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  药店国别: 德国药房
产地国家: 德国
所属类别: 抗微生物药物->广谱抗菌类
处方药:处方药
包装规格: 2克/瓶 5瓶/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
百时美施贵宝
生产厂家英文名:
BRISTOL MYERS SQUIBB
该药品相关信息网址1:
http://www.bms.com/
该药品相关信息网址2:
http://www.rxlist.com/maxipime-drug.htm
原产地英文商品名:
MAXIPIME 2g/vial 5vials/box
原产地英文药品名:
CEFEPIME HYDROCHLORIDE
中文参考商品译名:
马斯平 2克/瓶 5瓶/盒
中文参考药品译名:
盐酸头孢吡肟
原产地国家批准上市年份:
1996/01/18
英文适应病症1:
β-lactam antibiotics
英文适应病症2:
Anti-infective
临床试验期:
完成
中文适应病症参考翻译1:
β-内酰胺类抗生素
中文适应病症参考翻译2:
抗感染
药品信息:

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 详细处方信息以本药内容附件PDF文件(20104820005724.pdf)的“原文Priscribing Information
”为准
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部分中文MAXIPIME 处方资料(仅供参考)

分类:抗生素/β-内酰胺类/头孢菌素类

别名:盐酸头孢吡肟、头孢吡肟

用于治疗哪些病症?
    本品可用于治疗成人和2月龄至16岁儿童上述敏感细菌引起的中至重度感染,包括下呼吸道感染(肺炎和支气管炎),单纯性下尿路感染和复杂性尿路感染(包括肾盂肾炎)、非复杂性皮肤和皮肤软组织感染,复杂性腹腔内感染(包括腹膜炎和胆道感染)、妇产科感染、败血症、以及中性粒细胞减少伴发热患者的经验治疗。也可用于儿童细菌性脑脊髓膜炎。
    怀疑有细菌感染时应进行细菌培养和药敏试验,但是因为头孢吡肟是一革兰阳性和革兰阴性菌的广谱杀菌剂,故在药敏试验结果揭晓前可开始头孢吡肟单药治疗。对疑有厌氧菌混合感染时,建议合用其他抗厌氧菌药物,如甲硝唑进行初始治疗。一旦细菌培养和药敏试验结果揭晓,应及时调整治疗方案。

如何正确使用此药品?
    本品可用静脉滴注或深部肌肉注射给药。成人和16岁以上儿童或体重为40公斤或40公斤以上儿童患者,可根据病情,每次1~2克,每12小时一次,静脉滴注,疗程7~10天;轻中度尿路感染,每次0.5~1克,静脉滴注或深部肌肉注射,疗程7~10天;重度尿路感染,每次2克,每12小时一次,静脉滴注,疗程10天;对于严重感染并危及生命时,可以每8小时2克静脉滴注;用于中性粒细胞减少伴发热的经验治疗,每次2克,每8小时一次静脉滴注,疗程7~10天或至中性粒细胞减少缓解。如发热缓解但中性粒细胞仍处于异常低水平,应重新评价有无继续使用抗生素治疗的必要。
    2月龄至12岁儿童,最大剂量不可超过成人剂量(即每次2克剂量)。体重超过40公斤的儿童的剂量,可使用成人剂量。一般可每公斤体重40毫克,每12小时静脉滴注,疗程7~14天;对细菌性脑脊髓膜炎儿童患者,可为每公斤体重50毫克,每8小时一次,静脉滴注。对儿童中性粒细胞减少伴发热经验治疗的常用剂量为每公斤体重50毫克,每12小时一次(中性粒细胞减少伴发热的治疗为每8小时一次),疗程与成人相同。
    2月龄以下儿童经验有限。可使用每公斤体重50毫克剂量。然而2月龄以上儿童患者的资料表明,每公斤30毫克,每8或12小时一次对于1至2月龄儿童患者已经足够。对2月龄以下儿童使用本品应谨慎。儿童深部肌肉注射的经验有限。
    对肝功能不全患者,无调节本品剂量的必要。
    对肾功能不全病人,如肌酐清除率低于(含)60ml/min,则应调节本品用量,弥补这些病人减慢的肾清除速率。这些病人使用头孢吡肟的初始剂量与肾功能正常的患者相同。
    血液透析患者在治疗第一天可给予负荷剂量1克,以后每天0.5克。透析日,头孢吡肟应在透析结束后使用。每天给药时间尽可能相同。
    头孢吡肟治疗同时需进行血液透析的患者,在透析开始3小时,约68%药物可被清除。血液透析患者的马斯平剂量见上表。接受持续性腹膜透析,患者应每隔48小时给予常规剂量。
    尚无肾功能不全的儿童患者使用头孢吡肟的资料。但是,由于成人和儿童的头孢吡肟药代动力学相似,肾功能不全儿童患者头孢吡肟的用法与成人类似。
    静脉给药:对于严重或危及生命的病例,应首选静脉给药。
    静脉滴注时,可将本品1~2克溶于50~100毫升0.9%氯化钠注射液,5%或10%葡萄糖注射液,M/6乳酸钠注射液,5%葡萄糖和0.9%氯化钠混合注射液,乳酸林格氏和5%葡萄糖混合注射液中,药物浓度不应超过每毫升40毫克。经约30分钟滴注完毕。
    肌肉内注射:肌肉注射时,本品0.5克应加1.5毫升注射用溶液,或1克加3.0毫升溶解后,经深部肌群(如臀肌群或外侧股四头肌)注射。

使用后有哪些不良反应?
    通常本品对耐受性良好,不良反应轻微且多为短暂,终止治疗少见。常见的与本品可能有关的不良反应主要是腹泻,皮疹和注射局部反应,如静脉炎,注射部位疼痛和炎症。其他不良反应包括恶心、呕吐、过敏、瘙痒、发热、感觉异常和头痛。肾功能不全患者而未相应调整头孢吡肟剂量时,可引起脑病、肌痉挛、癫痫。如发生与治疗有关的癫痫。应停止用药,必要时,应进行抗惊厥治疗。本品治疗儿童脑膜炎患者,偶有惊厥、嗜睡、神经紧张和头痛,主要是脑膜炎引起,与本品无明显关系。
    偶有肠炎(包括伪膜性肠炎)、口腔念珠菌感染报告。
    与本品有关的实验室检查异常多为一过性,停药即可恢复,包括血清磷升高或减少,转氨酶(ALT和/或AST)升高,嗜酸性粒细胞增多,部分凝血酶原时间和凝血酶原时间延长。碱性磷酸酶、血尿素氮、肌酐、血钾、总胆红素升高,血钙降低,红细胞压积减少。与其他头孢菌素类抗生素类似,也有白细胞减少,粒细胞减少,血小板减少的报道。头孢菌素类抗生素还可引起Stevens-Johnson综合症,多形性红斑,毒性表皮坏死,肾功能紊乱,毒性肾病,再生障碍性贫血,溶血性贫血,出血,肝功能紊乱(胆汁淤积)和血细胞减少。


MAXIPIME®
(cefepime hydrochloride, USP) for Injection
For Intravenous or Intramuscular Use
To reduce the development of drug-resistant bacteria and maintain the effectiveness of

MAXIPIME® and other antibacterial drugs, MAXIPIME should be used only to treat or prevent

infections that are proven or strongly suspected to be caused by bacteria.

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DRUG DESCRIPTION
MAXIPIME (cefepime hydrochloride, USP) is a semi-synthetic, broad spectrum, cephalosporin antibiotic for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 72-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula:
Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C19H24N6O5S2) per mg, calculated on an anhydrous basis. It is highly soluble in water.

MAXIPIME for Injection is supplied for intramuscular or intravenous administration in strengths equivalent to 500 mg, 1 g, and 2 g of cefepime. (See DOSAGE AND ADMINISTRATION.) MAXIPIME is a sterile, dry mixture of cefepime hydrochloride and L-arginine. It contains the equivalent of not less than 90 percent and not more than 115 percent of the labeled amount of cefepime (C19H24N6O5S2). The L-arginine, at an approximate concentration of 725 mg/g of cefepime, is added to control the pH of the constituted solution at 4.0–6.0. Freshly constituted solutions of MAXIPIME will range in color from colorless to amber.

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INDICATIONS
MAXIPIME is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms (see also PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION):Pneumonia (moderate to severe) caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.

Empiric Therapy for Febrile Neutropenic Patients. Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients. (See Clinical Studies.)

Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.

Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes.

Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis. (See Clinical Studies.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of MAXIPIME and other antibacterial drugs, MAXIPIME should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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DOSAGE AND ADMINISTRATION
The recommended adult and pediatric dosages and routes of administration are outlined in the following table. MAXIPIME should be administered intravenously over approximately 30 minutes.

Patients with Hepatic Impairment
No adjustment is necessary for patients with hepatic impairment.
Patients with Renal Impairment

In patients with creatinine clearance less than or equal to 60 mL/min, the dose of MAXIPIME should be adjusted to compensate for the slower rate of renal elimination. The recommended initial dose of MAXIPIME should be the same as in patients with normal renal function except in patients undergoing hemodialysis. The recommended doses of MAXIPIME in patients with renal impairment are presented in Table 13.

When only serum creatinine is available, the following formula (Cockcroft and Gault equation)3 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:
Males: Creatinine Clearance (mL/min) = Weight (kg) × (140–age)
72 × serum creatinine (mg/dL) 
Females: 0.85 × above value

In patients undergoing continuous ambulatory peritoneal dialysis, MAXIPIME may be administered at normally recommended doses at a dosage interval of every 48 hours (see Table 13).

In patients undergoing hemodialysis, approximately 68% of the total amount of cefepime present in the body at the start of dialysis will be removed during a 3-hour dialysis period. The dosage of MAXIPIME for hemodialysis patients is 1 g on Day 1 followed by 500 mg every 24 hours for the treatment of all infections except febrile neutropenia, which is 1 g every 24 hours.

MAXIPIME should be administered at the same time each day and following the completion of hemodialysis on hemodialysis days (see Table 13).

Data in pediatric patients with impaired renal function are not available; however, since cefepime pharmacokinetics are similar in adults and pediatric patients (see CLINICAL PHARMACOLOGY), changes in the dosing regimen proportional to those in adults (see Tables 12 and 13) are recommended for pediatric patients.

Administration
For Intravenous Infusion, constitute the 500 mg, 1 g, or 2 g vial, and add an appropriate quantity of the resulting solution to an intravenous container with one of the compatible intravenous fluids listed in the Compatibility and Stability subsection. THE RESULTING SOLUTION SHOULD BE ADMINISTERED OVER APPROXIMATELY 30 MINUTES.

Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of a solution containing cefepime, it is desirable to discontinue the other solution.

ADD-Vantage® vials are to be constituted only with 50 mL or 100 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection in Abbott ADD-Vantage® flexible diluent containers. (See ADD-Vantage® Vial Instructions for Use.)

Intramuscular Administration: For intramuscular administration, MAXIPIME (cefepime hydrochloride) should be constituted with one of the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride, 5% Dextrose Injection, 0.5% or 1.0% Lidocaine Hydrochloride, or Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol (refer to Table 14).

Compatibility and Stability
Intravenous: MAXIPIME is compatible at concentrations between 1 mg per mL and 40 mg per mL with the following intravenous infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection, Normosol-R™, and Normosol-M™ in 5% Dextrose Injection. These solutions may be stored up to 24 hours at controlled room temperature 20°–25°C (68°–77°F) or 7 days in a refrigerator 2°–8°C (36°–46°F). MAXIPIME in ADD-Vantage® vials is stable at concentrations of 10–40 mg per mL in 5% Dextrose Injection or 0.9% Sodium Chloride Injection for 24 hours at controlled room temperature 20°– 25°C or 7 days in a refrigerator 2°–8°C.

Solutions of MAXIPIME, like those of most beta-lactam antibiotics, should not be added to solutions of ampicillin at a concentration greater than 40 mg per mL, and should not be added to metronidazole, vancomycin, gentamicin, tobramycin, netilmicin sulfate, or aminophylline because of potential interaction.

However, if concurrent therapy with MAXIPIME is indicated, each of these antibiotics can be administered separately.

Intramuscular: MAXIPIME (cefepime hydrochloride) constituted as directed is stable for 24 hours at controlled room temperature 20°-25°C (68°-77°F) or for 7 days in a refrigerator 2°– 8°C (36°-46°F) with the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol, or 0.5% or 1% Lidocaine Hydrochloride.

NOTE: PARENTERAL DRUGS SHOULD BE INSPECTED VISUALLY FOR PARTICULATE MATTER BEFORE ADMINISTRATION.

As with other cephalosporins, the color of MAXIPIME powder, as well as its solutions, tend to darken depending on storage conditions; however, when stored as recommended, the product potency is not adversely affected.

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HOW SUPPLIED
MAXIPIME® (cefepime hydrochloride, USP) for Injection is supplied as follows:
500 mg* 15 mL vial (tray of 10) NDC 51479-053-10
1 g* ADD-Vantage® vial (tray of 10) NDC 51479-054-20
1 g* 15 mL vial (tray of 10) NDC 51479-054-30
2 g* ADD-Vantage® vial (tray of 10) NDC 51479-055-10
2 g* 20 mL vial (tray of 10) NDC 51479-055-30
*Based on cefepime activity 

Storage
MAXIPIME IN THE DRY STATE SHOULD BE STORED BETWEEN 2°-25°C (36°-77°F) AND PROTECTED FROM LIGHT.

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SIDE EFFECTS
Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials using multiple doses of cefepime, 4137 patients were treated with the recommended dosages of cefepime (500 mg to 2 g intravenous every 12 hours). There were no deaths or permanent disabilities thought related to drug toxicity. Sixty-four (1.5%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. Thirty-three (51%) of these 64 patients who discontinued therapy did so because of rash. The percentage of cefepime-treated patients who discontinued study drug because of drug-related adverse events was very similar at daily doses of 500 mg, 1 g, and 2 g every 12 hours (0.8%, 1.1%, and 2.0%, respectively). However, the incidence of discontinuation due to rash increased with the higher recommended doses.

The following adverse events were thought to be probably related to cefepime during evaluation of the drug in clinical trials conducted in North America (n=3125 cefepime-treated patients).

At the higher dose of 2 g every 8 hours, the incidence of probably-related adverse events was higher among the 795 patients who received this dose of cefepime. They consisted of rash (4%), diarrhea (3%), nausea (2%), vomiting (1%), pruritus (1%), fever (1%), and headache (1%).

The following adverse laboratory changes, irrespective of relationship to therapy with cefepime, were seen during clinical trials conducted in North America.

A similar safety profile was seen in clinical trials of pediatric patients (see PRECAUTIONS: Pediatric Use).

Postmarketing Experience
In addition to the events reported during North American clinical trials with cefepime, the following adverse experiences have been reported during worldwide postmarketing experience.

As with some other drugs in this class, encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, and seizures have been reported. Although most cases occurred in patients with renal impairment who received doses of cefepime that exceeded the recommended dosage schedules, some cases of encephalopathy occurred in patients receiving a dosage adjustment for their renal function. (See also WARNINGS.)

If seizures associated with drug therapy occur, the drug should be discontinued.

Anticonvulsant therapy can be given if clinically indicated. Precautions should be taken to adjust daily dosage in patients with renal insufficiency or other conditions that may compromise renal function to reduce antibiotic concentrations that can lead or contribute to these and other serious adverse events, including renal failure.

As with other cephalosporins, anaphylaxis including anaphylactic shock, transient leukopenia, neutropenia, agranulocytosis and thrombocytopenia have been reported.

Cephalosporin-Class Adverse Reactions
In addition to the adverse reactions listed above that have been observed in patients treated with cefepime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, hepatic dysfunction including cholestasis, and pancytopenia.

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DRUG INTERACTIONS
Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with MAXIPIME because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.

Drug/Laboratory Test Interactions
The administration of cefepime may result in a false-positive reaction for glucose in the urine when using Clinitest® tablets. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix®) be used.

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WARNINGS
BEFORE THERAPY WITH MAXIPIME FOR INJECTION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS IMMEDIATE HYPERSENSITIVITY REACTIONS TO CEFEPIME, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO MAXIPIME OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES INCLUDING OXYGEN, CORTICOSTEROIDS, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

In patients with creatinine clearance less than or equal to 60 mL/min, the dose of MAXIPIME (cefepime hydrochloride) should be adjusted to compensate for the slower rate of renal elimination. Because high and prolonged serum antibiotic concentrations can occur from usual dosages in patients with renal impairment or other conditions that may compromise renal function, the maintenance dosage should be reduced when cefepime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organisms. (See specific recommendations for dosing adjustment in DOSAGE AND ADMINISTRATION.) During postmarketing surveillance, serious adverse events have been reported including life-threatening or fatal occurrences of the following: encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, and seizures (see ADVERSE REACTIONS: Postmarketing Experience). Most cases occurred in patients with renal impairment who received doses of cefepime that exceeded the recommended dosage schedules. However, some cases of encephalopathy occurred in patients receiving a dosage adjustment for their renal function. In the majority of cases, symptoms of neurotoxicity were reversible and resolved after discontinuation of cefepime and/or after hemodialysis.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MAXIPIME, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B, which contribute to the development of CDAD.

Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS
General
Prescribing MAXIPIME in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

As with other antimicrobials, prolonged use of MAXIPIME may result in overgrowth of nonsusceptible microorganisms. Repeated evaluation of the patient's condition is essential. Should superinfection occur during therapy, appropriate measures should be

taken.
Many cephalosporins, including cefepime, have been associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk, and exogenous vitamin K administered as indicated.

Positive direct Coombs' tests have been reported during treatment with MAXIPIME. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs' test may be due to the drug.

MAXIPIME (cefepime hydrochloride) should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Arginine has been shown to alter glucose metabolism and elevate serum potassium transiently when administered at 33 times the amount provided by the maximum recommended human dose of MAXIPIME. The effect of lower doses is not presently known.

Carcinogenesis, Mutagenesis, Impairment of FertilityNo animal carcinogenicity studies have been conducted with cefepime. In chromosomal aberration studies, cefepime was positive for clastogenicity in primary human lymphocytes, but negative in Chinese hamster ovary cells. In other in vitro assays (bacterial and mammalian cell mutation, DNA repair in primary rat hepatocytes, and sister chromatid exchange in human lymphocytes), cefepime was negative for genotoxic effects.

Moreover, in vivo assessments of cefepime in mice (2 chromosomal aberration and 2 micronucleus studies) were negative for clastogenicity. No untoward effects on fertility were observed in rats when cefepime was administered subcutaneously at doses up to 1000 mg/kg/day (1.6 times the recommended maximum human dose calculated on a mg/m2 basis).

Pregnancy
Teratogenic Effects: Pregnancy Category B
Cefepime was not teratogenic or embryocidal when administered during the period of organogenesis to rats at doses up to 1000 mg/kg/day (1.6 times the recommended maximum human dose calculated on a mg/m2 basis) or to mice at doses up to 1200 mg/kg (approximately equal to the recommended maximum human dose calculated on a mg/m2 basis) or to rabbits at a dose level of 100 mg/kg (0.3 times the recommended maximum human dose calculated on a mg/m2 basis).

There are, however, no adequate and well-controlled studies of cefepime use 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
Cefepime is excreted in human breast milk in very low concentrations (0.5 mcg/mL).

Caution should be exercised when cefepime is administered to a nursing woman.

Labor and Delivery
Cefepime has not been studied for use during labor and delivery. Treatment should only be given if clearly indicated.

Pediatric Use
The safety and effectiveness of cefepime in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, pneumonia, and as empiric therapy for febrile neutropenic patients have been established in the age groups 2 months up to 16 years. Use of MAXIPIME in these age groups is supported by evidence from adequate and well-controlled studies of cefepime in adults with additional pharmacokinetic and safety data from pediatric trials (see CLINICAL PHARMACOLOGY).

Safety and effectiveness in pediatric patients below the age of 2 months have not been established.

There are insufficient clinical data to support the use of MAXIPIME in pediatric patients under 2 months of age or for the treatment of serious infections in the pediatric population where the suspected or proven pathogen is Haemophilus influenzae type b.

IN THOSE PATIENTS IN WHOM MENINGEAL SEEDING FROM A DISTANT INFECTION SITE OR IN WHOM MENINGITIS IS SUSPECTED OR DOCUMENTED, AN ALTERNATE AGENT WITH DEMONSTRATED CLINICAL EFFICACY IN THIS SETTING SHOULD BE USED.

Geriatric Use
Of the more than 6400 adults treated with MAXIPIME in clinical studies, 35% were 65 years or older while 16% were 75 years or older. When geriatric patients received the usual recommended adult dose, clinical efficacy and safety were comparable to clinical efficacy and safety in nongeriatric adult patients.

Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. (See WARNINGS and ADVERSE REACTIONS.)

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored. (See CLINICAL PHARMACOLOGY: Special Populations, WARNINGS, and DOSAGE AND ADMINISTRATION.)

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OVERDOSE
Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid in the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.

(See WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION.)

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CONTRAINDICATIONS
MAXIPIME is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics.

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 详细处方信息以本药内容附件PDF文件(20104820005724.pdf)的“原文Priscribing Information
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于2019年1月7日更新

更新日期: 2019-1-8
附件:
20104820005724.pdf    







 
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