部分中文阿奇霉素I.V.注射剂处方资料（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 Medication name Generic name: Azithromycin - Intravenous Pronunciation: (ay-ZITH-roe-MYE-sin) Brand name(s): Zithromax Uses This medication is an antibiotic used to treat certain bacterial infections. This medication is known as a macrolide (erythromycin-type) antibiotic. It works by stopping the growth of bacteria. This medication is used to treat lung infections (pneumonia) or female pelvic infections (e.g., PID) caused by bacteria. Other uses This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This drug may also be used for other types of bacterial infections. How to use This medication is usually given by injection into a vein as directed by your doctor, usually once daily. It should be injected slowly over 1 hour.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.You should use this injectable medication only until you are able to take an antibiotic by mouth or until your treatment is finished. Dosage and length of treatment are based on your medical condition and response to therapy.Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, use this drug at evenly spaced intervals.Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.Tell your doctor if your condition persists or worsens. Precautions Before using azithromycin, tell your doctor or pharmacist if you are allergic to it; or to any other macrolide/ketolide antibiotics (e.g., clarithromycin, erythromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, a certain muscle disease (myasthenia gravis).Azithromycin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm. Before using azithromycin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using azithromycin safely.This medication contains sodium. Consult your doctor for more information if you are on a salt-restricted diet or if increased salt intake could worsen your condition (e.g., congestive heart failure).Older adults may be more sensitive to the side effects of this drug, especially swelling legs/feet (due to sodium and water retention) and the QT prolongation-related side effects (fast/irregular heartbeat, severe dizziness, and fainting).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Consult your doctor before breast-feeding. Drug interactions Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: digoxin, live bacterial vaccines, lovastatin, nelfinavir, warfarin.Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.Many drugs besides azithromycin may affect the heart rhythm (QT prolongation), including amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, pimozide, procainamide, quinidine, sotalol, among others. Side effects Nausea, vomiting, diarrhea/loose stools, stomach pain, or pain/redness at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: hearing changes (e.g., ringing in the ears, hearing loss), swelling legs/feet, eye problems (e.g., drooping eyelids, blurred vision), slurred speech, muscle weakness, persistent nausea/vomiting, severe abdominal/stomach pain, unusual weakness/tiredness, change in the amount of urine, dark urine, yellowing skin/eyes.Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches/sores in your mouth, a change in vaginal discharge, or other new symptoms.Get medical help right away if any of these rare but serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat.This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.An allergic reaction to this medication may return even if you stop the drug. If you have an allergic reaction, continue to watch for any of the above symptoms for several days after your last dose.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Missed dose For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If the dose is missed, contact your doctor immediately to establish a new dosing schedule. Do not double the dose to catch up. Overdose If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Notes Laboratory and/or medical tests may be performed to monitor for side effects and response to treatment. Storage Consult the product instructions and your pharmacist for storage details. Keep all medicines out of reach of children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Photos by medication strength Click the "Photos" link to see sample photographs for a specific medication strength. Common strengths Zithromax 500 mg IV Solution *The photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist. Important note HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. Information last revised June 2012. Copyright(c) 2012 First Databank, Inc. Intravenous Recon Soln azithromycin| Pneumonia due to Haemophilus Influenzae|Pfeiffer's Bacillus Pneumonia|Influenza Bacillus Pneumonia|Hemophilus Influenzae Pneumonia|H. Influenzae Pneumonia|H. Flu Pneumonia|Pneumonia due to Staphylococcus Pyogenes Aureus|Pneumonia due to Moraxella Catarrhalis|Pneumonia due to M. Catarrhalis|Pneumonia due to B. Catarrhalis|Pneumonia due to Neisseria Catarrhalis|Pneumonia due to Branhamella Catarrhalis|Primary Atypical Pneumonia|Eaton Agent Pneumonia|Infection of the Lungs due to Chlamydia|Pelvic Inflammatory Disease due to Chlamydia Trachomatis|PID due to Chlamydia Trachomatis|Pelvic Inflammatory Disease due to Neisseria Gonorrhea|Pelvic Inflammatory Disease due to Mycoplasma Hominis|PID due to Mycoplasma Hominis|Pyrexia of Unknown Origin in Children| Mediterranean Spotted Fever|Pneumonia caused by Pneumococcus Bacteria|Bacterial Pneumonia caused by Haemophilus Influenzae|Bacterial Pneumonia caused by Staphylococcus Aureus|Pneumonia caused by Legionella Pneumophila Bacteria|Pneumonia caused by the Bacteria Moraxella Catarrhalis|Pneumonia caused by Bacteria|Pneumonia caused by Mycoplasma Pneumoniae|Pneumonia caused by the Bacteria Chlamydia|Pelvic Inflammatory Disease|Chlamydia Trachomatis Infection of Female Pelvic Organs|PID with Gonorrhea|Mycoplasma Hominis Infection of the Female Pelvic Organs|Pediatric Fever without a Source| PID| Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First DataBank, Inc., 2012. This copyrighted material has been downloaded from a licensed data provider. The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. --------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: ZITHROMAX I.V. 500mg/vial 10vials/box 原产地英文药品名: AZITHROMYCIN 中文参考商品译名: 希舒美I.V.注射剂 500毫克/瓶 10瓶/盒 中文参考药品译名: 阿奇霉素 生产厂家中文参考译名: 辉瑞 生产厂家英文名: PFIZER