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PubMed2006

Update on the cefdinir spectrum and potency against pathogens isolated from uncomplicated skin and soft tissue infections in North America: are we evaluating the orally administered cephalosporins correctly?

The spectrum and potency of cefdinir, an orally administered cephalosporin, was reevaluated for the uncomplicated skin and soft tissue infection (uSSTI) indication using contemporary isolates from 2004 to 2005. Cefdinir continues to have high rates of susceptibility against methicillin-susceptible staphylococci (100.0%), beta-hemolytic streptococci (groups A and B; 100.0%), viridans group streptococci (88.9%), Escherichia coli (93.2%), and Klebsiella pneumoniae (90.0%). No diminished activity was detected since the last evaluation (1997-2002 isolates), and cefdinir remains significantly more potent (4- to 16-fold) than cephalexin, even when using surrogate agents of cephalexin susceptibility that were suspect for estimating true clinical utility. Activity greater than cephalexin (4-fold) was also noted for cefdinir against community-associated methicillin-resistant Staphylococcus aureus isolates. Cefdinir should be considered as a viable option for the therapy uSSTI caused by indicated species.

Administration, Oral↗
PubMed1996

Degradation kinetics and isomerization of cefdinir, a new oral cephalosporin, in aqueous solution. 2. Hydrolytic degradation pathway and mechanism for beta-lactam ring opened lactones.

Hydrolysis of cefdinir leads to pH-dependent isomerizations and beta-lactam ring-opening. Lactam ring opened gamma-lactones were produced as a mixture of four diastereoisomers based on the lactone methyl, and C-6 isomerizations in acidic to neutral solutions. Cefdinir and its 7-epimer were hydrolyzed to clarify the pathway leading to these lactones and the mechanism of C-6 epimerization with the aid of chiral separation techniques. Chiral separation using a bovine serum albumin column was employed to detect the beta-lactam ring opened products of cefdinir and its 7-epimer; the C-6 and C-7 isomerization was thereby observed; however, it was found to be pH-dependent at pH > or = 9. Optical activity detection applied to the lactones produced from cefdinir and its 7-epimer demonstrated that the corresponding peaks of these lactones were enantiomeric pairs. In addition, the smallest rate constant at pH 4 was observed for C-6 epimerization of the lactones, and it was found to proceed without deprotonation at C-6 by 1H-NMR spectroscopy. From the results of these studies, a plausible mechanism for C-6 epimerization has been proposed. Additionally, it was confirmed that two degradation pathways were involved during hydrolysis of cefdinir to the lactone.

Administration, Oral↗
PubMed2000

Comparison of a 5 day regimen of cefdinir with a 10 day regimen of cefprozil for treatment of acute exacerbations of chronic bronchitis.

Patients with acute exacerbations of chronic bronchitis were treated with cefdinir 300 mg bd for 5 days or cefprozil 500 mg bd for 10 days in a prospective, randomized, double-blind, multicentre study. Of the 548 patients enrolled, 281 (51%) were evaluable. The clinical cure rates at the test-of-cure visit were 80% (114/142) and 72% (100/139) for the evaluable patients treated with cefdinir and cefprozil, respectively. Respiratory tract pathogens were isolated from 409 (75%) of 548 admission sputum specimens, with the predominant pathogens being Haemophilus parainfluenzae, Haemophilus influenzae, Staphylococcus aureus and Moraxella catarrhalis. The microbiological eradication rates at the test-of-cure visit were 81% (157 of 193 pathogens) and 84% (166 of 198 pathogens) for the evaluable patients treated with cefdinir and cefprozil, respectively. Adverse event rates while on treatment were equivalent between the two treatment groups. The incidence of diarrhoea during therapy was higher for patients treated with cefdinir (17%) than for patients treated with cefprozil (6%) (P < 0.01), but most cases were mild and did not lead to discontinuation of treatment. These results indicate that a 5 day regimen of cefdinir is as effective and safe in the treatment of patients with acute exacerbations of chronic bronchitis as a 10 day regimen of cefprozil.

Acute Disease↗
PubMed2000

Pharmacodynamics and pharmacokinetics of cefdinir, an oral extended spectrum cephalosporin.

BACKGROUND: Oral second and third generation cephalosporins are undergoing continuing research and development in the arena of pediatric infectious disease in an attempt to fill voids created by existing agents in the quest for the "ideal" antimicrobial. This paper reviews the in vitro antimicrobial activity (pharmacodynamics) and pharmacokinetics of cefdinir, an extended spectrum oral cephalosporin, with an emphasis on those aspects relevant to the pediatric patient population. METHODS: A MEDLINE literature search was conducted for the years 1985 through 2000, identifying all English language papers examining the in vitro antimicrobial activity and human pharmacokinetics of cefdinir. Bibliographies of these papers were reviewed, as were relevant data on file with the manufacturer. DATA SYNTHESIS: Cefdinir exhibits broad range in vitro activity against Gram-positive and Gram-negative aerobes. It exhibits superior activity against Gram-positive aerobes, compared with drugs like cefixime, ceftibuten, cefuroxime and cefpodoxime. In addition it is stable to hydrolysis by many of the common betalactamases. The pharmacokinetic parameters of cefdinir in children are similar to those obtained in adults using similar milligram per m2 doses (300, 600 mg in adults = 7, 14 mg/kg in children, respectively). CONCLUSIONS: The pharmacodynamic and pharmacokinetic characteristics of cefdinir as described in this paper, as well as the results of the clinical trials program, support the use of this agent in the treatment of a wide variety of pediatric infectious diseases.

Adult↗
PubMed2000

Five-day cefdinir course vs. ten-day cefprozil course for treatment of acute otitis media.

OBJECTIVE: To compare the clinical efficacy of a 5-day cefdinir course with a 10-day cefprozil course in the treatment of pediatric acute otitis media (AOM). DESIGN: Comparative, investigator-blinded multicenter trial. SETTING: Primary care, ambulatory. PATIENTS: Children ages 6 months through 12 years with clinical symptoms and tympanic membrane signs of AOM, plus tympanometric-confirmed middle ear effusion in at least 1 ear. Of the 435 patients enrolled in the study, 373 were evaluable. INTERVENTION: Patients received cefdinir 14 mg/ kg/day divided twice a day for 5 days or cefprozil 30 mg/kg/day divided twice a day for 10 days. MAIN OUTCOME MEASURES: Clinical resolution of tympanic membrane signs and symptoms of AOM determined at end of therapy on Study Days 9 to 11. RESULTS: The clinical cure rate at end of therapy was 80% (152 of 190) for cefdinir-treated patients and 82.5% (151 of 183) for cefprozil-treated patients (95% confidence interval, 10.43% to 5.4%). Diarrhea and overall adverse reactions, respectively, occurred in 7.8 and 13% of cefdinir-treated patients and in 4.2 and 12% of cefprozil-treated patients. CONCLUSIONS: A short course 5-day regimen of cefdinir was as clinically effective and well-tolerated as a 10-day regimen of cefprozil in the treatment of nonrefractory AOM.

Acute Disease↗
PubMed2000

Cefdinir vs. amoxicillin/clavulanic acid in the treatment of suppurative acute otitis media in children.

An investigator-blinded, randomized, multicenter study was conducted to compare the efficacy and safety of cefdinir and amoxicillin/ clavulanate (amoxicillin/CA) in the treatment of pediatric patients with acute suppurative otitis media. Patients 6 months to 12 years of age were randomized in a 1:1:1 ratio to receive cefdinir 14 mg/kg once-daily, cefdinir 7 mg/kg b.i.d., or amoxicillin/CA 13.3 mg/kg t.i.d. Test-of-cure was determined 11 to 16 days posttherapy. Of the 752 patients who entered the study, 665 (88%) completed treatment and 595 (79%) were evaluable. Response rates in the three treatment groups were similar. Overall rates of adverse events were statistically lower in the cefdinir once-daily group than in the amoxicillin/CA group. Diarrhea was the most common adverse event in all treatment groups. Cefdinir given either once-daily or twice-daily is a safe and effective treatment for pediatric patients with acute suppurative otitis media.

Acute Disease↗
PubMed2004

Comparison of five-day cefdinir treatment with ten-day low dose amoxicillin/clavulanate treatment for acute otitis media.

BACKGROUND: Short course beta-lactam antibiotic therapy for acute otitis media (AOM) should improve patient adherence, but it has not been evaluated since the heptavalent pneumococcal conjugate vaccine became routinely used in the United States. METHODS: In a prospective, investigator-blinded, multicenter study, 425 patients, age 6 months-6 years, with a clinical diagnosis of nonrefractory AOM were randomized to receive either 5 days of cefdinir therapy (14 mg/kg divided twice daily) or 10 days of amoxicillin/clavulanate therapy (45/6.4 mg/kg divided twice daily). Clinical response was assessed at end of therapy (2-4 days postantibiotic, respectively) and week 4 (study days 25-28). RESULTS: With no difference in demographics between treatment groups, overall the mean age (+/-SD) was 2.8 +/- 1.8 years, 65% had received conjugated pneumococcal vaccination and 48% had bilateral AOM. The satisfactory clinical response rate at end of therapy was comparable for cefdinir versus amoxicillin/clavulanate (88%, 170 of 194 versus 85%, 164 of 192; 95% CI -4.9, 9.3). Although this must be interpreted with caution, cefdinir showed an apparent trend for higher efficacy than amoxicillin/clavulanate (92%, 72 of 78 versus 77%, 55 of 71; P = 0.019) in a subsample of patients 6-24 months old who had received conjugated pneumococcal vaccination. The incidence of drug-related adverse events was less for cefdinir than for amoxicillin/clavulanate (24%, 50 of 211 versus 38%, 82 of 214; P = 0.0018) CONCLUSION: For children with nonrefractory AOM, based only on clinical endpoints, 5 days of therapy with cefdinir 14 mg/kg divided twice daily was comparable overall with 10 days of therapy with low dose amoxicillin/clavulanate 45/6.4 mg/kg divided twice daily.

Acute Disease↗
PubMed1993

Stability of cefdinir (C1-983, FK482) to extended-spectrum plasmid-mediated beta-lactamases.

Fourteen plasmid-encoded extended-spectrum beta-lactamases were purified from Escherichia coli transconjugants of original clinical isolates. The Vmax, Km and Vmax/Km were each determined for ampicillin, carbenicillin, cephaloridine, cephalexin, cefuroxime, cefixime, cefdinir, ceftazidime and cefotaxime as substrates with eight of these enzymes and with the narrow-spectrum beta-lactamase, TEM-1. The relative rates of hydrolysis of ampicillin, cephaloridine, cephalexin, cefuroxime, cefixime, cefdinir, ceftazidime and cefotaxime were also determined for the remaining six enzymes. Cefdinir had Vmax/Km or relative rates of hydrolysis values either equal to or lower than ampicillin, cephaloridine, cephalexin and cefotaxime for all the enzymes tested. Overall, cefdinir was more stable to the 15 beta-lactamases tested than either cefuroxime or cefixime; however, ceftazidime was more stable than cefdinir to hydrolysis by eight of the enzymes tested.

Cefdinir↗
PubMed1997

Characteristics of cefdinir uptake by rabbit small intestinal brush-border membrane vesicles.

Aminocephalosporins with peptide-like structures have been shown to be absorbed by the intestinal peptide carrier. We investigated the transport mechanism of cefdinir, an oral monocarboxylic acid cephalosporin, using rabbit small intestinal brush-border membrane vesicles. Transport of cefdinir showed a slow and almost linear uptake rate for concentrations up to 30 mM with and without and inward H+ gradient. No overshoot phenomenon was observed in the presence of an inward H+ gradient. The uptake rate increased only slightly with decreasing extravesicular pH, and a protonophore had little effect on the uptake. Aminocephalosporins such as cephalexin only slightly inhibited cefdinir uptake even in the presence of an inward H+ gradient, and vice-versa. Monocarboxylic acids such as acetic acid and salicylic acid had little effect on cefdinir uptake. These findings suggest that in contrast with other oral cephalosporins cefdinir uptake through the brush-border membrane is slow and involves a mechanism similar to passive diffusion.

Animals↗
PubMedDate not supplied

In vitro activity of cefdinir (FK 482, PD 134393, CI-983): a new orally active cephalosporin.

Cefdinir is a new orally active cephalosporin which is undergoing in vitro and in vivo evaluations. Using the standard agar dilution method we compared the in vitro activity of this drug with other beta-lactam antibiotics against clinical isolates or Enterobacteriaceae (625 strains), Pseudomonas aeruginosa (68 strains), Xanthomonas maltophilia (36 strains), Acinetobacter (52 strains), Aeromonas hydrophilia (47 strains), staphylococci (364 strains) and enterococci (50 strains). Against most members of Enterobacteriaceae, Acinetobacter and A. hydrophilia, cefdinir showed excellent activity, inhibiting 94% of these isolates at < or = 32 micrograms/ml. Like other oral drugs of its class, it had little activity against P. aeruginosa and X. maltophilia. All the 120 isolates of methicillin-susceptible Staphylococcus aureus were inhibited by < 1.0 microgram/ml of cefdinir whereas 80% of methicillin-resistant S. aureus had a minimum inhibitory concentration of > 32 micrograms/ml. Of the 50 isolates of enterococci tested, 94% were inhibited by < or = 16.0 micrograms/ml of cefdinir. Against Enterobacteriaceae, its activity was superior to any oral drug tested. With the exception of vancomycin, the in vitro activity of cefdinir was superior or comparable to other antibiotics tested against methicillin-susceptible S. aureus, coagulase-negative staphylococci and enterococci.

Aeromonas↗
PubMedDate not supplied

In vitro activity of cefdinir (FK482) and ten other antibiotics against gram-positive and gram-negative bacteria isolated from adult and pediatric patients.

The in vitro activity of cefdinir, an oral aminothiazolyl hydroxyimino cephalosporin was compared with that of cefixime, cefpodoxime, cefaclor, cephalexin, ciprofloxacin, ofloxacin, oxacillin, ampicillin, vancomycin and trimethoprim-sulfamethoxazole against 279 gram-positive and gram-negative recent clinical isolates from adult and pediatric patients. Cefdinir was the most active drug among the cephalosporins against oxacillin-sensitive Staphylococcus aureus and coagulase-negative staphylococci, Streptococcus pneumoniae, S. pyogenes, Escherichia coli and Moraxella catarrhalis (MIC90 0.015-2 mg/l). Cefixime was the most active agent against Hemophilus influenzae, Klebsiella pneumoniae, K. oxytoca, Proteus mirabilis and P. vulgaris (MIC90 < 0.015-0.125 mg/l). The activity of cefpodoxime was better than that of cefixime against S. pneumoniae and oxacillin-sensitive staphylococci (MIC90 0.25-8 vs. 0.5-32 mg/l), similar to cefixime against S. pyogenes (MIC90 0.06 mg/l) and not as good as cefixime against H. influenzae, M. catarrhalis, Klebsiella spp. and Proteus spp. (MIC90 < 0.015-0.25 vs. 0.125-0.5 mg/l). The activity of cefdinir was greater than that of the other cephalosporins against Enterococcus faecalis (MIC90 16-32 vs. > 64 mg/l). None of the cephalosporins were active against methicillin-resistant, coagulase-positive or -negative staphylococci or Pseudomonas aeruginosa (MIC90 > 64 mg/l). Overall, the susceptibilities of adult and pediatric isolates were similar. Kinetic kill curves demonstrated rapid and similar killing at 6 h by cefdinir, cefixime, cefpodoxime and ofloxacin. At 24 h at 1 x MIC, the least regrowth was observed with cefdinir and cefpodoxime; at 2 x MIC, suppression of growth was similar with all four drugs.

Adult↗
PubMedDate not supplied

In vitro activity of two new oral cephalosporins, cefixime and cefdinir (CI 983), on human peripheral mononuclear and polymorphonuclear leukocyte functions.

The in vitro effects of cefixime and cefdinir (CI 983), two so-called third-generation oral cephalosporin derivatives, on human polymorphonuclear and mononuclear phagocyte functions (random migration and chemotaxis, specific and nonspecific phagocytosis, nitroblue tetrazolium reduction, superoxide production, microbicidal activity) were studied. Neither antibiotic, in the range of its attainable therapeutic concentration, exhibited any toxic effect on random migration, chemotaxis, metabolic activation and microbicidal mechanisms of phagocytic cells. Cefixime did not interfere in phagocytosis while cefdinir enhanced both phagocytosis frequency and index. The modulating effect on phagocytosis exerted by cefdinir was achieved at very low antibiotic concentrations (0.06 mg/l for polymorphonuclear leukocytes and 0.03 mg/l for monocytes) when non-opsonized zymosan particles were used as phagocytic challenge. Moreover, the effect was demonstrated both in the presence of cefdinir and after pretreatment of cells with the antibiotic and its removal by washings. As for specific phagocytosis, parameters were slightly increased by cefdinir but only the phagocytosis index was significantly improved in the presence of 2 mg/l of antibiotic.

Administration, Oral↗
PubMed2005

Susceptibility of recent bacterial isolates to cefdinir and selected antibiotics among children with urinary tract infections.

BACKGROUND: Cefdinir, an extended-spectrum cephalosporin administered orally, is approved by the U.S. Federal Drug Administration for treatment of skin and respiratory tract infections. During the last two years at the authors' institution, this agent has been used as an off-label treatment for urinary tract infections in children. OBJECTIVES: To evaluate antimicrobial susceptibility testing data in children to determine whether there is support for this prescribing practice. METHODS: In this retrospective study (2003-2004), the authors compared the susceptibility patterns of urinary pathogens to cefdinir and selected antibiotics in children who were evaluated for urinary tract infections in an urban tertiary academic pediatric emergency department. Pathogens (community acquired vs. opportunistic or nosocomial) were categorized as susceptible, indeterminate, or resistant on the basis of antibiotic susceptibility breakpoints. The frequency of these categorizations for individual drugs was determined. RESULTS: Seven hundred five isolates were recovered from urine during the study period. Pathogens isolated most frequently were Escherichia coli, Klebsiella spp, and Proteus spp. Of 431 isolates retained in the data set, 412 (95.6%) were susceptible to cefdinir. This rate was comparable or superior to rates observed for other antibiotics: 49.4% for ampicillin, 84.9% for trimethoprim-sulfamethoxazole, 88.4% for cefazolin, 93.3% for nitrofurantoin, 94.2% for ticarcillin-clavulanate potassium, 97.5% for gentamicin, and 97.7% for ceftriaxone. Cefdinir, however, had lower activity (64.7%) against 17 bacterial isolates categorized as opportunistic or nosocomial pathogens. CONCLUSIONS: Cefdinir provides good coverage against common pathogens responsible for urinary tract infections in children and compares favorably with other oral and parenteral antibiotics that are used in the empiric treatment of this infection.

Administration, Oral↗
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↗
PubMed1994

Interaction of cefdinir with beta-lactamases.

The interactions of cefdinir, a new orally-active third-generation cephalosporin, with cell-free beta-lactamase preparations were studied in comparison with some other beta-lactams. Cefdinir was very resistant to narrow-spectrum Ambler's class A beta-lactamases, as it was for other oximino beta-lactams: cefotaxime, ceftazidime, cefixime and cefuroxime. Cefaclor showed a low but significant hydrolysis by these beta-lactamases. These class-A enzymes include the widespread plasmid mediated TEM-1, TEM-2, SHV-1 and also the enzymes of Gram-positive penicillinases, such as that produced by S. aureus. The hydrolysis of cefdinir was hardly detectable by the Ambler's class C beta-lactamases (cephalosporinases) produced by E. coli, E. cloacae and M. morganii. A similar conclusion is shown for cefotaxime, ceftazidime, cefixime and cefuroxime: for these beta-lactamases, the hydrolysis of cefaclor was high. The P. vulgaris cephalosporinase differs from the previous cephalosporinases in that it hydrolyses cefotaxime, cefuroxime and cefaclor efficiently. However, the hydrolysis of cefdinir remains too low to be detected. Cefdinir, as other third-generation cephalosporins, showed some hydrolysis by the novel extended-spectrum beta-lactamases (ESBL): SHV-2, TEM-3, TEM-5, MEN-1 and other ESBL.

Bacteria↗
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↗