哌拉西林钠/他唑巴坦钠

【药理毒理】
本品为哌拉西林钠和他唑巴坦钠组成的复方制剂。哌拉西林为广谱半合成青霉素类抗生素，他唑巴坦为β-内酰胺酶抑制剂。本品对哌拉西林敏感的细菌和产β-内酰胺酶耐哌拉西林的下列细菌有抗菌作用: 革兰氏阴性菌：大多数质粒介导的产和不产β-内酰胺酶的下列细菌：大肠杆菌、克雷伯氏菌属（催产克雷伯氏菌、肺炎克雷伯氏菌）、变形杆菌属（奇异变形杆菌、普通变形杆菌）、沙门氏菌属、志贺氏菌属、淋病奈瑟氏菌、脑膜炎双球菌、莫根杆菌属、嗜血杆菌属（流感和副流感嗜血杆菌）、多杀巴氏杆菌、耶尔森菌属、弯曲菌属、阴道加特纳菌。染色体介导的产和不产β-内酰胺酶的下列细菌：弗劳地枸椽酸菌、产异枸椽酸菌、普鲁威登斯菌属、莫根杆菌、沙雷菌属（粘质沙雷氏菌、液压沙雷氏菌）、绿脓杆菌和其他假单胞菌属（洋葱假单胞菌、荧光假单胞菌）、嗜麦芽假单胞菌、不动杆菌属。革兰氏阳性菌：产和不产β-内酰胺酶的下列细菌：链球菌属（肺炎链球菌、酿脓链球菌、牛链球菌、无乳链球菌、绿色链球菌、C族和G族链球菌）、肠球菌属（粪肠球菌、屎肠球菌）、金黄色葡萄球菌（不包括MRSA）、腐生葡萄球菌、表皮葡萄球菌（凝固酶阴性葡萄球菌）、棒状杆菌属、单核细胞增多性李斯德杆菌、奴卡菌属。厌氧菌：产和不产β-内酰胺酶的下列细菌：拟杆菌属（二路拟杆菌、二向拟杆菌、多毛拟杆菌、产黑色素拟杆菌、口腔拟杆菌）、脆弱拟杆菌属（脆弱拟杆菌、普通拟杆菌、卵园拟杆菌、多形拟杆菌、单形拟杆菌、不解糖拟杆菌）、消化链球菌属、梭状芽胞杆菌属（难辨梭菌、产气荚膜杆菌）、韦荣氏球菌属、放线菌属。

【适应症】
本品适用于对哌拉西林耐药，但对哌拉西林/他唑巴坦敏感的产β－内酰胺酶的细菌引起的中、重度下述感染：
1．由耐哌拉西林、产β－内酰胺酶的大肠杆菌和拟杆菌属（脆弱拟杆菌、卵形拟杆菌、多形拟杆菌或普通拟杆菌）所致的阑尾炎（伴发穿孔或脓肿）和腹膜炎。
2．由耐哌拉西林、产β－内酰胺酶的金黄色葡萄球菌所致的非复杂性和复杂性皮肤及软组织感染，包括蜂窝织炎、皮肤脓肿、缺血性或糖尿病性足部感染。
3．由耐哌拉西林、产β－内酰胺酶的大肠杆菌所致的产后子宫内膜炎或盆腔炎性疾病。
4．由耐哌拉西林、产β－内酰胺酶的流感嗜血杆菌所致的社区获得性肺炎（仅限中度）。
5．由耐哌拉西林、产β－内酰胺酶的金黄色葡萄球菌所致的中、重度医院获得性肺炎（医院内肺炎）。

【用法和用量】将适量本品用20毫升稀释液（0.9％氯化钠注射液或灭菌注射用水），充分溶解后，立即加入250毫升液体（5％葡萄糖注射液或0.9％氯化钠注射液）中，静脉滴注，每次至少30分钟，疗程为7－10天。医院获得性肺炎疗程为7－14天。并可根据病情及细菌学检查结果进行调整。
对于正常肾功能（肌酐清除率≥90毫升/分）患者，成人及12岁以上儿童每次3.375g（含哌拉西林钠3g和他唑巴坦钠0.375g）静脉滴注，每6小时1次。治疗医院内肺炎时，起始量为每次3.375g，每4小时1次，同时合并使用氨基糖苷类药物；如果未分离出绿脓假单胞菌可根据感染程度及病情考虑停用氨基糖苷类药物。
对于肾功能不全患者，推荐的用量见下表：
肌酐清除率（毫升/分） 推荐用量
>40-90 每次3.375g，每6小时1次，每日总量12g/1.5g
20-40 每次2.25g，每6小时1次，每日总量8g/1.0g
<20 每次2.25g，每8小时1次，每日总量6g/0.75g
对于血透患者,每次最大剂量为2.25g,每8小时1次,并在每次血透后可追加0.75g。

【不良反应】
1．本品常见不良反应有：
1) 皮肤反应：如皮疹、瘙痒等；
2) 消化道反应：如腹泻、恶心、呕吐等；
3) 过敏反应；
4) 局部反应：如注射局部刺激反应、疼痛、静脉炎、血栓性静脉炎和水肿等。
5) 其他反应：如血小板减少、胰腺炎、发热、发热伴嗜酸粒细胞增多、腹泻或转氨酶升高等。 这些反应发生在本品和氨基糖苷类药物联合治疗时。
2．此外，本品尚可见下列不良反应：
1）腹泻、便秘、恶心、呕吐、腹痛、消化不良等；
2）斑丘疹、疱疹、荨麻疹、湿疹、瘙痒等；
3）烦躁、头晕、焦虑等；
4）其他反应：如鼻炎、呼吸困难等。

【禁忌】本品禁用于对青霉素类、头孢类抗生素或β-内酰胺酶抑制剂过敏者。

【注意事项】
1．在使用本品前，应详细询问患者对青霉素类药物、头孢菌素类药物、β内酰胺酶抑制剂有无过敏史。治疗中，若发生过敏反应，应立即停药，并给予适当处理，包括吸氧、静脉应用糖皮质激素等。
2．治疗期间，若患者出现腹泻症状，应考虑是否有伪膜性肠炎发生。若诊断确立，应采取相应治疗措施，包括维持水、电解质平衡、补充蛋白等。
3．本品含钠，需要控制盐摄入量的患者使用本品时，应定期检查血清电解质水平；对于同时接受细胞毒药物或利尿剂治疗的患者，要警惕发生低血钾症的可能。
4．当治疗由绿脓假单胞菌引起的医院内肺炎时，应与氨基糖苷类药物联合使用。
5．孕妇、哺乳期妇女慎用。
6．应定期检查造血功能，特别是对疗程≥21天的患者。
7．12岁以下儿童使用本品的安全有效性尚不清楚。
8．现有的临床研究资料表明本品对于医院内下呼吸道感染及复杂性尿路感染的疗效不佳。
9．药物相互作用：
氨基糖苷类：
体外试验中，本品与氨基糖苷类药物同用，可以灭活氨基糖苷类药物。
当本品与妥布霉素同用时，由于哌拉西林/他唑巴坦可能使妥布霉素失活，使妥布霉素的曲线下面积、肾脏清除率及尿中排泄将分别下降11％、32％和38％。严重肾功能不全患者如血透患者，联合应用妥布霉素与哌拉西林时，前者的药代动力学将会发生变化。
丙磺舒：
本品与丙磺舒联合应用，可以使哌拉西林半衰期延长21％，他唑巴坦半衰期延长71％。
万古霉素：
本品与万古霉素联合应用时，药代动力学不受影响。
皮下注射肝素、口服抗凝药物或其它可能影响血液凝固与血小板功能的药物时，应考虑监测凝血功能。
10．本品不能与其他药物在注射器或输液瓶中混合。本品与其它抗生素同用时，必须分开给药。本品不得与只含碳酸氢钠的溶液混合，不得加入血液制品及水解蛋白液。

【原产地英文商品名】:ZOSYN (3/0.375)g/vial 10vials/box
【原产地英文药品名】:PIPERACILLIN SODIUM/TAZOBACTAM SODIUM
【中文参考商品译名】:ZOSYN (3/0.375)克/瓶 10瓶/盒
【中文参考药品译名】:哌拉西林钠/他唑巴坦钠
【生产厂家中文参考译名】:惠氏
【生产厂家英文名】:WYETH PHARMS INC

Zosyn

Generic Name: piperacillin and tazobactam (pi PER a sil in and tay zoe BAK tam )
Brand Names: Zosyn

What is Zosyn?
Zosyn contains a combination of piperacillin and tazobactam. Piperacillin is an antibiotic in a group of drugs called penicillins. Piperacillin fights bacteria in the body.

Tazobactam is in a similar group of antibiotic drugs and also fights bacteria in the body.

Zosyn is used to treat many different infections caused by bacteria, such as urinary tract infections, bone and joint infections, severe vaginal infections, stomach infections, skin infections, and pneumonia.

Zosyn may also be used for other purposes not listed in this medication guide

Important information about Zosyn
Do not use Zosyn if you are allergic to piperacillin and tazobactam or to any other penicillin antibiotic, such as amoxicillin (Amoxil, Augmentin), ampicillin (Omnipen, Principen), carbenicillin (Geocillin), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), ticarcillin (Ticar, Timentin), penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids), and others.Before using Zosyn tell your doctor if you are allergic to cephalosporins such as Ceclor, Ceftin, Duricef, Keflex, and others, or if you have kidney disease, a bleeding or blood clotting disorder, low levels of potassium in your blood, a history of any type of allergy, or if you are on a salt-restricted diet.

Use Zosyn for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Before using Zosyn
Do not use Zosyn if you are allergic to piperacillin and tazobactam or to any other penicillin antibiotic, such as:
amoxicillin (Amoxil, Augmentin);
ampicillin (Omnipen, Principen);
carbenicillin (Geocillin);
dicloxacillin (Dycill, Dynapen);
oxacillin (Bactocill);
ticarcillin (Ticar, Timentin); or
penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids, and others).

Before using Zosyn, tell your doctor if you are allergic to any drugs (especially cephalosporins such as Ceclor, Ceftin, Duricef, Keflex, and others), or if you have:
kidney disease (or if you are on dialysis);
a bleeding or blood clotting disorder;
an electrolyte imbalance such as low levels of potassium in your blood;
cystic fibrosis;
a history of any type of allergy; or
if you are on a salt-restricted diet.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use Zosyn.

FDA pregnancy category B. Zosyn is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Piperacillin and tazobactam may pass into breast milk and could harm a nursing baby. Do not use Zosyn without telling your doctor if you are breast-feeding a baby

How should I use Zosyn?
Use Zosyn exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Zosyn is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Zosyn must be mixed with a liquid (diluent) before injecting it. Shake the medication and diluent until well dissolved. Do not mix the medicine or draw your dose into a syringe or IV bag until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Zosyn is usually given for 7 to 10 days, depending on the infection being treated. Follow your doctor's instructions.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Use Zosyn for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Zosyn will not treat a viral infection such as the common cold or flu.

Zosyn can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using Zosyn.

Store unmixed Zosyn, and the liquid diluent, at cool room temperature. After mixing the medicine and

diluent, you may store it at room temperature for up to 12 hours. Throw away any unused mixture that has not been used within that time. Mixed medication can also be stored in the refrigerator for up to 48 hours. Throw away any unused mixture that has not been used within that time.

What happens if I miss a dose?
Use the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.

Zosyn overdose symptoms may include severe anxiety, agitation, feeling restless or nervous, or seizure (convulsions).

What should I avoid while using Zosyn?
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to

Zosyn side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Zosyn: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
diarrhea that is watery or bloody;
easy bruising or bleeding, unusual weakness;
dry mouth, increased thirst, confusion, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting;
fever, chills, body aches, flu symptoms; or
seizure (convulsions).

Less serious Zosyn ide effects may include:
nausea, vomiting, stomach pain or upset;
constipation;
headache;
anxiety, sleep problems (insomnia);
skin rash or itching;
pain, swelling, or other irritation where the injection was given; or
vaginal yeast infection (itching or discharge).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

See also: Zosyn side effects in more detail

What other drugs will affect Zosyn?
Before using Zosyn, tell your doctor if you are using any of the following drugs:
probenecid (Benemid);
an antibiotic such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin, Neo-Tab), netilmicin (Netromycin), streptomycin, tobramycin (Nebcin, Tobi);
a blood thinner such as warfarin (Coumadin); or
any other medication used to prevent blood clots, such as alteplase (Activase), anistreplase (Eminase), clopidogrel (Plavix), dipyridamole (Persantine), streptokinase (Kabikinase, Streptase), ticlopidine (Ticlid), or urokinase (Abbokinase).

This list is not complete and there may be other drugs that can interact with Zosyn. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?
Your doctor or pharmacist can provide more information about Zosyn.

What does my medication look like?
Piperacillin and tazobactam is available with a prescription under the brand name Zosyn. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about Zosyn, especially if it is new to you.

Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects