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 详细处方信息以本药内容附件PDF文件（20143621585534.pdf）的“原文Priscribing Information”为准
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 部分中文Zipsor处方资料（仅供参考）

非类固醇类抗炎药(NSAID) Zipsor被批准用于治疗轻中度疼痛
    2009年6月17日，Xanodyne公司表示，Zipsor(双氯芬酸钾) 充液胶囊已获美国食品药物管理局(FDA)批准。Zipsor适用于治疗成人轻中度急性疼痛。
    两项控制良好、姆囊炎切除术后临床试验证实了Zipsor的安全性和疗效。根据制造商提供的数据，参与研究的患者所采用的剂量是目前美国所有上市的双氯芬酸钾制剂中的最低可用剂量(25 mg)。Xanodyne公司发布的新闻稿也指出，所推荐的较低的Zipsor每日双氯芬酸钾释放总剂量与当前FDA的建议一致，FDA规定在最短时间内使用最低有效剂量的非类固醇类抗炎药(NSAID) 。

FDA批准Xanodytie制药公司的Zipsor（双氯芬酸钾）液体胶囊
    Xanodyne制药公司目前宣布，该公司的Zipsor（双氯芬酸钾）液体胶囊目前获得美国FDA批准用于为成人（18岁或以上）轻度至中度急性疼痛缓解治疗。Xanodyne相关负责人表示：“Zipsor有很多独特之处，是首个依据设立对照的拇指滑液囊肿切除术（bunionectomy）后临床试验结果批准的非甾体类抗炎药，该产品25mg的剂量也为在美国上市的双氯芬酸钾药品中最低。Zipsor是美国市场上首个口服的非甾体类抗炎药物软胶囊。”

Drug Name: Zipsor (diclofenac potassium)
Company: Xanodyne
Approval Status: Approved June 2009
Treatment Area: mild to moderate acute pain

General Information
Zipsor (diclofenac potassium) liquid filled capsule is a benzeneacetic acid derivative non-steriod anti-inflammaotry drug. The mechanism of action of Zipsor, like that of other NSAIDs, is not completely understood but may involve inhibition of the cyclooxygenase (COX-1 and COX-2) pathways. Diclofenac’s mechanism may also be related to prostaglandin synthetase inhibition.

Zipsor is specifically indicated for the relief of mild to moderate acute pain in adults (18 years of age or older).

Zipsor is supplied as a 25mg liquid capsule designed for oral administration. The recommended initial dose is 25 mg four times a day.

Clinical Results
FDA Approval
The FDA approval of Zipsor was based on the results of two clinical studies. These multicenter, randomized, double-blind, placebo- controlled, parallel arm, multiple-dose clinical trials compared Zipsor 25 mg and placebo in patients with pain following bunionectomy with osteotomy. Once the criteria for randomization (pain intensity >4 on a 0-10 numerical pain rating scale) was met, the subjects received their initial dose of study medication followed by a re-medication dose when requested, and were then dosed every six hours over four days. Pain intensity was recorded at 3 and 6 hours postdose during the fixed dosing period. . In Study 1, mean baseline pain intensity scores were 6.9 in the Zipsor group (range: 4 to 10) and 7.3 in the placebo group (range: 4 to 10). In both studies, subjects treated with Zipsor had a lower mean pain intensity score over the 48-hour inpatient period following the first remedication dose.. The median time to onset of pain relief was less than one hour for Zipsor 25 mg across the clinical trials. The results from Study 2 were similar.

Side Effects
Adverse events associated with the use of Zipsor may include, but are not limited to, the following:
•Abdominal pain
•Constipation
•Diarrhea
•Dyspepsia
•Nausea
•Vomiting
•Dizziness
•Headache
•Somnolence
•Pruritus
•Increased sweating

Mechanism of Action
Zipsor (diclofenac potassium) liquid filled capsule is a benzeneacetic acid derivative non-steriod anti-inflammaotry drug. The mechanism of action of Zipsor, like that of other NSAIDs, is not completely understood but may involve inhibition of the cyclooxygenase (COX-1 and COX-2) pathways. Diclofenac’s mechanism may also be related to prostaglandin synthetase inhibition.

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 详细处方信息以本药内容附件PDF文件（20143621585534.pdf）的“原文Priscribing Information”为
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