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盐酸头孢吡肟注射剂|MAXIPIME ADV VL(CEFEPIME HCL)

2011-07-14 10:31:48  作者:新特药房  来源:中国新特药网天津分站  浏览次数:479  文字大小:【】【】【
简介: 【中文品名】头孢吡肟【药效类别】抗生素>头孢菌素类>第四代【通用药名】CEFEPIME【别  名】Maxipime,头孢匹美【CA 名 称】Pyrrolidinium, 1-[[(6R,7R)-7-[[(2Z)-(2-amino-4-thiazol)(methoxyimino)a ...

部份中文头孢吡肟处方资料(仅供参考)
【中文品名】头孢吡肟
【药效类别】抗生素>头孢菌素类>第四代
【通用药名】CEFEPIME
【别  名】Maxipime,头孢匹美
【CA 名 称】
Pyrrolidinium, 1-[[(6R,7R)-7-[[(2Z)-(2-amino-4-thiazol)(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4,2,0]oct-2-en-3-yl]methyl]-1-methyl-, inner salt
【CA登记号】[88040-23-7]
【结 构 式】

【分 子 式】C19H24N6O5S2
【收录药典】
【开发单位】百时美施贵宝公司
【首次上市】
【简  介】
头孢吡肟头孢吡肟是百时美施贵宝公司开发的第四代头孢菌素,1993年在瑞典首先用于临床,随后在欧、美、日本等多国上市。
本品的抗菌谱比第三代头孢菌素有了进一步扩大,故被称为第四代头孢菌素。头孢匹美的特点是对很多革兰氏阳性和革兰氏阴性细菌均有较强的抗菌活性,例如肠杆菌属、绿脓杆菌和其他非发酵性杆菌、嗜血杆菌属、奈瑟氏球菌属、葡萄球菌、链球菌(除肠球菌外),但是对肠球菌和耐甲氧西林的金葡萄菌的抗菌活性较差。由于本药透入到细胞内的速率极大地增加,导致了对酶的亲合性降低及水解速度减慢,因而对内酰胺酶稳定,所以对耐第三代头孢菌素的革兰氏阴性杆菌仍显出良好的抗菌活性。头孢匹美t1/2 2小时左右,与剂量不相关,给药剂量的85%以原形从尿中排出。主要分布在细胞外液腔内,如炎性体液(皮肤脓疤)、腹水、胆汁、支气管粘液及尿液可达有效浓度。主要用于难治性感染如金葡菌、肠杆菌属及绿脓杆菌引起的呼吸道感染,泌尿系统感染和败血症等。
【剂量与用法】
肌注或静注:成人和13岁以上儿童,1g/12小时,连用7~10天,严重感染可以根据具体情况延长,极严重感染也可增加剂量到2g/8小时。静脉注射应在3~5分钟完成,也可加到5%葡萄糖注射液或0.9%氯化钠注射液中静脉滴注15~30分钟完成。肾功损害患者(肌酐清除率<30ml/分)应调整剂量。
【注意事项】
①对头孢匹美或者头孢菌素类、青霉素类或其他β内酰胺抗生素过敏者禁用;
②治疗超过10天出现腹泻应特别注意伪膜性结肠炎的发生。如出现二重感染应及时采取措施;
③孕妇及哺乳妇女慎用;
④可能发生皮疹、瘙痒、腹痛、消化不良、胸痛、心动过速、咳嗽、咽喉疼痛、呼吸困难、头痛、眩晕、失眠、肢端麻木、焦虑、周身无力、多汗和背疼等;
⑤可能出现短暂的转氨酶、碱性磷酸酯酶、总胆红素、嗜酸细胞升高,贫血、白细胞减少、中性粒细胞减少和尿素氮升高也可发生。偶见溶血性贫血、出血等不良反应。
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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注:以下产品不同厂家和不同剂型,采购以咨询为准!
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产地国家: 美国
原产地英文商品名:
MAXIPIME FTV 1GM HW 10(Minimum order qty: 2)
原产地英文药品名:
CEFEPIME HCL
中文参考商品译名:
马斯平 1克/瓶 10瓶/盒 (最低订货量:2)
中文参考药品译名:
盐酸头孢吡肟
生产厂家英文名:
HOSPIRA WORLDWIDE INC
NDC: 00409-0219-01


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产地国家: 美国
原产地英文商品名:
MAXIPIME FTV 2GM HW 10(Minimum order qty: 2)
原产地英文药品名:
CEFEPIME HCL
中文参考商品译名:
马斯平 2克/瓶 10瓶/盒 (最低订货量:2)
中文参考药品译名:
盐酸头孢吡肟
生产厂家英文名:
HOSPIRA WORLDWIDE INC
NDC: 00409-0220-01


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产地国家: 美国
原产地英文商品名:
MAXIPIME ADV VL 1GM HW 25 
原产地英文药品名:
CEFEPIME HCL
中文参考商品译名:
马斯平 1克/小瓶 25小瓶/盒
中文参考药品译名:
盐酸头孢吡肟
生产厂家英文名:
HOSPIRA WORLDWIDE INC
NDC: 00409-0217-01
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产地国家: 美国
原产地英文商品名:
MAXIPIME ADV VL 2GM HW 25 
原产地英文药品名:
CEFEPIME HCL
中文参考商品译名:
马斯平 2克/小瓶 25小瓶/盒
中文参考药品译名:
盐酸头孢吡肟
生产厂家英文名:
HOSPIRA WORLDWIDE INC
NDC: 00409-0218-01
----------------------------------------------------------
产地国家: 美国
原产地英文商品名:
MAXIPIME 1g/vial 10vials/box
原产地英文药品名:
CEFEPIME HYDROCHLORIDE
中文参考商品译名:
马斯平 1克/瓶 10瓶/盒
中文参考药品译名:
盐酸头孢吡肟
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
-------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
MAXIPIME ADD-VANTAGE 1g/vial 10vials/box
原产地英文药品名:
CEFEPIME HYDROCHLORIDE
中文参考商品译名:
马斯平 ADD-VANTAGE 1克/瓶 10瓶/盒
中文参考药品译名:
盐酸头孢吡肟
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

责任编辑:admin


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