| 近日，新型的抗生素TYGACIL（tigecycline）不仅对革兰氏阳性和阴性细菌有抗菌活性，而且克服了tetracycline的抗药机转，并且对许多高度抗药性菌种拥有临床活性包含了VRE( vancomycin-resistant enterococci)以及MRSA (methicillin-resistant Staphylococcus aureus) 其广效的特性使得TYGACIL（tigecycline）在以前必须采用多种药品合并治疗的复杂性感染提供了单一药物的治疗因此TYGACIL（tigecycline）的上市，让临床医师在对治疗高度抗药性菌种的感染可有另一选择。 目前美国FDA只通过两个临床试验的疾病(复杂性皮肤及皮肤结构感染和复杂性腹腔内感染)的治疗。 并且临床试验发现对复杂性皮肤感染和复杂性腹腔内感染与其他抗生素(vancomycin或imipenem/cilastatin)在临床及细菌学上的治疗效益类似。 批准日期：2005年6月16日 公司：Pfizer Inc TYGACIL（替加环素 tigecycline）用于注射，用于静脉注射 美国最初批准：2005年 警告： 所有原因导致完整的BOXED警告的完整预定信息。 在临床试验的荟萃分析中，使用TYGACIL治疗的患者的全因死亡率高于对照组。该死亡风险差异的原因为0.6％（95％CI 0.1,1.2）尚未确定。 TYGACIL应保留用于不适合替代治疗的情况。 作用机制 替加环素是一种四环素类抗菌药[见MICROBIOLOGY]。 适应症和用法 TYGACIL是一种四环素类抗菌药，适用于18岁及以上的患者： 复杂的皮肤和皮肤结构感染 复杂的腹腔内感染 社区获得性细菌性肺炎 使用限制：TYGACIL不适用于治疗糖尿病足感染或医院获得性肺炎，包括呼吸机相关性肺炎。 为了减少耐药细菌的发展并保持TYGACIL和其他抗菌药物的有效性，TYGACIL应仅用于治疗已证实或强烈怀疑由细菌引起的感染。 剂量和给药 初始剂量为100mg，然后每12小时50mg，静脉内施用约30至60分钟。 严重肝功能损害（Child Pugh C）：初始剂量为100mg，然后每12小时25mg。 剂量形式和强度 对于注射：50mg，冻干粉末，用于在单剂量5mL小瓶或10mL小瓶中重建。 禁忌症 已知对替加环素的超敏反应。 警告和注意事项 全因死亡率：对3期和4期临床试验的荟萃分析显示，与对照相比，TYGACIL治疗患者的全因死亡率增加，风险差异为0.6％（95％CI 0.1,1.2）。这种增加的原因尚未确定。在仅限于批准的适应症的荟萃分析中也观察到增加[0.6％（95％CI 0.0,1.2）]。在TYGACIL治疗的呼吸机相关性肺炎患者中，死亡率差异最大。 过敏反应：已报道TYGACIL，可能危及生命。避免用于已知对四环素过敏的患者。 肝脏不良反应：已报告TYGACIL。在TYGACIL治疗期间发生异常肝功能检查的患者应监测肝功能恶化的证据，并评估继续替加环素治疗的风险/益处。 据报道，TYGACIL患有胰腺炎，包括死亡。如果怀疑是胰腺炎，那么考虑停用TYGACIL。 胎儿危害：给予孕妇时，TYGACIL可能会对胎儿造成伤害。 牙齿变色：在牙齿发育过程中使用TYGACIL可能会导致牙齿永久性变色。 艰难梭菌相关性腹泻（CDAD）：评估腹泻是否发生。 不良反应 最常见的不良反应（发生率> 5％）是恶心，呕吐，腹泻，腹痛，头痛和SGPT增加。 要报告可疑的不良反应，请致电1-800-438-1985联系辉瑞公司，或致电1-800-FDA-1088或www.fda.gov/medwatch联系FDA。 药物相互作用 如果对接受华法林治疗的患者给予TYGACIL，应监测合适的抗凝试验。 用于特定人群 儿科：不建议在18岁以下的患者中使用。由于成人试验中死亡风险较高，未进行儿科试验 包装提供/存储和处理 用于注射的TYGACIL（替加环素）以单剂量5mL玻璃小瓶或10mL玻璃小瓶供应，每个小瓶含有50mg替加环素冻干粉末用于重构。 提供： 5mL-10小瓶/盒。NDC 0008-4990-02 10毫升-10vials/盒。NDC 0008-4990-20 在重建之前，TYGACIL应储存在20°至25°C（68°至77°F）的温度下; 允许偏移15°至30°C（59°至86°F）。[参见USP受控室温] TYGACIL的重组溶液可以在室温下（不超过25°C / 77°F）储存长达24小时（小瓶中最多6小时，剩余时间在 静脉袋）[见剂量和用法]。 ---------------------------------------------------------------- 注：以下产品不同规格和不同价格，采购者以咨询为准 ---------------------------------------------------------------- TYGACIL 50MG 10ML SDV LYO PWD 10/PAC TIGECYCLINE 00008-4990-20 TYGACIL VIAL 50MG 10ML 10 TIGECYCLINE PFIZER INC 00008-4990-20 TYGACIL 50MG 5ML SDV LYO PWD 10/PAC TIGECYCLINE PFIZER INC. 00008-4990-02 TYGACIL SDV 50MG/5ML 10 TIGECYCLINE PFIZER INC 00008-4990-02 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2ccdb48e-c14a-4eeb-348c-4920ccfd7465 --------------------------------------------------------------------- Tygacil(tigecycline, tigecycline) is a new type of tetracycline, glycylcycline-based anti-infective drug developed by Wyeth Pharmaceuticals, derived from minocycline. Approved by the US Food and Drug Administration on June 16, 2005 for the treatment of complex adult intra-abdominal infections (cIAI), complex skin and skin structure infections (cSSSI). Tygacil has a broad-spectrum antibacterial effect. Compared with other tetracyclines, Tygacil has a significant effect on Gram-positive bacteria, and it still has high antibacterial activity against tetracycline-resistant bacteria, including methicillin-resistant Staphylococcus and penicillin-resistant pneumonia. Cocci, vancomycin-resistant enterococci and moderately sensitive Staphylococcus aureus to glycopeptides have good antibacterial effects. The approval of Tygacil is in line with the calls of today's humans for the urgent need for new anti-infectives to treat increasingly bacterial infections. Tygacil can be used as an empirical monotherapy to treat a variety of hospital-acquired and community-acquired cIAI and cSSSI, including complex appendicitis, burn infections, intra-abdominal abscesses, deep soft tissue infections, and ulcer infections. Tygacil can be used as a new broad-spectrum antibacterial effect in the early stages of treatment where specific bacterial infections are not known. Tygacil is approved by the FDA for adult cSSSI caused by the following bacteria: Escherichia coli, vancomycin-sensitive Enterococcus faecalis, methicillin-sensitive and resistant Staphylococcus aureus, Streptococcus agalactiae, Streptococcus angina (Streptococcus angina, Streptococcus mutans, and Streptococcus faecalis), Streptococcus pyogenes and Bacteroides fragilis; Also approved by the FDA for adult cIAI caused by the following bacteria: Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Klebsiella pneumoniae, vancomycin-sensitive Enterococcus faecalis, methicillin-sensitive Staphylococcus aureus, Streptococcus angina group (Streptococcus angina, Streptococcus mutans) And constellation Streptococcus), Bacteroides fragilis, Bacteroides variabilis, Bacteroides blacei, Bacteroides genus, Clostridium perfringens, and Streptococcus pneumoniae. Tygacil is contraindicated in tigecycline allergy. Tygacil should also be used with caution in patients who are allergic to tetracyclines or who have similar side effects as these antibiotics. The common side effects are nausea and vomiting. Pregnant women using Tygacil may cause fatal damage. The safety and efficacy of Tygacil in patients under 18 or lactating women has not been determined. The use of Tygacil during tooth development may cause permanent discoloration of the teeth. Since almost all anti-infectives have reports of pseudomembranous colitis, Tygacil should be used with caution as a monotherapy for patients with intestinal perforation. Dosage: The recommended initial dose of tigecycline is 100mg, the maintenance dose is 50mg, intravenous infusion every 12 hours; each infusion time is about 30 to 60 minutes. The recommended course of treatment for complex skin and skin structure infections or complex intra-abdominal infections with tigecycline is 5 to 14 days, depending on the severity of the patient, the site of infection and the clinical presentation of the patient. Patients with mild to moderate hepatic impairment (ChildPugh class A and ChildPugh class B), patients with impaired renal function, or hemodialysis patients do not need to adjust the dose; the recommended initial dose for patients with severe liver damage (ChildPugh class C) is still 100 mg, the maintenance dose is reduced. Up to 25mg every 12 hours. Adverse reactions: In clinical trials, the most common adverse events caused by tigecycline are nausea and vomiting, which usually occur within 1 to 2 days of treatment, to a lesser extent. |