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PubMed2005

A comparison of 5 days of therapy with cefdinir or azithromycin in children with acute otitis media: a multicenter, prospective, single-blind study.

BACKGROUND: Short-course therapy for acute otitis media (AOM) improves adherence and may reduce secondary bacterial resistance. METHODS: In this multicenter, prospective, investigator-blinded study, patients between the ages of 6 months and 6 years with a clinical diagnosis of AOM were randomized to receive cefdinir oral suspension 7 mg/kg q12h for 5 days or azithromycin oral suspension 10 mg/kg once daily on day 1 and 5 mg/kg once daily on days 2 through 5. Clinical response was assessed at the end-of-therapy (EOT) visit (days 7-9) and the follow-up visit (days 20-25). RESULTS: Three hundred fifty-seven patients were enrolled in the study. The treatment groups were similar at baseline with respect to demographic characteristics (mean [SD] age, 3.0 [1.7] years; 55% male), incidence of bilateral AOM (45%), and presenting signs and symptoms. The majority of evaluable children (77%) had previously received conjugated heptavalent pneumococcal vaccine (PCV7) against Streptococcus pneumoniae. At the EOT visit, clinical cure rates were comparable for cefdinir and azithromycin (87% [151/174] and 85% [149/176], respectively; 95% CI, -5.5 to 9.8). In addition, clinical cure rates at the EOT visit in the children who had been vaccinated with PCV7 were comparable between cefdinir and azithromycin (86% vs 83%; 95% CI, -6.5 to 11.8). No significant difference in clinical cure rates was observed at the follow-up visit (76% and 86%; 95% CI, -18.9 to 0.0). Parental satisfaction was similar between treatment groups with regard to ease of use, taste, compliance, health care resource utilization, and missed days of work and day-care. Both antibiotics were well tolerated; diarrhea and abnormal stools were the most common antibiotic-related adverse events (< or = 7% each). CONCLUSIONS: Short courses (5 days) of therapy with cefdinir or azithromycin were comparable in these children with AOM based on clinical end points, parental preferences, and health care utilization.

Acoustic Impedance Tests↗
PubMed2000

Five-day twice daily cefdinir therapy for acute otitis media: microbiologic and clinical efficacy.

OBJECTIVE: To examine the microbiologic and clinical efficacy of a 5-day course of cefdinir in the treatment of tympanocentesis-documented acute otitis media (AOM). DESIGN: Open label noncomparative trial. SETTING: Primary care, ambulatory. PATIENTS: Children ages 6 months through 12 years with signs of AOM and middle ear effusion confirmed by tympanometry in at least one ear. INTERVENTION: Patients underwent tympanocentesis at baseline and received cefdinir 7 mg/kg twice a day for 5 days. MAIN OUTCOME MEASURES: Presumptive eradication of middle ear pathogens determined by clinical cure of signs and symptoms of AOM at end of therapy (Study Days 7 to 9) and Visit 3 (Study Days 16 to 21). RESULTS: A total of 125 of 177 enrolled children had 134 pathogens isolated by tympanocentesis: Streptococcus pneumoniae, 69 (51.5%); Haemophilus influenzae 44 (32.8%; beta-lactamase-positive in 18 of 44 strains); beta-lactamase-positive Moraxella catarrhalis, 15 (11.2%); and Streptococcus pyogenes, 6 (4.5%). The clinical cure rates by patient in the microbiologically and overall clinically evaluable groups, respectively, were 73% (84 of 115) and 77.4% (130 of 168) at the end of therapy visit and 57.4% (66 of 115) and 61.9% (104 of 168) at Visit 3. Presumptive eradication rates at end of therapy were 8 of 11 (72.7%) and 4 of 8 (50%) for patients with penicillin-intermediate and -resistant S. pneumoniae isolates, respectively. Adverse reactions occurred in 16% of patients, with diarrhea (11%) occurring most frequently. CONCLUSIONS: A 5-day regimen of cefdinir was effective in the eradication of the common causative pathogens of nonrefractory AOM, including intermediate penicillin-resistant S. pneumoniae and beta-lactamase-producing organisms. Cefdinir should be considered a suitable second line antibiotic for AOM.

Acoustic Impedance Tests↗
PubMed2000

Comparison of the palatability of the oral suspension of cefdinir vs. amoxicillin/clavulanate potassium, cefprozil and azithromycin in pediatric patients.

BACKGROUND: Patient adherence to therapeutic regimens is extremely important to successful treatment of acute otitis media. Among pediatric patients medication palatability, particularly that of oral suspensions, is essential for patient acceptance, therapeutic compliance and successful outcome. METHODS: A series of six randomized, single blind, crossover trials were conducted, each comparing cefdinir oral suspension with one of the following antibiotic oral suspensions: amoxicillin/clavulanate potassium; cefprozil; or azithromycin. Each medication comparison was evaluated in a single center and multicenter study. Subjects 4 to 8 years of age were asked to taste and smell each medication and assign preference using a visual "smile-face" scale. Ratings were converted to a numeric score ranging from 5 ("really good") to 1 ("really bad"). RESULTS: Among the 715 subjects 85% rated the taste of cefdinir as good or really good, the highest possible ratings; 63% of subjects assigned the same ratings to amoxicillin/clavulanate potassium, cefprozil or azithromycin. Seventy-one percent rated the smell of cefdinir as good or really good; 64% assigned the same ratings to the comparators. CONCLUSIONS: Based on the findings from these trials, children 4 to 8 years of age preferred the taste and smell of cefdinir oral suspension to that of the comparator agents.

Administration, Oral↗
PubMed2005

Efficacy of penicillin versus cefdinir in eradication of group A streptococci and tonsillar flora.

Core tonsillar cultures were obtained from 40 children with recurrent tonsillitis treated with either penicillin or cefdinir. Group A beta-hemolytic streptococci were isolated from 11 penicillin- and 3 cefdinir-treated (P < 0.001) patients. beta-Lactamase producers were recovered from 17 penicillin- and 3 cefdinir-treated (P < 0.01) patients. Inhibiting alpha-hemolytic streptococci were isolated less often from penicillin-treated patients than from cefdinir-treated patients.

Cefdinir↗
PubMed2004

Effect of cefixime and cefdinir, oral cephalosporins, on cytochrome P450 activities in human hepatic microsomes.

The effects of two kinds of oral cephalosporins, cefixime and cefdinir, on cytochrome P450 (CYP) activities in human hepatic microsomes were investigated. Both cefixime and cefdinir at 2 mM concentration neither inhibited nor stimulated CYP1A1/2-mediated 7-ethoxyresorufin O-deethylation, CYP2A6-mediated coumarin 7-hydroxylation, CYP2B6-mediated 7-benzyloxyresorufin O-debenzylation, CYP2C8/9-mediated tolbutamide methylhydroxylation, CYP2C19-mediated S-mephenytoin 4'-hydroxylation, CYP2D6-mediated bufuralol 1'-hydroxylation, CYP2E1-mediated chlorzoxazone 6-hydroxylation, CYP3A4-mediated nifedipine oxidation, or CYP3A4-mediated testosterone 6beta-hydroxylation. The free fractions of cefixime and cefdinir in the incubation mixture, which were measured by ultracentrifugation, were 86.1-93.8% and 94.1-97.8%, respectively. These results suggest that both cefixime and cefdinir would not cause clinically significant interactions with other drugs, which are metabolized by CYPs, via the inhibition of metabolism.

Biotransformation↗
PubMed1994

In vitro evaluation of cefdinir (FK482), a new oral cephalosporin with enhanced antistaphylococcal activity and beta-lactamase stability.

Cefdinir (FK482), a new oral cephalosporin with enhanced beta-lactamase stability, was tested by microbroth dilution against respiratory, urogenital, and skin and skin-structure bacterial pathogens. Included were beta-lactamase (beta LAC)-producing and -nonproducing isolates. Activity was compared with that of other orally administered beta-lactams. Cefdinir minimum inhibitory concentrations for 90% of isolates MIC90s (microgram/ml) were < or = 0.5 versus beta LAC+/oxacillin-susceptible Staphylococcus, aureus, S. epidermidis, and S. saprophyticus; < or = 0.06 versus Streptococcus groups A and B, and Neisseria gonorrhoeae beta LAC+; 0.125 versus S. pneumoniae penicillin-susceptible and Proteus mirabilis beta LAC+; 0.25 versus beta LAC+ versus strains of Moraxella catarrhalis, Escherichia coli, Klebsiella pneumoniae, and K. oxytoca; 0.5 versus Haemophilus influenzae beta LAC-; 1 versus H. influenzae beta LAC+; 4 versus Legionella pneumophila beta LAC+; and 8 versus Enterococcus faecalis beta LAC-strains. Cefdinir was equally effective against both standard and high inocula of S. aureus strains producing A, B, C, or D beta LAC types. MICs were also generated versus quality-control reference strains.

Bacteria↗
PubMed2006

Selective method for the determination of cefdinir in human plasma using liquid chromatography electrospray ionization tandam mass spectrometry.

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.

Anti-Infective Agents↗
PubMed1996

Degradation kinetics and isomerization of cefdinir, a new oral cephalosporin, in aqueous solution. 1.

Hydrolytic degradation products of cefdinir were studied in acidic (pH 1), neutral (pH 6), and basic (pH 9) solutions. Seven major degradation products were isolated by preparative and/or high-performance liquid chromatography and characterized by UV, IR, 1H-NMR, and mass spectra. To clarify degradation pathways in each pH solution, kinetic and product analyses during hydrolysis of cefdinir were carried out along with the followup reaction of representative degradation products. Cefdinir was shown to degrade via two major degradation routes: beta-lactam ring-opening and pH-dependent isomerizations (lactonization, epimerization at C-6 or C-7, syn-anti isomerization of N-oxime function).

Administration, Oral↗
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↗
PubMed1995

Tests for susceptibility of Streptococcus pneumoniae to cefdinir: proposed interpretive criteria and quality control parameters for both microdilution and disc diffusion methods.

Proposed quality control (QC) parameters for susceptibility testing of Streptococcus pneumoniae to cefdinir were developed following the procedure recommended by the National Committee for Clinical Laboratory Standards. The proposed QC MIC range for microdilution susceptibility testing of S. pneumoniae ATCC 49619 is 0.06-0.25 mg/L. The proposed QC limits for inhibitory zone diameters of S. pneumoniae ATCC 49619 around 5 micrograms cefdinir disks is 26-31 mm. We recommend the following for tentative interpretive criteria for determining the susceptibility of S. pneumoniae to cefdinir: susceptible, MIC < or = 0.5 mg/L or inhibition zone diameter > or = 23 mm; intermediate, MIC 1.0 mg/L or inhibition zone, 20-22 mm; resistant, MIC > or = 2.0 mg/L or inhibition zone diameter, < or = 19 mm for broth microdilution and disc diffusion tests, respectively.

Cefdinir↗
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↗
PubMed1994

Predictive accuracy of disk diffusion test for Proteus vulgaris and Providencia species against five newer orally administered cephalosporins, cefdinir, cefetamet, cefprozil, cefuroxime, and loracarbef.

Three members of the tribe Proteeae (Proteus vulgaris, Providencia rettgeri, and Providencia stuartii) were tested against five newer orally administered cephalosporins (cefdinir, cefprozil, cefuroxime, cefetamet, and loracarbef) by the disk diffusion and reference broth microdilution methods. One hundred strains of these organisms were tested to confirm the excessive interpretive error rates that previously had been noted for the disk diffusion test. The results indicate that the suggested disk diffusion breakpoints for cefetamet and cefuroxime were without serious interpretive errors. In contrast, loracarbef, cefdinir, and cefprozil results exceeded acceptable interpretive error rates, with very major (false-susceptible) errors of 4, 5, and 9% respectively. Loracarbef currently has a warning in the National Committee for Clinical Laboratory Standards table footnotes addressing this problem. We recommend including cefdinir and cefprozil in the list of compounds requiring this warning. In addition, MICs of cefazolin, cefaclor, and cephalothin were determined to establish whether a class MIC concept to predict susceptibility for these agents was possible. When the indole-positive Proteus strains are tested, cefazolin MICs can be used to predict MICs of all tested orally administered cephems (8 to 13% total errors, with only a 0 to 1% very major error.

Administration, Oral↗
PubMedDate not supplied

Post-antibiotic effects of cefdinir on Escherichia coli, Klebsiella pneumoniae, Staphylococcus aureus and Streptococcus pyrogenes.

The post-antibiotic effects (PAEs) of a new cephalosporin, cefdinir, were determined against a range of organisms using a viable counting technique. Cefdinir exerted considerable PAEs against Staphylococcus aureus and Streptococcus pyogenes, but no overall post-antibiotic inhibition of growth was detected against Escherichia coli or Klebsiella pneumoniae. Exposure to cefdinir made the gram-negative organisms susceptible to the washing procedure used for drug removal, but this was followed by rapid recovery of viability in drug-free broth.

Cefdinir↗
PubMed2001

Successful steroid therapy for cefdinir-induced acute tubulointerstitial nephritis with progressive renal failure.

A 58-year-old woman was admitted to our hospital because of renal dysfunction that continued to progress even after withdrawal of cefdinir, the presumed cause of acute renal failure. Renal histologic findings included interstitial fibrosis accompanied by moderate lymphocytic infiltration, and tubular atrophy with reduced numbers of epithelial cells. Mesangial cells and glomerular basement membranes were nearly normal. Scintigraphy with 67gallium disclosed diffuse abnormal accumulation in both kidneys. A lymphocyte stimulation test with cefdinir was positive. The patient was diagnosed with acute tubulointerstitial nephritis caused by cefdinir. Serum creatinine concentrations continued to rise after withdrawal of the drug, but steroid therapy was effective in normalizing renal function.

Acute Disease↗
PubMed1996

Method development for the determination of cefdinir and its related substances by high-performance liquid chromatography.

The validation of the HPLC method used for the determination of cefdinir and its related substances is described. The developed method was specific and stability-indicating and provided a linear response with concentration. The system and method precision, expressed as relative standard deviations, were not greater than 1%, and the reproducibilities within and between laboratories were acceptable for the assay method. The procedure can quantitate related substances greater than approximately 0.05% of the principal cefdinir peak.

Calibration↗
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↗
PubMed2006

Isolation, structural elucidation and characterization of impurities in Cefdinir.

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.

Anti-Bacterial Agents↗