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利福昔明片说明书


【药品名称】
通用名称：利福昔明片
  
【成份】利福昔明。化学名称：4-脱氧-4-甲基砒啶[1，2-1，2]咪唑井[5，4-环]利福霉素SV。
【性状】本品为薄膜衣片，除去包衣后显桔红至暗红色。
【适应症】对利福昔明敏感的病原菌引起的肠道感染，包括急性和慢性肠道感染，腹泻综合症，夏季腹泻，旅行者腹泻和小肠结肠炎等。
【用法用量】成人口服。每次0.2g(1片)，每日3-4次。6-12岁儿童口服。每次0.1-0.2g(0.5-1片)，每日4次。12岁以上儿童，剂量同成人。可根据医嘱调节剂量和服用次数。除非是遵照医嘱的情况下，每一疗程不应超过7天。
【不良反应】部分患者用药后可出现恶心（通常出现在第一次服药后），但症状可迅速消退。大剂量长期用药，极少数患者可能出现蕈麻疹样皮肤反应。1，中枢神经系统有出现头痛的报道。2，代谢/分泌系统肝性脑病患者服用本药后可出现体重下降，血清钾和血清钠浓度轻度升高。3，胃肠道系统常见的症状为腹涨，腹痛，恶心和呕吐。以上症状发生率者均低于1%。4，皮肤大剂量长期用药，极少数患者可能出现蕈麻疹样皮肤反应。5，其他有用药后可能引起足水肿的报道。
【禁忌】以下患者禁用：1.对本药或利福霉素过敏者；2.肠梗阻者；3.严重的肠道溃疡性病变者。
【注意事项】
1.儿童连续服用本药不能超过7日。2.对6岁以下儿童建议不要服用本药片剂。3.长期大剂量用药或肠黏膜受损时，会有极少量（少于1%）被吸收，导致尿液呈粉红色。4.请置于儿童触及不到的地方。5.如果出现对抗生素不敏赶的微生物，应中断治疗并采取其他适当治疗措施。6.对驾驶和操纵机器的影响，未知。
【孕妇及哺乳期妇女用药】1.药物对妊娠的影响：动物实验本药无致畸作用。但妊娠期妇女用药的安全性和有效性尚不明确。因此，妊娠期妇女需权衡利弊后用药。2.药物对哺乳的影响：本药口服后只有极少量被吸收，在乳汁中的浓度也极低，哺乳期妇女可在有适当医疗监测的情况下服用本药。
【儿童用药】建议6岁以下儿童不要服用，6岁及6岁以上儿童服用方法请参见[用法用量]
【药物相互作用】口服利福昔明只有少于1%口服剂量经胃肠道吸收，所以利福昔明不会引起因药物的相互作用而导致的全身问题。
【药物过量】试验证明服用本品剂量达1.6g/日，既没有局部也没有全身的不良事件发生。一旦过量服用应洗胃，并配合其他适当治疗。
【药理毒理】药理作用：利福昔明是广谱肠道抗生素。它是利福霉素SV的半合成衍生物。利福昔明和其它利福霉素类抗生素一样，通过与细菌DNA-依赖RNA聚合酶的B-亚单位不可逆转地结合而抑制细菌RNA的合成，最终抑制细菌蛋白质的合成。由于其与酶的结合是不可逆的，所以其活性为对敏感菌的杀菌活性。对利福昔明抗菌活性的研究资料显示，本品与利福霉素具有同样广泛的抗菌谱，对多数革兰氏阳性菌和革兰氏阴性菌，包括需氧菌和厌氧菌的感染具有杀菌作用。由于利福昔明口服时不被胃肠道吸收，所以它是通过杀灭肠道的病原体而在局部发挥抗菌作用。毒理作用：重复给药毒性：大鼠每天口服本品25,50及100mg/kg，连续180天后，耐受性好，除雌鼠血清总胆固醇呈剂量相关性增加外(可能为对肠道菌群产生作用的结果)，未见其他异常改变。遗传毒性：体内外研究未见本品有致突变作用。生殖毒性：大鼠及家兔给予本品50及100mg/kg未见致畸作用及其他生殖毒性。
【药代动力学】在鼠，家狗和人体药代动力学的研究证明，本品经口服不被吸收(吸收小于1%)。
【贮藏】密封，在阴暗干燥处保存。

What is Xifaxan?
Xifaxan (rifaximin) is an antibiotic that fights bacterial infection only in the intestines.
Rifaximin works differently from other antibiotics because it passes through your stomach and into your intestines without being absorbed into your blood stream. Because rifaximin treats only the intestinal tract, it will not treat infections of other parts of the body.
Xifaxan is used to treat travelers' diarrhea caused by Escherichia coli (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 E. coli bacteria.
Xifaxan is also used to treat irritable bowel syndrome in adults whose main symptom is diarrhea.
Xifaxan is also used to lower the risk of worsened brain function in adults with liver failure. Brain function can be affected when the liver stops working and cannot remove toxic substances from the body.
Important information
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. Rifaximin 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 this medicine. Xifaxan does not treat all bacterial forms of traveler's diarrhea.
Before taking this medicine
You should not take Xifaxan if you are allergic to rifaximin, rifabutin, rifampin, or rifapentine.
To make sure Xifaxan is safe for you, tell your doctor if you have:
liver disease;
diarrhea with a fever; or
watery or bloody diarrhea.
It is not known whether Xifaxan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether rifaximin passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.
Xifaxan should not be given to a child younger than 12 years old.
How should I take Xifaxan?
Take Xifaxan exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take Xifaxan with or without food.
Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Rifaximin will not treat a viral infection such as the flu or a common cold.
Do not share this medicine with another person, even if they have the same symptoms you have.
Call your doctor if your symptoms do not improve after 24 to 48 hours, or if they get worse while using this medicine.
Xifaxan does not treat all bacterial forms of traveler's diarrhea.
Store at room temperature away from moisture and heat.
Xifaxan dosing information
Usual Adult Dose for Traveler's Diarrhea:
200 mg orally 3 times a day for 3 days


Comments:
-Should not use in patients with diarrhea complicated by fever and/or blood in the stool or diarrhea caused by pathogens other than Escherichia coli


Use: For the treatment of travelers' diarrhea due to noninvasive strains of E coli
Usual Adult Dose for Hepatic Encephalopathy:
550 mg orally twice a day


Comments:
-In trials, lactulose was used concomitantly in 91% of patients; differences in treatment effect of patients not using concomitant lactulose could not be assessed.


Use: For reduction in risk of overt hepatic encephalopathy recurrence
Usual Pediatric Dose for Traveler's Diarrhea:
12 years or older: 200 mg orally 3 times a day for 3 days


Comments:
-Should not use in patients with diarrhea complicated by fever and/or blood in the stool or diarrhea caused by pathogens other than E coli


Use: For the treatment of travelers' diarrhea due to noninvasive strains of E coli
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 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, 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 signs of an allergic reaction to Xifaxan: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Xifaxan and call your doctor at once if you have:
severe stomach pain, diarrhea that is watery or bloody;
fever; or
rapid weight gain, especially in your face and midsection.
Common Xifaxan side effects may include:
swelling in your hands, feet, or midsection;
nausea;
headache, dizziness;
tired feeling; or
abnormal liver function tests.
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?
Tell your doctor about all your current medicines and any you start or stop using, especially:
cyclosporine;
lopinavir and ritonavir;
an antibiotic-azithromycin, clarithromycin, erythromycin;
antifungal medicine-itraconazole, ketoconazole; or
heart or blood pressure medicine-amiodarone, captopril, carvedilol, diltiazem, dronedarone, felodipine, quinidine, ranolazine, verapamil.
This list is not complete. Other drugs may interact with rifaximin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.