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当前位置:药品说明书与价格首页 >> 肝病 >> 丙肝 >> 药品推荐 >> 硝唑尼特口服悬浮液(Alinia,Nitazoxanide)

硝唑尼特口服悬浮液(Alinia,Nitazoxanide)

2012-05-07 01:24:52  作者:新特药房  来源:互联网  浏览次数:281  文字大小:【】【】【
简介: 英文药名: Alinia(Nitazoxanide Tablets) 中文药名: 硝唑尼特口服液 药品介绍 药品英文名 Nitazoxanide 药品别名 NTZ 药物剂型 片剂:500mg。口服混悬液60ml(每ml含20mg硝唑尼特)。 药理作用 ...

英文药名: Alinia(Nitazoxanide Tablets)

中文药名: 硝唑尼特口服液

药品介绍
 
药品英文名
 
Nitazoxanide
 
药品别名
 
NTZ
 
药物剂型
 
片剂:500mg。口服混悬液60ml(每ml含20mg硝唑尼特)。
 
药理作用
 
本药为硝基噻唑苯酰胺化合物,其结构与阿司匹林类似。本药抗原虫活性与干扰丙酮酸-铁氧化还原蛋白酶(PyruvateFerred0xin 0xid0reductase)依赖的电子转移反应有关。本药在体内、体外均有活眭。对厌氧菌(甲硝唑敏感或耐药菌株)及幽门螺旋菌的活性强于甲硝唑。对隐孢子虫、贾第鞭毛虫、阿米巴原虫引起的原虫性腹泻有良好的疗效,并可用于治疗艾滋病人所患隐孢子虫病。
 
 药动学
 
本药口服后1~4h达血药浓度峰值。血浆蛋白结合率为98%~99%,药物主要在血浆中代谢。代谢物包括替唑尼特、尿水杨酸及氨硝噻唑,其中替唑尼特(硝唑尼特的去乙酰化物)具有药物活性。代谢物主要随胆汁排泄,经肾脏排泄量低于10%。其活性代谢物替唑尼特半衰期约为1~1.6h。 
 
适应证
 
用于治疗隐孢子虫、贾第鞭毛虫、阿米巴原虫引起的原虫性腹泻。

禁忌证
 
对硝唑尼特、替唑尼特过敏者(国外资料)。 
 
注意事项
 
1.交叉过敏:
本药可能与替唑尼特存在交叉过敏。
2.慎用:
(1)对阿司匹林或水杨酸过敏者。
(2)心血管疾病患者。
(3)肝、肾功能不全者。
(4)胃肠道疾病患者(以上均为国外资料)。
3.药物对妊娠的影响:尚缺乏足够的对照研究资料,妊娠妇女应谨慎用药。
4.药物对哺乳的影响:
尚不清楚本药是否经乳汁分泌。
5.用药前后及用药时应当检查或监测:
(1)全血计数。
(2)肝功能。
(3)必要时作寄生虫相关检查。
6.本药宜与食物同服,以减少胃肠道症状。
7. 4岁以下儿童多服用口服混悬液。

贮法:密闭、干燥,避光保存。 
 
不良反应
 
1.心血管系统:有出现低血压伴心动过速的报道。
2.中枢神经系统:有出现头痛的报道。
3.胃肠道:可出现腹痛、腹泻、呕吐。有报道儿童用药后腹痛发生率为7.8%,腹泻及呕吐发生率小于2%。
4.肝脏:偶见丙氨酸氨基转移酶升高。也有出现巩膜呈灰黄色的报道(小于1%),但是否为黄疸所致尚不清楚,与肝功能的关系也尚不明确。 
 
用法用量
 
1.成人常规剂量:
口服给药:
(1)治疗小球隐孢子虫所致腹泻:一次500mg,一日1次,连服3日。
(2)治疗艾滋病人的隐孢子虫病:一次500mg,一日2次,连服3个月,可改善艾滋病人因隐孢子虫病引起的症状。
(3)贾第鞭毛虫病:一次500mg,一日2次,连服3日。
2.儿童常规剂量:口服给药:
(1)治疗小球隐孢子虫引起的腹泻:
①1~4岁的患儿,一次100mg,一日2次,连服3日。
②4~11岁的患儿,一次20mg,一日2次,连服3日。
(2)贾第鞭毛虫病:
①1~4岁的患儿,一次100mg,一日2次,连服3日。
②4~11岁的患儿,一次200mg,一日2次,连服3日。
 
药物相应作用
 
尚不明确。


Alinia(Nitazoxanide Tablets)

Nitazoxanide Oral suspension

What is this medicine?

NITAZOXANIDE (nye ta ZOX a nide) is an anti-infective. It is used to treat diarrhea caused by some parasites.
 
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
•bile or gallbladder problems
•diabetes
•immune system problems
•kidney disease
•liver disease
•an unusual or allergic reaction to nitazoxanide, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Take with food. Shake well before using. Use a specially marked spoon or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 year old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

•warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for a follow-up visit as directed. You may need to have tests done to check that the infection is cleared. Tell your doctor if your symptoms do not start to get better or if they get worse.

Practice good hygiene to prevent infection of others. Wash your hands, scrub your fingernails and shower often. Every day change and launder linens and undergarments. Scrub toilets often and keep floors clean.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•breathing problems
•fast, irregular heartbeat
•fever or chills
•redness, blistering, peeling or loosening of the skin, including inside the mouth
•tremor
•unusual bleeding or bruising
•unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
•bone or muscle pain
•diarrhea
•dizziness
•dry mouth
•headache
•nausea, vomiting
•stomach pain
•urine discoloration

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

After this medicine is mixed by your pharmacist, store it at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Keep container tightly closed. Throw away any unused medicine after 7 days.

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
Alinia(nitazoxanide)片剂和口服混悬剂获FDA宣布批准用于治疗成人和12岁以上儿童因小隐孢子虫感染引起的腹泻,先前该药已被FDA批准用于治疗幼儿同种感染症状。这也是过去31个月内,该药第三次被批准扩大适应症。小隐孢子虫是引起水传播疾病爆发的主要根源之一,这一点已得到公认,因此FDA此次做出的批准决定意义非同一般。
近期的一项临床试验显示,与安慰剂组相比,Alinia能够显著减少腹泻的持续时间,缓解其他胃肠道不适症状。药物的起效时间快,患者对其耐受性好,不良反应与安慰剂组类似

硝唑尼特治疗慢性乙肝最新疗效

硝唑尼特(Nitazoxanide,Alinia®, Romark Laboratories, L.C., Tampa, Fl, USA)是第一个thiazolide类药物,2002年在美国获得批准,用于治疗免疫功能健全的成人和儿童的小球隐孢子虫和蓝氏贾第虫感染。而现在大量的临床前及临床试验表明硝唑尼特对于乙肝病毒和丙肝病毒感染有活性。

抗病毒作用机制

硝唑尼特抗原虫和厌氧菌的作用机制是直接抑制丙酮酸铁氧还蛋白氧化还原酶反应。但其抗病毒作用机制与此不同。其作用机制可能是激活一种蛋白激酶,这种蛋白激酶可以被双链RNA激活,而这种蛋白激酶也是干扰素诱导的抗病毒反应的中介物质。这种蛋白激酶称为PKR,其激活导致底物真核启动因子2α(eIF2a)的磷酸化。硝唑尼特代表了一类新作用机制的抗病毒药,由于其针对宿主的抗病毒机制,因此发生病毒耐药的门槛要显著高于直接针对病毒的药物。

抗乙肝和丙肝病毒体外活性

最初是在应用硝唑尼特治疗艾滋病人原虫感染时偶然发现其具有抗肝病毒活性,其后应用标准的体外抗病毒检测方法证实了硝唑尼特及其代谢物替唑尼特的抗病毒活性。硝唑尼特和替唑尼特都是潜在的乙肝病毒抑制剂,与其它抗病毒药物如拉米夫定、阿德福韦联用具有协同效应,硝唑尼特和替唑尼特同样对耐受拉米夫定、阿德福韦的乙肝病毒变异体有效。此外,在以a- 和 1b基因型启动复制子的细胞和2a基因型细胞培养模型中,硝唑尼特和替唑尼特也是潜在的丙肝病毒抑制剂,与干扰素联用具有协同效应。以硝唑尼特预先处理丙肝病毒复制模型三天,使病毒对之后的干扰素治疗更敏感,这为正在进行的联合治疗之前采用硝唑尼特导入期的临床研究提供了依据。

治疗慢性乙肝

单独使用硝唑尼特治疗慢性乙肝(疗程为一年)的疗效已得到初步证明,每天两次,每次500mg硝唑尼特的给药方案使4名HBeAg阳性患者血清乙肝病毒 DNA水平全部出现下降,4名患者中2名患者乙肝病毒 DNA含量降低到检测水平以下,3名患者HBeAg转阴,1名患者HBsAg转阴。8名HBeAg阴性患者中7名患者乙肝病毒 DNA降低到检测水平以下,2名患者HBsAg转阴。另外,硝唑尼特单独治疗组有1例,硝唑尼特加阿德福韦联合治疗组也有1例患者在治疗后,获得了乙肝病毒 DNA低于检测水平,HBeAg和HBsAg抗原转阴的效果。这些初步研究结果显示硝唑尼特治疗HBsAg转阴率要高于目前已批准的其他任何乙肝治疗药物。与干扰素相似的作用机制提示,硝唑尼特单独使用或与核苷(酸)类似物联用都可能使HBsAg阴转率提高(治疗终极终点)。一项正式的Ⅱ期试验计划将于2009年启动(但检索尚未发现硝唑尼特治疗乙肝的临床试验注册信息)。

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