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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗微生物药物->抗感染
处方药:处方药
包装规格: 500毫克/片 30片/盒
计价单位:
   
生产厂家中文参考译名:
辉瑞
生产厂家英文名:
PFIZER
该药品相关信息网址1:
http://www.drugs.com/zithromax.html
该药品相关信息网址2:
http://www.rxlist.com/zithromax-drug.htm
原产地英文商品名:
ZITHROMAX TABLET 500mg/tab 30tabs/box
原产地英文药品名:
AZITHROMYCIN
中文参考商品译名:
希舒美片剂 500毫克/片 30片/盒
中文参考药品译名:
阿奇霉素
原产地国家批准上市年份:
2002/05/24
英文适应病症1:
Acute pharyngitis, tonsillitis
英文适应病症2:
Sinusitis, otitis media, acute bronchitis, chronic bronchitis
英文适应病症3:
Pneumonia
英文适应病症4:
Urethritis and cervicitis
英文适应病症5:
Skin and soft tissue infections
临床试验期:
完成
中文适应病症参考翻译1:
急性咽炎、扁桃体炎
中文适应病症参考翻译2:
鼻窦炎、中耳炎、急性支气管炎、慢性支气管炎
中文适应病症参考翻译3:
肺炎
中文适应病症参考翻译4:
尿道炎和宫颈炎
中文适应病症参考翻译5:
皮肤软组织感染
药品信息:

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 详细处方信息以本药内容附件PDF文件(2010101400375013.pdf)的“原文Priscribing Information”为准
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部分中文阿奇霉素处方资料(仅供参考)

药品名称
别名:阿红霉素,阿齐红霉素
英文名:Azithromycin
品名:希舒美 Zithromax

规格
悬浮液 100mg, 200mg/5ml X 15ml, 200mg/5ml X 22.5ml;阿奇霉素片 250mg, 500mg, 600mg。

药理作用
阿奇霉素为氮杂内酯类抗生素,其作用机理是通过与敏感微生物的50s核糖体的亚单位结合,从而干扰其蛋白质的合成(不影响核酸的合成)。
体外试验和临床研究均表明,阿奇霉素对以下多种致病菌有效:
*革兰阳性需氧微生物:金黄色葡萄球菌、酿脓链球菌、肺炎链球菌、溶血性链球菌。
阿奇霉素对于耐红霉素的革兰阳性菌有交叉耐药性。大多数粪链球菌(肠球菌)以及耐甲氧西林的葡萄球菌对阿奇霉素耐药。
*革兰阴性需氧微生物:流感嗜血杆菌、卡他摩拉菌。
*其他微生物:沙眼衣原体。
体外试验和临床研究已证实,阿奇霉素可预防和治疗鸟胞内分支杆菌复合体(由鸟胞内分支杆菌和胞内分支杆菌组成)引起的疾病。
细菌产生的β—内酰胺酶不影响阿奇霉素的活性。
对以下微生物已有体外研究结果,但是其临床意义尚不清楚,包括链球菌属(C、F、G)、草绿色链球菌、百日咳杆菌、空肠弯曲杆菌、杜克嗜血杆菌、嗜肺性军团菌、双路普雷活氏菌、产气荚膜梭菌、消化链球菌属、包柔螺旋体、肺炎支原体、梅毒螺旋体、解脲支原体等。
毒理研究
*遗传毒性:人淋巴细胞试验、小鼠骨髓微核试验和小鼠体外淋巴瘤细胞试验的结果阿奇霉素未表现出致突变作用。
*生殖毒性:大鼠和小鼠的生殖毒性试验均表明,当阿奇霉素(经口给药)剂量达产生中等程度的母体毒性的剂量水平(即200mg/kg/日,按体表面积计算,约为人用药剂量500mg/kg/日的2-4倍)时,未发现致畸胎作用。
尚未发现对生育力和胎儿的损害。目前尚无在妊娠妇女中进行充分的和严格对照的临床试验。由于动物生殖研究的结果并不总是能预测人的情况,因此,只有在确实必要时,孕妇才能使用本品。尚不知本品是否在人乳汁中分泌,由于许多药物经人乳汁分泌,因此哺乳期的妇女在使用时应注意。
*致癌性:尚无有关本品动物长期用药的致癌性研究资料。

药代动力学
口服后迅速吸收,生物利用度为37%。单剂口服0.5g后,达峰时间为2.5~2.6小时,血药峰浓度(Cmax)为0.4~0.45mg/L。本品在体内分布广泛,在各组织内浓度可达同期血浓度的10~100倍,在巨噬细胞及纤维母细胞内浓度高,前者能将阿奇霉素转运至炎症部位。本品单剂给药后的血消除半衰期(t1/2β)为35~48小时,给药量的50%以上以原形经胆道排出,给药后72小时内约4.5%以原形经尿排出。
本品的血清蛋白结合率随血药浓度的增加而减低,当血药浓度为0.02μg/ml时,血清蛋白结合率为15%;当血药浓度为2μg/ml时,血清蛋白结合率为7%。国外资料显示,轻中度肾功能不全患者(肾小球滤过率为10~80ml/min)药代参数无明显变化,严重肾功能不全者(肾小球滤过率为小于10ml/min)与正常者有显著差异,全身暴露量增加33%。

适应症
(1).化脓性链球菌引起的急性咽炎、急性扁桃体炎。
(2).敏感细菌引起的鼻窦炎、中耳炎、急性支气管炎、慢性支气管炎急性发作。
(3).肺炎链球菌、流感嗜血杆菌以及肺炎支原体所致的肺炎。
(4).沙眼衣原体及非多种耐药淋病奈瑟菌所致的尿道炎和宫颈炎。
(5).敏感细菌引起的皮肤软组织感染。

用法用量
成人
沙眼衣原体或敏感淋球菌所致性传播疾病
单次口服1g。其它感染500mg/次/日,连续服用3天。儿童按10mg/kg计算每天用量,每天1次,连服3天。
15kg以下儿童
每日单次口服100mg。
15-25kg儿童
每日单次口服200mg。
26-35kg儿童
每日单次口服300mg。
36-45kg儿童
每日单次口服400mg,疗程为3天。
任何疑问,请遵医嘱!

禁忌症
对阿奇霉素、红霉素或其他任何一种大环内酯类药物过敏者禁用。

不良反应
轻至中度腹泻(稀便),上腹部不适(痛或痉挛),恶心、呕吐、偶见轻中度腹胀。曾见轻度中性粒细胞减少症,但是否与阿奇霉素有关尚未证实。偶见一过性肝转氨酶升高。

注意事项
1.进食可影响阿奇霉素的吸收,故需在饭前1小时或饭后2小时口服。
2.轻度肾功能不全患者(肌酐清除率>40ml/分钟)不需作剂量调整,但阿奇霉素对较严重肾功能不全患者中的使用尚无资料,给这些患者使用阿奇霉素时应慎重。
3.由于肝胆系统是阿奇霉素排泄的主要途径,肝功能不全者慎用,严重肝病患者不应使用。用药期间定期随访肝功能。
4.用药期间如果发生过敏反应(如血管神经性水肿、皮肤反应、Stevens-Johnson综合症及毒性表皮坏死等),应立即停药,并采取适当措施。
5.治疗期间,若患者出现腹泻症状,应考虑假膜性肠炎发生。如果诊断确立,应采取相应治疗措施,包括维持水、电解质平衡、补充蛋白质等。
6.使用本品期间,如出现任何不良事件和/或不良反应,请咨询医生。
7.同时使用其他药品,请告知医生。
8.请放置于儿童不能够触及的地方。

孕妇及哺乳期妇女用药
动物实验显示本品对胎儿无影响,但在人类孕妇中应用尚缺乏经验,故在孕妇中应用须充分权衡利弊。尚无资料显示本品是否可分泌至母乳中,故哺乳期妇女应用须谨慎考虑。

儿童用药
治疗小于6个月小儿中耳炎、社区获得性肺炎及小于2岁小儿咽炎或扁桃体炎的疗效与安全性尚未确定。

药物相互作用
根据国外进行的药物相互作用研究资料介绍,获得以下有关本品信息:
抗酸剂:在探讨抗酸剂与阿奇霉素同时给药的药动学研究中,阿奇霉素的峰浓度大约降低了25%,未见对总生物利用度的影响。对服用阿奇霉素又需要服用抗酸剂的患者,不应同一时间服用这些药物。
西替利嗪:健康志愿者同时口服阿奇霉素和西替利嗪(20mg)5天,稳态浓度下两者在药代动力学上无相互作用,亦未观察到QT间期的显著变化。去羟肌苷(二去氧次黄嘌呤核苷):与服用安慰剂相比较,6例HIV阳性患者每日同时服用1200mg的阿奇霉素和400mg的去羟肌苷并未影响去羟肌苷的稳态药代动力学。
地高辛:曾有报告,某些大环内酯类抗生素影响一些患者的地高辛肠内代谢。因此对同时服用阿奇霉素和地高辛的患者,应注意其地高辛血药浓度有升高的可能性。
齐多夫定:单剂量1000mg和多剂量1200mg或600mg的阿奇霉素对齐多夫定或其葡萄糖醛酸代谢物的血浆药代动力学或尿排泄几乎没有影响。然而口服阿奇霉素可以增加外周血单核细胞中的磷酸化齐多夫定的浓度,后者是临床活性代谢产物。这些发现的临床意义尚不清楚,但对患者来说可能是有益的。
阿奇霉素对肝内细胞色素P450系统无显著影响。阿奇霉素与红霉素等其他大环内酯类抗生素不同,不影响其它药物的药代动力学,不会因诱导肝内细胞色素P450或通过形成细胞色素代谢复合物而失去活性。
麦角:由于理论上存在有麦角中毒的可能性,故不主张阿奇霉素与麦角类衍生物同时使用。已进行了阿奇霉素与下列主要通过肝内细胞色素P450系统代谢的药物之间的药代动力学研究。
阿托伐他汀:每日同时服用阿托伐他汀10mg与阿奇霉素500mg,对阿托伐他汀的血药浓度没有影响(HMGCOA-reductaseinhibitionassay)(3羟基-3-甲基-戊二酰辅酶A还原酶抑制分析)。
卡马西平:对健康志愿者的药代动力学研究表明,同时应用卡马西平和阿奇霉素,对卡马西平及其活性代谢物的血药浓度无显著影响。
西咪替丁:在单剂量西咪替丁的药代动力学研究中,在服用阿奇霉素前二小时用药,未见阿奇霉素的药代动力学有所改变。
香豆素类口服抗凝剂:在健康志愿者进行的药代动力学研究中,阿奇霉素并不影响口服单剂量15mg的华法林的抗凝作用。在阿奇霉素上市后,有报道同时应用阿奇霉素和香豆素类口服抗凝剂可使抗凝作用增强。虽然因果关系尚未确定,但是对同时使用香豆素类口服抗凝剂的患者,应注意经常监测凝血酶原时间。
环孢素:在健康志愿者中进行药代动力学研究,每日口服阿奇霉素500mg,连续3天后再口服环孢素单剂量10mg/kg,环孢素的峰浓度和5小时药时曲线下面积显著增加。故二者同时使用时必须慎重。如必须同时使用,应监测环孢素的血药浓度,以便相应调整剂量。
依非韦伦:同时应用阿奇霉素(单剂600mg)和依非韦伦(每天400mg,共7天),未发现具有显著临床意义的药代动力学改变。
氟康唑:同时应用单体氟康唑800mg与单剂阿奇霉素1200mg,未见氟康唑的药代动力学有明显改变,阿奇霉素的总暴露量和半衰期也无改变,血药峰浓度则降低18%,但无显著临床意义。
茚地那韦:同时应用单剂量的阿奇霉素1200mg,对于茚地那韦(每天3次,每次800mg,连续5天)的药代动力学无显著影响。
甲泼尼龙:在健康志愿者中进行的药物相互作用研究中,阿奇霉素对甲泼尼龙的药代动力学参数无显著影响。
咪达唑仑:健康志愿者同时使用阿奇霉素(500mg/天,共3天)和咪达唑仑(单剂15mg),后者的药代动力学和药效学无显著改变。奈非那韦:同时应用阿奇霉素1200mg和奈非那韦(750mg,每天3次给药,直到达到血药稳态浓度为止),未发生具有显著临床意义的药物相互作用,所以不需要调整剂量。
利福布丁:本品与利福布丁合用对两者的血清浓度均无影响。阿奇霉素与利福布丁合用时,会发生中性粒细胞减少症。虽然中性粒细胞减少症和使用利福布丁有关,但是否与阿奇霉素合用有关尚无定论。
西地那非:在健康男性志愿者中进行的研究中,尚无证据表明阿奇霉素(每天500mg,共3天)对西地那非或主要循环代谢产物的血药峰浓度、药时曲线下面积有影响。
特非那丁:药代动力学研究表明,阿奇霉素与特非那丁之间无药物相互作用。虽两者相互作用的病例罕有报道,而且这种作用的可能性亦不能完全排除,可仍无特定证据表明这种相互作用发生过。
茶碱:在健康志愿者中阿奇霉素与茶碱无相互作用。
三唑仑:与服用安慰剂相比较,14名健康志愿者同时服用阿奇霉素(第1天500mg,第2天250mg)与三唑仑(第2天给予0.125mg),对三唑仑的药代动力学无显著影响。
TMP/SMZ:每日服用TMP/SMZ160mg/800mg,连续7天,并在第7天同时服用阿奇霉素单剂1200mg,测得TMP/SMZ的血药浓度、总暴露量和尿清除率均无显著改变。阿奇霉素的血药浓度亦与其他研究中相仿。

Zithromax
Generic Name: azithromycin (a ZITH roe MYE sin)
Brand Names: Azithromycin 3 Day Dose Pack, Azithromycin 5 Day Dose Pack, Zithromax, Zithromax TRI-PAK, Zithromax Z-Pak, Zmax

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What is Zithromax?
Zithromax is an macrolide antibiotic related to erythromycin.It fights bacteria in the body.

Zithromax is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, and sexually transmitted diseases.

In children, it is used to treat middle ear infection, pneumonia, tonsillitis, and strep throat.

Zithromax may also be used for other purposes not listed in this medication guide.

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Important information about Zithromax
Do not use Zithromax if you have ever had an allergic reaction to azithromycin or similar drugs such as erythromycin (E-Mycin, Ery-Tab, E.E.S.), clarithromycin (Biaxin), telithromycin (Ketek), or troleandomycin (Tao).

There are many other medicines that can interact with azithromycin. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Take Zithromax for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Zithromax will not treat a viral infection such as the common cold or flu.

Do not take antacids that contain aluminum or magnesium within 2 hours before or after you take Zithromax. This includes Rolaids, Maalox, Mylanta, Milk of Magnesia, Pepcid Complete, and others. These antacids can make Zithromax less effective when taken at the same time.

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Before taking Zithromax
Do not use Zithromax if you have ever had an allergic reaction to azithromycin or similar drugs such as erythromycin (E-Mycin, Ery-Tab, E.E.S.), clarithromycin (Biaxin), telithromycin (Ketek), or troleandomycin (Tao).

If you have any of these conditions, you may need a dose adjustment or special tests to safely use Zithromax:
liver disease;
kidney disease;
myasthenia gravis;
a heart rhythm disorder; or
a history of Long QT syndrome.

FDA pregnancy category B. Zithromax is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether azithromycin passes into breast milk or if it could harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

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How should I take Zithromax?
Take Zithromax exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor. The dose and length of treatment with Zithromax may not be the same for every type of infection.

To use the oral suspension single dose packet: Open the packet and pour the medicine into 2 ounces of water. Stir this mixture and drink all of it right away. Do not save for later use. Throw away any mixed Zithromax oral suspension that has not been used within 12 hours.

To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Zithromax may be taken with or without food. Take the medicine with food if it upsets your stomach.

Shake the oral Zithromax suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Take Zithromax for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Zithromax will not treat a viral infection such as the common cold or flu.

Store Zithromax at room temperature away from moisture and heat. Throw away any unused liquid medicine after 10 days.

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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.

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What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, diarrhea, and stomach discomfort.

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What should I avoid while taking Zithromax?
Do not take antacids that contain aluminum or magnesium within 2 hours before or after you take Zithromax. This includes Rolaids, Maalox, Mylanta, Milk of Magnesia, Pepcid Complete, and others. These antacids can make Zithromax less effective when taken at the same time.

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 Zithromax and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Zithromax can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

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Zithromax side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Zithromax: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:
diarrhea that is watery or bloody;
chest pain, uneven heartbeats;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious Zithromax side effects may include:
mild nausea, vomiting, diarrhea, constipation;
stomach pain or upset;
dizziness, tired feeling, or headache;
nervous feeling, sleep problems (insomnia);
vaginal itching or discharge;
mild itching or skin rash;
ringing in your ears, problems with hearing; or
decreased sense of taste or smell.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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What other drugs will affect Zithromax?
Many drugs can interact with Zithromax. Below is just a partial list. Tell your doctor if you are using:
digoxin (Lanoxin, Lanoxicaps);
carbamazepine (Carbatrol, Tegretol);
cyclosporine (Neoral, Sandimmune);
phenytoin (Dilantin);
pimozide (Orap);
theophylline (Theo-Dur, Theolair, Theochron);
triazolam (Halcion);
warfarin (Coumadin);
another antibiotic, especially clarithromycin (Biaxin) or erythromycin (E-Mycin, E.E.S, Ery-Tab);
a calcium channel blocker such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;
cholesterol-lowering medicines such as lovastatin (Mevacor), atorvastatin (Lipitor), or simvastatin (Zocor) ;
ergot medicine such as methysergide (Sansert), ergotamine (Ergostat, Medihaler, Cafergot, Ercaf, Wigraine), dihydroergotamine mesylate (D.H.E., Migranal Nasal Spray); or
HIV medicines such as nelfinavir (Viracept), ritonavir (Norvir) or saquinavir (Invirase).

This list is not complete and there are many other drugs that can interact with Zithromax. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

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Where can I get more information?
Your pharmacist can provide more information about Zithromax.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. 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. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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更新日期: 2015-01-06
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