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 详细处方信息以本药内容附件PDF文件（201091922555311.pdf.pdf）的“原文Priscribing Information”为准
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部分中文TYGACIL信息仅供参考

Indications
TYGACIL® (tigecycline) is indicated for the treatment of adults with:

Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, and Bacteroides fragilis

Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros

Important Safety Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of TYGACIL and other antibacterial drugs, TYGACIL should be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria

Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening

TYGACIL is contraindicated in patients with known hypersensitivity to tigecycline

TYGACIL should be administered with caution in patients with known hypersensitivity to tetracycline class antibiotics

Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL

The safety and efficacy of TYGACIL in patients with hospital-acquired pneumonia have not been established

In clinical trials, the most common treatment-emergent adverse events in patients treated with TYGACIL were nausea (29.5%) and vomiting (19.7%)

TYGACIL may cause fetal harm when administered to a pregnant woman

The safety and effectiveness of TYGACIL in patients below age 18 and lactating women have not been established

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis

Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective

The use of TYGACIL during tooth development may cause permanent discoloration of the teeth. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated

Prothrombin time or other suitable anticoagulant test should be monitored if TYGACIL is administered with warfarin

Monotherapy should be used with caution in patients with clinically apparent intestinal perforation

In patients with severe hepatic impairment (Child Pugh C), the initial dose of TYGACIL should be 100 mg followed by 25 mg every 12 hours. Patients should be treated with caution and monitored for treatment response

The following drugs should not be administered simultaneously through the same Y‑site as TYGACIL: amphotericin B and diazepam

    美国食品和药物管理局（fda）批准了tygacil(tm) (tigecycline)，这是一种新的静脉注射抗菌素，它有着广谱的抗菌活性，包括杀灭具有抗药性的细菌耐甲氧西林金葡菌(mrsa)的活性。tygacil被批准用于治疗复杂的成年人腹内感染(ciai)和复杂的皮肤和皮肤结构感染(csssi) 。这种新一类抗菌素中的首个产品是正当越来越需要新的抗菌素来治疗严重的抗药性感染的时候被批准的。

　　wyeth pharmaceuticals的负责全球医疗事务的资深副总裁joseph camardo说：“威胁生命的感染是全球越来越关注的问题。细菌感染越来越难治疗了，因为抗药菌株在不断增加。tygacil的获得批准为医师们提供了一种用来治疗复杂皮肤、皮肤结构和腹内感染的患者的重要选择。”

　　tygacil可以作为经验型单一疗法用来治疗各种各样的 医院获得性和社区获得性ciai和csssi，其中包括复杂阑尾炎、烧伤感染、腹内脓肿、深层软组织感染以及溃疡感染。tygacil向医师们提供了一种新的可在治疗初期当着具体是哪种细菌尚不明了的时候使用的广谱选择。此外，tygacil不需要根据肾功能受损情况对患者进行剂量调整，而且使用方便，每12小时使用一次即可。

　　临床方面的一个挑战
　　美国疾病控制和预防中心（cdc）说，被抗药性细菌感染的人的住院时间会比较长，而且需要用多种药物来治疗。由于抗药性细菌越来越多，往往需要使用多种抗菌素来治疗感染。对抗菌素的抗药性使美国社会每年耗费40亿美元至50亿美元。据cdc说，对抗菌素的抗药性已经变得如此普遍，以至于世界上的一些重要的细菌感染都对普遍使用的抗菌素产生了抗药性。

　　此外，目前正在开发的广谱抗菌素少之又少。抗菌素的开发放慢到如此地步，以至fda很少有机会批准新制剂。事实上，过去20年中（1998－2002与1983－1987相比）新的抗菌素的开发和批准减少了56%。现在需要新的类型的抗菌素来治疗常见病原菌的越来越大的抗药性。

tygacil简介
　　tygacil是称作甘氨酰四环素类（glycylcyclines）新的一类抗菌素中被批准的首个药物。它是由wyeth开发来杀灭那些已经影响到抗菌素的使用的具有抗菌素的细菌的。

　　tygacil被批准用于罹患由以下细菌引起的皮肤和皮肤结构感染 (csssi) 的成年人：escherichia coli、enterococcus faecalis

　　(仅指vancomycin易感分离菌)、staphylococcus aureus (methicillin易感和抗药分离菌)、streptococcus agalactiae、streptococcus anginosus grp、(包括s. anginosus、s. intermedius和s. constellatus)、streptococcus pyogenes和bacteroides fragilis。

　　tygacil还被批准用来治疗罹患由以下细菌引起的复杂腹内感染 (ciai)的成年人：citrobacter freundii、enterobacter cloacae、escherichia coli、klebsiella oxytoca、klebsiella pneumoniae、enterococcus faecalis (仅指vancomycin易感分离菌)、staphylococcus aureus (仅指methicillin易感分离菌)、streptococcus anginosus grp. (包括s. anginosus、s. intermedius和s. constellatus)、bacteroides fragilis、bacteroides thetaiotaomicron、bacteroides uniformis、bacteroides vulgatus、clostridium perfringens和peptostreptococcus micros。

　　tygacil 的新药应用申请(nda)报告中包括四次关键的第叁阶段试验的数据，这些试验所研究的是用tygacil治疗ciai和csssi的安全性和有效性。申请报告中还包括先生该药杀灭革兰阴性和革兰阳性细菌、厌氧菌以及某些抗药病原菌的活性的试管数据。

　　在临床试验中，与vancomycin和aztreonam结合使用相比，采用tygacil的经验型单一疗法对csssi的临床治愈率相仿。此外，采用tygacil的经验型单一疗法对ciai的临床治愈率与采用imipenem/cilastatin的经验型疗法的治愈率相仿。tygacil的中止率(5.0％) 与vancomycin和aztreonam (5.3％) 和imipenem/cilastatin (4.4％)相仿。

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 详细处方信息以本药内容附件PDF文件（201091922555311.pdf.pdf）的“原文Priscribing Information”为准
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