当前位置：药品说明书与价格首页 >> 肝病 >> 新药推荐 >> 利福昔明片,昔服申|XIFAXAN（RIFAXIMIN Tablets）

利福昔明片,昔服申|XIFAXAN（RIFAXIMIN Tablets）

2011-11-18 11:59:00 作者：新特药房来源：中国新特药网天津分站浏览次数：400 文字大小：【大】【中】【小】

简介：2010年3月,美国FDA批准了Salix制药有限公司的利福昔明(rifaximin)550mg片剂Xifaxan的新药申请,用于减少≥18岁终末期肝病患者的显性肝性脑病复发风险。利福昔明是近30年来在美获准用于治疗此类患者的第一 ...

关键字：利福昔明片Xifaxan(Rifaximin Tablets)

英文名称：XIFAXAN（RIFAXIMIN Tablets）

中文名称：利福昔明昔服申

品牌药生产商：SALIX PHARMS

部分中文Xifaxan处方资料（仅供参考）

XIFAXAN 550mg

Manufacturer:

Salix Pharmaceuticals, Inc.

Pharmacological Class:

Rifamycin

Active Ingredient(s):

Rifaximin 550mg; tabs.

Indication(s):

Reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥18 years of age.

Pharmacology:

Hepatic encephalopathy is caused by an accumulation of toxic substances (eg, ammonia) in the blood that may occur when liver function is reduced. Rifaximin, a non-aminoglycoside semi-synthetic antibacterial derived from rifamycin SV, acts by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase resulting in inhibition of bacterial RNA synthesis. Rifaximin is believed to have an effect on gastrointestinal flora, thereby reducing the intestinal bacteria that is producing the ammonia.

Clinical Trials:

A multicenter, randomized, placebo-controlled, double-blind, 6-month trial was conducted to assess the efficacy of Xifaxan 550mg in reducing the recurrence of overt hepatic encephalopathy episodes. The study enrolled 299 adult patients who experienced ≥2 episodes of hepatic encephalopathy associated with chronic liver disease in the previous 6 months and who were defined as being in remission (Conn score 0 or 1).

Efficacy of Xifaxan 550mg was assessed by the time to first breakthrough overt hepatic encephalopathy episode (defined as marked deterioration in neurological function and Conn score ≥2). During the 6-month treatment period, breakthrough overt hepatic encephalopathy episodes were experienced by 22% of patients treated with Xifaxan 550mg compared to 46% of patients who received placebo. Comparison of Kaplan-Meier estimates of event-free curves showed that Xifaxan 550mg significantly reduced the risk of hepatic encephalopathy breakthrough by 58% during the 6-month treatment period.

Legal Classification:

Adults:

≥18yrs: 550mg twice daily.

Children:

<18yrs: not recommended.

Warnings/Precautions:

Not studied in patients with MELD scores >25; only 8.6% of patients in the controlled trial had MELD >19. Increased systemic exposure in patients with more severe hepatic dysfunction; caution should be exercised in patients with severe hepatic impairment (Child-Pugh C). Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Adverse Reaction(s):

Peripheral edema, nausea, dizziness, fatigue, ascites.

How Supplied:

Tabs—60

Last Updated:

5/20/2010

FDA批准利福昔明（Xifaxan）治疗肝性脑病新适应症

利福昔明(Rifaximin)为利福霉素的衍生物，通过与细菌DNA-依赖RNA聚合酶的β-亚单位不可逆的结合而抑制细菌RNA的合成，最终抑制细菌蛋白质的合成。是第一个非氨基糖苷类肠道用抗生素。临床主要用于对利福昔明敏感的病原菌引起的肠道感染。

2010年3月25日，美国食品药品管理局（FDA）宣布批准利福昔明（Xifaxan）用于降低肝性脑病（HE）的复发风险。此前Xifaxan曾作为治疗旅行者腹泻药物获批。此次利福昔明作为罕见病药获优先审评的资格并批准此新适应症。

一项安慰剂随机对照临床试验评估了Xifaxan治疗HE的有效性，该临床试验的受试者由美国、加拿大和俄罗斯的成年患者组成。参加试验的肝病患者为无HE症状或有轻度HE症状者，与使用安慰剂治疗的患者相比，使用Xifaxan治疗的患者更少出现肝性脑病。

Xifaxan在严重肝病患者中的疗效尚未得以确认。在试验过程中，由于大部分患者同时服用了半乳糖甙果糖（一种合成糖，有助于阻止肠道的氨吸收进入血液），因此，无法评估Xifaxan作为单独治疗HE的确切疗效。
Xifaxan的常见不良反应主要为上下肢肿胀（外周性水肿）、恶心、嗳气和头痛。

注：以下产品不同规格和不同价格，购买时请以电话咨询为准！
---------------------------------------------------------------
原产地英文商品名:
XIFAXAN 550mg/tab 60tabs/bottle
原产地英文药品名:
RIFAXIMIN
中文参考商品译名:
XIFAXAN 550毫克/片 60片/瓶
中文参考药品译名:
利福昔明
中文参考化合物名称:
4-脱氧-4-甲基砒啶[1，2-1，2]咪唑井[5，4-环]利福霉素SV
生产厂家中文参考译名:
SALIX PHARMS
生产厂家英文名:
SALIX PHARMS

---------------------------------------------------------------
原产地英文商品名:
XIFAXAN 200mg/tab 30tabs/bottle
原产地英文药品名:
RIFAXIMIN
中文参考商品译名:
XIFAXAN 200毫克/片 30片/瓶
中文参考药品译名:
利福昔明
中文参考化合物名称:
4-脱氧-4-甲基砒啶[1，2-1，2]咪唑井[5，4-环]利福霉素SV
生产厂家中文参考译名:
SALIX PHARMS
生产厂家英文名:
SALIX PHARMS

---------------------------------------------------------------
原产地英文商品名:
XIFAXAN 200mg/tab 100tabs/bottle
原产地英文药品名:
RIFAXIMIN
中文参考商品译名:
XIFAXAN 200毫克/片 100片/瓶
中文参考药品译名:
利福昔明
中文参考化合物名称:
4-脱氧-4-甲基砒啶[1，2-1，2]咪唑井[5，4-环]利福霉素SV
生产厂家中文参考译名:
SALIX PHARMS
生产厂家英文名:
SALIX PHARMS

---------------------------------------------------------------

Xifaxan

Generic Name: rifaximin (rif AX i min)
Brand Names: Xifaxan
----------------------------------------------------------------------
What is Xifaxan?
Xifaxan (rifaximin) is an antibiotic that fights bacterial infection only in the intestines.
Xifaxan is used to treat travelers' diarrhea caused by E. coli in adults and children who are at least 12 years old. Most people get this infection by eating food or drinking fluids that have been contaminated with the bacteria.
Xifaxan is also used to lower the risk of worsened brain function, or hepatic encephalopathy, in adults with liver failure. Brain function can be affected when the liver stops working and cannot remove toxic substances from the body.
Xifaxan may also be used for other purposes not listed in this medication guide.
----------------------------------------------------------------------
Important information about Xifaxan
You should not use take Xifaxan if you are allergic to rifaximin or medications such as rifabutin (Mycobutin), rifampin (Rifater, Rifadin, Rifamate), or rifapentine (Priftin).
Before you take Xifaxan, tell your doctor if you have severe liver disease, diarrhea with fever, or diarrhea that is watery or has blood in it.
Take Xifaxan for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Xifaxan will not treat a viral infection such as the common cold or flu, or any form of diarrhea that is caused by a virus. Call your doctor if your symptoms do not improve after 24 hours, or if they get worse while taking rifaximin. Xifaxan does not treat all bacterial forms of traveler's diarrhea.
----------------------------------------------------------------------
Before taking Xifaxan
You should not use take Xifaxan if you are allergic to rifaximin or medications such as rifabutin (Mycobutin), rifampin (Rifater, Rifadin, Rifamate), or rifapentine (Priftin).
If you have any of these other conditions, you may need a Xifaxan dose adjustment or special tests:
severe liver disease;
diarrhea with a fever; or
watery or bloody diarrhea.
FDA pregnancy category C. It is not known whether Xifaxan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Xifaxan. It is not known whether rifaximin passes into breast milk or if it could harm a nursing baby. Do not use Xifaxan without telling your doctor if you are breast-feeding a baby.
----------------------------------------------------------------------
How should I take Xifaxan?
Take Xifaxan exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Xifaxan can be taken with or without food.
Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Xifaxan will not treat a viral infection such as the common cold or flu, or any form of diarrhea that is caused by a virus. Call your doctor if your symptoms do not improve after 24 hours, or if they get worse while taking rifaximin. Xifaxan does not treat all bacterial forms of traveler's diarrhea.

Store at room temperature away from moisture and heat.
----------------------------------------------------------------------
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
----------------------------------------------------------------------
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
----------------------------------------------------------------------
What should I avoid while taking Xifaxan?
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Xifaxan and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
----------------------------------------------------------------------
Xifaxan side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Xifaxan: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Xifaxan and call your doctor at once if you have a fever or diarrhea that is watery or bloody.
Less serious Xifaxan side effects are more likely, and may include:
bloating, gas, stomach pain;
feeling like you need to empty your bowel urgently;
feeling like your bowel is not completely empty;
nausea, vomiting, constipation;
headache, dizziness;
tired feeling; or
swelling in your hands, feet, or torso.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
----------------------------------------------------------------------
What other drugs will affect Xifaxan?
There may be other drugs that can interact with Xifaxan. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
----------------------------------------------------------------------
Where can I get more information?
Your pharmacist can provide more information about Xifaxan.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Xifaxan only for the indication prescribed.
Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.