部分中文硫酸庆大霉素处方资料（仅供参考）
英文药名: Gentamicin Ointment
中文药名: 庆大霉素软膏
药品说明
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　　
药效学
参阅硫酸链霉素。
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　
参阅硫酸链霉素。
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。
规格
庆大霉素霜0.10% X 15grams, 450grams；
庆大霉素膏0.10% X 15grams
gentamicin topical
COMMON BRAND NAME(S): Garamycin
GENERIC NAME(S): GENTAMICIN SULFATE
Uses
This medication is used to treat minor skin infections (such as impetigo, folliculitis) or minor infections related to some skin conditions (such as eczema, psoriasis, minor burns/cuts/wounds). Gentamicin works by stopping the growth of certain bacteria. It belongs to a class of drugs known as aminoglycoside antibiotics.
This antibiotic only treats bacterial infections. It will not work for virus or fungus infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.
How to use gentamicin topical
This medication is for use on the skin only.
Wash your hands before using. Clean and dry the affected area as directed. If you are treating impetigo, remove any dried, crusty skin to increase contact between the antibiotic and the infected area. Then gently apply a small amount of medication in a thin layer as directed by your doctor, usually 3 to 4 times a day. You may cover the area with a sterile gauze bandage if so directed. Keep the infected area clean. Wash your hands after use, unless you are using this product to treat the hands.
Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wipe off the medication and rinse thoroughly with water.
Dosage and length of treatment is based on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Do not apply large amounts of this medication, use it more often, or use it for longer than prescribed. Your condition will not improve any faster, and your risk of side effects may increase.
Continue to use this medication for the full length of treatment prescribed, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.
Tell your doctor if your skin infection persists or if it worsens.
What conditions does gentamicin topical treat?Side Effects
Skin irritation, redness, and itching may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Rarely, use of this medication for prolonged or repeated periods may result in other types of skin infections (such as fungal or other bacterial infections). Contact your doctor if you notice any unusual skin symptoms or if your condition does not improve.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
List gentamicin topical side effects by likelihood and severity.Precautions
Before using gentamicin, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (such as tobramycin, amikacin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history.
Rarely, this medication may be absorbed into the blood if you are applying it to large areas of skin, especially if the areas are cracked, broken, or raw. Injured skin may absorb more of this product, and the chance of serious side effects may increase. Consult your doctor for more details.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
Interactions
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.
Some products that may interact with this drug include: aminoglycoside antibiotics given by injection (such as amikacin, gentamicin, tobramycin).
This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
Overdose
This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Notes
Do not share this medication with others.
This medication has been prescribed for your current skin infection only. Do not use it later for another infection unless your doctor directs you to do so. A different medication may be necessary in that case.
Missed Dose
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Storage
Store at room temperature between 59-86 degrees F (15-30 degrees C). Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2014. Copyright(c) 2014 First Databank, Inc.
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