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当前位置:药品说明书与价格首页 >> 综合药讯 >> 双氯芬酸钾软胶囊|Zipsor(diclofenac potassium)

双氯芬酸钾软胶囊|Zipsor(diclofenac potassium)

2011-04-26 23:43:17  作者:新特药房  来源:中国新特药网天津分站  浏览次数:169  文字大小:【】【】【
简介:制造商: Xanodyne Pharmaceuticals药厂 药理分类: 类固醇消炎药(benzeneacetic酸衍生物)。 活性成分(补): 双氯芬酸钾25毫克; Liq的充满帽;含有明胶。 指示(补): 轻度至中度急性疼痛。 药理作用 ...

制造商:
Xanodyne Pharmaceuticals药厂

药理分类:
类固醇消炎药(benzeneacetic酸衍生物)。

活性成分(补):
双氯芬酸钾25毫克; Liq的充满帽;含有明胶。
指示(补):
轻度至中度急性疼痛。

药理作用:
双氯芬酸钾是一种benzeneacetic酸衍生物非甾体抗炎药(NSAID),展示消炎,镇痛,抗-退热活动。双氯芬酸的作用机制被认为是涉及到抑制环氧合酶(COX - 1和COX - 2的)途径,以及前列腺素合成酶的抑制作用。

临床试验:
两个多中心,随机,双盲,安慰剂对照,平行臂,多剂量的临床试验进行评估疼痛病人经与截骨bunionectomy的Zipsor疗效。与疼痛强度等级≥4(在0〜10数字疼痛量表),病患被随机分派接受安慰剂的Zipsor或初始剂量,剂量由remedication病人要求时次之,然后剂量超过四天每六个小时。疼痛强度记录给药后3和6小时,在固定剂量的时期。在这两项研究,与Zipsor接受治疗的病人在48小时后第一次住院期间低剂量remedication平均疼痛强度评分。在整个临床试验中,平均时间在Zipsor治疗的患者的疼痛缓解了不到一小时。

法律分类:
接收

成人:
≥18yrs:25毫克每日4次。

儿童:
“18yrs:不推荐。

禁忌(补):
阿司匹林过敏。冠状动脉搭桥手术。

警告/注意事项:
不生体相等性的双氯芬酸的其他形式。牛蛋白的敏感性。高血压;监视器。瑞士法郎。水肿。哮喘。历史溃疡病或胃肠出血。出血性疾病。脱水。监测血液,肝和肾功能的长期使用。老人。虚弱。妊娠(Cat.C:“30周妊娠; Cat.D:≥30周妊娠:避免)。哺乳母亲:不推荐。

互动(补):
避免使用阿司匹林。会增强蛋白结合药物(如hydantoins,磺胺类,磺脲类)。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。甲氨蝶呤的排泄减少。提高锂的水平。加强与环孢素肾毒性。注意与其他肝毒性药物(如对乙酰氨基酚,某些抗生素,抗癫痫药物)。

不良反应(补):
胃肠不适,腹痛,消化不良,头晕,头痛,嗜睡,皮肤瘙痒,皮疹(停止如果发生),增加出汗,胃肠道溃疡/出血,肝酶升高(如肝停止开发),血液恶液质,肾乳头坏死。见文献回复:心血管事件的风险。

如何提供:
帽- 100

最后更新:
2009年9月17日

Manufacturer:

Xanodyne Pharmaceuticals

Pharmacological Class:

NSAID (benzeneacetic acid derivative).

Active Ingredient(s):

Diclofenac potassium 25mg; liq filled caps; contains gelatin.

Indication(s):

Mild to moderate acute pain.

Pharmacology:

Diclofenac potassium is a benzeneacetic acid derivative nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and anti-pyretic activities. The mechanism of action of diclofenac is thought to involve inhibition of the cyclooxygenase (COX-1 and COX-2) pathways, as well as prostaglandin synthetase inhibition.

Clinical Trials:

Two multicenter, randomized, double-blind, placebo-controlled, parallel-arm, multiple-dose clinical trials were conducted to assess the efficacy of Zipsor in patients with pain following bunionectomy with osteotomy. Patients with a pain intensity rating ≥4 (on a 0–10 numerical pain scale) were randomized to receive an initial dose of Zipsor or placebo, followed by a remedication dose when requested by the patient, and then dosed every six hours over four days. Pain intensity was recorded at 3 and 6 hours postdose during the fixed dosing period. In both studies, patients treated with Zipsor had a lower mean pain intensity score over the 48-hour inpatient period following the first remedication dose. Across the clinical trials, the median time to onset of pain relief in patients treated with Zipsor was less than one hour.

Legal Classification:

Rx

Adults:

≥18yrs: 25mg 4 times daily.

Children:

<18yrs: not recommended.

Contraindication(s):

Aspirin allergy. Coronary artery bypass graft surgery.

Warnings/Precautions:

Not bioequivalent to other forms of diclofenac. Bovine protein sensitivity. Hypertension; monitor. CHF. Edema. Asthma. History of ulcer disease or GI bleeding. Bleeding disorders. Dehydration. Monitor blood, hepatic, and renal function in chronic use. Elderly. Debilitated. Pregnancy (Cat.C: <30 weeks gestation; Cat.D: ≥30 weeks gestation: avoid). Nursing mothers: not recommended.

Interaction(s):

Avoid aspirin. May potentiate protein-bound drugs (eg, hydantoins, sulfonamides, sulfonylureas). May antagonize ACE inhibitors, diuretics. Increased risk of GI bleed with oral corticosteroids, anticoagulants (monitor), alcohol, smoking. Methotrexate excretion reduced. Increases lithium levels. Increased nephrotoxicity with cyclosporine. Caution with other hepatotoxic drugs (eg, acetaminophen, certain antibiotics, antiepileptics).

Adverse Reaction(s):

GI upset, abdominal pain, dyspepsia, dizziness, headache, somnolence, pruritus, rash (discontinue if occurs), increased sweating; GI ulcer/bleed, elevated liver enzymes (discontinue if hepatotoxicity develops), blood dyscrasias, renal papillary necrosis. See literature re: risk of cardiovascular events.

How Supplied:

Caps—100

责任编辑:admin


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