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的翻译结果:
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Results Cefixime had the highest absorption peak at 288 nm and a good linearity within the range of 1.5～37.5 μg/ml(A=0.7,r=0.9999).
结果头孢克肟在288 nm处有最大吸收,在1.5~37.5μg/mL范围内与吸收度呈良好的线性关系:A=0.0457ρ-0.0037,r=0.9999。
RESULTS The pharmacokinetic parameters of cefixime dispersants,capsules,tablets and reference were as follows:T_(1/2) was(5.552±0.555),(5.495±0.630),(5.480±0.673) and(5.544±0.736)
结果试验制剂头孢克肟分散片、胶囊、片剂主要药动学参数T1/2分别为(5.552±0.555)、(5.495±0.630)和(5.480±0.673)h;
The relative bioavailability of cefixime mastication tablets was F_(0-16)(98±8) % and F_(0-∞)(98±8) %.
以头孢克肟胶囊为参比 ,头孢克肟咀嚼片相对生物利用度F0
16 为 (98± 8) % ,F0
∞ 为(98± 8) %。
Result: The linear range of cefixime was 2 - 120μg·ml~(-1), the average recovery was 100.6% (n = 9), RSD = 1.4%.
结果:头孢克肟浓度在2-120μg·ml~(-1)范围内,与峰面积呈良好的线性关系,r=0．999 9; 平均回收率为100．6％(n= 9),RSD=1．4％。
Determination of the concentration of cefixime in the human plasma by HPLC
HPLC法测定人血浆中头孢克肟血药浓度
The amounts of cefixime excreted in urine within 24h was 16.6±1.9% and 17.3±2.2%(P>0.05).
24h尿药排泄总量为16.6±1.9％和17.3±2.2％(P>0.05)。 (2)进食可延缓该药的吸收速率。
The relative bioavailabllity of the tested cefixime capsule was (99.4% ± 10.0)%.
受试制剂的相对生物利用度为(99.4%±10.0)%。
Linear calibration curve for cefixime was measured over the range of 0. 1～3. 2μg/ml in plasma and 1.0～32. 0 μg/ml in urine, and the correlation coefficients were all 0. 9999. The detection limit was 0. 05μg/ml in plasma and 0. 2 μg/ml in urine.
血浆和尿样浓度分别在0.1～3.2和1.0～32μg/ml范围内呈线性相关。
The standard curves of cefixime in plasma and in BAL were linear in the range from 0.1～4.0 μg/ml ( r=0.9999)and 0. μg/ml (
=0.9998) respectively.
结果　CFX血浆浓度在 0 .1～ 4.0 μg/ml,BAL中浓度在 0 .0 12 5～ 0 .4μg/ml范围内具有良好线性关系 ;
Results A two-compartment model were used for the best fitting of concentration-time data after cefixime was orally given. The following pharmacokinetic parameters were obtained: for test and reference drugs, Cmax were 2.56 ± 0.69 and 2.32 ± 0.63 mg. L-1;
结果不同时间药物在血清中的浓度符合2室模型,计算所得的供试制剂和参比制剂之间的主要药代动力学参数如下:Cmax为2.56±0.69,2.32±0.63 mg·L-1;
Synthesis of cefixime
头孢克肟的合成
PHARMACOKINETICS OF CEFIXIME IN HEALTHEALTHY VOLUNTEERS
头孢克肟在正常人中的药物代谢动力学研究
查询“cefixime”译词为用户自定义的双语例句&&&&我想查看译文中含有：的双语例句
为了更好的帮助您理解掌握查询词或其译词在地道英语中的实际用法，我们为您准备了出自英文原文的大量英语例句，供您参考。&&&&&&&&&&&&&&&&&&&& The in-vitro antibacterial activity of cefixime, a new oral cephalos-porin was studied against 900 clinical isolates in parallel with other oral cephalspor-ins, cefaclor, cefadroxil and cephalexin. The MIC data showed that cefixime was active against streptococci, but comparatively inactive against staphylococci and ente-rococci. Cefixime was extremely active against Enterobacteriaceae with the exception of Ent. cloacae, and the MIC50 and MIC90 of most species were 0.125 and 2μg/ml respect... &&&&&&&&&&&&本文报道口服Cefixime对900株需氧菌和厌氧菌的体外抗菌作用,并与其它口服的头孢克罗、头孢羟氨苄和头孢氨苄进行了比较。Cefixime对链球菌具较强作用,但对葡萄球菌的作用较差;对肠球菌无效。对肠杆菌科细菌的抗菌活性四者之中以Cefixime最强。Cefixime对头孢氨苄耐药株仍具高度活性,其MIC均值可降低60～1200倍以上。绿脓杆菌、硝酸盐阴性杆菌、鲁氏不动杆菌和产碱杆菌对Cefixime和其它3种头孢菌素的敏感性均较差。四者对厌氧菌的作用除厌氧球菌外其抗菌活性都很弱。Cefixime对β-内酰胺酶稳定,口服吸收良好,抗菌作用强,是一个值得进行临床研究的口服头孢菌素。&&&&&&&& Tie antibacterial activities of 18 antimicrobial agents against anaerobes were determined. Our study showed that the first, second and third generations of cefaiosporins, josamycin and erythromycin possess good activities against all the anaerobes except Bacteroids. Therefore these agents can be used in infections caused by the sensitive anaerobes. Oral preparations of the previous agents such as cefalexin, cetradine, cefixime, josamycin and erythromycin are especially preferable for outpatients. Amon... &&&&&&&&&&&&比较十八种抗菌药物对厌氧菌的体外抗菌活性,结果表明:实验选择的一、二、三代头孢菌素、交沙霉素及红霉素对类杆菌以外的厌氧菌具良好的抗菌作用,可用于治疗这些细菌引起的厌氧菌感染。此类药物中的口服制剂头孢氨苄、头孢拉定、头孢克肟、交沙霉素及红霉素更适用于一般门诊病人。 氟喹诺酮类抗菌药物中,氟嗪酸和丙氟哌酸稍优于其他品种,对50％左右的厌氧消化球菌及丙酸杆菌有一定的抗菌活性,其他品种则较差,仅对部分梭形杆菌有抗菌活性。 脆弱类杆菌对许多常用抗菌药物耐药,因此,甲硝哒唑仍应作为治疗脆弱类杆菌感染的首选药物,氯林可霉素及氯霉素作为替代选用药物。&&&&&&&& A double column and double pump HPLC switching system is described for the analysis of cefixime in human plasma and urine. The system used μBondapak C_(18) short pretreatment column for on--line sample clean--up and a Hitachi GEL 3056 (ODS) analytical column for separation. A mixed solution of 0. 01 mol/L H_3PO_4--0. 1 mol/L KH_2PO_4--H_2O (20:1:79) was used as the pretreatment mobile phase and CH_2CH--0.01 mol/L H_3PO_4--0. 1 mol/L KH_2PO_4--H_2O (13:20:1:66) was used as analytical mobile phase. The ... &&&&&&&&&&&&用双泵HPLC柱切换系统直接进样测定血浆和尿样中头孢克肟(cefixime,CFIX)的浓度。血浆和尿样的回收率分别为99.1%和98.6%;最低检测浓度分别为0.05和0.2μg/日内和日间的RSD小于5%;血浆和尿样浓度分别在0.1～3.2和1.0～32μg/ml范围内呈线性相关。此方法集样品净化、富集成分和色谱分析一次连续进行,操作简便、快速,可以进较大的样品量,灵敏度相对明显提高。&nbsp&&&&&&&&相关查询:
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2008 CNKI－中国知网
北京市公安局海淀分局 备案号：110 1081725
&2008中国知网(cnki) 中国学术期刊(光盘版)电子杂志社Cefixime Monograph for Professionals -
Class: Third Generation Cephalosporins
Chemical Name: [6R - [6&,7&(Z)]] - 7 - [[(2 - Amino - 4 - thiazoyl)[(carboxymethoxy)imino]acetyl]amino] - 3 - ethenyl - 8 - oxo - 5 - thia - 1 - azabicyclo[4.2.0]oct - 2 - ene - 2 - carboxylic acid
CAS Number:
Brands: Suprax
Introduction
A &- third generation cephalosporin.
Uses for Cefixime
Acute Otitis Media (AOM)
Treatment of AOM
caused by Haemophilus influenzae,
Moraxella catarrhalis,
or Streptococcus pyogenes (group A &-hemolytic streptococci).
When anti-infectives indicated, AAP recommends high-dose amoxicillin or amoxicillin and clavulanate as drugs of choice for initial treatment of AOM; certain cephalosporins (cefdinir, cefpodoxime, cefuroxime, ceftriaxone) recommended as alternatives for initial treatment in penicillin-allergic patients without a history of severe and/or recent penicillin-allergic reactions.
Pharyngitis and Tonsillitis
Treatment of pharyngitis and tonsillitis caused by susceptible S. pyogenes (group A &-hemolytic streptococci).
Generally effective in eradicating S. pyogenes efficacy in prevention of subsequent rheumatic fever not established to date.
AAP, IDSA, AHA, and others recommend a penicillin regimen (10 days of oral penicillin V or oral amoxicillin or single dose of IM penicillin G benzathine) as treatment of choice for S. pyogenes pharyng
other anti-infectives (oral cephalosporins, oral macrolides, oral clindamycin) recommended as alternatives in penicillin-allergic patients.
If an oral cephalosporin used, 10-day regimen of first generation cephalosporin (cefadroxil, cephalexin) preferred instead of other cephalosporins with broader spectrums of activity (e.g., cefaclor, cefdinir, cefixime, cefpodoxime, cefuroxime).
Respiratory Tract Infections
Treatment of acute exacerbations of chronic bronchitis caused by S. pneumoniae,
H. influenzae,
or M. catarrhalis.
Slideshow: Amoxicillin: 13 Burning Questions
Treatment of mild to moderate community-acquired pneumonia (CAP) caused by S. pneumoniae,
H. influenzae,
M. catarrhalis,
Escherichia coli, H. parahaemolyticus, or H. parainfluenzae.
Treatment of mild to moderate sinusitis caused by S. pneumoniae,
H. influenzae,
M. catarrhalis,
E. coli, H. parahaemolyticus, or H. parainfluenzae.
Because of variable activity against S. pneumoniae and H. influenzae, IDSA no longer recommends second or third generation oral cephalosporins for empiric monotherapy of acute bacterial sinusitis. Oral amoxicillin or amoxicillin and clavulanate usually recommended for empiric treatment.
If an oral cephalosporin used as an alternative in children (e.g., in penicillin-allergic individuals), combination regimen that includes a third generation cephalosporin (cefixime or cefpodoxime) and clindamycin (or linezolid) recommended.
Urinary Tract Infections (UTIs)
Treatment of uncomplicated UTIs
caused by susceptible E. coli
or Proteus mirabilis;
also has been used for treatment of uncomplicated UTIs caused by susceptible Citrobacter spp.,
C. diversus,
C. freundii,
Enterobacter spp.,
E. aerogenes,
E. agglomerans,
Klebsiella spp.,
K. pneumoniae,
Morganella morganii, Proteus spp.,
or Serratia.
Has been used for treatment of uncomplicated UTIs
caused by susceptible gram-positive bacteria, including Staphylococcus epidermidis, Staphylococcus spp.,
Streptococcus agalactiae,
nonhemolytic streptococci,
or Enterococcus faecalis.
Consider that treatment failures have been reported and gram-positive bacteria (e.g., staphylococci, S. agalactiae, enterococci) have been isolated in urine during or after cefixime treatment and usually are resistant to cefixime.
Treatment of pyelonephritis and other complicated UTIs
caused by susceptible Enterobacteriaceae, including E. coli.
Gonorrhea and Associated Infections
Treatment of uncomplicated urethral, endocervical, or rectal infections caused by susceptible Neisseria gonorrhoeae.
Because of concerns related to recent reports of N. gonorrhoeae with reduced susceptibility to cephalosporins, CDC states that oral cephalosporins no longer recommended as first-line treatment for uncomplicated gonorrhea. For treatment of uncomplicated urogenital, anorectal, or pharyngeal gonorrhea, CDC recommends a combination regimen that includes a single dose of IM ceftriaxone and either a single dose of oral azithromycin or 7-day regimen of oral doxycycline.
Cefixime recommended by CDC as an alternative in patients with urogenital or rectal gonorrhea when ceftriaxone cannot be u used in conjunction with single dose of oral azithromycin or 7-day regimen of oral doxycycline.
Consider that N. gonorrhoeae with reduced susceptibility to cefixime, including some treatment failures, reported in US and other countries.
Perform test-of-cure follow-up (culture or nucleic acid amplification test [NAAT]) 1 week after cefixime treatment.
If infection persists (treatment failure), culture relevant clinical specimens and perform in vitro susceptibility tests. Also consult infectious disease specialist, STD/HIV Prevention Training Center (), or CDC (404-639-8659) for treatment advice and report the case to CDC through local or state health departments within 24 hours of diagnosis.
For all gonorrhea patients, ensure that their sex partners from preceding 60 days are evaluated promptly with culture and treated with a recommended regimen if indicated.
Lyme Disease
Has been used for treatment of disseminated Lyme disease. Other cephalosporins (cefotaxime, ceftriaxone, cefuroxime axetil) usually recommended by IDSA and others when a cephalosporin is used in the treatment of Lyme disease.
Salmonella and Shigella Infections
Has been used for treatment of typhoid fever (enteric fever) or septicemia caused by multidrug-resistant Salmonella typhi.
Has been used for treatment of shigellosis caused by susceptible Shigella.
Cefixime Dosage and Administration
Administration
Oral Administration
Administer orally as capsules, conventional tablets, chewable tablets, or oral suspension.
Capsules and conventional tablets: Administer without regard to meals. (See Food under Pharmacokinetics.)
Chewable tablets: Must be chewed or crushed before swallowing.
Reconstitution
Reconstitute oral suspension at the time of dispensing by adding amount of water specified on the container in 2 shake after each addition. The reconstituted suspension contains 100, 200, or 500 mg/5 mL.
Shake oral suspension well just prior to administration of each dose.
Available as dosage expressed in terms of cefixime.
Capsules containing 400 mg of cefixime are bioequivalent to conventional 400-mg tablets when administered under fasting conditions.
Chewable tablets are bioequivalent to oral suspension.
Conventional tablets and oral suspension are not bioequivalent (see Absorption under Pharmacokinetics).
Pediatric Patients
General Pediatric Dosage
Children beyond neonatal period: AAP recommends 8 mg/kg daily in 1 or 2 equally divided doses for treatment of mild or moderate infections. AAP states the drug is inappropriate for treatment of severe infections.
Children weighing 5&7.5 kg: Oral suspension containing 100 mg/5 mL is preferred preparation.
Children weighing 7.6&10 kg: Oral suspension containing 100 or 200 mg/5 mL is preferred preparation.
Children weighing &10 kg: Chewable tablets not recommended.
Acute Otitis Media (AOM)
Children 6 months to 12 years of age: 8 mg/kg once daily or 4 mg/kg every 12 hours for 10&14 days.
Children &12 years of age or weighing &45 kg: 400 mg daily for 10&14 days.
Do not use capsules or conventional tablets for treatment of AOM.
Pharyngitis and Tonsillitis
Children 6 months to 12 years of age: 8 mg/kg once daily or 4 mg/kg every 12 hours for &10 days.
Children &12 years of age or weighing &45 kg: 400 mg once daily or 200 mg every 12 hours for &10 days.
Respiratory Tract Infections
Acute Exacerbations of Chronic Bronchitis
Children 6 months to 12 years of age: 8 mg/kg once daily or 4 mg/kg every 12 hours for 10&14 days.
Children &12 years of age or weighing &45 kg: 400 mg once daily or 200 mg every 12 hours for 10&14 days.
Empiric Treatment of Acute Bacterial Sinusitis
8 mg/kg daily in 2 equally divided doses for 10&14 days.
Urinary Tract Infections (UTIs)
Uncomplicated UTIs
Children 6 months to 12 years of age: 8 mg/kg once daily or 4 mg/kg every 12 hours for 5&10 days.
Children &12 years of age or weighing &45 kg: 400 mg once daily or 200 mg every 12 hours for 5&10 days.
Gonorrhea and Associated Infections
Uncomplicated Urethral, Endocervical, or Rectal Gonorrhea
Prepubertal children weighing &45 kg: 8 mg/kg (up to 400 mg) as a single dose.
Children &8 years of age or weighing &45 kg: 400 mg as a single dose.
Use in conjunction with single dose of oral azithromycin or 7-day regimen of oral doxycycline.
Not recommended by CDC as first-line treatment. (See Gonorrhea and Associated Infections under Uses.)
Salmonella and Shigella Infections
Typhoid Fever
Children 6 months to 16 years of age: 5&10 mg/kg twice daily.
Usually given for 14
high rate of treatment failure occurred when given for only 7 days.
Shigellosis
8 mg/kg daily for 5 days.
Acute Otitis Media (AOM)
400 mg once daily or 200 mg every 12 hours for 10&14 days.
Do not use capsules or conventional tablets for treatment of AOM.
Pharyngitis and Tonsillitis
400 mg once daily or 200 mg every 12 hours for &10 days.
Respiratory Tract Infections
Acute Exacerbations of Chronic Bronchitis
400 mg once daily or 200 mg every 12 hours for 10&14 days.
Urinary Tract Infections (UTIs)
Uncomplicated UTIs
400 mg once daily or 200 mg every 12 hours for 5&10 days.
Gonorrhea and Associated Infections
Uncomplicated Urethral, Endocervical, or Rectal Gonorrhea
400 mg as a single dose.
Single 800-mg dose also has been used.
Use in conjunction with oral azithromycin (single 1-g dose) or oral doxycycline (100 mg twice daily for 7 days). Not recommended by CDC as first-line treatment. (See Gonorrhea and Associated Infections under Uses.)
Lyme Disease
200 mg daily for 100 days (administered with oral probenecid).
Special Populations
Renal Impairment
Dosage adjustments necessary in patients with Clcr &60 mL/minute.
Adults with Clcr 21&59 mL/minute: 260 mg daily as oral suspension, preferably as oral suspension containing 200 or 500 mg/5 mL; conventional tablets and chewable tablets not recommended.
Adults with Clcr &20 mL/minute: 200 mg daily as conventional tablets or chewable tablets, 172 mg daily as oral suspension containing 100 mg/5 mL, 176 mg daily as oral suspension containing 200 mg/5 mL, or 180 mg daily as oral suspension containing 500 mg/5 mL.
Adults undergoing hemodialysis: 260 mg daily as oral suspension, preferably as oral suspension containing 200 or 500 mg/5 mL; conventional tablets and chewable tablets not recommended.
Adults undergoing continuous peritoneal dialysis: 200 mg daily as conventional tablets or chewable tablets, 172 mg daily as oral suspension containing 100 mg/5 mL, 176 mg daily as oral suspension containing 200 mg/5 mL, or 180 mg daily as oral suspension containing 500 mg/5 mL.
Geriatric Patients
No dosage adjustments except those related to renal impairment.
(See Renal Impairment under Dosage and Administration.)
Cautions for Cefixime
Contraindications
Known hypersensitivity to cefixime or other cephalosporins.
Warnings/Precautions
Superinfection/Clostridium difficile-associated Diarrhea and Colitis
Possible emergence and overgrowth of nonsusceptible bacteria or fungi, especially Enterobacter, Pseudomonas, enterococci, staphylococci, or Candida.
Careful observation of the patient is essential. Institute appropriate therapy if superinfection occurs.
Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.
C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including cefixime, and may range in severity from mild diarrhea to fatal colitis.
C. difficile produces toxins A and B which contribute to development of CDAD;
hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.
Consider CDAD if diarrhea develops during or after therapy and manage accordingly.
Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.
If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.
Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.
Sensitivity Reactions
Hypersensitivity Reactions
Hypersensitivity reactions such as anaphylaxis (including shock and fatalities), angioedema, serum sickness-like reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.
If an allergic reaction occurs, discontinue cefixime and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).
Cross-hypersensitivity
Partial cross-allergenicity among cephalosporins and other &-lactam antibiotics, including penicillins and cephamycins.
Use caution.
Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. Cefixime is contraindicated in individuals hypersensitive to cephalosporins. Avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.
General Precautions
Selection and Use of Anti-infectives
To reduce development of drug-resistant bacteria and maintain effectiveness of cefixime and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.
When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.
Phenylketonuria
Chewable tablets containing 100, 150, and 200 mg of cefixime contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 3.3, 5, and 6.7 mg of phenylalanine, respectively.
Coombs& Test Results
Positive direct Coombs& test results reported with cephalosporins.
This may interfere with certain hematologic studies or transfusion cross-matching procedures.
Decreased Prothrombin Activity
Prolonged PT
and prolonged partial thromboplastin time
reported rarely.
Patients with renal or hepatic impairment, poor nutritional status, prolonged anti-infective therapy, and previous anticoagulant therapy (stabilized) appear to be at risk. Monitor PT in such patients and administer exogenous vitamin K as indicated.
Specific Populations
Category B.
Distribut not known whether distributed into milk in humans. Discontinue nursing or the drug.
Pediatric Use
Safety and efficacy not established in children &6 months of age. Frequency of adverse GI effects (e.g., diarrhea, loose stools) similar to that in adults.
Geriatric Use
Insufficient experience in patients &65 years of age to determine whether geriatric patients respond differently than younger adults.
Possible increased
not considered clinically important.
Consider age-related decreases in renal function when selecting dosage and adjust dosage if necessary.
(See Renal Impairment under Dosage and Administration.)
Renal Impairment
Increased serum half-life.
Dosage adjustments necessary if Clcr &60 mL/minute.
(See Renal Impairment under Dosage and Administration.)
Common Adverse Effects
GI effects (diarrhea,
loose or frequent stools, abdominal pain,
dyspepsia,
flatulence).
Interactions for Cefixime
Specific Drugs and Laboratory Tests
Drug or Test
Interaction
Antacids (aluminum- or magnesium-containing)
No clinically important effect on cefixime pharmacokinetics
Anticoagulants, oral (warfarin)
Possible increased PT (with or without bleeding)
Carbamazepine
Increased carbamazepine concentrations
Monitor carbamazepine concentrations
Nifedipine
Possible increased plasma concentrations and AUC of cefixime
Probenecid
Increased cefixime plasma concentrations and AUC
Salicylates
Possible decreased plasma concentrations and AUC of cefixime
Clinical importance unclear
Tests for glucose
Possible false-positive reactions in urine glucose tests using Clinitest, Benedict&s solution, or Fehling&s solution
Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)
Tests for ketones
Possible false-positive reaction for ketones in urine if nitr not reported with tests using nitroferricyanide
Cefixime Pharmacokinetics
Absorption
Bioavailability
30&50% of a singl
peak serum concentrations attained within 2&6 hours.
Capsules containing 400 mg of cefixime are bioequivalent to conventional tablets containing 400 mg of the drug when administered under fasting conditions.
Chewable tablets are bioequivalent to the oral suspension.
Conventional tablets and oral suspension a studies in adults indicate oral suspension results in peak serum concentrations 25&50% higher than concentrations attained with tablets.
Conventional tablets and oral suspension: Food decreases rate but not extent of absorption.
Capsules: Food decreases absorption by about 15% (based on AUC) or 25% (based on peak serum concentrations).
Distribution
Distributed into bile,
tonsils, maxillary sinus mucosa, middle ear discharge, blister fluid,
and prostatic fluid.
Distribution into CSF unknown.
Crosses the placenta.
Not detected in human milk following a single 100-mg oral dose.
Plasma Protein Binding
Elimination
Metabolism
Does not appe no biologically active metabolites detected in serum or urine.
Elimination Route
Eliminated by renal and nonrenal mechanisms.
7&50% of a dose excreted unchanged in urine within 24 hours.
In animal studies, &10% of a dose may be excreted unchanged in bile.
Not substantially removed by hemodialysis or peritoneal dialysis.
Adults with normal renal function: 2.4&4 hours.
Special Populations
Adults with moderate renal impairment (Clcr 20&40 mL/minute): Serum half-life averages 6.4 hours.
Adults with severe renal impairment (Clcr 5&20 mL/minute): Serum half-life averages 11.5 hours.
Capsules, Conventional Tablets, Chewable Tablets
For Suspension
20&25&C. After reconstitution, store suspension in tight container at room temperature or discard after 14 days.
Actions and Spectrum
Based on spectrum of activity, classified as a third generation cephalosporin.
Expanded spectrum of activity against gram-negative bacteria compared with first and second gener
less active against Enterobacteriaceae than some other third-generation cephalosporins.
Usually bactericidal.
Like other &-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.
Spectrum of activity includes many gram-positive and gram-negat inactive against most anaerobic bacteria.
Inactive against chlamydia, fungi, and viruses.
Gram-positive aerobes: Active in vitro against Streptococcus pneumoniae and Streptococcus pyogenes (group A &-hemolytic streptococci).
Also active in vitro against S. agalactiae (group B streptococci)
and groups C, F, and G streptococci.
Most staphylococci, enterococci, and Listeria monocytogenes are resistant.
Strains of staphylococci resistant to penicillinase-resistant penicillins (methicillin-resistant [oxacillin-resistant] staphylococci) should be considered resistant to cefixime, although results of in vitro susceptibility tests may indicate susceptibility.
Gram-negative aerobes: Active in vitro against Neisseria gonorrhoeae,
Haemophilus influenzae (including &-lactamase-producing strains),
Moraxella catarrhalis (including &-lactamase-producing strains),
Escherichia coli, and Proteus mirabilis.
Also active in vitro against H. parainfluenzae,
Klebsiella, Pasteurella multocida, P. vulgaris, Providencia, Salmonella, Shigella, and Serratia. Most Enterobacter
and Pseudomonas are resistant.
Advice to Patients
Advise patients that antibacterials (including cefixime) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).
Importance of completing full course of therapy, even if feeling better after a few days.
Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefixime or other antibacterials in the future.
Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.
Importance of discontinuing cefixime and informing clinician if an allergic reaction occurs.
Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects consult specific product labeling for details.
Cefixime (Trihydrate)
Dosage Forms
Brand Names
Manufacturer
400 mg (of cefixime)
For suspension
100 mg (of cefixime) per 5 mL
200 mg (of cefixime) per 5 mL
500 mg (of cefixime) per 5 mL
Tablets, chewable
100 mg (of cefixime)
150 mg (of cefixime)
200 mg (of cefixime)
Tablets, film-coated
400 mg (of cefixime)
Suprax (scored)
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Suprax 100MG/5ML Suspension (LUPIN PHARMACEUTICALS): 100/$293.93 or 300/$850.38
AHFS DI Essentials. & Copyright, , Selected Revisions October 1, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
& Use is not currently included in the labeling approved by the US Food and Drug Administration.
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