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Avycaz 2.5g per vial(ceftazidime/avibactam 复方冻干粉注射剂)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 (2克:5克)/瓶 10瓶/盒  
包装规格 (2克:5克)/瓶 10瓶/盒  
计价单位: 盒 
生产厂家中文参考译名:
Actavis plc
生产厂家英文名:
Actavis plc
该药品相关信息网址1:
https://www.avycaz.com/safety
该药品相关信息网址2:
http://www.medilexicon.com/drugs/avycaz.php
该药品相关信息网址3:
原产地英文商品名:
Avycaz injection(2G:5G)/VIAL 10VIAL/box
原产地英文药品名:
ceftazidime/avibactam
中文参考商品译名:
Avycaz注射用复方(2克:5克)/瓶 10瓶/盒
中文参考药品译名:
头孢他啶/阿维巴坦
曾用名:
简介:

 

近日,新型抗生素产品Avycaz获得FDA批准上市,用于复杂性腹腔内感染 (cIAI)(联合甲硝唑)及复杂性尿路感染的治疗。
Avycaz是一款固定剂量的复方药物,所含有的头孢他啶是先前获批的头孢菌素类抗菌药,Avibactam是一种新型β-内酰胺酶抑制剂。
“FDA致力于让治疗药物用来治疗未满足医疗需求的患者,”FDA药品审评价与研究中心抗生素产品办公室主任、医学博士、公共卫生学硕士Cox称。“当用来治疗患者感染的抗菌药物有限或没有替代药物时,Avycaz可拿来使用是非常重要的。”
批准日期:2015年2月25日    公司:阿特维斯
AVYCAZ(头孢他啶/阿维巴坦[ceftazidime and avibactam)])注射用于静脉注射
美国最初批准:2015年
最近的重大变化
适应症和用法,复杂的腹腔内感染:3/2019
适应症和用法,复杂的尿路感染:3/2019
作用机制
AVYCAZ是一种抗菌药物[见临床药理学]。
剂量和用药:3/2019
适应症和用法
AVYCAZ是ceftazidime,一种头孢菌素和avibactam,abeta-lactamase抑制剂的组合,用于治疗由指定的易感革兰氏阴性微生物引起的以下感染:
•复杂的腹腔内感染(cIAI),与甲硝唑联合使用,适用于3个月及以上的成人和儿童患者。
•复杂的尿路感染(cUTI),包括肾盂肾炎,3个月及以上的成人和儿科患者。
•18岁及以上患者的医院获得性细菌性肺炎和呼吸机相关细菌性肺炎(HABP / VABP)。
为了减少抗药性细菌的发展并保持AVYCAZ和其他抗菌药物的有效性,AVYCAZ应该仅用于治疗被证实或强烈怀疑由易感细菌引起的感染。
剂量和给药
成年肌酐清除率(CrCl)患者AVYCAZ的剂量大于50毫升/分钟
感染             剂量           频率           输液时间
cIAI,        AVYCAZ 2.5克    每8小时一次。    2小时
包括佩莱肾炎,(头孢他啶2克
HABP/VABP      和avibactam0.5克)
AVYCAZ在儿科患者中的用量2至少于18岁估计肾小球滤过率(eGFR)大于50mL/min/1.73m2,3个月至不到2年没有肾功能损害。
感染           年龄范围         剂量           注入时间/频率
            2年到少于18年 AVYCAZ 62.5mg/kg至
                              最多2.5克
                         (头孢他啶50 mg/kg
                       和avibactam 12.5毫克/千克
                            到最大剂量
                           头孢他啶2克和
                          avibactam 0.5克)
cIAI和的CuTi包含肾盂肾炎                         2小时/每8小时一次 
         6个月到少于2年     AVYCAZ 62.5mg/kg
                           (头孢他啶50mg/kg
                          和avibactam 12.5毫克/千克)
对于cIAI的治疗,应同时给予甲硝唑
•建议的治疗时间:
o cIAI:5至14天
o cUTI包括肾盂肾炎:7至14天
o HABP/VABP:7至14天(仅限成人)
•成人肾功能损害患者的剂量
AVYCAZ在成人肾功能不全患者中的用量
预计肌酐净空(毫升/分钟)      剂量b                         频率
31至50岁  AVYCAZ 1.25克(头孢他啶1剂,avibactam 0.25克)  每8小时一次
16至30岁 AVYCAZ 0.94克(头孢他啶0.75克和avibactam 0.19克)每12小时一次
6至15c   AVYCAZ 0.94克(头孢他啶0.75克和avibactam 0.19克)每24小时一次
小于或   AVYCAZ 0.94克(头孢他啶0.75克和avibactam 0.19克)每48小时一次
等于5C
a使用Cockcroft-Gault公式计算。
b所有剂量的AVYCAZ均在2小时内给药
c头孢他啶和avibactam均可血液透析; 因此,管理血液透析后血液透析后的AVYCAZ。
有关肾功能损害的2岁及以上儿科患者的cIAI或cUTI剂量,请参阅完整处方信息。在肾功能不全2岁以下的儿科患者中,没有足够的信息来推荐cIAI或cUTI的给药方案。
•有关构成供应的干粉和随后所需稀释的说明,请参阅完整的处方信息。
•有关药物相容性,请参阅完整处方信息。
剂量形式和强度
用于注射的AVYCAZ 2.5g(头孢他啶和阿维巴坦)作为无菌粉末提供,用于在含有头孢他啶2克(相当于2.635克头孢他啶五水合物/碳酸钠粉末)和0.5克(相当于0.551克的维他命钠)的单剂量小瓶中构建。
禁忌症
AVYCAZ禁用于AVYCAZ(头孢他啶和avibactam),含avibactam的产品或头孢菌素类其他成分已知严重超敏反应的患者。
警告和注意事项
•基线CrCl为30至小于或等于50mL/min的成人cIAI患者的疗效降低:在肾功能改变的成人和百科患者中至少每天监测CrCl并相应地调整AVYCAZ的剂量。
•过敏反应:包括过敏反应和严重的皮肤反应。有青霉素过敏史的患者可能会出现超敏反应。如果发生过敏反应,请停止AVYCAZ。
•艰难梭菌相关性腹泻(CDAD):CDAD已报告几乎所有全身性抗菌药物,包括AVYCAZ。
评估腹泻是否发生。
•中枢神经系统反应:可能发生癫痫发作和其他神经系统事件,尤其是肾功能不全患者。调整患有肾功能损害的住院患者。
不良反应
•成人cIAI,cUTI和HABP/VABP患者:cIAI中最常见的不良反应(≥5%,与甲硝唑一起使用时)患者出现腹泻,恶心和呕吐。cUTI患者最常见的不良反应(3%)是腹泻和恶心.HABP/VABP患者中最常见的不良反应(≥5%)是腹泻和呕吐。
•儿科cIAI和cUTI患者:儿科患者最常见的不良反应(> 3%)为呕吐,腹泻,皮疹和输液性静脉炎。
要报告疑似不良反应,请致电1-800-678-1605联系Allergan或1-800-FDA-1088或www.fda.gov/medwatch联系FDA。
用于特定人群
•尚未确定3个月以下儿科患者的安全性和有效性。
•尚未建立HABP/VABP儿科患者的安全性和有效性。
包装提供/存储和处理
注射用AVYCAZ 2.5克(头孢他啶和avibactam)以单剂量透明玻璃小瓶供应
含有:头孢他啶2克(相当于2.635克头孢他啶五水合物/碳酸钠)和
avibactam 0.5克(相当于0.551克avibactam钠)。
样品瓶作为单个样品瓶提供(NDC#0456-2700-01)和装有10个小瓶的纸箱(NDC#0456-2700-10)
AVYCAZ样品瓶应储存在25°C(77°F); 允许的偏差在15°C至30°C(59°F至86°F)之间
[参见USP受控室温]。 避光。 在纸箱中存放直至使用。
完整说明资料附件:https://www.allergan.com/assets/pdf/avycaz_pi
AVYCAZ (ceftazidime and avibactam) for injection, for intravenous use
AVYCAZ® is indicated for the treatment of HABP/VABP, cUTI (including pyelonephritis), and cIAI (in combination with metronidazole) caused by designated susceptible microorganisms.
INDICATIONS AND USAGE
Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP)
AVYCAZ® (ceftazidime and avibactam) is indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae in patients 18 years or older.
Complicated Intra-Abdominal Infections (cIAI)
AVYCAZ, in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae, Klebsiella oxytoca, Citrobacter freundii complex, and Pseudomonas aeruginosa in patients 18 years or older.
Complicated Urinary Tract Infections (cUTI), including Pyelonephritis
AVYCAZ is indicated for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Citrobacter freundii complex, Proteus mirabilis, and Pseudomonas aeruginosa in patients 18 years or older.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVYCAZ and other antibacterial drugs, AVYCAZ should be used to treat only indicated infections that are proven or strongly suspected to be caused by susceptible bacteria.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
AVYCAZ is contraindicated in patients with known serious hypersensitivity to the components of AVYCAZ (ceftazidime and avibactam), avibactam-containing products, or other members of the cephalosporin class.
WARNINGS AND PRECAUTIONS
In a Phase 3 cIAI trial, clinical cure rates were lower in a subgroup of patients with baseline creatinine clearance (CrCl) of 30 to less than or equal to 50 mL/min compared to those with CrCl greater than 50 mL/min. The reduction in clinical cure rates was more marked in patients treated with AVYCAZ plus metronidazole compared to meropenem-treated patients. Within this subgroup, patients treated with AVYCAZ received a 33% lower daily dose than is currently recommended for patients with CrCl of 30 to less than or equal to 50 mL/min. Clinical cure rate in patients with normal renal function/mild renal impairment (CrCl greater than 50 mL/min) was 85% (322/379) with AVYCAZ plus metronidazole vs 86% (321/373) with meropenem, and clinical cure rate in patients with moderate renal impairment (CrCl 30 to less than or equal to 50 mL/min) was 45% (14/31) with AVYCAZ plus metronidazole vs 74% (26/35) with meropenem. The decreased clinical response was not observed for patients with moderate renal impairment at baseline (CrCl 30 to less than or equal to 50 mL/min) in the Phase 3 cUTI trials or the Phase 3 HABP/VABP trial. Monitor CrCl at least daily in patients with changing renal function and adjust the dosage of AVYCAZ accordingly.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with AVYCAZ is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. Exercise caution if this product is to be given to a penicillin or other beta-lactam-allergic patient because cross sensitivity among beta-lactam antibacterial drugs has been established. Discontinue the drug if an allergic reaction to AVYCAZ occurs.
Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial drugs, including AVYCAZ, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial drugs. If CDAD is suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible.
Seizures, nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported in patients treated with ceftazidime, particularly in the setting of renal impairment. Adjust dosing based on CrCl.
Prescribing AVYCAZ in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
ADVERSE REACTIONS
The most common adverse reactions in cIAI patients (≥ 5% when used with metronidazole) were diarrhea (8%), nausea (7%), and vomiting (5%). The most common adverse reactions in cUTI patients (3%) were diarrhea and nausea. The most common adverse reactions in HABP/VABP patients (≥ 5%) were diarrhea (15%) and vomiting (6%).
https://www.avycaz.com/

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