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 详细处方信息以本药内容附件PDF文件（201242400431812.pdf）的“原文Priscribing Information”为准
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部分中文硝唑尼特处方资料（仅供参考）

英文药名: Alinia (Nitazoxanide Tablets)

中文药名: 硝唑尼特片

药品介绍
Romark大药厂1月10日宣布已经在美国开始开发Alinia(硝唑尼特，nitazoxanide) 片的新适应症—慢性丙型肝炎。该公司已经向FDA提交了新药临床申请，并申请了快速审批资格。在美国开始的临床试验将首先评价硝唑尼特500mg，每日两次，给药24周对之前干扰素和利巴韦林联合治疗失败的病人的疗效。硝唑尼特是一类称为thiazolides化合物的第一个成员，该类化合物为小分子，通过抑制病毒结构蛋白的合成来阻断特定病毒的复制。研究表明硝唑尼特及其循环中的代谢产物tizoxanide，可以在低浓度时抑制细胞培养中的HBV和HCV。

一项II期、双盲、安慰剂对照临床试验已于2005年初在埃及的Romark消化病研究中心进行。病人是HCV基因型4型感染者，大约10%的病人之前经过PEG化干扰素+利巴韦林联合治疗而失败。这项试验考察口服硝唑尼特单独治疗对慢性丙肝的效果。对头20名病人阶段性分析表明，50%接受硝唑尼特治疗（500mg，每日2次）的病人在治疗24周末，HCV RNA水平达到检测水平以下，而安慰剂组的病人为0 (P=0.03)。药物耐受性良好，无明显不良反应，该试验仍在进行中。

Alinia已经在美国上市，但适应症是微小隐孢子虫(Cryptosporidium parvum,Cp)和蓝氏贾第鞭毛虫（Giardia lamblia）引起的腹泻。正在开发的其他适应症包括艰难梭状芽孢杆菌（Clostridium difficile）相关疾病、克隆氏病和慢性丙肝。硝唑尼特最初被开发为广谱抗肠道寄生虫药物和抗厌氧菌药物，和甲硝唑相比安全性更好。它也是第一个被证明对微小隐孢子虫引起的肠道疾病有效的药物。

基于硝唑尼特的抗病毒活性研究，Romark 公司于2005年初在埃及开始了一系列II期临床试验。

Alinia
Pronunciation: nye-ta-ZOX-a-nide
Generic Name: Nitazoxanide
Brand Name: Alinia

Alinia is used for:
Treating certain parasitic infections of the intestine.

Alinia is an antiparasitic agent. It works by interfering with the production of certain substances that are needed by the parasite to live.

Do NOT use Alinia if:
you are allergic to any ingredient in Alinia
Contact your doctor or health care provider right away if any of these apply to you.

Before using Alinia:
Some medical conditions may interact with Alinia. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have liver or gallbladder problems, kidney problems, immune system problems, or HIV infection

Some MEDICINES MAY INTERACT with Alinia. Tell your health care provider if you are taking any other medicines, especially any of the following:
Warfarin because its actions and side effects may be increased by Alinia

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alinia may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Alinia:
Use Alinia as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Alinia with food.
If you miss a dose of Alinia, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Alinia.

Important safety information:
Alinia may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Alinia. Using Alinia alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Alinia is not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Alinia, discuss with your doctor the benefits and risks of using Alinia during pregnancy. It is not known if Alinia is excreted in breast milk. If you are or will be breast-feeding, check with your doctor or pharmacist to discuss the risk to your baby.

Possible side effects of Alinia:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; headache; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; fainting; fast heartbeat; severe or persistent dizziness; shortness of breath; unusual tiredness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Alinia:
Store Alinia at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Alinia out of the reach of children and away from pets.

General information:
If you have any questions about Alinia, please talk with your doctor, pharmacist, or other health care provider.
Alinia is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.
Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Alinia. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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 详细处方信息以本药内容附件PDF文件（201242400431812.pdf）的“原文Priscribing Information”为准
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