近日，美国FDA批准AVYCAZ(AVIBACTAM SODIUM CEFTAZIDIME)与甲硝唑联合用于治疗复杂性腹腔内感染(cIAI)及复杂性尿路感染 (cUTI) 成人患者，其中包括肾脏感染（肾盂肾炎），适用于治疗选择有限或没有替代治疗选择的患者。
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: Actavis plc
注射用复方AVYCAZ(头孢他啶[ceftazidime]-avibactam)，为静脉使用
美国初次批准：2015
适应证和用途
AVYCAZ(头孢他啶-avibactam)是一个头孢霉菌素和一个β-内酰胺酶抑制剂的组合适用为18岁或以上有以下被指定的敏感微生物所致感染患者的治疗:
⑴ 与甲硝唑[metronidazole]联用对复杂腹腔内感染(cIAI)
⑵ 复杂尿路感染(cUTI)包括肾盂肾炎
因为当前对AVYCAZ只能得到有限的临床安全性和疗效数据，保留AVYCAZ在受限制或无另外治疗选择的患者中使用。[见临床研究(14)].
为减低药物-耐药细菌发生发展和保持AVYCAZ和其他抗菌药的有效性，AVYCAZ只应被用于治疗感染是已被证明或被强烈怀疑被敏感细菌所致。
剂量和给药方法

⑴ 推荐治疗时间：
cIAI：5至14天
cUTI 包括肾盂肾炎：7至14天
⑵ 对组成性供应干粉和随后要求稀释指导见完整处方资料。
⑶对药物兼容性见完整处方资料。
剂型和规格
注射用AVYCAZ(头孢他啶-avibactam)在一次性使用小瓶含2克头孢他啶和0.5克avibactam。
禁忌证
对头孢他啶，avibactam或头孢霉菌素类对其他成员已知严重超敏性。
警告和注意事项
⑴有基线CrCL 30至50mL/min患者中减低疗效。从而监视CrCL至少每天 in有改变肾功能和患者中调整AVYCAZ的剂量。
⑵超敏性反应：包括过敏性反应和严重皮肤反应。有青霉素过敏史患者可能发生交叉-超敏性. 如发生过敏反应，终止AVYCAZ。
⑶艰难梭菌-伴腹泻：接近所有全身抗菌药都曾报道艰难梭菌-伴腹泻(CDAD)，包括AVYCAZ。如发生腹泻评价。
⑷中枢神经系统反应：可能发生癫痫发作和其他神经学事件，尤其是在有肾受损患者。在有肾受损患者中调整剂量。
不良反应
最常见不良反应(在任一适应证> 10%的发生率)是呕吐，恶心，便秘，和焦虑。
如何供应/贮存和处置
AVYCAZ注射液是在单次使用，透明玻璃小瓶供应。2克头孢他啶(等同于2.635克头孢他啶五水/碳酸钠)和0.5克avibactam(等同于0.551克avibactam钠) – 各个小瓶(NDC# 0456-2700-01)和纸盒含10小瓶(NDC# 0456-2700-10)
贮存未重建的AVYCAZ小瓶在25°C(77°F)；外出允许15°C和30°C间(59°F和86°F)[见USP对照室温]。避光保护。
患者咨询资料
严重过敏反应
忠告患者，其家庭，或护理人员可能发生需要立即治疗的过敏反应，包括严重过敏反应。询问他们关于对AVYCAZ，其他β-内酰胺(包括头孢霉菌素)，或其他过敏原任何以前超敏性反应[见警告和注意事项(5.2)]。
潜在地严重腹泻
忠告患者，其家庭，或护理人员腹泻是抗菌药所致常见问题。有时可能发生频繁水性或血性腹泻和可能是更严重肠道感染征象。如发生严重水性或血性腹泻，告诉他们联系他或她的卫生保健提供者[见警告和注意事项(5.3)]。
神经系统反应
忠告患者，其家庭，或护理人员使用AVYCAZ可能发生神经学不良反应。指导患者其家庭，或护理人员任何神经学体征和症状立即告知卫生保健提供者，包括脑病(意识障碍包括混乱，幻觉，木僵，和昏迷)，肌阵挛，和癫痫发作，为立即治疗，剂量调整，或AVYCAZ的终止[见警告和注意事项(5.4)]。
抗菌耐药性
与患者，其家庭，或护理人员商讨抗菌药包括AVYCAZ只应用于治疗细菌性感染。它们不治疗病毒感染(如，感冒)。当AVYCAZ被处方治疗某种细菌性感染，患者应被告诉虽然治疗过程早期常感觉好些，用药应采取严格按照医生指示。跳过剂量或不完成完整治疗过程可能(1) 降低立即治疗的有效性和(2)增加细菌将发生耐药性可能性和在未来用AVYCAZ或其他抗菌药将不能治疗[见警告和注意事项(5.5)]。

Indications and Usage
Complicated Intra-Abdominal Infections (cIAI)
AVYCAZ™ (ceftazidime-avibactam), in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Providencia stuartii, Enterobacter cloacae, Klebsiella oxytoca, and Pseudomonas aeruginosa in patients 18 years or older.
As only limited clinical safety and efficacy data for AVYCAZ are currently available, reserve AVYCAZ for use in patients who have limited or no alternative treatment options.
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 microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Citrobacter freundii, Proteus spp., and Pseudomonas aeruginosa in patients 18 years or older.
As only limited clinical safety and efficacy data for AVYCAZ are currently available, reserve AVYCAZ for use in patients who have limited or no alternative treatment options.
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. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Important Safety Information
Contraindications
AVYCAZ is contraindicated in patients with known serious hypersensitivity to AVYCAZ, avibactam-containing products, ceftazidime, or other members of the cephalosporin class.
WARNINGS AND PRECAUTIONS
•In a Phase 3 complicated intra-abdominal infections (cIAI) trial, clinical cure rates were lower in a subgroup of patients with baseline creatinine clearance (CrCL) of 30 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 30 to 50 mL/min. 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, 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 creatinine clearance.
•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 (incidence of ≥10% in either indication) were vomiting, nausea, constipation, and anxiety.