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英文药名: Rocephin(Ceftriaxone Injection Vial)
中文药名: 罗氏芬（头孢曲松钠注射液）
生产厂家: Roche Pharmaceuticals
药品名称
【分类】抗生素/头孢菌素类
【别名】头孢曲松钠、头孢三嗪、头孢曲松、头孢氨噻三嗪、安塞隆、罗塞嗪
【外文名】Ceftriaxone，CeftriaxoneSodium，Rocekin，Rocephin，RO13-9904
【性状】本品为白色或类白色结晶性粉末。
药理作用
该产品是广谱的第三代头孢菌素，抗菌谱与头孢噻肟相似，通过抑制细菌细胞壁的合成而具有杀菌活性，对广泛的革兰氏阴性菌和革兰氏阳性菌发挥杀菌作用。对革兰氏阴性菌和革兰氏阳性菌产生的大多数b-内酰胺酶(青霉素酶和头孢菌素酶)具有很高的稳定性，头孢曲松的半衰期长达8小时，具有24小时的杀菌活性，对组织穿透力强；50-60%的头孢曲松以原形经肾排泄，40-50%以原形经肝脏排泄。
药代动力学
肌内注射本品0.5g和1g，约于2小时后达到血药峰浓度（Cmax），分别为43mg/L和80mg/L。肌内注射0.5g后24小时的血药浓度为6.0mg/L，血消除半衰期（t1/2b）为7.1小时。1分钟内静注0.5g，即刻血药峰浓度（Cmax）为150.9mg/L，24小时后的血药浓度为9.9mg/L，血消除半衰期（t1/2b）为7.87小时。30分钟内静滴本品lg，滴注结束时的即刻血药峰浓度（Cmax）为150.7mg/L，24小时的血药浓度为9.3mg/L。给化脓性脑膜炎病人每日肌内注射15～20mg/kg后，6小时的脑脊液浓度平均为5.16mg/L，12小时的浓度为2.3mg/L。静脉滴注本品1g后5小时和14小时胆汁中浓度分别为1600mg/L和13.5mg/L。蛋白结合率为95%。头孢曲松在人体内不被代谢，约40%的药物以原形自胆道和肠道排出，60%自尿中排出。丙磺舒不能增高本品血药浓度或延长其半衰期。
适应症
罗氏芬(注射用头孢曲松钠)用于敏感致病菌所致的下呼吸道感染、尿路、胆道感染，以及盆腔感染、皮肤软组织感染、骨和关节感染、败血症、脑膜炎等及手术期感染预防。本品单剂可治疗单纯性淋病。
用法用量
不同年龄的人，使用的剂量也不同。
成人和12岁以上儿童：通常剂量是1-2克，每天一次(每24小时)。危重病例或由中度敏感菌引起的感染，剂量可增至4克，每天一次。
新生儿(14天以下)：每天剂量为按体重20-50mg/Kg，不超过50mg/Kg。无需区分早产儿及足月婴儿。
婴儿及儿童(15天至12岁)：每天剂量按体重20-80mg/kg，对儿童脑膜炎推荐每天100mg/kg(不超过4g).
使用方法有三种：
肌肉注射：罗氏芬250mg或500mg溶于1%利多卡因溶液2ml中，1g溶于3.5ml中用于臀部深注射，不主张一处肌注1g以上剂量，利多卡因溶液绝对不能用于静脉注射。
静脉注射：罗氏芬250mg或500mg溶于5ml无菌注射用水中，1g溶于10ml中用于静脉注射，注射时间不能少于2-4分钟。
静脉滴注：罗氏芬2g溶于40ml以下任何一种不含钙的溶液：0.9%氯化钠溶液，5%葡萄糖溶液，0.45%氯化钠 2.5%葡萄糖溶液，无菌注射用水等，滴注时间至少30分钟。
任何疑问，请遵医嘱！
禁忌症
对于已知对头孢菌素类抗生素过敏的病人是禁用的。
不良反应
全身性副作用：胃肠道不适-稀便或腹泻、恶心、呕吐、胃炎、舌炎血液学改变-嗜酸细胞增多，白细胞减少，粒细胞减少，溶血性贫血，血小板减少皮肤反应-皮疹、过敏性皮炎、荨麻疹、水肿、多形红斑、瘙痒等。局部副作用：极少情况下，静脉用药后发生静脉炎，缓慢注射(2-4分钟)则可避免该现象。
注意事项
（1）给药前需进行过敏试验。
（2）交叉过敏反应：对一种头孢菌素或头霉素（cephamycin）过敏者对其他头孢菌素或头霉素也可能过敏。对青霉素类、青霉素衍生物或青霉胺过敏者也可能对头孢菌素或头霉素过敏。对青霉素过敏病人应用头孢菌素时发生过敏反应者达5%～10%；如作免疫反应测定时，则对青霉素过敏病人对头孢菌素过敏者达20%。
（3）对青霉素过敏病人应用本品时应根据病人情况充分权衡利弊后决定。有青霉素过敏性休克或即刻反应者，不宜再选用头孢菌素类。
（4）有胃肠道疾病史者，特别是溃疡性结肠炎、局限性肠炎或抗生素相关性结肠炎（头孢菌素类很少产生伪膜性结肠炎）者应慎用。
（5）由于头孢菌素类毒性低，所以有慢性肝病患者应用本品时不需调整剂量。病人有严重肝肾损害或肝硬化者应调整剂量。
（6）肾功能不全患者肌酐清除大于5m1/分钟，每日应用本品剂量少于2g时，不需作剂量调整。血液透析清除本品的量不多，透析后无需增补剂量。
（7）对诊断的干扰：应用本品的患者以硫酸铜法测尿糖时可获得假阳性反应，以葡萄糖酶法则不受影响；血尿素氮和血清肌酐可有暂时性升高；血清胆红质、碱性磷酸酶、丙氨酸氨基转移酶(ALT)和门冬氨酸氨基转移酶(AST)皆可升高。
（8）本品的保存温度为25℃以下。
孕妇及哺乳期妇女用药
孕妇和哺乳期妇女应用头孢菌素类虽尚未见发生问题的报告，其应用仍须权衡利弊。
儿童用药
新生儿（出生体重小于2kg者）的用药安全尚未确定。有黄疸的新生儿或有黄疸严重倾向的新生儿应慎用或避免使用本品。
老人用药
除非老年患者虚弱、营养不良或有重度肾功能损害时，老年人应用头孢曲松一般不需调整剂量。
药物相互作用
（1）头孢菌素类静脉输液中加入红霉素、四环素、两性霉素B、血管活性药(间羟胺、去甲肾上腺素等)、苯妥英钠、氯丙嗪、异丙嗪、维生素B族、维生素C等时将出现混浊。由于本品的配伍禁忌药物甚多，所以应单独给药。
（2）应用本品期间饮酒或服含酒精药物时在个别病人可出现双硫仑样反应，故在应用本品期间和以后数天内，应避免饮酒和服含酒精的药物。
规格
按C18H18N8O7S3计算（1）0.25g（2）1.0g（3）2.0g（4）10g
贮藏
遮光，密闭，在阴凉干燥处保存。
Medication name
Generic name: Ceftriaxone - Injection
Brand name(s): Rocephin
Uses
Ceftriaxone is an antibiotic used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria.
How to use
This medication is given by injection into a muscle or vein as directed by your doctor. The dosage is based on your medical condition and response to therapy.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, use this drug at evenly spaced intervals.Continue to use this medication until the full prescribed treatment period is finished, 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 condition persists or worsens.
Precautions
Before using ceftriaxone, tell your doctor or pharmacist if you are allergic to it; or to other cephalosporins; or to penicillins; 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, especially of: gallbladder disease, kidney disease, liver disease, stomach/intestinal diseases (e.g., colitis).Avoid giving any products by vein that contain calcium (including solutions such as Ringer's solution, Hartmann's solution, parenteral nutrition-TPN/PPN) to a newborn less than 1 month old who is receiving this medication. Doing so can cause serious problems in the vital organs.Ceftriaxone is not recommended for use in newborns with high blood bilirubin levels.Tell your doctor if you are pregnant before using this medication.This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Drug interactions
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: aminoglycoside antibiotics (e.g., tobramycin, gentamicin), "blood thinners" (e.g., warfarin), chloramphenicol, live bacterial vaccines, calcium-containing IV fluids.Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.This medication may interfere with certain medical/laboratory tests (e.g., urine glucose tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
Side effects
Swelling, redness, pain, or soreness at the injection site may occur. This medication may also infrequently cause loss of appetite, nausea, vomiting, diarrhea, or headache. 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 right away if you have any serious side effects, including: dark urine, easy bruising/bleeding, fast/pounding/irregular heartbeat, seizures, unusual weakness/tiredness, yellowing eyes/skin, change in the amount of urine, chest pain, trouble breathing, mental/mood changes (such as confusion).This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.
Missed dose
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.
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: trouble breathing, seizures.
Notes
Laboratory and/or medical tests (e.g., complete blood count, kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Storage
Consult the package instructions or your pharmacist for other storage details. 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.
Photos by medication strength
Click the "Photos" link to see sample photographs for a specific medication strength.
Common strengths
Rocephin 1 gram Solution for Injection
Rocephin 10 gram Solution for Injection
Rocephin 2 gram Solution for Injection
Rocephin 250 mg Solution for Injection
Rocephin 500 mg Solution for Injection
The photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist.
Important note
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Rocephin 1 gram solution for injection *Photos
Rocephin 10 gram solution for injection
Rocephin 2 gram solution for injection
Rocephin 250 mg solution for injection
Rocephin 500 mg solution for injection
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