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PubMed2002

In vitro selection of resistance in Haemophilus influenzae by amoxicillin-clavulanate, cefpodoxime, cefprozil, azithromycin, and clarithromycin.

Abilities of amoxicillin-clavulanate, cefpodoxime, cefprozil, azithromycin, and clarithromycin to select resistant mutants of Haemophilus influenzae were tested by multistep and single-step methodologies. For multistep studies, 10 random strains were tested: 5 of these were beta-lactamase positive. After 50 daily subcultures in amoxicillin-clavulanate, MICs did not increase more than fourfold. However, cefprozil MICs increased eightfold for one strain. Clarithromycin and azithromycin gave a >4-fold increase in 8 and 10 strains after 14 to 46 and 20 to 50 days, respectively. Mutants selected by clarithromycin and azithromycin were associated with mutations in 23S rRNA and ribosomal proteins L4 and L22. Three mutants selected by clarithromycin or azithromycin had alterations in ribosomal protein L4, while five had alterations in ribosomal protein L22. Two mutants selected by azithromycin had mutations in the gene encoding 23S rRNA: one at position 2058 and the other at position 2059 (Escherichia coli numbering), with replacement of A by G. One clone selected by clarithromycin became hypersusceptible to macrolides. In single-step studies azithromycin and clarithromycin had the highest mutation rates, while amoxicillin-clavulanate had the lowest. All resistant clones were identical to parents as observed by pulsed-field gel electrophoresis. The MICs of azithromycin for azithromycin-resistant clones were 16 to >128 micro g/ml, and those of clarithromycin for clarithromycin-resistant clones were 32 to >128 micro g/ml in multistep studies. For strains selected by azithromycin, the MICs of clarithromycin were high and vice versa. After 50 daily subcultures in the presence of drugs, MICs of amoxicillin-clavulanate and cefpodoxime against H. influenzae did not rise more than fourfold, in contrast to cefprozil, azithromycin, and clarithromycin, whose MICs rose to variable degrees.

Amino Acid Sequence↗
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↗
PubMed1996

Comparison of cefprozil, cefpodoxime proxetil, loracarbef, cefixime, and ceftibuten.

OBJECTIVE: To discuss the pharmacokinetics, spectrum of activity, clinical trials, and adverse effects of cefprozil, cefpodoxime proxetil, loracarbef, cefixime, and ceftibuten, an investigational cephalosporin. DATA SOURCES: Literature was identified by a MEDLINE search from 1986 to January 1995. STUDY SELECTION: Randomized, controlled studies were selected for evaluation; however, uncontrolled studies were included when data were limited for indications approved by the Food and Drug Administration. DATA EXTRACTION: Data were evaluated with respect to in vitro activity, study design, clinical and microbiologic outcomes, and adverse drug reactions. DATA SYNTHESIS: Cefprozil, cefpodoxime proxetil, loracarbef, cefixime, and cefributen are active in vitro against organisms frequently involved in community-acquired infections such as Streptococcus pneumoniae, Escherichia coli, beta-lactamase-positive or -negative Haemophilus influenzae, and Moraxella catarrhalis. Except for cefixime and ceflibuten, they all are active against methicillin-susceptible Staphylococcus aureus. Even though there were problems in study design (discussed within the text), clinical data demonstrate that these new oral beta-lactam compounds are as efficacious as conventional therapies for a variety of community-acquired infections. CONCLUSIONS: Cefprozil, cefpodoxime, cefixime, loracarbef, and ceftibuten demonstrate in vitro activity against the major organisms that cause community-acquired infections. Clinical trials confirm that these agents are as effective as traditional therapies for the management of acute otitis media, pharyngitis/tonsillitis, sinusitis, bronchitis, pneumonia, urinary tract infections, and skin and skin-structure infections. In addition, cefixime and cefpodoxime are effective therapies for uncomplicated gonococcal infections. Selection of a specific agent will be influenced by susceptibility data and safety, as well as issues of compliance and cost.

Bacterial Infections↗
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↗
PubMed2005

Effectiveness of amoxicillin, azithromycin, cefprozil and clarithromycin in the treatment of acute otitis media in children: a population-based study.

UNLABELLED: Population-based studies may give results different from randomized clinical trials assessing the efficacy of antibiotics. OBJECTIVE: To determine the effectiveness of amoxicillin, azithromycin, cefprozil and clarithromycin in the treatment of acute otitis media (AOM) in children. METHODS: Using Quebec Health Insurance databases (RAMQ), we selected a cohort of children aged < or = 6 years, with a first episode of AOM between 1999 and 2002. The index AOM was defined as a medical service claim with a diagnosis of AOM and an antibiotic dispensation in the following 72 hours. Failures were defined as a new antibiotic dispensation, a hospitalization or outpatient visit for complications related to AOM in the 30 days after the index AOM. Data were analyzed using logistic regression. RESULTS: Overall, 12,693 failures occurred among 60,513 first episodes of AOM. Azithromycin was the only antibiotic that was associated with a decreased risk of failure overall, when compared to amoxicillin (OR 0.88, 95% CI: 0.82, 0.94). However in the first 3 days of treatment (n = 680), azithromycin was more associated with treatment failure (OR 1.6, 95% CI: 1.3, 2.0). Compared to amoxicillin, post-therapy failures (n = 9387) were more likely to occur with cefprozil (OR 1.2, 95%CI: 1.2, 1.3) but were less with azithromycin (OR 0.8 95% CI: 0.8, 0.9). CONCLUSIONS: Azithromycin had the lowest risk of failure 30 days after the onset of treatment but an increased risk of failure during the first few days of treatment. Amoxicillin remains an effective first-line drug for treating first AOM episodes.

Acute Disease↗
PubMed1994

Revised disk diffusion interpretive criteria for cefaclor, loracarbef, cefprozil and cefixime when testing Haemophilus influenzae on haemophilus test medium.

The aim of the current five-center collaborative study was to reassess the interpretive criteria for cefaclor, loracarbef, cefprozil and cefixime previously adopted or proposed by the National Committee for Clinical Laboratory Standards (NCCLS) for disk diffusion susceptibility tests with Haemophilus influenzae on Haemophilus Test Medium (HTM) agar. MICs and zones of inhibition were determined using NCCLS methods, HTM and two collections of strains of Haemophilus influenzae. One group of strains consisted of 118 stock organisms taken largely from various recent U.S. antibiotic resistance surveillance studies. The emphasis in this selected group of organisms was on strains that were beta-lactamase negative but ampicillin resistant (BLNAR) by some other mechanism. The second collection of test organisms consisted of 50 recent clinical isolates of Haemophilus influenzae obtained from each of the five participating study centers. This group was considered representative of the type of Haemophilus influenzae currently recovered from clinical sources in the USA. Frequency distribution assessment and error-rate bounded analysis of scattergram comparisons of MICs and zone sizes were used to develop the following zone diameters interpretive for disk diffusion susceptibility tests with Haemophilus influenzae on HTM agar: cefaclor, > or = 20 mm (susceptible, S) and < or = 16 mm (resistant, R); loracarbef, > or = 19 mm (S) and < or = 15 mm (R); and cefprozil, > 18 mm (S) and < 14 mm (R). The respective MIC correlates for all three antimicrobial agents were < or = 8 micrograms/ml (S) and 32 micrograms/ml (R).(ABSTRACT TRUNCATED AT 250 WORDS)

Cefaclor↗
PubMed1994

Comparative studies of cefprozil in the management of skin and soft-tissue infections.

Six multicenter clinical trials comparing cefprozil with cefaclor, amoxicillin-clavulanate or erythromycin in the management of skin and soft-tissue infections caused by susceptible bacteria demonstrate that cefprozil, given once or twice daily, is an effective chemotherapeutic agent in this context. Its pharmacokinetic behavior is compatible with once-daily or twice-daily administration, with a probability of improved patient compliance. Safety and tolerability compare favorably with other agents used in skin and soft-tissue infections.

Adolescent↗
PubMed2005

A pooled analysis of seven randomized crossover studies of the palatability of cefdinir oral suspension versus amoxicillin/clavulanate potassium, cefprozil, azithromycin, and amoxicillin in children aged 4 to 8 years.

OBJECTIVE: This analysis of the results of 7 trials compared the taste and smell acceptability scores of cefdinir oral suspension and 4 other pediatric antibiotic oral suspensions--amoxicillin/clavulanate potassium, cefprozil, azithromycin, or generic amoxicillin--using a visual smile-face scale. METHODS: Data from 7 randomized, single-blind, cross-over trials were pooled and analyzed. In each study, children aged 4 to 8 years were asked to taste and smell 2 different antibiotic suspensions 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: A total of 1011 healthy subjects were randomly assigned to 1 of 2 treatment-order groups; 965 were evaluable for the taste and smell analyses. Baseline demographics of evaluable subjects were similar among test groups. Approximately even proportions of participants were female or male (50.1 % vs 49.9%), most (84.1%) were white, and slightly more participants were aged 7 or 8 years rather than younger (age 4 years, 16.0%; age 5 years, 17.4%; age 6 years, 18.7%; age 7 years, 23.2%; age 8 years, 24.8%). Of the 965 children who tasted both antibiotic suspensions and determined their preference, 798 (82.7%) rated the taste of cefdinir as really good or good (the highest possible ratings); 712 (73.8%) assigned the same ratings to amoxicillin/clavulanate potassium, cefprozil, azithromycin, or generic amoxicillin (P < or = 0.001). With regard to smell, 671 (69.5%) rated the smell of cefdinir as really good or good; 636 (65.9%) assigned these same ratings to the comparator agents (P = NS). CONCLUSION: In this pooled analysis of data from 7 randomized, single-blind, crossover trials, children between the ages of 4 and 8 years preferred the taste of cefdinir oral suspension to that of other pediatric antibiotic suspensions. Based on smile-face scores, subjects found the smell of cefdinir oral suspension to be at least as good as that of the comparators.

Administration, Oral↗
PubMed2006

Flow-injection chemiluminescent determination of cefprozil using Tris (2,2'-bipyridyl) ruthenium (II)-permanganate system.

A rapid and sensitive chemiluminescence (CL) method using flow-injection (FI) has been developed for the determination of a second generation cephalosporin, cefprozil. The method is based on the CL reaction of cefprozil with acidic potassium permanganate and tris (2,2'-bipyridyl) ruthenium (II), Ru (bipy)3(2+). The CL intensity is greatly enhanced when quinine sulfate is used as a sensitizer. After optimization of the different experimental parameters, a calibration graph was obtained over a concentration range of 0.1-3.0 microg ml(-1) with minimum detectability of 0.005 microgml(-1) (S/N=3). The correlation coefficient was 0.9998 (n=6) with a relative standard deviation (%R.S.D.) of 1.63% for 2.0 microgml(-1). The proposed method was successfully applied to commercial tablets. The average percentage recovery (n=6) was 99.9+/-1.40.

Cephalosporins↗
PubMed1994

Serum sickness-like reactions associated with cefprozil therapy.

Four patients had serum sickness-like reactions during treatment with cefprozil, a new cephalosporin. Two patients had had previous mild reactions associated with cephalosporin therapy. It remains uncertain whether cefprozil-associated serum sickness-like reaction represents a unique or a class-related adverse drug reaction.

Adult↗
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↗
PubMed1992

Short report: cefprozil for the eradication of Helicobacter pylori infection.

Helicobacter pylori infection has proven to be extraordinarily difficult to eradicate. Antimicrobial monotherapies have been particularly disappointing, with most eradication rates in the range of 0 to 15%. We evaluated cefprozil (250 mg q.d.s. for 14 days) in 12 H. pylori-infected subjects. The 13C-urea breath test was used to evaluate effectiveness of therapy. Eradication was defined as a negative urea breath test 4 to 6 weeks after the end of treatment. Suppression of H. pylori was demonstrated in 4 of 12 (33%) by a negative urea breath test two days after start of treatment. H. pylori infection was not eradicated in any subject (0%). Adverse events were intermittent and mild. Cefprozil does not appear to offer promise as monotherapy for the eradication of H. pylori.

Adult↗
PubMed1993

Cefprozil.

Cefprozil is a new, orally bioavailable, cephalosporin with significant activity against the bacteria commonly associated with upper and lower respiratory tract infection, and skin and soft tissue infections. Its absorption and elimination dynamics suggest once- or twice-daily dosing. The low-rate of gastrointestinal and dermatologic side effects associated with cefprozil administration suggest that it may have a significant role in the management of patients with these infections. Children with pharyngitis or urinary tract infection are more appropriately treated with antibiotics having a narrower spectrum of activity. With a variety of newer cephalosporins being marketed in the early 1990s, it will be important for the clinician to examine the data from ongoing comparative clinical trials to determine which antibiotic is best for a patient with a specific infection and whether the added cost justifies its use.

Adult↗
PubMed2002

Effects of amino acid alterations in penicillin-binding proteins (PBPs) 1a, 2b, and 2x on PBP affinities of penicillin, ampicillin, amoxicillin, cefditoren, cefuroxime, cefprozil, and cefaclor in 18 clinical isolates of penicillin-susceptible, -intermediate, and -resistant pneumococci.

Amino acid alterations in or flanking conserved motifs making up the active binding sites of penicillin-binding proteins (PBPs) 1a, 2b, and 2x of pneumococci were correlated with changes in affinities of penicillin, ampicillin, amoxicillin, cefditoren, cefuroxime, cefprozil, and cefaclor for these PBPs. Four penicillin-susceptible (PSSP), eight penicillin-intermediate (PISP), and six penicillin-resistant (PRSP) pneumococci were studied by DNA sequencing of the penicillin-binding sites of the pbp1a, -2x, and -2b genes of strains and by determining 50% inhibitory concentrations of the seven agents for PBP1a, -2x, and -2b. Two PSSP strains had alterations in PBP2x (L(546)-->V) (one strain) or PBP2b (T(445)-->A) (one strain). All eight PISP strains had at least two alterations--T(338)-->P or A or H(394)-->Y in PBP2X and T(445)-->A in BPB2b. All PRSP strains had the same changes seen in PISP strains, as well as T(371)-->A or S substitutions in PBP1a. The two most resistant PRSP strains had a second change in PBP2x (M(339)-->F) in a conserved motif. The affinities of penicillin and ampicillin for all three PBPs were decreased for PRSP and most PISP strains. The affinity of amoxicillin for PBP1a and -2x was decreased only for PRSP. Cefaclor and cefprozil showed decreased affinity of PRSP but not PISP for all three PBPs. Cefuroxime showed decreased affinity of PISP and PRSP for PBP1a and -2x but no change for PBP2b. Cefditoren showed no difference in PBP affinity based on penicillin or cefditoren MICs, indicating a different PBP target for this agent. Overall, the MICs for and PBP affinities of the strains correlated with the changes found in the PBP active binding sites.

Adult↗
PubMed1990

Pharmacokinetics and tissue penetration of cefprozil.

The pharmacokinetics of cefprozil after a single 500 mg oral dose were studied, measuring plasma, inflammatory fluid and urine concentrations. Mean peak plasma concentrations of 9.6 mg/l (measured by bioassay) were achieved at a mean time of 1.9 h after administration. The mean plasma elimination half-life was 1.4 h; 63.6% of the dose was eliminated in urine by 24 h. Mean peak levels in inflammatory fluid reached 4.9 mg/l after 3.5 h. Mean plasma levels remained 2 mg/l for almost 5 h post dose and more than 6 h in inflammatory fluid. These data suggest that infections caused by highly susceptible pathogens might respond to a twice daily dosing regimen and less susceptible pathogens might require a higher dose or more frequent administration.

Adult↗
PubMed1995

Antibacterial activities of cefprozil compared with those of 13 oral cephems and 3 macrolides.

Thirteen oral cephems (cefprozil, loracarbef, cefaclor, cefuroxime axetil, cefpodoxime proxetil, cefetamet pivoxil, cefixime, cefdinir, cefadroxil, cephradine, cephalexin, cefatrizine, and cefroxadine), the cephalosporin class representative cephalothin, cefazolin, and the macrolides erythromycin, clarithromycin, and azithromycin were compared for their antibacterial activities against 790 recent clinical isolates. These oral agents differed in their spectra and antibacterial potencies against community-acquired pathogens.

Administration, Oral↗
PubMed1993

Quality control guidelines for cefdinir, cefepime, cefetamet, cefmetazole, cefpodoxime, cefprozil, and clinafloxacin (CI-960) for various National Committee for Clinical Laboratory Standards susceptibility testing methods. Quality Control Study Group.

Several multilaboratory studies to determine quality control (QC) ranges for a variety of National Committee for Clinical Laboratory Standards (NCCLS) susceptibility tests are summarized. Replicate testing used multiple lots of media and antimicrobial disks in accordance with NCCLS recommendations, including the appropriate medium modifications for tests with Haemophilus spp. and Neisseria gonorrhoeae. QC ranges for MIC and disk diffusion testing of N. gonorrhoeae ATCC 49226 were proposed for cefepime, cefetamet, cefmetazole, and cefpodoxime. Disk diffusion QC ranges for Haemophilus influenzae ATCC 49247 or ATCC 49766 were recommended with cefepime, cefetamet (10- and 30-microgram disks), cefmetazole, cefpodoxime, and cefprozil. Disk diffusion QC ranges for Staphylococcus aureus ATCC 25923 and Escherichia coli ATCC 25922 with cefdinir and clinafloxacin and those for Pseudomonas aeruginosa ATCC 27853 with clinafloxacin were also proposed.

Anti-Infective Agents↗