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At least 19 recordsLinked to original sources

PubMed1991

[Pharmacokinetic and clinical studies of cefdinir in the pediatric field. Pediatric Study Group of Cefdinir].

We studied pharmacokinetics and clinical effects of 5% and 10% fine granules of cefdinir (FK 482, CFDN), a new oral cephalosporin, in the pediatric field and the following results were obtained. 1. Pharmacokinetics (blood concentration and urinary excretion) Pharmacokinetics of CFDN in 163 children was investigated. Cmax and T 1/2 were 0.92 +/- 0.45 micrograms/ml and 1.95 +/- 1.06 hours, respectively, in the fasting state, and were 0.63 +/- 0.29 micrograms/ml and 2.26 +/- 0.65 hours, respectively, in the non-fasting state, at a dose level of 3 mg (potency)/kg. At a dose level of 6 mg (potency)/kg, Cmax and T 1/2 were 1.29 +/- 0.49 micrograms/ml and 2.11 +/- 1.85 hours, respectively, in the fasting state and were 1.28 +/- 0.48 micrograms/ml and 2.01 +/- 0.84 hours, respectively, in the non-fasting state. Data of Cmax and AUC showed that blood concentration of the drug depended on dose levels. Urinary recovery rates in the first 8 hours were 20.5 +/- 8.8% in the fasting state and 14.8 +/- 5.9% in the non-fasting at a dose level of 3 mg (potency)/kg and 16.5 +/- 6.7% and 17.8 +/- 2.4%, respectively, at 6 mg (potency)/kg. 2. Clinical effects Clinical effects of CFDN on various infections were studied in 612 children who were treated with 5% fine granules of CFDN (5% granule group) and in 208 with 10% fine granules of CFDN (10% granule group). CFDN granules were administered mainly at daily doses of 9.0-18.0 mg (potency)/kg in 3 divided portions. Clinical efficacy rates in 428 children of the 5% granule group and in 159 of the 10% granule group from whom causative bacteria were isolated, were 94.9% and 96.2%, respectively. The clinical efficacy rates for patients who were responsive to previous antibiotic therapy were 91.2% in the 5% granule group and 100% in the 10% granule group. Bacteriological eradication rate was 82.1% for 491 strains in the 5% granule group, and was 84.0% for 175 strains in the 10% granule group. The incidences of side effects were 3.9% (24/608) in the 5% fine granule group and 5.8% (12/206) in the 10% granule group. All of the side effects were slight gastrointestinal disorders, and no serious side effects were found. As for clinical laboratory test results, slight elevations of eosinophile, platelet or transaminase were observed. Based on the above results, it is considered that the appropriate dose levels of CFDN for pediatric infections ranged from 9.0 to 18.0 mg (potency)/kg a day, divided into 3 portions.

Administration, Oral↗

PubMedDate not supplied

Antibacterial activity of cefpodoxime in comparison with cefixime, cefdinir, cefetamet, ceftibuten, loracarbef, cefprozil, BAY 3522, cefuroxime, cefaclor and cefadroxil.

The new oral cephalosporins cefpodoxime, cefixime, cefdinir, cefetamet and ceftibuten demonstrate enhanced activity against Enterobacteriaceae susceptible to the established compounds as well (e.g. cefuroxime, cefaclor, cefadroxil). In addition, cefpodoxime, cefixime, cefdinir, cefetamet and ceftibuten include in their spectrum species hitherto resistant to oral cephalosporins (Proteus vulgaris, Providencia spp., Yersinia enterocolitica). Besides, the majority of these compounds demonstrate relevant activity (MIC50 equal to or below 2 mg/l) against Enterobacter spp., Citrobacter freundii, Serratia spp. and Morganella morganii. Ceftibuten is the most potent oral cephalosporin against most of the Enterobacteriaceae. Non-fermentative bacilli (Acinetobacter spp., Pseudomonas spp.) remain completely resistant to oral cephalosporins (except some Acinetobacter species against cefdinir and Pseudomonas cepacia against ceftibuten). Antistaphylococcal activity for oral cephalosporins is highest for cefdinir followed by BAY 3522, cefprozil, cefuroxime and cefpodoxime. Loracarbef, cefaclor and cefadroxil are about equally active, while the other compounds are only weakly active (cefixime) or inactive (cefetamet, ceftibuten). Enterococci are insensitive to new generation oral cephalosporins as they have been to established compounds. The most active oral cephalosporins against hemolytic streptococci are cefdinir and cefprozil. Streptococcus pneumoniae, Streptococcus milleri and Streptococcus mitior are most susceptible to cefpodoxime, cefdinir, cefuroxime and BAY 3522. Penicillin resistant pneumococci have to be regarded as resistant to all oral cephalosporins. Fastidious pathogens like Haemophilus spp., Moraxella catarrhalis and Neisseria gonorrhoeae are more susceptible to cefpodoxime, cefixime, cefdinir, cefetamet and ceftibuten than to the other oral cephalosporins. The activity of oral cephalosporins is only weak against Listeria spp., Helicobacter pylori and anaerobic pathogens (except BAY 3522). Bordetella pertussis remains resistant to all absorbable cephalosporins. Progress in antibacterial activity of oral cephalosporins was mainly achieved by cefpodoxime, cefixime, cefdinir, cefetamet and ceftibuten against Enterobacteriaceae and the fastidious pathogens and against staphylococci and the nonenterococcal streptococci by cefdinir, BAY 3522, cefprozil and cefpodoxime.

Bacteria↗

PubMedDate not supplied

In vitro activity evaluations of cefdinir (FK482, CI-983, and PD134393). A novel orally administered cephalosporin.

Cefdinir, a so-called third-generation oral cephalosporin was tested in vitro against over 700 pathogens from patients with bacteremia. Cefdinir was very active against the Enterobacteriaceae with a 50% minimum inhibitory concentration (MIC50) value range of less than or equal to 0.03-8 micrograms/ml. The enteric species having the highest MIC90S (greater than or equal to 16 micrograms/ml) were Citrobacter freundii, and the enterobacters, Morganella morganii, Proteus vulgaris, and Serratia marcescens. Cefdinir was generally two- to fourfold less active than cefixime, but markedly more potent with a wider spectrum compared with older oral cephalosporins, cefaclor or cefuroxime. In contrast to cefixime, cefdinir inhibited Staphylococcus aureus (MIC90, 1 micrograms/ml) and other staphylococci. Pneumococci, beta-hemolytic streptococci, Haemophilus influenzae, Moraxella catarrhalis, and pathogenic Neisseria spp. (MIC90S, 0.12-0.5 micrograms/ml) were cefdinir susceptible, but Pseudomonas aeruginosa, oxacillin-resistant staphylococci and Bacteroides fragilis gr. strains were resistant. Cefdinir was generally bactericidal with a minimal inoculum effect at 10(6) colony-forming units per spot. Cefdinir beta-lactamase hydrolysis by some recently described extended broad spectrum beta-lactamases was suspected. Cefdinir exhibited a wide, balanced spectrum for an oral cephalosporin indicating possible clinical use against susceptible pathogens in respiratory tract, urinary tract, genital and cutaneous infections.

Cefdinir↗

PubMed1992

The sensitivity of clinical bacteria isolated in Scotland to the oral cephalosporin, cefdinir.

The minimum inhibitory concentration (MIC) of cefdinir (CI-983, FK-482), cephalexin cefuroxime, cefixime and ceftazidime were determined against clinical isolates. Cefdinir was as effective as cefixime against Haemophilus and Moraxella (Branhamella) strains and both were more effective than cefuroxime. Against streptococci, cefdinir was much more effective than cefixime and had similar efficacy to cefuroxime. Against staphylococci, cefdinir had the lowest MIC50 of all of the drugs tested. The efficacy of these antibiotics was tested against Escherichia coli K12 strains harbouring 16 of the new extended-spectrum plasmid-mediated beta-lactamases, and cefdinir was more effective than ampicillin, cephalexin, cefuroxime, ceftazidime and aztreonam.

Administration, Oral↗

PubMed1992

Comparative in vitro activity of cefdinir (CI-983; FK-482) against staphylococci, gram-negative bacilli and respiratory tract pathogens.

The in vitro activity of cefdinir (CI-983; FK-482), a new oral cephalosporin, was compared with that of other antimicrobial agents against clinical isolates of staphylococci, gram-negative bacilli and common respiratory tract pathogens. Cefdinir (MIC90 less than or equal to 2.0 micrograms/ml) was more active than cefixime (MIC90 greater than 64 micrograms/ml) and equally as active as cefuroxime (MIC90 2.0 micrograms/ml) against oxacillin-susceptible staphylococci. Cefdinir was active against Haemophilus influenzae, including beta-lactamase producers (MIC90 0.5 microgram/ml), Moraxella catarrhalis (MIC90 less than or equal to 0.12 microgram/ml), Streptococcus pneumoniae (MIC90 less than or equal to 0.06 microgram/ml) and Streptococcus pyogenes (MIC90 less than or equal to 0.06 microgram/ml). The activity of cefdinir against gram-negative bacilli was variable; organisms with chromosomal cephalosporinases were often resistant.

Bacteria↗

PubMedDate not supplied

Susceptibility testing interpretive criteria and drug stability for cefdinir, cefetamet, and cefpodoxime against Neisseria gonorrhoeae.

Cefdinir, cefetamet, and cefpodoxime, three orally administered cephalosporins, were tested against 100 strains of Neisseria gonorrhoeae having various antimicrobial susceptibility patterns. Triplicate testing of each organism strain was performed for all agar dilution and disk diffusion tests. Cefdinir was the most active compound (MIC90) micrograms/ml) especially against gonococci with chromosomal-mediated resistance to penicillin. The recommended susceptible interpretive criteria were as follows: for the 5-micrograms cefdinir disk, > or = 31 mm (MIC correlate, < or = 0.25 microgram/ml); for the 10-micrograms cefetament disk, > or = 29 mm (MIC correlate, < or = 0.5 microgram/ml; for the 30-micrograms cefetamet disk, > or = 31 mm (MIC correlate, < or = 0.5 microgram/ml); and for the 10-micrograms cefpodoxime disk, > or = 29 mm (MIC correlate, < or = 0.5 microgram/ml). No organisms resistant to these new cephalosporins were detected. Cefdinir, cefetamet, and defpodoxime were stable in GC agar medium for at least 21 days when stored at 2 degrees-5 degrees C.

Cefdinir↗

PubMed1992

Cefdinir (FK482), an orally administered cephalosporin in vitro activity comparison against recent clinical isolates from five medical centers and determination of MIC quality control guidelines.

Cefdinir, a new oral cephalosporin, was compared to cefaclor, cefadroxil, cefixime, and cefuroxime against greater than 5000 recent aerobic clinical isolates. This multicenter study revealed broad-spectrum cefdinir activity against all Enterobacteriaceae (MIC50s, 0.06-2 micrograms/ml) except Enterobacter cloacae, Morganella morganii, Proteus vulgaris, and Serratia marcescens (MIC50s, greater than or equal to 4 micrograms/ml). Oxacillin-susceptible staphylococci (MIC90s, 0.5-2 micrograms/ml), beta-hemolytic Streptococcus group B (MIC90, 0.06 micrograms/ml), and Acinetobacter lwoffii were also susceptible to cefdinir. The activity of cefdinir was similar to that of cefixime and cefuroxime against Gram-negative organisms and superior to all tested oral cephems when tested against Gram-positive cocci. None of the cephalosporins were active against oxacillin-resistant Staphylococcus spp., enterococci, Pseudomonas spp., or Xanthomonas maltophilia. MIC quality control range guidelines were established for the strains recommended by the National Committee for Clinical Laboratory Standards documents.

Anti-Bacterial Agents↗

PubMed1991

The in-vitro activity of cefdinir (FK482), a new oral cephalosporin.

The in-vitro activity of cefdinir (FK482), an orally absorbed aminothiazolyl cephalosporin, was compared with that of cefuroxime, cefixime, cephalexin, cefaclor and co-amoxiclav. Cefdinir was highly active against Staphylococcus aureus, inhibiting 90% of strains at 0.03 mg/L. The respiratory pathogens Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis were also susceptible (MIC90 less than or equal to 1 mg/L). The common members of the Enterobacteriaceae were susceptible (MIC90 less than or equal to 1 mg/L), but those possessing chromosomal beta-lactamases were more resistant. Cefdinir appeared highly stable to the TEM-1 and SHV-1 beta-lactamases with only relatively minor degrees of hydrolysis being seen with TEM-3, -5 and -9.

Bacteria↗

PubMed1992

Comparative kill and growth rates determined with cefdinir and cefaclor and with Streptococcus pneumoniae and beta-lactamase-producing Haemophilus influenzae.

The relationship between the growth rate and the kill rate was used to evaluate and to compare the in vitro bactericidal activities of cefdinir, a new oral cephalosporin, and cefaclor against Streptococcus pneumoniae and beta-lactamase-producing strains of Haemophilus influenzae. These frequently encountered pathogens of community-acquired respiratory tract infections are usually susceptible to both drugs. The MIC ranges for cefdinir and cefaclor were, respectively, 0.03 to 0.06 and 0.25 to 0.5 micrograms/ml for S. pneumoniae and 0.25 and 4 to 8 micrograms/ml for H. influenzae. The colony counts (CFU per milliliter) measured after 6 h of exposure to a range of antibiotic concentrations in broth were plotted against the colony count of the control culture over the same period of time. Higher kill rates versus bacterial growth rates were noted for S. pneumoniae for both drugs (positive balance). Conversely, lower kill rates versus growth rates were noted for H. influenzae for both drugs (negative balance). In conclusion, the bactericidal activities of both drugs against S. pneumoniae and H. influenzae were similar when expressed by the relationship between the growth rate and the kill rate at 6 h, but cefdinir was more active at lower concentrations.

Cefaclor↗

PubMedDate not supplied

Antimicrobial activity of three investigational oral cephalosporins (BK-218, cefdinir, and RU29246) against Legionella.

Three new, orally administered cephalosporins (BK-218, cefdinir, RU29246) were tested against 13 representative strains of Legionella. Cefdinir was most active [50% minimum inhibitory concentration (MIC50), 1 micrograms/ml], a potency comparable to the reference drug cefixime and eightfold less active than erythromycin. BK-218 was the least active cephalosporin (MIC50, 8 micrograms/ml) or 100-fold less potent than rifampin. These investigational cephems appear poorly suited by activity assays for Legionellosis therapy.

Anti-Bacterial Agents↗

PubMedDate not supplied

Haemophilus test medium interpretive criteria for disk diffusion susceptibility tests with cefdinir, cefetamet, cefmetazole, cefpodoxime, cefdaloxime (RU29246, HR-916 metabolite), and trospectomycin.

The disk diffusion zones and the MICs of six newer antimicrobials with significant activity against Haemophilus influenzae were compared using the Haemophilus test medium (HTM) and National Committee for Clinical Laboratory Standards methods. The rank order of potency was cefpodoxime (MIC50, < or = 0.03 micrograms/ml) > cefetamet > cefdinir > cefdaloxime = trospectomycin > cefmetazole (MIC50, 2 micrograms/ml). Susceptible breakpoint interpretive criteria for HTM tests were established that conformed to prior recommendations for each drug when tested against other species. Absolute agreement between methods ranged from 89% to 100% with < or = 1% false-susceptible interpretive errors. The recommended, tentative disk diffusion susceptible interpretive criteria were for 5-micrograms cefdinir disks > or = 20 mm (MIC correlate, < or = 1 micrograms/ml); for 10-micrograms cefetamet disks > or = 18 mm (MIC correlate, < or = 4 micrograms/ml); for 30-micrograms cefetamet disks > or = 21 mm (MIC correlate, < or = 4 micrograms/ml); for 30-micrograms cefmetazole disks > or = 16 mm (MIC correlate, < or = 16 micrograms/ml); for 10-micrograms cefpodoxime disks > or = 21 mm (MIC correlate, < or = 2 micrograms/ml); for 30-micrograms cefdaloxime disks > or = 23 mm (MIC correlate, < or = 2 micrograms/ml) and for 30-micrograms trospectomycin disks > or = 17 mm (MIC correlate, < or = 16 micrograms/ml). beta-Lactamase-negative, ampicillin-resistant (BLNAR) H. influenzae isolates consistently had the highest MICs for each cephalosporin tested.(ABSTRACT TRUNCATED AT 250 WORDS)

Ampicillin Resistance↗

PubMed1992

Interpretive criteria for disk diffusion tests using 5-microgram cefdinir disks with rapidly growing clinical isolates.

Preliminary interpretive zone diameter criteria were calculated for the 5-micrograms cefdinir disk diffusion test by using two potential MIC breakpoints (less than or equal to 0.5 and less than or equal to 1 micrograms/ml). The absolute agreement between tests ranged from 85.9 to 92.4%, and the false-susceptibility errors were principally contributed by the Enterobacter spp. (2.2% error). One proposed criterion was greater than or equal to 20-mm zone diameter (less than or equal to 1 micrograms/ml) for susceptibility and less than or equal to 16-mm zone diameter (greater than 2 micrograms/ml) for resistance to cefdinir. Clinical laboratory users of the disk diffusion method should be cautioned about the possibility of very major interpretive errors among enterobacter isolates.

Cefdinir↗

PubMed1990

[Clinical investigation of cefdinir in the pediatric field].

We performed pharmacokinetic, bacteriological and clinical studies on cefdinir granules (CFDN, FK482), and obtained the results summarized below. 1. Serum levels of CFDN when granular form was given in a single dose of 6 mg/kg before meal peaked at 0.81 micrograms/ml 6 hours after dosing. The serum half-life of the drug was 2.45 hours. 2. CFDN was administered to 18 patients with bacterial infections which consisted mainly of respiratory tract infections in doses of 1.3-7.4 mg/kg three times daily for 3-9 days. Clinical efficacies were "excellent" in 10 patients, "good" in 7, and "poor" in one, with an overall efficacy rate of 94.4%. 3. As for bacteriological effects on 20 strains of causative organisms, all the 10 strains of Gram-positive organisms were eradicated, with an eradication rate of 100%. Meanwhile, the eradication rate on 10 strains of Gram-negative organisms was 87.5%. Overall, bacteriological effect was "eradicated" in 17 strains, "decreased" in one, and "unknown" in 2, with an eradication rate of 94.4%. 4. No side effects nor abnormal laboratory test values were noted in any of the patients. We have concluded that cefdinir is useful in the treatment of infection in the pediatric field.

Administration, Oral↗

PubMed1992

MIC quality control guidelines for Haemophilus susceptibility tests using cefdinir (FK482), cefepime, cefetamet, cefpirome, ceftibuten, fleroxacin, temafloxacin, clarithromycin, RP59500, and trospectomycin.

A multilaboratory study was performed to establish broth microdilution MIC quality control (QC) guidelines for 10 investigational drugs which previously demonstrated significant activity against Haemophilus influenzae. MIC QC ranges for H. influenzae ATCC 49247 with Haemophilus test medium were determined by using multiple contemporary lots of Haemophilus test medium and the National Committee for Clinical Laboratory Standards' recommended numbers of replicate tests. On the basis of these results, QC ranges (generally modal MIC +/- one log2 dilution) are proposed for cefdinir, cefepime, cefetamet, cefpirome, ceftibuten, fleroxacin, temafloxacin, clarithromycin, RP59500, and trospectomycin. The proposed QC guidelines for clarithromycin and temafloxacin were recently accepted by the National Committee for Clinical Laboratory Standards.

Anti-Bacterial Agents↗

PubMed1992

Disk diffusion quality control guidelines for Haemophilus susceptibility tests using cefdinir, CI-960, fleroxacin, temafloxacin, and trospectomycin.

A multilaboratory study to determine disk diffusion quality control ranges for Haemophilus influenzae ATCC 49247 and five investigational drugs was performed. Multiple lots of Haemophilus Test Medium and antibiotic disks were used for replicate testing in conformance with the recommendations of the National Committee for Clinical Laboratory Standards. Quality control disk zone diameter ranges were proposed for cefdinir, CI-960, fleroxacin, temafloxacin, and trospectomycin.

Anti-Bacterial Agents↗

PubMed1992

MIC and disk diffusion quality control guidelines for Neisseria gonorrhoeae susceptibility tests of cefdinir, cefetamet, CI-960, fleroxacin, lomefloxacin, and temafloxacin.

Cefdinir (FK482), cefetamet (Ro 15-8074), CI-960, fleroxacin, lomefloxacin, and temafloxacin have potent activities against Neisseria gonorrhoeae. They were tested in a multilaboratory study to establish quality control guidelines. Quality control ranges for N. gonorrhoeae ATCC 49226 were determined by using multiple GC agar lots, three disk lots, and a number of test replicates consistent with the M23-T guidelines of the National Committee for Clinical Laboratory Standards. The MIC ranges included 2 to 4 log2 dilution steps. The recommended inhibition zone diameter ranges were generally 7 to 8 mm and included greater than or equal to 91.3% of all recorded study results.

Anti-Infective Agents↗

PubMed1990

[Studies on FK482 (Cefdinir). IV. Synthesis and structure-activity relationships of 7 beta-[(Z)-2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]- 3-substituted cephalosporin derivatives].

The synthesis of 7 beta-[(Z)-2-(aminothiazol-4-yl)-2-hydroxyiminoacetamido] cephalosporins (Ia-i) modified at the C-3 position of a cephem nucleus and the effect of the C-3 substituents on the antibacterial activity and oral absorbability are discussed. The cephems (Ie, h and i) having a C-3 substituent such as 1-propenyl, ethylthio and vinylthio group as well as FK482 (cefdinir) exhibited excellent antibacterial activities against both gram-positive and gram-negative bacteria. However, those compounds showed poor absorption rate after oral administration in rats. It is concluded that the vinyl moiety at the 3-position is necessary to display fairly oral absorptivity in a series of 7 beta-[(Z)-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]c eph ems.

Animals↗

PubMed1992

Bactericidal activity and postantibiotic effect of cefdinir (Cl 983, FK 482) against selected pathogens.

The bactericidal activity and the postantibiotic effect (PAE) of cefdinir (Cl 983, FK 482) (CDR), were determined against Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Branhamella catarrhalis and Escherichia coli (5 strains each) in comparison to erythromycin (E), cotrimoxazole (SXT) and amoxicillin-clavulanic acid (AMC). Kinetic studies of kill showed that CDR was rapidly bactericidal at concentrations 2 and 4 times the minimum inhibitory concentration (MIC): a reduction of 99.9% in CFU values was observed after 6-8 h for many of the isolates tested. As expected, a PAE was observed when S. aureus was treated with CDR at MIC (range of individual values for 5 strains 0.8-1.5 h) and 4 x MIC (range 1.1-1.4 h). Moreover, CDR showed a significant PAE at both its MIC and 4 x MIC against S. pneumoniae (range 0.5-1.0 h and 0.9-1.1 h), H. influenzae (range 0.4-0.7 h and 0.4-0.8 h), B. catarrhalis (range 0.5-0.7 h and 0.65-0.95 h) and E. coli (range 0.5-0.6 h and 0.5-0.7 h). The good bactericidal activity and the significant PAE of CDR against Gram-positive and Gram-negative bacteria (including respiratory pathogens) are a promising indication for the clinical efficacy of this cephalosporin in several bacterial infections.

Amoxicillin↗