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  药店国别: 美国药房
产地国家: 美国
所属类别: 作用于消化系统药物->十二指肠溃疡
处方药:处方药
包装规格: 150毫克/胶囊 60胶囊/瓶
计价单位:
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生产厂家中文参考译名:
史克必成
生产厂家英文名:
SMITHKLINE BEECHAM
该药品相关信息网址1:
http://www.drugs.com/axid.html
原产地英文商品名:
AXID PULVULES 150mg/capsule 60capsules/bottle
原产地英文药品名:
NIZATIDINE
中文参考商品译名:
AXID PULVULES 150毫克/胶囊 60胶囊/瓶
中文参考药品译名:
尼扎替丁
原产地国家批准上市年份:
1988/04/12
英文适应病症1:
Duodenal ulcer
英文适应病症2:
Gastric ulcer
临床试验期:
完成
中文适应病症参考翻译1:
十二指肠溃疡
中文适应病症参考翻译2:
胃溃疡
药品信息:

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 详细处方信息以本药内容附件PDF文件(201181123024216.pdf)的“原文Priscribing Information”为准
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部分中文尼扎替丁处方资料(仅供参考)

【性状】本品为结晶状,熔点130~132℃。

【药理】本品为H2受体阻断剂。动物试验表明,本品对由组胺、胃泌素和食物等刺激引起的胃酸分泌的抑制作用比西咪替丁强8.9倍,其抗溃疡作用比西咪替丁强3~4倍,而与雷尼替了相似。临床研究证明,本品能显著抑制夜间胃酸分泌达12小时。健康受试者1次口服本品300mg,抑制夜间胃酸分泌平均为90%,10小时后胃酸分泌仍然减少52%。口服本品75~300mg并不影响胃分泌物中胃蛋白酶的活性,胃蛋白酶总分泌量的减少与胃分泌物体积的减少成比例。本品对基础血清胃泌素或食物引起的高胃泌素血症几无作用;在给予本品后12小时摄食,未见胃泌素分泌反跳。本品无抗雄性激素作用。口服本品后,绝对生物利用度超过90%,给药150mg或300mg,Cmax为700~1800μg/L和1400~3600μg/L,tmax为0.5~5小时,给药后12小时血药浓度低于10μg/L;t1/2β为1~2小时,Vd为0.8~1.5L/kg,CL为40~60L/h,口月民150mg时AUC为314.6(μg·h)/ml。由于本品半衰期短,清除迅速,肾功能正常的个体一般下发生蓄积。本品口服剂量的90%以上在12小时内随尿排泄,少于6%的剂量随粪排泄,约60%的口服剂量以原形排泄;CLr为500ml/min,这表明本品系经肾小管主动分泌而排泄,中至重度肾功能障碍明显延长本品半衰期并降低清除率,本品的血浆蛋白结合率约为35%。
对内镜检查确诊的活动性十二指肠溃疡患者,用安慰剂作对照进行双盲试验,发现给予本品后溃疡愈合比安慰剂快;在第4周至少有2/3使用本品的患者溃疡已愈合,而使用安慰剂者仅占1/3。对复发性十二指肠溃疡患者进行多中心双盲研究,临睡前服用本品150mg可使十二指肠溃疡复发率明显降低,在最初3个月内本品与安慰剂组分别为13%和40%,在6个月内分别为24%和57%,在12月内分别为34%和64%,两组均有明显差异。

【应用】活动性十二指肠溃疡和良性胃溃疡,疗程8周;也可用于十二指肠溃疡愈合后进行预防。

【注意】
(1)对本品过敏者禁用,对其它H2受体拮抗剂过敏者慎用。
(2)妊娠妇女和儿童的安全性尚未明确,必需使用时应谨慎。
(3)肾功能不全患者使用本品应减量。
(4)服用本品后尿胆素原测定可呈假阳性。
(5)不良反应发生率约2%。主要有皮疹、瘙痒、便秘、腹泻、口渴、恶心、呕吐等;也有神经系统症状如:头晕、失眠、多梦、头痛;偶见鼻炎、咽炎、鼻窦炎、虚弱、胸背痛及多汗等,罕见腹胀和食欲不振。

What is Axid?
Axid is used to treat and prevent ulcers. It is also used to treat gastroesophageal reflux disease (GERD) and to treat and maintain healing of erosive esophagitis. Axid may also be used for other conditions as determined by your health care provider.

Axid is a histamine H2 antagonist. It works by reducing acid in the stomach by blocking one of the chemicals (histamine) that stimulates the production of stomach acid.

Do NOT use Axid if:
you are allergic to any ingredient in Axid or other H2 antagonists (eg, famotidine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Axid:
Some medical conditions may interact with this medicine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, plan 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 or other substances
if you have kidney or liver problems
if you have a history of the blood disease porphyria

Some MEDICINES MAY INTERACT with Axid. Tell your health care provider if you are taking any other medicines, especially any of the following:
Ketoconazole because effectiveness may be decreased by Axid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Axid 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 Axid:
Use this medication as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Axid maybe taken with or without food.

Use a measuring device marked for medicine dosing. Ask your health care provider or pharmacist if you are unsure of how to measure the dose.

Continue to use Axid even if you feel well. Do not miss any doses.

Antacids may be taken as needed to help relieve stomach pain, unless your health care provider instructed otherwise.

If you miss a dose of this medication, take it as soon as possible. If it is almost time for your 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 Axid.

Important safety information:
Axid may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medication. Using Axid alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.

Use Axid with extreme caution in the ELDERLY because they may be more sensitive to its effects.

Use Axid with extreme caution 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 Axid, discuss with your doctor the benefits and risks of using this medication during pregnancy. Axid is excreted in breast milk. Do not breast-feed while taking this medication.

Possible side effects of Axid:
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; dizziness; headache.

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).

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 详细处方信息以本药内容附件PDF文件(201181123024216.pdf)的“原文Priscribing Information”为准
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更新日期: 2011-9-15
附件:
 
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