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 详细处方信息以本药内容附件PDF文件（201891618125233.pdf）的“原文Priscribing Information”为准
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部分中文卷曲霉素处方资料（仅供参考）

名称：卷曲霉素

英文名：Capreomycin

中文别名：缠霉素、结核霉素、卷须霉素、卷曲霉素

英文别名：Capastat、Capreomycin Sulfate、Caprocin、Caprolin、Capromycin、Ogostal

别名：缠霉素、结核霉素、卷须霉素、卷曲霉素、Capastat、Capreomycin Sulfate、Caprocin、Caprolin、Capromycin、Ogostal

药理作用：本品为多肽复合物，毒性与氨基苷类相似，对结核杆菌有抑制作用，机理尚不明。 

动力学：本品很少经胃肠道吸收，须注射用药。本品在尿中浓度甚高，也可穿过胎盘，不能渗透进入脑脊液(CSF)。肌注后l～2小时血药浓度达峰值，血药峰浓度平均 28～32μg/ml(范围20～47μg/ml)。Ｔ1/2为 3～6小时，肌注1g后尿中平均浓度1680μg/ml。主要经肾小球滤过以原形排出，给药12小时内以原形排出50～60％；少量可经胆汁排出。肾功能损害患者Ｔ1/2延长，血清中可有卷曲霉素积蓄。 

适应症：卷曲霉素适用于结核分枝杆菌所致的肺部结核病，经一线抗结核药(如链霉素、异烟肼、利福平和乙胺丁醇)治疗失败者，或由于毒性作用或细菌耐药性产生，因而不适用上述药物者。本品主要对分枝杆菌有效。 卷曲霉素单用时细菌可迅速产生耐药性，故本品只能与其他抗菌药联合用于结核病的治疗。

用法用量：临用时，加氯化钠注射液使溶解。肌内注射：成人一日1g，用 60一 120日，然后每周 2— 3次，每次 1g。 用药期间应注意检查：①听力图每周 1一 2次；②定期作前庭功能及肾功能测定，每周一次，尿素氮(BUN) 30mg/100ml以上需减量或停药；③肝功能测定，尤其与其他肝毒性抗结核药合用时；④血钾浓度测定，用药前、治程中每月测定一次。 注射时需作深部肌内注射，注射过浅可加重疼痛并发生无菌性脓肿； 肾功能损害患者(BUN＞ 30mg/100ml)需减量或停药； 用药 2— 3周后如病情好转，患者仍需继续用完整个疗程。 细菌对本品与氨基糖甙类和其他同类抗生素(如紫霉素)间可有不完全的交叉耐药性。
 
不良反应：
(1)发生率较多者：血尿、尿量或排尿次数显著增加或减少，食欲减低或极度口渴(低钾血症、肾毒性)。
(2)发生率较少者：听力减低、耳鸣或耳部饱满感(耳毒性-听力)、步态不稳、眩晕(耳毒性-前庭)、呼吸困难、嗜睡、极度软弱无力(神经肌肉阻滞、肾毒性、低血钾)、心律失常、精神改变、肌痛或肌痉挛、胃痛、胃气胀、或脉弱(低钾血症)、恶心或呕吐(耳毒性-前庭、肾毒性、低钾血症)。 能引起过敏反应:皮疹,药热,面部潮红或苍白,气喘,心悸,胸闷,腹痛,过敏性休克.可引起肾及听力损害.肾毒性表现为尿素氮升高、肌酐清除率降低、蛋白尿、管型床等，必须认真观察，必要时停药，停药后症状可消失。对第八对颅神经有损害，一般用药至2～4月可出现前庭功能障碍，而听觉损害则较少见。本品和氨基糖甙类一样有一定的神经肌肉阻滞作用。

禁忌：卷曲霉素可通过胎盘组织。动物实验证实，每日给药 50mg/kg或以上，在少数大鼠中引起“波状肋“，因此孕妇应用时必须充分权衡利弊。 下列情况应慎用：①对失水患者，由于血药浓度增高，可能增加中毒的危险；②听力减退，重症肌无力或帕金森病、肾功能不全者慎用；③老年人用量宜酌减。 肾功能不全慎用.孕妇禁用.哺乳期应慎用。本品不供儿童应用。

相互作用：
(1)与氨基糖苷类合用，可增加产生耳毒性、肾毒性和神经肌肉阻滞作用的可能性，发生听力减退，停药后仍可继续进展至耳聋，可能是暂时性的，但往往呈永久性。神经肌肉阻滞作用可导致骨骼肌软弱与呼吸抑制或麻痹(呼吸暂停)，用抗胆碱酯酶药或钙盐可能使阻滞恢复。
(2)与两性霉素 B、万古霉素、杆菌肽、巴龙霉素、环孢菌素，卡氮芥、顺铂、布美他尼、依他尼酸、呋塞米同时或先后应用可增加耳毒性及肾毒性发生的可能性，同用时需进行听力和肾功能测定。
(3)抗组胺药、布克利嗪（buclizine）、赛克利嗪、美克利嗪(meclozine)、吩噻嗪类、噻吨类、曲美苄胺，与卷曲霉素合用可能掩盖耳鸣、头昏或眩晕等耳毒性症状。
(4)卷曲霉素与抗神经肌肉阻滞药合用时可拮抗后者对骨骼肌的作用，因此在合用的当时或合用后，需调整抗肌无力药的剂量。
(5)与乙硫异烟胺合用时，可能加重副作用。
(6)甲氧氟烷或多粘菌素类注射剂与卷曲霉素同时或先后应用时，肾毒性或神经肌肉阻滞作用可能增加，故应避免合用；神经肌肉阻滞作用可致骨骼肌软弱和呼吸抑制或麻痹(呼吸暂停)；在外科手术过程中或手术后两者合用时亦应谨慎，用抗胆碱酯酶药或钙盐有助于阻滞恢复。
(7)本品与阿片类镇痛药合用时，两者的中枢呼吸抑制作用可能相加，导致呼吸抑制作用加重或抑制时间延长或呼吸麻痹(呼吸暂停)，必须密切观察和随访患者。

制剂：按卷曲霉素计。注射用硫酸卷曲霉素每瓶1g。 肌注,一日0.75-1g,一次或分2次用。用药2—4周后，根据情况可酌减给药次数，即每次 1g，每周 2—3次，持续6～12个月。取灭菌注射用水或等渗氯化钠注射液 2ml溶解药物，振摇 2—3分钟至完全溶解后应用。 注射用硫酸卷曲霉素：每瓶 0.5g。 

GENERIC NAME: CAPREOMYCIN - INJECTION (KAP-ree-oh-MY-sin)

BRAND NAME(S): Capastat Sulfate

WARNING: Use capreomycin with extreme caution in people with hearing or kidney problems and in those using other drugs that may cause hearing or kidney problems (see Drug Interactions section).

Other injectable medications used to treat tuberculosis (e.g., streptomycin) should not be used with capreomycin because they will increase the risk of hearing and kidney problems.

USES: This medication is used with other drugs to treat tuberculosis (TB) infections. Capreomycin belongs to a class of drugs known as antibiotics. It is believed to work by preventing the growth of the bacteria that causes TB.

HOW TO USE: This medication is given by injection into a muscle or infused into a vein over 1 hour, usually by a health care professional. It is usually given once a day for 2 to 4 months then reduced to 2 or 3 times a week depending on your condition and response to treatment, or use as directed by your doctor. Before using this product, check it visually for particles. When mixed, this medication may be nearly colorless or very pale yellow. The color may darken over time, but this does not make this medication less effective. If the liquid has particles or has changed to any other color than pale or dark yellow, do not use it. Dosage is based on your medical conditions, kidney function, and response to treatment.If you are getting this medication by injection into a muscle, remember to change the injection site with each dose to prevent irritation. Also, inject this medication into a large muscle such as the buttock or thigh to lessen pain from the injection.Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear. Stopping the medication too early may result in a return of the infection. It may be necessary to continue treatment for TB for 1 to 2 years. If needed, your doctor may switch you to a drug for this same condition that can be taken by mouth.This medication works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it on the same day(s) of the week or at the same time each day, depending on your doctor's instructions. If you are taking this medication several times a week, it may help to mark your calendar with a reminder.Do not use more or less of this drug than prescribed or stop using it (or other TB medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of TB bacteria to increase, make the infection more difficult to treat (resistant), or worsen side effects. If TB becomes resistant to this medication, it might also become resistant to other TB medications.If you are giving yourself injections at home, make sure you learn how to prepare and inject this medication properly. Ask your doctor, pharmacist, or nurse any questions you may have about how to give yourself this medication. Learn how to store and discard needles, medical supplies, and any unused medication safely. Never reuse needles or syringes. Consult your pharmacist.Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Pain, irritation, or skin hardening at the injection site 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.Tell your doctor immediately if any of these unlikely but serious side effects occur: change in the amount of urine, ringing in the ears, trouble hearing, dizziness.Tell your doctor immediately if any of these rare but very serious side effects occur: muscle weakness/cramps, irregular heartbeat, easy bleeding/bruising.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.

PRECAUTIONS: Before using capreomycin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, hearing trouble, dehydration, liver disease, a certain muscle disease (myasthenia gravis), Parkinson's disease.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for side effects while using this drug.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that may harm either the kidneys or hearing (e.g., amphotericin B, colistin, cidofovir, polymyxin, vancomycin, aminoglycosides such as amikacin/gentamicin/kanamycin/tobramycin), certain anesthetics, live bacterial vaccines.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, ringing in the ears, loss of ability to hear high sounds, trouble breathing, change in the amount of urine.

NOTES: If your doctor tells you that you are contagious, then you must avoid contact with others to prevent the spread of your TB infection.Laboratory and/or medical tests (e.g., TB cultures, kidney function, hearing tests, liver function, chest X-rays, potassium blood levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: It is important to use each dose as scheduled. 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. If you miss more than one dose, contact your health care professional to establish a new dosing schedule. Do not double the dose to catch up.

STORAGE: Store unopened vials at room temperature between 59-86 degrees F (15-30 degrees C) away from light and heat. Once mixed the medication is good for 24 hours if refrigerated between 36-46 degrees F (2-8 degrees C). Discard the mixed medication if it is not used within this time. Keep all medicines 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.

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 详细处方信息以本药内容附件PDF文件（201891618125233.pdf）的“原文Priscribing Information”为准
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