英文药名: Gentamicin Ointment

中文药名: 庆大霉素软膏

药品名称
通用名称：庆大霉素
英文名：Gentamicin
其它中文名：硫酸正泰霉素、正泰霉素、艮他霉素
其它英文名：Ampullen、Cidomycin、Garamycin、Gentalin、Refobaci

药理作用　　 
药动学
肌注后吸收迅速而完全。局部冲洗或局部应用后亦可经身体表面吸收一定量。吸收后主要分布于细胞外液，其中5～15％再分布到组织中，在肾皮质细胞中积蓄，本品可穿过胎盘。分布容积为 0.2～0.25L/kg(0.06～0.63L/kg)。尿液中药物浓度高。支气管分泌物、脑脊液、蛛网膜下腔、眼组织以及房水中含药量少。蛋白结合率低或很低。肌内注射或静脉滴注后 30～60分钟血药浓度达峰值，成人肌注后的血药峰浓度(μg/ml)一般为按体重肌注剂量(mg/kg)的 4倍，静滴完毕后可达 4～6μg/ml，婴儿单次给药 2.5mg/kg后可达 3～6μg/ml；发热或大面积烧伤患者，血药浓度可能有所降低。Ｔ1/2成人为 2～3小时，肾功能衰退者40～50小时。发热、贫血、严重烧伤患者或合用羧苄青霉素的患者Ｔ1/2可能缩短；但在妇科、外科及烧伤的不同患者间有很大差异。小儿Ｔ1/2为 5～l1.5小时，体重轻的Ｔ1/2较长。本品在体内不代谢，经肾小球滤过排出，尿中浓度可超过100μg/ml，24小时内排出 50～93％。新生儿出生 3天以内者，给药12小时内排出 10％；新生儿出生 5～40天者给药 12小时内排出40％。血液透析与腹膜透析可从血液中清除相当药量，使Ｔ1/2显著缩短。

适应症　　
①本品适用于绿脓杆菌、变形杆菌(吲哚阳性和阴性)、大肠杆菌、克雷伯菌属、肠杆菌属、沙雷菌属、枸橼酸杆菌属以及葡萄球菌(包括耐青霉素(G)与耐甲氧西林菌株)所致的新生儿脓毒症、败血症、中枢神经系统感染(包括脑膜炎)、尿路生殖系统感染、呼吸道感染、胃肠道感染(包括腹膜炎)、胆道感染、皮肤、骨骼、中耳炎、鼻窦炎；软组织感染(包括烧伤)、李斯特菌病；
②本品用于绿脓杆菌或葡萄球菌所严重中枢神经系统感染时(脑膜炎、脑室炎)，可同时用本品鞘内注射作为辅助治疗；
③本品不适用于单纯性尿路感染初治，除非病原菌对其他毒性较低的抗菌药物不敏感，本品对链球菌中的多数菌种(尤其 D组)、肺炎球菌和厌氧菌(如类杆菌属或梭状芽胞杆菌属)无效；
④本品口服可用于肠道感染或结肠手术前准备，也可用本品肌注合并克林霉素或甲硝唑以减少结肠手术后感染率。

用法用量　　
成人肌肉注射或稀释后静脉滴注，一次 80mg(8万单位)，一日 2— 3次，间隔 8小时。或按体重 1一 1.7mg/kg(以庆大霉素计，下同)。每 8小时 1次；或按体重 0.75一1.25mg/kg，每 6小时 1次，共 7一 10日。
小儿按体重每日 3— 5mg/kg，分 2— 3次给药。
血液透析后，可根据感染严重程度，成人按体重补给一次剂量 1— 1.7mg/kg；小儿按体重补给 2— 2.5mg/kg。

给药说明　　
(1)应监测血药浓度，尤其在新生儿、老年和肾功能不全的患者。庆大霉素的有效治疗浓度范围为 4一 10μg/ml。应避免高峰血药浓度持续在 12μg／ml以上和谷浓度超过2μg ／ml。但外科、妇科、产科或烧伤患者由于个体差异较大，按计算剂量可能低于最小常用量或超过最大常用量。接受庆大霉素鞘内注射者应同时监测脑脊液内药物浓度。
(2)不能测定血药浓度时，应根据测得的肌酐清除率调整剂量。
(3)给予首次饱和剂量(1一 2mg/kg)后，有肾功能不全，前庭功能或听力减退的患者所用维持量应酌减：剂量不变，延长给药间隔时间；或给药间期不变，每次剂量减少或停用庆大霉素，其维持量可按下式计算：
①延长给药间期(小时)，每次剂量不变(1一 2mg/kg)，给药间期＝患者血肌酐值(mg/100ml)×8或
②减少维持剂量，每 8小时给药一次：每次剂量= 患者体重（kg）×常规用量（mg/kg）/患者血肌酐值(mg/100ml)。由于庆大霉素在体内不代谢，主要经尿排出，因此肾功能减退的患者中可能引起药物积聚达中毒浓度。
(4)患者应给予充足的水分，以减少肾小管损害。
(5)长期应用可能导致耐药菌过度生长。
(6)有抑制呼吸作用，不得静脉推注。对链球菌感染无效。由链球菌引起的上呼吸道感染不应使用。

不良反应　
(1)曾有报道庆大霉素全身应用合并鞘内注射时引起腿部抽搐、皮疹、发热和全身痉挛等。庆大霉素引起肾功能减退的发生率较妥布霉素为高。
(2)发生率较多者有听力减退、耳鸣或耳部饱满感(耳毒性)、血尿、排尿次数显著减少或尿量减少、食欲减退、极度口渴(肾毒性)、步履不稳、眩晕(耳毒性，影响前庭；肾毒性)。发生率较低者有呼吸困难、嗜睡、极度软弱无力(神经肌肉阻滞或肾毒性)。
(3)停药后如发生听力减退、耳鸣或耳部饱满感，需引起注意。
不良反应与卡那霉素进近似,用量小时反应较轻.如用量大,疗程长,偶见肠道菌群紊乱,一旦出现即停药,可恢复正常.可有白细胞减少,听力及肾损害.个别病例口周、面部和四肢皮肤发麻,眩晕,耳鸣.偶有过敏性休克，主要症状为呼吸道阻塞及循环障碍、半数以上病例经抢救无效而死亡，故有人认为本品的最严重的不良反应为速发型过敏性休克. 可引起罗姆伯格氏症(闭目难立，暗处和洗脸时站不稳)中毒症状。大剂量使用可有尿闭,急性肾衰,及神经系统症状. 吸入可有过敏反应,哮喘.滴眼可有水肿,中毒性结膜炎.
本品偶可引起呼吸抑制，国内外均有报道。本品还偶可引起多发性神经病变和中毒性脑病。过敏反应少见，偶可出现皮肤瘙痒，荨麻疹等，一般不影响药物的继续应用，停药后皮疹很快消退。本品引起过敏性白细胞减少及中性粒细胞减少者也偶有所见。
本品偶可引起贫血、白细胞减少、粒细胞减少、血小板减少、低血压。
本品可引起恶心、食欲减退、呕吐、腹胀等胃肠道不适症状，少数患者可出现肝功能改变，如血清氨基转移酶升高、絮浊反应阳性等。二重感染也有发生者。

禁用/慎用
对于肾功能不全者或长期用药者应进行药物监测。

药物相互作用　
本品与青霉素 G联合，几乎对所有粪链球菌及其变种如屎链球菌种、坚忍链球菌均具协同作用。
本品与竣苄西林足量联合时，对绿脓杆菌的某些敏感菌株具协同作用(但两种药物不可混合在同一输液瓶内应用，因青霉素类可使氨基糖苷类的血药浓度减低)。
本品与头孢菌素类合用时肾脏毒性增加的问题，各家报道结果不一，权威学者认为目前尚无定论，但从临床经验及有关专著均倾向于二者合用可致肾毒性增加，故临床在选用前宜充分权衡利弊、慎重对待。
氨基糖苷类药物相互作用：
(1)与强利尿药(如呋塞米、依他尼酸等)联用可加强耳毒性。
(2)与其他有耳毒性的药物(如红霉素等)联合应用，耳中毒的可能加强。
(3)与头孢菌素类联合应用，可致肾毒性加强。右旋糖酐可加强本类药物的肾毒性。
(4)与肌肉松弛药或具有此种作用的药物(如地西泮等)联合应用可致神经—肌肉阻滞作用的加强。新斯的明或其他抗胆碱酯酶药均可拮抗神经-肌肉阻滞作用。
(5)本类药物与碱性药(如碳酸氢钠、氨茶碱等)联合应用，抗菌效能可增强，但同时毒性也相应增强，必须慎重。
(6)青霉素类对某些链球菌的抗菌作用可因氨基糖苷类的联用而得到加强，如目前公认草绿色链球菌性心内膜炎和肠球菌感染在应用青霉素的同时可加用链霉素(或其他氨基糖苷类)。但对其他细菌是否有增效作用并未肯定，甚至有两种药物联用而致治疗失败的报道，因此，这两类药物的联合必须遵循其适应证不要随意使用。

Garamycin
Generic Name: gentamicin (gen tah MY sin)
Brand Names: Garamycin

What is Garamycin (gentamicin)?
Gentamicin is an antibiotic. It fights bacteria in the body.

Gentamicin is used to treat severe or serious bacterial infections.

Gentamicin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Garamycin (gentamicin)?
If you are injecting gentamicin at home, your healthcare provider will give you detailed instructions on how and where to inject the medication. If you do not understand these directions, do not attempt to inject the medication. Contact your healthcare provider for further instructions.

Gentamicin may cause damage to the kidneys and/or nerves. Kidney function and drug levels in the blood may be monitored with blood tests during treatment. Tell your doctor if you experience hearing loss, dizziness, numbness, skin tingling, muscle twitching, or seizures which may be signs of nerve damage.

What should I discuss with my healthcare provider before using Garamycin (gentamicin)?
Do not use gentamicin without first talking to your doctor if you have
sulfite sensitivity;
kidney disease;
hearing loss or loss of balance due to ear problems;
Parkinson's disease; or
a neuromuscular disorder such as myasthenia gravis.

You may not be able to use gentamicin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Do not use gentamicin without first talking to your doctor if you are pregnant or could become pregnant during treatment. Do not use gentamicin without first talking to your doctor if you are breast-feeding a baby.

How should I take Garamycin (gentamicin)?
If you are injecting gentamicin at home, your healthcare provider will give you detailed instructions on how and where to inject the medication. If you do not understand these directions, do not attempt to inject the medication. Contact your healthcare provider for further instructions.

Do not use any gentamicin that is discolored, has particles in it, or looks different from your previous doses. Throw away any unused gentamicin after the amount of time determined by your pharmacist or doctor.

Adequate hydration is important during treatment with gentamicin. Fluids may be administered intravenously during treatment.

It is important that the medication be given on a regular schedule and for the entire amount of time prescribed by your doctor.

Gentamicin may cause damage to the kidneys and/or nerves. Kidney function and drug levels in the blood may be monitored with blood tests during treatment. Tell your doctor if you experience hearing loss, dizziness, numbness, skin tingling, muscle twitching, or seizures which may be signs of nerve damage.

Dispose of used needles and syringes in a puncture resistant container out of the reach of children.

Your healthcare provider will store gentamicin as directed by the manufacturer or give you detailed storage instructions if you are storing the medication at home.

What happens if I miss a dose?
Contact your doctor if a dose is missed.

What happens if I overdose?
Contact your doctor or seek emergency medical attention if an overdose is suspected. An overdose of the medication may result in damage to the kidneys or hearing loss, dizziness, numbness, skin tingling, muscle twitching, or seizures (which may be signs of nerve damage).

What should I avoid while taking Garamycin (gentamicin)?
There are no restrictions on food, beverages, or activity while taking gentamicin unless otherwise directed by your doctor.

Garamycin (gentamicin) side effects
If you experience any of the following serious side effects, stop taking gentamicin and seek emergency medical attention:
an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);
little or no urine;
decreased hearing or ringing in the ears;
dizziness, clumsiness, or unsteadiness;
numbness, skin tingling, muscle twitching, or seizures; or
severe watery diarrhea and abdominal cramps.

Other, less serious side effects may be more likely to occur. Continue to take gentamicin and talk to your doctor if you experience
increased thirst;
loss of appetite;
nausea or vomiting;
a rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Garamycin (gentamicin)?
Other drugs, especially those that affect the kidneys, can interact with gentamicin resulting in dangerous side effects and/or decreased effectiveness. Do not take any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, without first talking to your doctor during treatment with gentamicin.

Where can I get more information?
Your pharmacist has additional information about gentamicin written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. 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. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.