药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(2018112800261625.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文罗氏芬处方资料(仅供参考)
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。
English name: Rocephin (Ceftriaxone Injection Vial)
Chinese medicine name: Rochefene (Ceftriaxone Sodium Injection)
Manufacturer: Roche Pharmaceuticals
Drug name
[Category] Antibiotics / Cephalosporins
[alias] ceftriaxone sodium, ceftriaxone, ceftriaxone, cefotaxime, anselone, roseserazine
[Foreign name]Ceftriaxone,CeftriaxoneSodium,Rocekin,Rocephin,RO13-9904
[Properties] This product is white or off-white crystalline powder.
Pharmacological action
This product is a broad-spectrum third-generation cephalosporin. Its antibacterial spectrum is similar to that of cefotaxime. It has bactericidal activity by inhibiting the synthesis of bacterial cell walls and exerts bactericidal action against a wide range of Gram-negative and Gram-positive bacteria. Most of the b-lactamases (penicillinase and cephalosporinase) produced by Gram-negative and Gram-positive bacteria have high stability, and ceftriaxone has a half-life of up to 8 hours with 24 hours. The bactericidal activity is strong for tissue penetration; 50-60% of ceftriaxone is excreted by the kidney in the original form, and 40-50% is excreted by the liver in the original form.
Pharmacokinetics
Intramuscular injection of 0.5 g and 1 g of this product reached a peak plasma concentration (Cmax) of about 23 hours, which were 43 mg/L and 80 mg/L, respectively. The blood concentration was 6.0 mg/L 24 hours after intramuscular injection of 0.5 g, and the blood elimination half-life (t1/2b) was 7.1 hours. 0.5 g was intravenously injected within 1 minute, and the peak plasma concentration (Cmax) was 150.9 mg/L, the blood concentration after 24 hours was 9.9 mg/L, and the blood elimination half-life (t1/2b) was 7.87 hours. The lg was intravenously instilled within 30 minutes, and the peak plasma concentration (Cmax) at the end of the instillation was 150.7 mg/L, and the blood concentration at 24 hours was 9.3 mg/L. After daily intramuscular injection of 15-20 mg/kg in patients with purulent meningitis, the average cerebrospinal fluid concentration at 6 hours was 5.16 mg/L, and the concentration at 12 hours was 2.3 mg/L. The concentrations in the bile at 5 hours and 14 hours after intravenous infusion of 1 g of the product were 1600 mg/L and 13.5 mg/L, respectively. The protein binding rate was 95%. Ceftriaxone is not metabolized in the human body, and about 40% of the drug is excreted from the biliary tract and intestines in the original form, and 60% is excreted from the urine. Probenecid does not increase the blood concentration of the product or prolong its half-life.
Indications
Rochefene (Ceftriaxone sodium for injection) for lower respiratory tract infections caused by sensitive pathogens, urinary tract, biliary tract infections, as well as pelvic infections, skin and soft tissue infections, bone and joint infections, sepsis, meningitis, etc. And prevention of infection during surgery. This product can treat simple gonorrhea in a single dose.
Usage and Usage
People of different ages use different doses.
Adults and children over the age of 12: Usually the dose is 1-2 grams once a day (every 24 hours). In critical cases or infections caused by moderately sensitive bacteria, the dose can be increased to 4 grams once a day.
Newborns (less than 14 days): The daily dose is 20-50 mg/Kg and no more than 50 mg/Kg. There is no need to distinguish between premature and term infants.
Infants and children (15 days to 12 years old): daily doses are 20-80 mg/kg, recommended for children with meningitis 100 mg/kg per day (no more than 4 g).
There are three ways to use it:
Intramuscular injection: Rochefen 250mg or 500mg dissolved in 2ml of 1% lidocaine solution, 1g dissolved in 3.5ml for deep hip injection, does not claim an intramuscular injection of more than 1g dose, lidocaine solution can not be used for intravenous injection.
Intravenous injection: Rochefene 250mg or 500mg dissolved in 5ml of sterile water for injection, 1g dissolved in 10ml for intravenous injection, the injection time should not be less than 2-4 minutes.
Intravenous drip: Roggein 2g is dissolved in any calcium-free solution below 40ml: 0.9% sodium chloride solution, 5% dextrose solution, 0.45% sodium chloride 2.5% glucose solution, sterile water for injection, etc. , the infusion time is at least 30 minutes.
Any questions, please follow the doctor's advice!
Contraindications
It is contraindicated for patients known to be allergic to cephalosporin antibiotics.
Adverse reactions
Systemic side effects: gastrointestinal discomfort - loose stools or diarrhea, nausea, vomiting, gastritis, glossitis, hematologic changes - eosinophilia, leukopenia, neutropenia, hemolytic anemia, thrombocytopenia, skin reactions - rash, allergies Dermatitis, urticaria, edema, polymorphous erythema, itching, etc. Local side effects: In rare cases, phlebitis occurs after intravenous administration, and slow injection (2-4 minutes) can avoid this phenomenon.
Notes
(1) An allergy test is required before administration.
(2) Cross-allergic reactions: People who are allergic to a cephalosporin or cephamycin may also be allergic to other cephalosporins or cephalosporins. Those who are allergic to penicillins, penicillin derivatives or penicillamine may also be allergic to cephalosporins or cephalosporins. Allergic reactions to cephalosporins in patients with penicillin allergy are 5% to 10%; for immunological reactions, 20% are allergic to cephalosporins in patients allergic to penicillin.
(3) When applying this product to patients with allergic penicillin, the product should be weighed according to the patient's condition. Those who have penicillin anaphylactic shock or immediate response should not use cephalosporins.
(4) Those with a history of gastrointestinal disease, especially ulcerative colitis, Crohn's disease or antibiotic-associated colitis (cephalosporins rarely produce pseudomembranous colitis) should be used with caution.
(5) Because of the low toxicity of cephalosporins, patients with chronic liver disease do not need to adjust the dose when applying this product. Patients with severe liver and kidney damage or cirrhosis should adjust the dose.
(6) The creatinine clearance in patients with renal insufficiency is greater than 5m1/min. When the dose of this product is less than 2g per day, no dose adjustment is needed. The amount of this product is not much removed by hemodialysis, and there is no need to supplement the dose after dialysis.
(7) Interference with diagnosis: Patients who use this product can obtain false positive reaction when measuring urine sugar by copper sulfate method, and the glucose enzyme law is not affected; blood urea nitrogen and serum creatinine may temporarily rise. High; serum bilirubin, alkaline phosphatase, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) can be elevated.
(8) The storage temperature of this product is 25 ° C or less.
Pregnant women and lactating women
Although the use of cephalosporins in pregnant and lactating women has not yet been reported, the application still has to weigh the pros and cons.
Child medication
The safety of medication for newborns (born less than 2 kg) has not been determined. Newborns with jaundice or neonates with severe jaundice should be used with caution or avoid using this product.
Older medication
The use of ceftriaxone in the elderly generally does not require a dose adjustment unless the elderly patient is weak, malnourished, or has severe renal impairment.
medicine interactions
(1) cephalosporin intravenous infusion with erythromycin, tetracycline, amphotericin B, vasoactive drugs (m-hydroxylamine, norepinephrine, etc.), phenytoin, chlorpromazine, promethazine, There will be turbidity when vitamin B, vitamin C, etc. Because this product has a lot of contraindications, it should be administered alone.
(2) During the application of this product, alcohol may cause a disulfiram-like reaction in individual patients. Therefore, during the application of this product and within a few days, alcohol and alcohol-containing drugs should be avoided.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(2018112800261625.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- |