英文药名：Azactam（Aztreonam for Injection）

中文药名：氨曲南注射剂

生产厂家：卫材
药品介绍
药品英文名
Aztreonam
药品别名
阿兹曲南、氨噻酸单胺菌素、氨噻羧单胺菌素、单酰胺菌素、君刻单、菌克单、噻肟单酰胺菌素、Azactam、Aztreonamum、Primbactam、SQ-26776
药物剂型
注射剂(粉):0.5g，1.0g。
药理作用
氨曲南属单环β-内酰胺类抗生素，是一种杀菌药。其抗菌作用机制是能迅速通过革兰阴性需氧菌细胞的外膜壁，对青霉素结合蛋白3(PBP-3)具有高度亲和性，通过作用于PBP-3，抑制细菌细胞壁的合成，导致细胞溶解和死亡。本药抗菌作用特点是抗菌谱较窄，仅对需氧革兰阴性杆菌具抗菌作用，对铜绿假单胞菌的抗菌活性与头孢他定相似，对许多细菌产生的β-内酰胺酶高度稳定(稳定性高于第三代头孢菌素)，但是对革兰阳性菌和厌氧菌无效。本药对大肠杆菌、克雷白杆菌、沙雷杆菌、奇异变形杆菌、吲哚阳性变形杆菌、枸橼酸杆菌、流感嗜血杆菌、铜绿假单胞菌及其他假单胞菌、某些肠杆菌属、淋球菌等有较强抗菌活性，对军团菌属耐药。本品可被超广谱和染色体介导的酶水解，不诱导β-内酰胺酶活性。
药动学
氨曲南口服几乎不吸收(不足1%)；肌注吸收完全，肌注后生物利用度为100%。肌内注射1g，0.6～1.3h血药浓度达峰值，约为40～46.5μg/ml；静脉注射1g，血药浓度可达125μg/ml。血药吸收后体内分布广泛，在胆汁、乳汁、水疱液、支气管分泌物、羊水、心包膜、胸、腹腔液中均可达较高浓度。脑膜有炎症时，也有一定量药物可透过血-脑脊液屏障到达脑脊液中。
本药还可广泛分布至子宫内膜、输卵管、卵巢、前列腺、脂肪、胆囊、肾脏、大肠、肝、肺、心肌、骨骼肌、皮肤等组织中，并可透过胎盘进入胎儿血循环。本药血清蛋白结合率为56%～60%，半衰期为1.4～2.2h，肾功能损害时可延长至4.7～6.0h，约6%～16%药物可在体内代谢成无活性的代谢物。给药后8h内，60%～75%以原形从尿中排出，只有1%的药量在粪便中发现。血液透析4h可使血药浓度下降27%～58%，腹膜透析后血药浓度约下降10%，应增加给药量。
适应证
临床用于革兰阴性需氧菌引起的下呼吸道感染、尿路感染(泌尿道感染)、皮肤感染和软组织感染、败血症、腹内感染、产后和妇科感染、骨和创伤感染、淋病、膀胱炎、小儿化脓性腹膜炎。本品与其他抗生素合用，可用于治疗有革兰阳性菌感染的混合感染。
禁忌证
1.对本药过敏者。
2.对其他β-内酰胺类药曾有过敏性休克反应者。
3.对利多卡因等局麻药有过敏史者。
4.对头孢他啶过敏者。
注意事项
1.交叉过敏:本药与青霉素类、头孢菌素类等其他β-内酰胺类药交叉过敏反应的发生率很低；但国外有研究发现，头孢他啶可以完全抑制氨曲南的侧链，与本药存在交叉过敏。2.慎用:(1)过敏体质者；(2)肾功能不全者；
(3)肝功能不全者(有报道酒精性肝硬化患者对本药的总清除率可降低20%～25%)；肝功能受损的患者应观察其动态变化。
(4)孕妇；
(5)哺乳期妇女；
(6)婴幼儿；
(7)老年患者。
4.药物对检验值或诊断的影响:直接抗人球蛋白(Coombs)试验可呈阳性反应。
不良反应
1.过敏反应:以皮疹、荨麻疹、药物热等过敏反应较多见，偶见过敏性休克。
2.胃肠道反应:可出现腹痛、腹泻、恶心、呕吐、味觉改变等胃肠道症状。
3.血液系统:少数患者用药后可能出现暂时性嗜酸粒细胞增多、血小板减少、血小板增多、凝血激酶时间(PTT)及凝血酶原时间(PT)延长。
4.肝脏毒性:少数患者用药后可出现暂时性肝功能损害(血清丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、乳酸脱氢酶值升高)。
5.肾脏毒性:少数患者大剂量应用本药会引起肾功能损害(血肌酐值暂时性升高)。
6.有报道用药后偶见头痛、倦怠、眩晕等症状。
7.肌内注射或静脉给药时，如浓度过大或速度太快可致注射部位疼痛、硬结，严重者可致血栓性静脉炎，发生率为0.5%～1.8%，其中因反应不能继续治疗者2%。
8.实验室检查异常多无临床意义，不需中断治疗。9.儿科患者仅有个别儿童发生腹泻、皮疹、腹痛。
用法用量
1.肌内注射或静脉给药：每次1～2g，每8～12小时1次。危重患者或由铜绿假单胞菌所致的严重感染；每次2g，每6～8小时1次，每天最大剂量不宜超过8g。无并发症的尿路感染:每次0.5～1g，每8～12小时1次。
2.肾功能不全时剂量:
给药时应根据肌酐清除率调整剂量:
(1)肌酐清除率为每分钟30～10ml者，起始量1～2g，以后维持量按常用量减半，间隔时间为6、8、12小时1次；
(2)肌酐清除率小于每分钟10ml者，起始量0.5～1g，以后维持量按常用量的1/4，间隔时间为6、8、12小时1次。3.透析时剂量:每次血液透析后，除维持量外，应另给予起始量的1/8。
药物相应作用
1.本品与氨基糖苷类抗生素(庆大霉素、妥布霉素、阿米卡星等)联合，对铜绿假单胞菌、不动杆菌、沙雷杆菌、肺炎克雷白杆菌、普鲁威登菌、肠杆菌属、大肠杆菌、摩根杆菌等起协同抗菌作用。
2.本品与头孢西丁在体外与体内起拮抗作用。与萘夫西林、氯唑西林、红霉素、万古霉素等在药效方面不相互干扰。
3.某些抗生素(如头孢西丁、伊米配能)在体外对一些革兰阴性需氧菌可诱导高浓度的β-内酰胺酶，提示这些抗生素不宜与本品合用。
4.与利尿剂同用可增加肾毒性。
完整处方资料附件： http://www.info.pmda.go.jp/go/pack/6122400D1028_1_12/
Medication name
Generic name: Aztreonam - Injection
Pronunciation: (az-TREE-oh-nam)
Brand name(s): Azactam
Uses
Aztreonam is used to treat a wide variety of bacterial infections. This medication is an antibiotic that works by stopping the growth of bacteria.
How to use
This medication is usually given by injection into a vein or a muscle as directed by your doctor. The dosage is based on your medical condition and response to therapy.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.Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals as directed.Continue to use aztreonam 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 relapse of the infection.Tell your doctor if your condition persists or worsens.
Precautions
Before using aztreonam, tell your doctor or pharmacist if you are allergic to it; or to penicillins, cephalosporins, or certain other antibiotics (e.g., imipenem, meropenem); 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.This drug may rarely make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.This medication passes into breast milk in small amounts. While there have been no reports of harm to nursing infants, 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: cefoxitin, imipenem, live bacterial vaccines.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.Aztreonam may cause false positive results with some diabetic urine testing products (cupric sulfate-type). Consult your doctor or pharmacist for recommendations. Make sure laboratory personnel and your doctors know you use this drug.
Side effects
Diarrhea, nausea, vomiting, dizziness, headache, blurred vision, or redness/discomfort/pain/swelling at the injection site may occur. If any of these effects persist or worsen, notify 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 right away if you have any serious side effects, including: fast/irregular heartbeat, confusion, easy bruising/bleeding, ringing in the ears, seizures, chest pain, yellowing eyes or skin, dark urine, severe stomach/abdominal pain, persistent nausea or vomiting, unusual fatigue, persistent signs of infection (e.g., fever, sore throat).This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a 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 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..Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection), or a new type of bacterial infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.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 you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.
Overdose
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center 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 your progress or check for side effects. Consult your doctor for more details.
Storage
Consult the product instructions and your pharmacist for storage details. Keep all medicines away from 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.
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产地国家: 日本
原产地英文商品名:
Azactam(アザクタム注射用) 0.5g/vial 10vials/box
原产地英文药品名:
Aztreonam
中文参考商品译名:
Azactam(アザクタム注射用) 0.5克/瓶 10瓶/盒
中文参考药品译名:
氨曲南
生产厂家中文参考译名:
卫材
生产厂家英文名:
Eisai Co., Ltd.

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产地国家: 日本
原产地英文商品名:
Azactam(アザクタム注射用) 1g/vial 10vials/box
原产地英文药品名:
Aztreonam
中文参考商品译名:
Azactam(アザクタム注射用) 1克/瓶 10瓶/盒
中文参考药品译名:
氨曲南
生产厂家中文参考译名:
卫材
生产厂家英文名:
Eisai Co., Ltd.