀释后静脉滴注。 指示(补): 轻度至中度疼痛。中度至重度疼痛的阿片类药物的辅助手段。发烧。 药 ...

制造商:
坎伯兰制药公司

药理分类:
类固醇消炎药(丙酸deriv。)

活性成分(补):
布洛芬100mg/mL;为稀释后静脉滴注。
指示(补):
轻度至中度疼痛。中度至重度疼痛的阿片类药物的辅助手段。发烧。

药理作用:
布洛芬是一种非甾体抗炎与解热镇痛作用剂。它被认为是前列腺素合成,通过发挥其治疗作用的抑制。

临床试验:
对急性疼痛的疗效Caldolor进行了评价,两个多中心,随机,双盲,安慰剂对照研究。在第一项研究,319位女性谁经历了一个与择期腹部子宫切除术或Caldolor 800毫克或管理的每6小时需要的基础上吗啡安慰剂治疗。与Caldolor治疗的患者表现出的平均消费量显着明显的吗啡超过24比那些接受安​​慰剂的病人数减少。在第二个疼痛的研究中,谁经历了406择期腹部或骨科手术患者随机接受需要的基础上Caldolor 400毫克,800毫克Caldolor,或管理的每6小时服用安慰剂,吗啡。该研究未能证明在统计上显着的成果800毫克或400毫克接受Caldolor和安慰剂病患的差异,虽然有利于积极治疗的趋势。

两项随机,双盲研究进行了评估,减少发热的Caldolor疗效。在第一项研究,120华氏度的温度≥101例患者随机Caldolor 400毫克,200毫克,100毫克或管理的24个小时,每4小时服用安慰剂。三Caldolor剂量导致了每个患者的比例有显温度降低后,4比安慰剂组(65%,73%,77%和32%,分别)小时“(<101 ° F)之间。在第二项研究中,60例无并发症恶性疟原虫疟疾患者有温度≥100.4 ° F组随机Caldolor 400毫克或安慰剂治疗管理的72小时,每6小时。在最初24小时的治疗,显着降低了发热观察到Caldolor治疗的患者。

法律分类:
接收

成人:
≥17yrs:给由静脉输注超过30分钟。使用最低有效剂量。保持足够的水分。疼痛:400毫克,800毫克每6小时需要。发热:最初400毫克,400毫克随后由每4-6小时或100 - 200毫克,每4小时为需要。马克斯:3200mg/day。

儿童:
<17yrs:不推荐。

禁忌(补):
阿司匹林过敏。冠状动脉搭桥手术。第三早孕。

警告/注意事项:
晚期肾疾病:不推荐。历史溃疡病或胃肠出血。主动消化性溃疡。肾或肝功能受损。哮喘。水肿。高血压,监测血压。心力衰竭。出血性疾病。监测血液,肝和肾长期使用功能。如果停止视觉,皮疹或肝功能障碍发生。脱水。老人。虚弱。劳动和交付。妊娠(Cat.C:“30周妊娠,Cat.D:≥30周妊娠)。哺乳母亲:不推荐。

互动(补):
避免使用阿司匹林。可拮抗ACE抑制剂,利尿剂。胃肠道出血的风险增加口服类固醇,抗凝血剂(显示器),酒精,吸烟。提高锂的水平。五月甲氨蝶呤增加毒性。

不良反应(补):
恶心,腹胀,呕吐,消化不良,头痛,出血,头晕,胃肠道溃疡/出血,肝酶升高(如肝停止开发),视力模糊,皮疹/严重皮肤感染(如中断发生),周围水肿,贫血/血液恶液质,高血压,肾乳头坏死,无菌性脑膜炎。见文献回复:心血管事件的风险。

如何提供:
单剂量瓶(400mg/4mL,800mg/8mL)-25

最后更新:
2009年10月15日

CALDOLOR

Manufacturer:

Cumberland Pharmaceuticals, Inc.

Pharmacological Class:

NSAID (propionic acid deriv.)

Active Ingredient(s):

Ibuprofen 100mg/mL; for IV infusion after dilution.

Indication(s):

Mild-to-moderate pain. Moderate-to-severe pain adjunct to opioids. Fever.

Pharmacology:

Ibuprofen is a non-steroidal anti-inflammatory agent with antipyretic and analgesic effects. It is thought to exert its therapeutic effects through inhibition of prostaglandin biosynthesis.

Clinical Trials:

The efficacy of Caldolor for acute pain was evaluated in two multi-center, randomized, double-blind, placebo-controlled studies. In the first study, 319 women who had undergone an elective abdominal hysterectomy were treated with either Caldolor 800mg or placebo administered every 6 hours and morphine on an as needed basis. Patients treated with Caldolor demonstrated a statistically significant greater reduction in mean morphine consumption over 24 hours versus those patients receiving placebo. In the second pain study, 406 patients who had undergone elective abdominal or orthopedic surgery were randomized to receive Caldolor 400mg, Caldolor 800mg, or placebo administered every 6 hours, and morphine on an as needed basis. This study failed to demonstrate a statistically significant difference in outcome between patients receiving Caldolor 800mg or 400mg and placebo, although there were trends favoring the active treatments.

Two randomized, double-blind studies were conducted to evaluate the efficacy of Caldolor in reducing fever. In the first study, 120 patients with temperatures of ≥101°F were randomized to Caldolor 400mg, 200mg, 100mg or placebo administered every 4 hours for 24 hours. Each of the three Caldolor doses resulted in a statistically greater percentage of patients with a reduced temperature (<101°F) after 4 hours compared to placebo (65%, 73%, 77% and 32%, respectively). In the second study, 60 patients with uncomplicated P. falciparum malaria having temperatures ≥100.4°F were randomized to Caldolor 400mg or placebo administered every 6 hours for 72 hours of treatment. Within the first 24 hours of treatment, a significant reduction in fever was observed in the Caldolor treated patients.

Legal Classification:

Rx

Adults:

≥17yrs: Give by IV infusion over 30 minutes. Use lowest effective dose. Maintain adequate hydration. Pain: 400mg–800mg every 6 hours as needed. Fever: initially 400mg, followed by 400mg every 4–6 hours or 100–200mg every 4 hours as needed. Max: 3200mg/day.

Children:

<17yrs: not recommended.

Contraindication(s):

Aspirin allergy. Coronary artery bypass graft surgery. 3rd trimester pregnancy.

Warnings/Precautions:

Advanced renal disease: not recommended. History of ulcer disease or GI bleeding. Active peptic ulcer. Impaired renal or hepatic function. Asthma. Edema. Hypertension; monitor BP. Heart failure. Bleeding disorders. Monitor blood, hepatic and renal function in chronic use. Discontinue if visual, rash or liver dysfunction occurs. Dehydration. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C: <30 weeks gestation, Cat.D: ≥30 weeks gestation). Nursing mothers: not recommended.

Interaction(s):

Avoid aspirin. May antagonize ACE inhibitors, diuretics. Increased risk of GI bleed with oral corticosteroids, anticoagulants (monitor), alcohol, smoking. Increases lithium levels. May increase toxicity of methotrexate.

Adverse Reaction(s):

Nausea, flatulence, vomiting, dyspepsia, headache, hemorrhage, dizziness; GI ulcer/bleed, elevated liver enzymes (discontinue if hepatotoxicity develops), blurred vision, rash/serious skin infections (discontinue if occurs), peripheral edema, anemia/blood dyscrasias, hypertension, renal papillary necrosis, aseptic meningitis. See literature re: risk of cardiovascular events.

How Supplied:

Single-dose vials (400mg/4mL, 800mg/8mL)—25

责任编辑:admin


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