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当前位置:药品说明书与价格首页 >> 消化系统药物 >> 药品目录 >> Apriso(美沙拉嗪肠溶缓释微丸胶囊)

Apriso(美沙拉嗪肠溶缓释微丸胶囊)

2012-05-08 22:54:39  作者:新特药房  来源:互联网  浏览次数:307  文字大小:【】【】【
简介: 美国FDA批准了Salix Pharmaceuticals, Ltd.公司的美沙拉嗪缓释胶囊(mesalamine extended-release capsules),商品名为Apriso ,该制剂为目前唯一的每日给药1次的24小时缓释制剂。 Apriso的通用名称 ...

 美国FDA批准了Salix Pharmaceuticals, Ltd.公司的美沙拉嗪缓释胶囊(mesalamine extended-release capsules),商品名为Apriso ,该制剂为目前唯一的每日给药1次的24小时缓释制剂。

Apriso的通用名称为

美沙拉嗪0.375克; EXT-REL帽;含有苯丙氨酸0.56mg/cap。

法律分类:
RX
为Apriso的药理学类
对氨基水杨酸。

对Apriso的制造商
Salix制药公司
主治为Apriso的
缓解成人溃疡性结肠炎(UC)的维护。

成人剂量为Apriso的
≥0-18岁:1.5G每天一次在上午。

为Apriso的儿童用药
<18yrs:不推荐。

警告/ Apriso的注意事项
柳氮磺胺过敏。肾功能不全或肾脏疾病史的开头和治疗期间定期评估肾功能。肝功能损害。老人(显示器CBCS)。怀孕(Cat.B)。哺乳的母亲。

为Apriso的相互作用
不要合作,管理与制酸剂。

Apriso的不良反应
头痛,胃肠不适,上腹部疼痛,鼻咽炎,流感样症状,鼻窦炎;肾功能损害,美沙拉嗪引起的急性不容忍综合征(例如,痉挛,腹痛,血性腹泻,发烧,头痛,皮疹);停止,如果发生。

Apriso的是如何提供的?
CAPS-120

The FDA has approved Apriso (mesalamine extended-release capsules, from Salix) for remission maintenance of ulcerative colitis (UC) in adults. In two randomized, double-blind, placebo-controlled studies involving 562 patients, Apriso was more effective in maintaining long-term UC remission and sustaining improvement of UC symptoms for six months than placebo.
Apriso is expected to launch during the first quarter of 2009 in 0.375g dosage strength.
APRISO

Generic Name for APRISO

Mesalamine 0.375g; ext-rel caps; contains phenylalanine 0.56mg/cap.

Legal Classification:

Rx

Pharmacological Class for APRISO

Aminosalicylate.

Manufacturer of APRISO

Salix Pharmaceuticals, Inc.

Indications for APRISO

Maintenance of remission of ulcerative colitis (UC) in adults.

Adult dose for APRISO

≥18yrs: 1.5g once daily in the AM.

Children's dosing for APRISO

<18yrs: not recommended.

Warnings/Precautions for APRISO

Sulfasalazine allergy. Renal dysfunction or history of renal disease; assess renal function at the beginning and periodically during treatment. Hepatic impairment. Elderly (monitor CBCs). Pregnancy (Cat.B). Nursing mothers.

Interactions for APRISO

Do not co-administer with antacids.

Adverse Reactions for APRISO

Headache, GI upset, upper abdominal pain, nasopharyngitis, flu-like symptoms, sinusitis; renal impairment, mesalamine-induced acute intolerance syndrome (eg, cramping, abdominal pain, bloody diarrhea, fever, headache, rash); discontinue if occurs.

How is APRISO supplied?

Caps—120

Related Disease:

Colorectal disorders
Ulcerative colitis~oral agents

责任编辑:admin


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