您好,欢迎光临世界标品! 登录 注册(订药物标准品请用邮件联系我们)

中国医药研发对照标品提供商
Non-clinical Research-used
Medicine Sample Provider

当前本网站药物产品种数共 8063 处方药 7688 非处方药 259 保健品/医疗用具 116

世界标品医药目录搜索(中英文):
世界各国官方药品目录搜索(英文):
世界标品医药知识搜索(中英文):

联系方式
国际免费电话:
QQ客服1:1793093587
QQ客服2:1586083059
QQ客服3:2786706041
QQ客服6:2992753224
QQ客服7:2394834588

咨询邮箱:
scimed.shanghai@shijiebiaopin.com
info@shijiebiaopin.com
pharmacy.shijiebiaopin1@gmail.com
pharmacy.shijiebiaopin2@gmail.com

  药店国别: 荷兰药房
产地国家: 荷兰
所属类别: 抗微生物药物->头孢菌素类
处方药:处方药
包装规格: 1克/瓶 25瓶
计价单位:
   
生产厂家英文名:
EUROCEPT PHARMACEUTICALS
该药品相关信息网址1:
http://www.rxlist.com/mandol-drug.htm
原产地英文商品名:
MANDOL for injection 1g 25 vials (Min order qty: 3)
原产地英文药品名:
CEFAMANDOLE NAFATE
中文参考商品译名:
MANDOL 1克/瓶 25瓶 (最低订货量:3)
中文参考药品译名:
头孢孟多酯钠
原产地国家批准上市年份:
1978/09/27
英文适应病症1:
Respiratory tract infections, urinary tract infection, biliary tract infections, skin and soft tissue infections
英文适应病症2:
Septicemia
英文适应病症3:
Peritonitis and pelvic infection
英文适应病症4:
Prevention of infection after heart surgery
临床试验期:
完成
中文适应病症参考翻译1:
呼吸道感染、尿路感染、胆道感染、皮肤软组织感染
中文适应病症参考翻译2:
败血症
中文适应病症参考翻译3:
腹膜炎和盆腔感染
中文适应病症参考翻译4:
预防心内手术术后感染
药品信息:

 

友情提示:MANDOL已停产。

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(201042523271817.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文MANDOL处方资料(仅供参考)

头孢孟多酯钠(Cefamandole Nafate) 
中文别名:
头孢孟多酯钠、头孢孟多甲酸酯钠、注射用头孢孟多
英文别名:Cephamandole、Mandol
药品类别:头孢菌素类抗生素
药理药动
    药效学:参阅青霉素钠、头孢噻吩。头孢孟多酯钠的抗菌活性仅为头孢孟多的1/5~1/10,头孢孟多酯钠进入体内迅速水解为头孢孟多,所以两者在体内的抗菌作用基本相同。头孢孟多对多数革兰阳性球菌有较强的抗菌作用,其活性与头孢噻吩和头孢唑林相仿,肠球菌和耐甲氧西林金葡菌对本品耐药。本品对白喉杆菌和革兰阳性厌氧菌(球菌和梭状芽孢杆菌)均有良好作用,对大肠杆菌、奇异变形杆菌、肺炎杆菌和流感杆菌的活性较头孢噻吩和头孢唑林为强,部分产气杆菌、吲哚阳性变形杆菌和普鲁威登菌均对本品敏感。伤寒杆菌、志贺菌属、淋球菌和脑膜炎球菌对本品也甚敏感,对脆弱类抨菌的抗菌作用较差。沙雷菌、产碱杆菌、不动杆菌属和绿脓杆菌对本品耐药。
    药动学:头孢孟多酯钠经肌内或静脉给药在体内迅速水解为头孢孟多。肌内注射头孢孟多 lg(即注射相当于 lg头孢孟多的头孢盂多酯钠,以下同),血药峰浓度于 l小时到达,为21.2μg/ml,6小时的血药浓度为 1.3μg/ml。静脉注射和静脉滴注(滴注时间1小时)1g后即刻血药浓度分别为 104.7和 53.9μg/ml,15分钟后皆约下降一半, 4小时后仅有微量,分别为0.19和 0.06μg/ml。头孢孟多的分布容积为 0.16L/kg。动物注射本品后,药物迅速分布于全身各组织器官中,心、肺、肝、脾、胃、肠、生殖器官等脏器中的浓度为血药浓度的 8~24%,肾、胆汁和尿中的药物浓度分别为血药浓度的2、4.6和145倍。胆汁中浓度为141~325μg/ml,腹水、心包液和关节液中为 5.5~25μg/ml。当脑膜有炎症时,本品可透过血脑屏障,其脑脊液中浓度与蛋白量有关。细菌性脑膜炎病人按体重静脉注射 33mg/kg,脑脊液蛋白低于或高于100mg/ml时,药物浓度分别为 0~0.62和 0.57~7.4μg/ml。蛋白结合率为78%。正常成人肌内注射和静脉给药的T1/2分别0.9和0.57~0.69小时。肾功能中度和重度减退病人的T1/2分别延长至3和10小时以上。本品在体内不代谢,经肾小球滤过和肾小管分泌,自尿中以原形药排出。肌内注射lg后0~3小时的尿药浓度在3000μg/ml以上,24小时的排出量为61%。静脉给药后24小时的尿排泄量为70~9O%。少量(0.08%)可经胆汁中排泄。口服丙磺舒可增加本品的血药浓度并延长T1/2时间。腹膜透析清除本品的效能差,透析12小时只能清除给药量的 3.9%;血液透析的清除率较高,重度肾功能损害经血液透析后,T1/2可缩短至 6.2小时。
适应症
    适用于敏感细菌所致的呼吸道感染、尿路感染、胆道感染、皮肤软组织感染、败血症、腹膜炎和盆腔感染等。本品也可用于预防心内手术术后感染。
本品主要用于肺炎球菌、金葡菌和表皮葡萄球菌(包括产酶菌)、大肠杆菌、肺炎杆菌、变形杆菌等敏感菌所致的各种感染。以本品治疗上述敏感菌所致的呼吸道感染、尿路感染、皮肤软组织感染、腹膜炎和盆腔炎等感染,有效率较高。本品也可用于预防心内手术术后感染。
用法用量
    肌内注射、徐缓静脉注射(3— 5分钟)或静脉滴注,成人每日剂量为 2.0—8.0g,分 3— 4次给药,最高剂量为每日 12g。皮肤感染、无并发症的肺炎和尿路感染,每 6小时0.5一1g即可。
肾功能减退者可按肌酐清除率计算剂量。先予以首剂饱和量(1-2g),以后肌酐清除率大于 50ml/min者每 6小时给予2g,清除率为 25— 5 0和 10— 25ml/min,剂量分别为每 6小时1.5g和1g。肌酐清除率低于 10ml/min者每 12小时 0.75一1g。 1个月以内的新生儿和早产儿不推荐应用此药。1个月以上的婴儿和小儿每日剂量按体重50一 150mg/kg,分 3一 4次给予。 用于预防手术感染时,剂量为术前 0.5一 1小时肌内注射或静脉注射 1一2g,以后每 6小时 1一 2g,至术后 24小时为止。
制剂与规格
    以头孢孟多计。注射用头孢孟多酯钠(1) 0.5g(2) 1g
肌注,一日2-4g,分3-4次用;静脉滴注,成人一次0.5-1g,一日4次;较重感染,一次1g,一日6次;极重感染一日可用12g.儿童一日50-100mg/kg,极重感染一日可用到200-250mg/kg,分次给予.
不良反应
    不良反应临床应用发生的副作用少,约为 7.8%,可有肌肉注射区疼痛和血栓性静脉炎,后者较头孢噻吩为重。过敏反应表现为药疹、嗜酸粒细胞增多、Coombs反应阳性等,药物热偶见。少数病人出现血清门冬氨酸氨基转移酶、血清丙氨酸氨基转移酶、碱性磷酸酶、血清肌酐升高,多系暂时性。头孢孟多所致的可逆性肾病也有报告。
    少数病人应用大剂量本品时,可出现凝血功能障碍所致的出血倾向,凝血酶原时间和出血时间延长,多见于肾功能减退病人,系由于本品干扰维生素K在肝中的代谢,导致低凝血酶原血症有关。因此,在停药和注射维生素 K后,凝血功能即可恢复正常,同时给予维生素 K可预防此反应的发生。
个别病例白细胞减少,肾损害,暂时性血清转氨酶升高.可引起皮疹,搔痒,血管神经性水肿,药热,嗜酸性粒细胞增多.大剂量可致出血倾向.
    不良反应少,约为 7.8%,可有肌肉注射区疼痛和血检性静脉炎。过敏反应表现为药疹、嗜酸粒细胞增多、Coombs反应阳性等,药物热偶见。血清谷丙转氨酶可有暂时性升高,也有个别患者出现肾功能异常、少数患者应用大剂量本品时可出现凝血功能障碍所致的出血倾向。
应用头孢孟多期间饮酒或服用含酒精制剂可出现戒酒硫样反应。
本品可干扰凝血功能,大剂量应用时可致出血倾向,因此在治疗前和治疗过程中应测出血时间。
禁忌症
    (1)应用头孢孟多期间饮酒可出现双硫醒样反应。
    (2)乳汁中本品含量甚少,但哺乳期应用时应权衡利弊。
    (3)肾功能减退病人应减少剂量,并须注意出血并发症的发生。
    青霉素过敏或过敏体质者慎用;对头孢菌素类过敏者禁用本品。
    乳汁中本品含量甚少,但哺乳期应用时应权衡利弊。
药物相互作用
    参阅头孢噻吩、头孢哌酮。
    (1)头孢孟多酯钠注射剂含有碳酸钠,因而与含有钙或镁的溶液(包括林格氏液或乳酸林格氏液)有配伍禁忌。两者不能混合在同一容器中;如必须合用时,应分开在不同容器中给药。
    (2)头孢孟多与产生低凝血酶原血症、血小板减少症或胃肠道溃疡的药物同用,将干扰凝血功能和增加出血危险。
    (3)头孢盂多与氨基糖苷类、多粘菌素类、呋塞米、利尿酸合用,可增加肾毒性的可能。
    (4)丙磺舒可抑制头孢菌素类的肾小管分泌,两者同时应用将增加和延长头孢菌素类的血药浓度。
    (5)红霉素可增加头孢孟多对脆弱类杆菌的体外抗菌活性 100以上。头孢孟多与庆大霉素或丁胺卡那霉素的合用对某些革兰阴性杆菌在体外可出现协同现象。
    (6)应用头孢孟多期间饮酒可出现双硫醒样反应。
头孢孟多与庆大霉素或阿米卡星的合用对某些革兰阴性杆菌在体外可出现协同现象。本品与含有钙和镁的溶液(包括林格液或乳酸林格液)有配伍禁忌,两者不能混合在同一容器中。头孢盂多与产生低凝血酶原血症、血小板减少症或胃肠道溃疡的药物同用,将干扰凝血功能和增加出血危险。与氨基糖甙类、多粘菌素、呋塞米、利他尼酸联合有增加肾毒性的可能。

DRUG DESCRIPTION
Mandol? (Cefamandole Nafate for Injection, USP) is a semisynthetic broad-spectrum cephalosporin antibiotic for parenteral administration. It is 5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(formyloxy)phenylacetyl]amino]-3-[[(1-methyl-1 H -tetrazol-5-yl)thio]methyl]-8-oxo-, monosodium salt, [6 R- [6(alpha),7(beta)( R *)]]. Cefamandole has the empirical formula C 19 H 17 N 6 NaO 6 S 2 representing a molecular weight of 512.49.

Mandol also contains 63 mg sodium carbonate/g of cefamandole activity. The total sodium content is approximately 77 mg (3.3 mEq sodium ion) per g of cefamandole activity. After addition of diluent, cefamandole nafate rapidly hydrolyzes to cefamandole, and both compounds have microbiologic activity in vivo. Solutions of Mandol range from light-yellow to amber, depending on concentration and diluent used. The pH of freshly reconstituted solutions usually ranges from 6.0 to 8.5.

-------------------------------------------------------------------------

INDICATIONS
Mandol is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below:

Lower respiratory infections, including pneumonia, caused by S. pneumoniae, H. influenzae, Klebsiella spp., S. aureus (penicillinase- and non-penicillinase-producing), (beta)-hemolytic streptococci, and P. mirabilis

Urinary tract infections caused by E. coli, Proteus spp. (both indole-negative and indole-positive), Enterobacter spp., Klebsiella spp., group D streptococci (Note: Most enterococci, eg, E. faecalis, are resistant), and S. epidermidis

Peritonitis caused by E. coli  and Enterobacter spp.

Septicemia caused by E. coli, S. aureus (penicillinase- and non-penicillinase-producing), S. pneumoniae, S. pyogenes (group A (beta)-hemolytic streptococci), H. influenzae, and Klebsiella spp.

Skin and skin structure infections caused by S. aureus (penicillinase- and non-penicillinase-producing), S. pyogenes (group A (beta)-hemolytic streptococci), H. influenzae, E. coli, Enterobacter spp., and P. mirabilis

Bone and joint infections caused by S. aureus (penicillinase- and non-penicillinase-producing)

Clinical microbiologic studies in nongonococcal pelvic inflammatory disease in females, lower respiratory infections, and skin infections frequently reveal the growth of susceptible strains of both aerobic and anaerobic organisms. Mandol has been used successfully in those infections in which several organisms have been isolated. Most strains of B. fragilis are resistant in vitro; however, infections caused by susceptible strains have been treated successfully.

Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to cefamandole. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.

In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, Mandol may be used concomitantly with an aminoglycoside ( see Precautions ). The recommended doses of both antibiotics may be given, depending on the severity of the infection and the patient's condition. The renal function of the patient should be carefully monitored, especially if higher dosages of the antibiotics are to be administered.

Antibiotic therapy of (beta)-hemolytic streptococcal infections should continue for at least 10 days.

Preventive Therapy  The administration of Mandol preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated (eg, gastrointestinal surgery, cesarean section, vaginal hysterectomy, or cholecystectomy in high-risk patients such as those with acute cholecystitis, obstructive jaundice, or common-bile-duct stones).

In major surgery in which the risk of postoperative infection is low but serious (cardiovascular surgery, neurosurgery, or prosthetic arthroplasty), Mandol may be effective in preventing such infections.

If signs of infection occur, specimens for culture should be obtained for identification of the causative organism so that appropriate antibiotic therapy may be instituted.

-------------------------------------------------------------------------

DOSAGE AND ADMINISTRATION
Dosage Adults:   The usual dosage range for cefamandole is 500 mg to 1 g every 4 to 8 hours.

In infections of skin structures and in uncomplicated pneumonia, a dosage of 500 mg every 6 hours is adequate.

In uncomplicated urinary tract infections, a dosage of 500 mg every 8 hours is sufficient. In more serious urinary tract infections, a dosage of 1 g every 8 hours may be needed.

In severe infections, 1-g doses may be given at 4 to 6-hour intervals.

In life-threatening infections or infections due to less susceptible organisms, doses up to 2 g every 4 hours (ie, 12 g/day) may be needed.

Infants and Children:   Administration of 50 to 100 mg/kg/ day in equally divided doses every 4 to 8 hours has been effective for most infections susceptible to Mandol. This may be increased to a total daily dose of 150 mg/kg (not to exceed the maximum adult dose) for severe infections. ( See recommendations regarding this age group in WARNINGS and Precautions.)

Note:   As with antibiotic therapy in general, administration of Mandol should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by group A (beta)-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment for several weeks; and doses smaller than those indicated above should not be used.

For perioperative use of Mandol, the following dosages are recommended:

Adults  1 or 2 g intravenously or intramuscularly 1 / 2 to 1 hour prior to the surgical incision followed by 1 or 2 g every 6 hours for 24 to 48 hours.

Pediatric Patients (3 months of age and older)  50 to 100 mg/kg/day in equally divided doses by the routes and schedule designated above.

Note:   In patients undergoing prosthetic arthroplasty, administration is recommended for as long as 72 hours.

In patients undergoing cesarean section, the initial dose may be administered just prior to surgery or immediately after the cord has been clamped.

Impaired Renal Function  When renal function is impaired, a reduced dosage must be employed and the serum levels closely monitored. After an initial dose of 1 to 2 g (depending on the severity of infection), a maintenance dosage schedule should be followed (see chart). Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism.

When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

Males:          Weight (kg) x (140 - age)
                   72 x serum creatinine

Females:      0.9 x above value

Modes of Administration  Mandol may be given intravenously or by deep intramuscular injection into a large muscle mass (such as the gluteus or lateral part of the thigh) to minimize pain.

Intramuscular Administration  Each g of Mandol should be diluted with 3 mL of 1 of the following diluents: Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9% Sodium Chloride Injection, or Bacteriostatic Sodium Chloride Injection. Shake well until dissolved.

Intravenous Administration  The intravenous route may be preferable for patients with bacterial septicemia, localized parenchymal abscesses (such as intra-abdominal abscess), peritonitis, or other severe or life-threatening infections when they may be poor risks because of lowered resistance. In those with normal renal function, the intravenous dosage for such infections is 3 to 12 g of Mandol daily. In conditions such as bacterial septicemia, 6 to 12 g/day may be given initially by the intravenous route for several days, and dosage may then be gradually reduced according to clinical response and laboratory findings.

If combination therapy with Mandol and an aminoglycoside is indicated, each of these antibiotics should be administered in different sites. Do not mix an aminoglycoside with Mandol in the same intravenous fluid container.

A SOLUTION OF 1 G OF MANDOL IN 22 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.

The choice of saline, dextrose, or electrolyte solution and the volume to be employed are dictated by fluid and electrolyte management.

For direct intermittent intravenous administration, each g of cefamandole should be reconstituted with 10 mL of Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection. Slowly inject the solution into the  vein  over  a  period  of  3  to  5 minutes, or give it through the tubing of an administration set while the patient is also receiving 1 of the following intravenous fluids:

0.9% Sodium Chloride Injection; 5% Dextrose Injection; 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; or Sodium Lactate Injection (M/6).

Intermittent intravenous infusion with a Y-type administration set or volume control set can also be accomplished while any of the above-mentioned intravenous fluids are being infused. However, during infusion of the solution containing Mandol, it is desirable to discontinue the other solution. When this technique is employed, careful attention should be paid to the volume of the solution containing Mandol so that the calculated dose will be infused. If Sterile Water for Injection is used as the diluent, reconstitute with approximately 20 mL/g to avoid a hypotonic solution.

For continuous intravenous infusion, each g of cefamandole should be diluted with 10 mL of Sterile Water for Injection. An appropriate quantity of the resulting solution may be added to an IV bottle containing 1 of the following fluids: 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; or Sodium Lactate Injection (M/6).

STABILITY
Reconstituted Mandol is stable for 24 hours at room temperature (25°C) and for 96 hours if stored under refrigeration (5°C). During storage at room temperature, carbon dioxide develops inside the vial after reconstitution. This pressure may be dissipated prior to withdrawal of the vial contents, or it may be used to aid withdrawal if the vial is inverted over the syringe needle and the contents are allowed to flow into the syringe.

Solutions of Mandol in Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection that are frozen immediately after reconstitution in the conventional vials in which the drugs are supplied are stable for 6 months when stored at -20°C. If the product is warmed (to a maximum of 37°C), care should be taken to avoid heating it after the thawing is complete. Once thawed, the solution should not be refrozen.

-------------------------------------------------------------------------
 
HOW SUPPLIED
Vials (Dry Powder):
1 g. * 10-mL size (No. 7061) (Traypak ** of 25) NDC 0002-7061-25
2 g, * 20-mL size (No. 7064) (Traypak of 10) NDC 0002-7064-10
*Equivalent to cefamandole activity.
** Traypak TM (multivial carton, Lilly).

1.Bauer AW, Kirby WMM, et al: Antibiotic susceptibility testing by a standardized single disk method. Am J Clin Pathol 1966;45:493. Standardized disk susceptibility test. Federal Register 1974;39:19182-19184. National Committee for Clinical Laboratory Standards. Approved Standard: M2-A3 Performance standards for antimicrobial disk susceptibility tests Fourth Edition, December, 1988.
2.Determined by the ICS agar-dilution method (Ericsson HM, Sherris JC: Acta Pathol Microbiol Scand 1971;[suppl 217]:B), or any other method that has been shown to give equivalent results.

-------------------------------------------------------------------------

SIDE EFFECTS
Gastrointestinal  Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Nausea and vomiting have been reported rarely. As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely.

Hypersensitivity  Anaphylaxis, maculopapular rash, urticaria, eosinophilia, and drug fever have been reported. These reactions are more likely to occur in patients with a history of allergy, particularly to penicillin.

Blood  Thrombocytopenia has been reported rarely. Neutropenia has been reported, especially in long courses of treatment. Some individuals have developed positive direct Coombs' tests during treatment with the cephalosporin antibiotics.

Liver  Transient rise in SGOT, SGPT, and alkaline phosphatase levels has been noted.

Kidney  Decreased creatinine clearance has been reported in patients with prior renal impairment. As with some other cephalosporins, transitory elevations of BUN have occasionally been observed with Mandol; their frequency increases in patients over 50 years of age. In some of these cases, there was also a mild increase in serum creatinine.

Local Reactions  Pain on intramuscular injection is infrequent. Thrombophlebitis occurs rarely.

 -------------------------------------------------------------------------

DRUG INTERACTIONS
No Information Provided

-------------------------------------------------------------------------

WARNINGS
BEFORE THERAPY WITH MANDOL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.

In neonates, accumulation of other cephalosporin-class antibiotics (with resulting prolongation of drug half-life) has been reported.

Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics (including macrolides, semisynthetic penicillins, and cephalosporins); therefore, it is important to consider its diagnosis in patients who develop diarrhea in association with the use of antibiotics. Such colitis may range in severity from mild to life threatening.

Treatment with broad-spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associated colitis.

Mild cases of pseudomembranous colitis usually respond to drug discontinuance alone. In moderate to severe cases, management should include sigmoidoscopy, appropriate bacteriologic studies, and fluid, electrolyte, and protein supplementation. When the colitis does not improve after the drug has been discontinued, or when it is severe, oral vancomycin is the drug of choice for antibiotic-associated pseudomembranous colitis produced by C. difficile. Other causes of colitis should be ruled out.

 -------------------------------------------------------------------------

PRECAUTIONS
General  Although Mandol rarely produces alteration in kidney function, evaluation of renal status is recommended, especially in seriously ill patients receiving maximum doses.

Prolonged use of Mandol may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporins.

A false-positive reaction for glucose in the urine may occur with Benedict's or Fehling's solution or with Clinitest? tablets. There may be a false-positive test for proteinuria with acid and denaturization-precipitation tests.

As with other broad-spectrum antibiotics, hypoprothrombinemia, with or without bleeding, has been reported rarely, but it has been promptly reversed by administration of vitamin K. Such episodes usually have occurred in elderly, debilitated, or otherwise compromised patients with deficient stores of vitamin K. Treatment of such individuals with antibiotics possessing significant gram-negative and/or anaerobic activity is thought to alter the number and/or type of intestinal bacterial flora, with consequent reduction in synthesis of vitamin K. Prophylactic administration of vitamin K may be indicated in such patients, especially when intestinal sterilization and surgical procedures are performed.

In a few patients receiving Mandol, nausea, vomiting, and vasomotor instability with hypotension and peripheral vasodilatation occurred following the ingestion of ethanol.

Cefamandole inhibits the enzyme acetaldehyde dehydrogenase in laboratory animals. This causes accumulation of acetaldehyde when ethanol is administered concomitantly.

Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Carcinogenesis, Mutagenesis, Impairment of Fertility  Certain (beta)-lactam antibiotics containing the N-methylthiotetrazole side chain have been reported to cause delayed maturity of the testicular germinal epithelium when given to neonatal rats during initial spermatogenic development (6 to 36 days of age). In animals that were treated from 6 to 36 days of age with 1,000 mg/kg/day of cefamandole (approximately 5 times the maximum clinical dose), the delayed maturity was pronounced and was associated with decreased testicular weights and a reduced number of germinal cells in the leading waves of spermatogenic development. The effect was slight in rats given 50 or 100 mg/kg/day. Some animals that were given 1,000 mg/kg/day during days 6 to 36 were infertile after becoming sexually mature. No adverse effects have been observed in rats exposed in utero, in neonatal rats (4 days of age or younger) treated prior to the initiation of spermatogenesis, or in older rats (more than 36 days of age) after exposure for up to 6 months. The significance to humans of these findings in rats is unknown because of differences in the time of initiation of spermatogenesis, rate of spermatogenic development, and duration of puberty.

Usage in Pregnancy  Pregnancy Category B  Reproduction studies have been performed in rats given doses of 500 or 1,000 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to Mandol. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers  Caution should be exercised when Mandol is administered to a nursing woman.

Usage in Infants Mandol has been effectively used in this age group, but all laboratory parameters have not been extensively studied in infants between 1 and 6 months of age; safety of this product has not been established in premature infants and term neonates under 1 month of age. Therefore, if Mandol is administered to infants, the physician should determine whether the potential benefits outweigh the possible risks involved.

-------------------------------------------------------------------------

OVERDOSE
The administration of inappropriately large doses of parenteral cephalosporins may cause seizures, particularly in patients with renal impairment. Dosage reduction is necessary when renal function is impaired ( see Dosage and Administration ). If seizures occur, the drug should be promptly discontinued; anticonvulsant therapy may be administered if clinically indicated. Hemodialysis may be considered in cases of overwhelming overdosage.

-------------------------------------------------------------------------

CONTRAINDICATIONS
Mandol is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(201042523271817.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

于2010年4月26日更新

更新日期: 2015-04-19
附件:




201042523271817.PDF    

 
调控比例: 100%
订购表单下载
Copyrights © 2010,2011,2012 www.ShiJieBiaoPin.com, Inc., All rights Reserved www.ShiJieBiaoPin.com, Inc.
客服工作时间:太平洋时间18:00-24:00
国际免费电话:
友情提示:以上电话为免费电话,无需您承担任何费用,世界标品提供中文客服,请您放心拨打!
电子邮箱:info.shijiebiaopin.com@gmail.com, info@shijiebiaopin.com