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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
AVYCAZ(头孢他啶[ceftazidime]-avibactam)注射用复方，为静脉使用
美国初次批准：2015
作用机制
AVYCAZ是一种抗微生物药[见临床药理学]。
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].
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50 mL/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。
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。
AVYCAZ(AVIBACTAM SODIUM CEFTAZIDIME)POWDER IV (INFUSION)
Avycaz (ceftazidime-avibactam) is a combination of a cephalosporin and a beta-lactamase inhibitor.
Avycaz 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.
Avycaz is also 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.
Avycaz is supplied as a solution for intravenous infusion. The recommended dosage of Avycaz is 2.5 grams (2 grams ceftazidime and 0.5 grams avibactam) administered every 8 hours by intravenous (IV) infusion over 2 hours. For treatment of cIAI, metronidazole should be given concurrently.
AVYCAZ Rx
Generic Name and Formulations:
Ceftazidime 2g, avibactam 0.5g; per vial; pwd for IV inj after reconstitution and dilution; sodium content 6.4mEq/vial.
Company:
Allergan
Select therapeutic use: Bacterial infections
Indications for AVYCAZ:
Susceptible infections including complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including pyelonephritis.
Adult:
Give by IV infusion over 2hrs. ≥18yrs: 2.5g every 8hrs. cIAI: treat for 5–14 days. cUTI: treat for 7–14 days. Renal impairment (CrCl 31–50mL/min): 1.25g every 8hrs; (CrCl 16–30mL/min): 0.94g every 12hrs; (CrCl 6–15mL/min): 0.94g every 24hrs; (CrCl ≤5mL/min): 0.94g every 48hrs; give after hemodialysis on hemodialysis days.
Children:
<18yrs: not established.
Contraindications:
Cephalosporin hypersensitivity.
Warnings/Precautions:
Penicillin or other beta-lactam allergy. Discontinue if allergic reaction occurs. Evaluate and manage fluid, electrolyte levels, supplement protein intake if C.diff-associated diarrhea suspected or confirmed. Renal impairment; monitor CrCl at least daily and adjust dose as necessary. Pregnancy. Nursing mothers.
Interactions:
Concomitant probenecid: not recommended. False (+) urine glucose test possible.
Pharmacological Class:
Cephalosporin + beta-lactamase inhibitor.
Adverse Reactions:
Diarrhea, nausea, vomiting, constipation, anxiety; C.diff-associated diarrhea, hypersensitivity reactions, CNS reactions (eg, seizure, encephalopathy, coma).
Generic Availability:
NO
How Supplied:
Single-use vial—1, 10
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d9c2803f-dc9c-4b19-b4a3-8303bc8c15fd
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