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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.
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The therapeutic use of oral cephalosporins to treat infectious diseases continues to challenge clinicians; many attempts have been made over recent years to improve the efficacy and spectrum of these anti-infectives. Many oral cephalosporins are in development and include cefdinir, cefprozil, cefetamet pivoxil, cefcapene pivoxil, cefcanel daloxate hydrochloride in Phase II trials, S-1090 in Phase III trials and the novel compounds E1100, E1101 and BRL-57347. Differences between these drugs are sometimes subtle and the improvement over existing compounds modest, although recent cephalosporins have shown greater activity against Gram-negative bacterial infections. A better knowledge of the pharmacodynamic and pharmacokinetic interrelationships of existing oral cephalosporins is demanded for a more rational use of these compounds and to avoid the subsequent development of resistance. Perhaps with such an approach, the perceived need for new cephalosporins will diminish.
In this study, the pharmacokinetics of cefdinir were investigated after L-phenylalanine supplementation and a high-protein diet (HPD) in humans to explore changes in the activities of intestinal and renal oligopeptide transporters.
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The final analysis included 1033 patients: 530 (51%) before the CPG (pre-CPG) and 503 (49%) after the CPG (post-CPG). Pre-CPG, ceftriaxone (72%) was the most commonly prescribed antibiotic, followed by ampicillin (13%). Post-CPG, the most common antibiotic was ampicillin (63%). The effect of the CPG was associated with a 34% increase in ampicillin use (P < .001). Discharge antibiotics also changed post-CPG, showing a significant increase in amoxicillin use (P < .001) and a significant decrease in cefdinir and amoxicillin/clavulanate (P < .001), with the combined effect of the CPG and ASP leading to 12% (P < 0.001) and 16% (P < .001) reduction, respectively. Overall, treatment failure was infrequent (1.5% vs 1%).
Three unknown impurities in Cefdinir bulk drug at levels below 0.2% (ranging from 0.05 to 0.2%) have been detected by high performance liquid chromatography (HPLC). These impurities were isolated from crude sample of Cefdinir using preparative HPLC. Based on the spectral data (NMR, IR and MS) the structures of these impurities were characterized as (6R, 7R)-7-[(z)-2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid-5-oxide (I). (6R, 7R)-7-[(z)-2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-8-oxo-3-vinyl-5-thia-1-azabi-cyclo [4.2.0] oct-3-ene-2-carboxylic acid (II). (6R, 7R)-7-[(z)-2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-8-oxo-3-methyl-5-thia-1-azabicyclo-[4.2.0]oct-2-ene-2-carboxylic acid (III), respectively. The origin and structural elucidation of all impurities have been discussed.
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.
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A total of 113 patients were enrolled between August 2006 and April 2007, 104 cases of which were performed for bacteriological study. The incidence of bacterial growth was 60.6% (95% CI 51.0-69.4%). The most common bacteria was H. influenzae (25.0%, 95% CI 16.9-35.3%), followed by S. pneumoniae (14.3%, 95% CI 8.2-23.5%) and S. aureus (9.5%, 95% CI 4.7-17.9%), respectively, whilst M. catarrhalis was found only in 2.4% (95% CI 0.5-7.3%). Eight in 12 S. pneumoniae isolates were tested for the minimal inhibitory concentration of penicillin and found to be penicillin resistant strain in five specimens. Beta-lactamase producing H. influenzae was found in eight out of 20 isolates. H. influenzae had a tendency to be sensitive to amoxicillin/clavulanate, cefuroxime, cefpodoxime, azithromycin, clarithromycin, ofloxacin, levofloxacin and gatifloxacin, whilst S. pneumoniae had a tendency to be sensitive to amoxicillin/clavulanate, cefaclor ampicillin/sulbactam, cefuroxime, ofloxacin, levofloxacin, gatifloxacin, cefpodoxime, cefixime and cefdinir. The effectiveness of antibiotics prescription according to the Thai CPG of ABRS and antimicrobial sensitivity were comparable, 88.5% (95% CI 69.8-97.6%) and 82.2% (95% CI 67.9-92%), respectively.
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A sensitive and selective liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method was developed for the determination of cefdinir in human plasma. After a simple protein precipitation using trichloracetic acid, the post-treatment samples were applied to a prepacked RP18 Waters SymmetryShield column interfaced with a triple quadrupole tandem mass spectrometer. Positive electrospray ionization was employed as the ionization source. The mobile phase consisted of methanol-water-formic acid (25:75:0.075, v/v/v). The analyte and I.S. cefaclor were both detected by the use of selected reaction monitoring mode. The method was linear in the concentration range of 5-2,000 ng/ml. The lower limit of quantification was 5 ng/ml. The intra- and inter-day relative standard deviation across three validation runs over the entire concentration range was less than 4.3%. The accuracy determined at three concentrations (36, 360 and 1,800 ng/ml for cefdinir) ranged from 99.6 to 106.7% in terms of recovery. The chromatographic run time for each plasma sample was less than 3 min. The method herein described was successfully applied for the evaluation of pharmacokinetic profiles of cefdinir capsule in 12 healthy volunteers.