cefzil and Otitis-Media

Cefprozil is a novel third generation, broad-spectrum oral cephalosporin with activity against a spectrum of aerobic gram-negative and positive bacteria, as well as certain anaerobes. The beta-lactamase stability of cefprozil may exceed that of other oral cephalosporins for some important pathogens. Cefprozil may be a suitable alternative to several other commonly used beta-lactams and cephalosporins in the treatment of mild to moderate upper and lower respiratory tract infections including sinusitis, otitis media, pharyngitis/tonsillitis, secondary bacterial infection of acute bronchitis, and acute bacterial exacerbations of chronic bronchitis, and skin and skin structure infections in children. Available data indicate the safety of cefprozil in both pediatric and adult population.

Topics: Bronchitis; Cefprozil; Cephalosporins; Humans; Otitis Media; Pharyngitis; Respiratory Tract Infections; Sinusitis; Skin Diseases, Infectious

The oral second generation cephalosporin cefprozil has a broad spectrum microbiologic profile, with good in vitro activity against respiratory pathogens; 90% or more of Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis isolates are susceptible to cefprozil. Clinical trials of cefprozil have consistently demonstrated good clinical success rates in upper and lower respiratory tract infections, including otitis media, sinusitis, pharyngitis/ tonsillitis and acute bacterial exacerbations of chronic bronchitis. Most recently cefprozil has demonstrated success in children with recurrent and persistent acute otitis media. Data from clinical trials including more than 4000 children and adults have shown that cefprozil is well-tolerated. The most common adverse events associated with cefprozil are gastrointestinal disturbances (i.e. diarrhea and nausea). In two patient satisfaction surveys (pediatric and adult), cefprozil was cited for having a low incidence of side effects and was rated by children as having a pleasing taste. These data indicate that cefprozil is a practical therapeutic choice for the treatment of upper and lower respiratory tract infections.

Topics: Adult; Bronchitis; Cefprozil; Cephalosporins; Child; Child, Preschool; Drug Tolerance; Humans; Infant; Otitis Media; Patient Satisfaction; Pharyngitis; Respiratory Tract Infections; Sinusitis; Tonsillitis

Cefprozil was evaluated in the treatment of acute otitis media with effusion in three open, randomized, multicenter comparative clinical trials. In two trials, 891 pediatric patients were enrolled to either cefprozil or amoxicillin-clavulanate dosage regimens. The treatment groups were comparable in demographic characteristics, and presented with otalgia, middle-ear effusion, or inflamed or bulging tympanic membrane on otoscopic examination. In all patients, tympanocentesis and a culture were required. Two cefprozil oral doses were evaluated, 30 mg/kg/day and 40 mg/kg/day divided into two equal doses (b.i.d.). Amoxicillin-clavulanate was administered at 40 mg/kg/day in three divided doses (t.i.d.). The recommended duration of therapy was ten days. The predominant bacteria isolated were Haemophilus influenzae and Moraxella catarrhalis. The overall satisfactory clinical response rates were similar for cefprozil (83%) and amoxicillin-clavulanate (81%). The bacteriological response rates did not differ significantly, at 84% and 82%. Cefprozil eradicated the most common pathogen, Streptococcus pneumoniae, more often at 91%, vs. 84% for amoxicillin-clavulanate. The eradication rates were similar against Haemophilus influenzae and Moraxella catarrhalis. The patients treated with cefprozil had a lower rate of adverse clinical events (11%) compared to those with amoxicillin-clavulanate (20%). More gastrointestinal adverse experiences, including diarrhea, were reported in the amoxicillin-clavulanate-treated patients. In Study 3, cefprozil 30 mg/kg/day (b.i.d.) was compared to cefaclor 40 mg/kg/day (t.i.d.) and cefixime 8 mg/kg/day (q.d) in the treatment of acute otitis media in 388 pediatric patients. The patients were treated for 10 days, with a follow-up of 18 days. The overall clinical cure rates were 85%, 89% and 85%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cefaclor; Cefixime; Cefotaxime; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Multicenter Studies as Topic; Otitis Media; Randomized Controlled Trials as Topic

Cefprozil is an orally active cephalosporin which has demonstrated activity against a wide range of organisms in vitro. It is particularly active against the Gram-positive organisms Streptococcus pyogenes, pneumoniae and agalactiae and against methicillin-susceptible Staphylococcus aureus. Strains of methicillin-resistant S. aureus are not susceptible to cefprozil. Cefprozil is also moderately active against Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, many Enterobacteriaceae and certain anaerobic organisms, and is relatively stable to hydrolysis by a number of beta-lactamases. In comparative trials, the clinical and bacteriological efficacy of cefprozil 500mg or 20 mg/kg administered once or twice daily has been comparable with multiple daily dosage regimens of erythromycin in patients with tonsillitis or pharyngitis, with cefaclor and amoxicillin/clavulanate in lower respiratory tract infections, with amoxicillin/clavulanate and erythromycin in skin and skin-structure infections and with cefaclor in acute uncomplicated urinary tract infections. The clinical efficacy of cefprozil is similar to that of cefaclor in patients with tonsillitis or pharyngitis but the bacteriological efficacy of cefprozil is significantly greater than that of cefaclor. Cefprozil is clinically more effective than cefuroxime axetil in the treatment of lower respiratory tract infections and demonstrated greater efficacy than cefaclor in one of 2 comparative studies when administered twice daily in patients with skin and skin-structure infections. In children with acute otitis media, cefprozil 15 mg/kg twice daily was as effective as cefaclor or amoxicillin/clavulanate 13.3 mg/kg 3 times daily and was as effective as cefixime 8 mg/kg once daily. The most frequently reported adverse effects associated with cefprozil, diarrhoea and nausea, are usually mild to moderate in severity and discontinuation of treatment is rarely necessary. Thus, cefprozil with its convenient administration regimen appears to be a suitable alternative to cefaclor, cefixime, amoxicillin/clavulanate or erythromycin for the treatment of upper and lower respiratory tract infections, skin and skin-structure infections, and otitis media in children. While cefprozil has shown similar efficacy to cefaclor in the treatment of uncomplicated urinary tract infections, well-controlled clinical trials comparing its efficacy with that of cotrimoxazole (trimethoprim+sulfamethoxazole) in this indicat

Topics: Animals; Bacteria; Bacterial Infections; Cefprozil; Cephalosporins; Humans; Microbial Sensitivity Tests; Otitis Media; Skin Diseases, Infectious; Urinary Tract Infections

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.

Topics: Adult; Bacteria; Bacterial Infections; Cefprozil; Cephalosporins; Child; Humans; Microbial Sensitivity Tests; Otitis Media; Pharyngitis

The use of short-term intramuscular ceftriaxone for pediatric ambulatory conditions raises concerns regarding the promotion of resistance among colonizing enteric bacteria. This study was designed to assess the prevalence of stool colonization with resistant Gram-negative bacilli after single-dose ceftriaxone treatment compared with other regimens for acute otitis media.. Children age 3 months to 7 years and diagnosed with acute otitis media were randomized to receive treatment with single-dose ceftriaxone or with oral cefprozil, amoxicillin or azithromycin. Stool samples were obtained at enrollment and then 3-5 days, 10-14 days, and 28-30 days after therapy was initiated and screened for the presence of facultative Gram-negative bacilli resistant to ceftriaxone, cefprozil, amoxicillin, piperacillin, piperacillin-tazobactam and tobramycin. Mean prevalence of colonization by resistant organisms for each treatment group was compared at each time point.. One thousand nine subjects were enrolled. The prevalence of colonization by a Gram-negative bacillus resistant to at least 1 of the screening antibiotics decreased after receipt of ceftriaxone but returned close to values measured at study entry by 30 days. A qualitatively similar pattern was noted for the 3 other regimens, but a quantitatively greater decrease in the prevalence of colonization by a resistant bacterium was noted at the 3- to 5-day and 10- to 14-day visits among azithromycin recipients (P < 0.001). Colonization by a Gram-negative bacillus resistant specifically to ceftriaxone was unusual at each study visit, regardless of treatment assignment.. A single intramuscular dose of ceftriaxone had a similar effect on the prevalence of antibiotic-resistant Gram-negative facultative bacilli in the stool of healthy children when compared with commonly used oral agents.

Topics: Acute Disease; Administration, Oral; Amoxicillin; Anti-Bacterial Agents; Azithromycin; Cefprozil; Ceftriaxone; Cephalosporins; Child; Child, Preschool; Drug Resistance; Feces; Female; Gram-Negative Bacteria; Humans; Infant; Injections, Intramuscular; Male; Otitis Media

Despite the wide-scale use of cefprozil for acute otitis media (AOM), there are only limited data available regarding the pharmacokinetic profile of this agent in the pediatric population.. To characterize the plasma and middle ear fluid (MEF) pharmacokinetic profile of cefprozil in pediatric patients with AOM.. Pharmacokinetic sampling was obtained as part of a phase IV, multicenter, open-label study of children with AOM receiving cefprozil suspension 15 mg/kg twice daily. A single blood sample was obtained 4-6 days after the initiation of cefprozil therapy and a simultaneous MEF sample was obtained by tympanocentesis when clinically indicated. Cefprozil concentrations in both matrices were determined using a validated high-performance liquid chromatography methodology. A composite profile of cefprozil concentration data in each matrix was constructed and values for the pharmacokinetic parameters were obtained using conventional modeling techniques.. Plasma concentrations were obtained in 53 children aged 6-48 months. In this population the maximum concentration (C(max)) in plasma was 9.18 microg/mL, the time to C(max) (t(max)) was 1.5 hours, and the terminal elimination half-life (t((1/2))(beta)) was 0.98 hours. Simultaneous plasma and MEF concentration data were available in 22 children. In this subset the C(max) in plasma was 8.2 microg/mL, the t(max) was 1.9 hours, and the t((1/2))(beta) was 1.02 hours; the corresponding MEF C(max) was 2.4 microg/mL, the t(max) was 3.5 hours, and the t((1/2))(beta) was 1.23 hours. Cefprozil MEF penetration as assessed using the ratio of the area under the concentration-time curves from the two matrices was 28%. Moreover, concentrations in MEF approximated 1 microg/mL 6 hours' post-dose.. The plasma profile of cefprozil in the current analysis is consistent with previously reported values in children receiving the 15 mg/kg twice daily dose. MEF penetration and the duration of drug exposure at the site of infection support the clinical utility of this agent for organisms with minimum inhibitory concentrations (MIC) of < or =1 microg/mL. However, these results also predict higher clinical failure when using this dose of cefprozil against penicillin-non-susceptible Streptococcus pneumoniae or Haemophilus influenzae because of typically higher MIC values for these organisms.

Topics: Acute Disease; Anti-Bacterial Agents; Area Under Curve; Cefprozil; Cephalosporins; Child, Preschool; Chromatography, High Pressure Liquid; Ear, Middle; Half-Life; Humans; Infant; Otitis Media

Topics: Acute Disease; Adult; Aged; Ambulatory Care; Anti-Bacterial Agents; Cefprozil; Cephalosporins; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Otitis Media; Respiratory Tract Infections; Treatment Outcome

Young children contract as many as six to eight upper respiratory tract viral infections per year, and these infections frequently lead to secondary bacterial infections such as acute otitis media and sinusitis. Cefprozil is an orally active third generation cephalosporin which has demonstrated activity against the gram-positive organisms Streptococcus pyogenes, pneumoniae and agalactiae and against methicilin-susceptible Staphylococcus aureus. Cefprozil is also active against various gram-ves and certain anaerobic organisms, and is stable to hydrolysis by a number of b-lactamases. Present study is an effort to study the efficacy and safety of cefprozil in children with acute otitis media. Three hundred and thirty four children aged 6 months through 12 years with clinical symptoms and tympanic membrane signs of AOM received cefprozil 30 mg/kg/day in two divided doses per day for 10 days. Clinically, 96.6% patients were cured, 2.4% improved and there was failure of therapy in 1% of the patients. There was no need for any rescue medication and any change in antibiotic in any patient. A satisfactory bacteriological outcome was (i.e. cure, presumed cure, and cure plus reinfection with a different pathogen) was achieved in 95% of patients. In conclusion, cefprozil is a well tolerated and effective drug for acute otitis media in children. Moreover, its expanded spectrum of activity, ability to achieve adequate concentrations in tissues, suitability for twice-daily dosing, and proven tolerability suggest that it is a better alternative to agents conventionally used in acute otitis media.

Topics: Acute Disease; Anti-Bacterial Agents; Cefprozil; Cephalosporins; Child; Child, Preschool; Female; Humans; Infant; Male; Otitis Media; Prospective Studies; Treatment Outcome

To compare the effects on the bacterial flora of the adenoids of antimicrobial therapy with amoxicillin or cefprozil, we enrolled in a prospective randomized study 60 children scheduled for elective adenoidectomy because of recurrent otitis media. They were randomized before surgery into 3 groups of 20 patients each: a no-therapy group, and groups with 10 days of either amoxicillin or cefprozil therapy. Core adenoid materials were quantitatively cultured for aerobic and facultative bacteria. The in vitro ability of alpha-hemolytic streptococci (AHS) to inhibit the growth of non-type B Haemophilus influenzae and Streptococcus pneumoniae was determined. The number of organisms in adenoids obtained from patients treated with either antibiotic was reduced as compared to that in adenoids from controls. However, in patients treated with amoxicillin, a significant decline in the number of AHS, and an increase (in Staphylococcus aureus) or no change in the number of other beta-lactamase-producing bacteria (BLPB) was noted. In contrast, in those treated with cefprozil, no change was noted in the frequency of recovery of AHS, and the number of BLPB decreased. Interfering AHS were more often recovered in patients treated with cefprozil. We conclude that the adenoids contain more interfering AHS after therapy with a second-generation oral cephalosporin (cefprozil) than after amoxicillin therapy. This study suggests a potential beneficial effect of using an antimicrobial that selectively spares interfering AHS while inhibiting BLPB.

Topics: Adenoids; Amoxicillin; Anti-Bacterial Agents; Antibiosis; Cefprozil; Cephalosporins; Child; Child, Preschool; Female; Haemophilus influenzae; Humans; Male; Otitis Media; Prospective Studies; Streptococcus pneumoniae; Streptococcus pyogenes

We present results of multi center, open clinical trial on using cefprozil (cephalosporin II generation) in acute otitis media in children. Results indicate very good treatments effect (89.3%) and good tolerance of the drug (10.7% side effects).

Topics: Acute Disease; Cefprozil; Cephalosporins; Child; Child, Preschool; Female; Humans; Infant; Male; Otitis Media; Treatment Outcome

The recommendation of the Drug-Resistant Streptococcus pneumoniae Therapeutic Working Group that high-dose amoxicillin, with or without clavulanate, be used to treat acute otitis media (AOM) addressed concerns about the efficacy of existing therapies against drug-resistant S. pneumoniae. This recommendation relied on pharmacodynamic predictions of concentrations of amoxicillin in middle-ear fluid remaining higher than minimum inhibitory concentrations against intermediately resistant S. pneumoniae for >40% of the dosing interval.. This study compared the tolerability and efficacy of cefprozil and high-dose amoxicillin/clavulanate in patients with AOM.. Patients were randomized to receive 10 days of investigator-blinded oral treatment with either cefprozil suspension (30 mg/kg/d in 2 divided doses) or amoxicillin/clavulanate (45/6.4 mg/kg/d) plus amoxicillin (45 mg/kg/d) in 2 divided doses. The primary efficacy end point was the clinical cure rate 4 to 7 days after the end of treatment. Clinical response by age (6 months-<2 years vs > or =2-7 years), disease severity, and unilateral versus bilateral ear infection was also examined. The primary measures of tolerability were the frequency and severity of adverse events and their relation to study drug. Adverse events were either spontaneously reported or elicited during examination and questioning of the patient. Identified adverse events were coded and recorded using the COSTART (Coding Symbols for Thesaurus of Adverse Reaction Terms) system.. Three hundred four children between the ages of 6 months and 7 years with > or =1 sign or symptom of AOM were enrolled in the study, and 303 (150 cefprozil, 153 amoxicillin/clavulanate) were treated. Twenty-three patients in each treatment group were not evaluable; thus, 257 children were included in the analysis of evaluable patients. Clinical cure rates were 87% (110/127) with cefprozil and 89% (116/130) with amoxicillin/clavulanate (95% CI for the difference in cure rate, -10.7% to 4.1%). No between-group differences in efficacy were noted by age, disease severity, or unilateral or bilateral involvement. The overall incidence of drug-related adverse events was significantly lower with cefprozil than with amoxicillin/clavulanate (19% vs 32%, respectively; P = 0.008), as was the incidence of diarrhea (9% vs 19%, respectively; P = 0.021). Adverse events prompted discontinuation of therapy in 4 (3%) cefprozil patients and 8 (5%) amoxicillin/clavulanate patients.. Based on a search of MEDLINE, this study is the first direct comparison of cefprozil versus high-dose amoxicillin/clavulanate. Cefprozil was as effective as high-dose amoxicillin/clavulanate, with a lower incidence of adverse events.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefprozil; Cephalosporins; Child; Child, Preschool; Drug Therapy, Combination; Drug Tolerance; Female; Humans; Infant; Male; Otitis Media; Single-Blind Method

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).. Comparative, investigator-blinded multicenter trial.. Primary care, ambulatory.. 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.. 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.. Clinical resolution of tympanic membrane signs and symptoms of AOM determined at end of therapy on Study Days 9 to 11.. 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.. 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.

Topics: Acute Disease; Cefdinir; Cefprozil; Cephalosporins; Child; Child, Preschool; Female; Humans; Infant; Male; Otitis Media; Treatment Outcome

A randomized comparative clinical trial was conducted to investigate the possibility of decreasing the duration of treatment of acute otitis media by comparing the clinical outcome and safety of a five-day and a ten-day course of cefprozil. A total of 708 pediatric patients were enrolled in the study, 560 of whom were evaluable for efficacy. Cefprozil was found to be completely effective in 87.1% of cases after five days of treatment, and in 91.2% after ten days of treatment. Of 19 patients with three or more previous episodes of acute otitis media, ten patients in the ten-day treatment group had a 100% cure rate, while in the five-day group four experienced cure, three improvement, and two failure. A five-day course of treatment with cefprozil can be recommended only if children have no history of recurrent acute otitis media.

Topics: Acute Disease; Adolescent; Cefprozil; Cephalosporins; Child; Child, Preschool; Drug Administration Schedule; Female; Humans; Infant; Male; Otitis Media; Treatment Outcome

Cefprozil was evaluated in the treatment of acute otitis media with effusion in three open, randomized, multicenter comparative clinical trials. In two trials, 891 pediatric patients were enrolled to either cefprozil or amoxicillin-clavulanate dosage regimens. The treatment groups were comparable in demographic characteristics, and presented with otalgia, middle-ear effusion, or inflamed or bulging tympanic membrane on otoscopic examination. In all patients, tympanocentesis and a culture were required. Two cefprozil oral doses were evaluated, 30 mg/kg/day and 40 mg/kg/day divided into two equal doses (b.i.d.). Amoxicillin-clavulanate was administered at 40 mg/kg/day in three divided doses (t.i.d.). The recommended duration of therapy was ten days. The predominant bacteria isolated were Haemophilus influenzae and Moraxella catarrhalis. The overall satisfactory clinical response rates were similar for cefprozil (83%) and amoxicillin-clavulanate (81%). The bacteriological response rates did not differ significantly, at 84% and 82%. Cefprozil eradicated the most common pathogen, Streptococcus pneumoniae, more often at 91%, vs. 84% for amoxicillin-clavulanate. The eradication rates were similar against Haemophilus influenzae and Moraxella catarrhalis. The patients treated with cefprozil had a lower rate of adverse clinical events (11%) compared to those with amoxicillin-clavulanate (20%). More gastrointestinal adverse experiences, including diarrhea, were reported in the amoxicillin-clavulanate-treated patients. In Study 3, cefprozil 30 mg/kg/day (b.i.d.) was compared to cefaclor 40 mg/kg/day (t.i.d.) and cefixime 8 mg/kg/day (q.d) in the treatment of acute otitis media in 388 pediatric patients. The patients were treated for 10 days, with a follow-up of 18 days. The overall clinical cure rates were 85%, 89% and 85%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cefaclor; Cefixime; Cefotaxime; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Multicenter Studies as Topic; Otitis Media; Randomized Controlled Trials as Topic

Cefprozil is a new oral cephalosporin with activity against the most common pathogens isolated in acute otitis media. This randomized study enrolled 361 patients (mean age 29 months). Physical examination and culture via tympanocentesis were required less than 48 h before therapy. One hundred and ninety-one patients were evaluable for clinical efficacy; 99 received cefprozil (20 mg/kg/day bd) and 92 received amoxycillin/clavulanate (13.3 mg/kg/day tid). Duration of treatment was 7-9 days for 81 patients, 10 days for 105 patients and 11-16 days for five patients. The treatment groups were comparable with respect to demographics, severity of infection and number of previous episodes. Clinical evaluations of efficacy were based on physical examination including otoscopy within a 14 day period after therapy. Satisfactory clinical responses were achieved in 84% of cefprozil-treated patients and 87% of amoxycillin/clavulanate-treated patients. Pathogens most commonly isolated included Haemophilus influenzae (33%) and Streptococcus pneumoniae (22%). All 361 patients were evaluable for safety. Adverse clinical events were reported in 13% (24) of cefprozil-treated patients and 20% (36) of amoxycillin/clavulanate-treated patients. Cefprozil, administered twice a day, is comparable to a regimen of amoxycillin/clavulanate three times a day in the treatment of acute otitis media in children.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefprozil; Cephalosporins; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Neisseriaceae Infections; Otitis Media; Pneumococcal Infections; Streptococcus pneumoniae

Cefprozil (CFPZ, BMY-28100) is a new oral cephem antibiotic without an ester linkage. Pharmacokinetic and clinical studies using CFPZ 10% fine granules were performed in pediatric patients. 1. Pharmacokinetic investigation Peak serum concentrations of CFPZ after dose of 7.5 mg/kg and 10 mg/kg were, respectively, 3.65 +/- 0.24 micrograms/ml and 6.38 +/- 3.23 micrograms/ml at 1-2 hours. The average half-life with 7.5 mg/kg administration was 0.90 +/- 0.16 hours and that with 10 mg/kg was 1.29 +/- 0.50 hours. The urinary excretion of CFPZ was about 45% (35.3-50.0%) in 6 hours. 2. Clinical investigation Enrolled in the study were 22 patients including 4 with pharyngitis, 3 with tonsillitis, 3 with bronchitis, 5 with pneumonia, 4 with urinary tract infection, and 1 each with pertussis, purulent lymphadenitis and otitis media. Responses were excellent in 14 patients, good in 5 patients and fair in 1 patient. In the assessment of the bacteriological efficacy, 8 out of 17 strains of organism identified previous to the treatment were eradicated, 5 strains were found replaced by other bacteria and 4 strains persisted, hence the eradication rate was 76.5%. 3. No adverse reactions attributable to the drug were observed. From the above results, it has been concluded that CFPZ is a highly effective and safe agent for moderate respiratory and urinary tract infections in children.

Topics: Administration, Oral; Adolescent; Age Factors; Cefprozil; Cephalosporins; Child; Female; Humans; Lymphadenitis; Male; Otitis Media; Respiratory Tract Infections; Urinary Tract Infections

Early treatment of profound bilateral sensorineural hearing loss with cochlear implantation has become routine, resulting in an increased proportion of children implanted at younger ages. These children are at a relatively high risk for acute otitis media (AOM), and are more likely to develop mastoiditis in the implanted ear. Despite the significant risks associated with mastoiditis, including compromise of the implant, there are no specific guidelines on the management of this population. We propose a treatment algorithm emphasizing early but conservative operative intervention.. A retrospective chart review included eight patients, who experienced mastoiditis, in the context of cochlear implantation at our center from August 2005 to November 2012. During this period 806 implant surgeries were completed.. The median age at which mastoiditis occurred was 37 months, and the mean time from implantation to mastoiditis was 9.56 months. All patients underwent drainage of the middle ear in conjunction with intravenous antibiotics, and two additionally underwent post-auricular incision and drainage.. Recent mastoidectomy may be a risk factor for the development of a post-auricular abscess in children, who develop AOM following cochlear implantation. A treatment algorithm was developed, which emphasizes early operative drainage in conjunction with aggressive antibiotic therapy. Conclusions A consistent approach to the management of mastoiditis in children with cochlear implants has not been established. Rapid initiation of aggressive antibiotic therapy and a low threshold for conservative operative intervention results in effective resolution of infection while allowing preservation of the implant.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefprozil; Cefuroxime; Cephalexin; Cephalosporins; Child; Child, Preschool; Clindamycin; Cochlear Implantation; Cochlear Implants; Drainage; Female; Hearing Loss, Sensorineural; Humans; Infant; Infusions, Intravenous; Male; Mastoiditis; Otitis Media; Prosthesis-Related Infections; Retrospective Studies; Risk Factors

Population-based studies may give results different from randomized clinical trials assessing the efficacy of antibiotics.. To determine the effectiveness of amoxicillin, azithromycin, cefprozil and clarithromycin in the treatment of acute otitis media (AOM) in children.. 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.. 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).. 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.

Topics: Acute Disease; Administration, Oral; Amoxicillin; Anti-Bacterial Agents; Azithromycin; Cefprozil; Cephalosporins; Child; Child, Preschool; Clarithromycin; Cohort Studies; Female; Follow-Up Studies; Humans; Male; Otitis Media; Quebec; Risk Factors; Time Factors; Treatment Outcome

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Azithromycin; Cefprozil; Ceftriaxone; Cephalosporins; Drug Resistance, Multiple, Bacterial; Humans; Microbial Sensitivity Tests; Otitis Media; Risk Assessment; Sensitivity and Specificity; Streptococcus pneumoniae

The effect on the nasopharyngeal bacterial flora of therapy for 10 days with co-amoxiclav or cefprozil was studied in 50 children with acute otitis media. Before therapy, potential pathogens (Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis) were isolated in 14 (56%) of those treated with co-amoxiclav and 15 (60%) of those treated with cefprozil. Following therapy, the reduction in the number of these pathogens was the same in the two groups. However, differences between the groups were noted in the recovery of organisms with interfering capability, namely alpha-haemolytic streptococci, Peptostreptococcus anaerobius and Prevotella melaninogenica. Fifty interfering organisms were recovered from each group before therapy. After therapy with co-amoxiclav or cefprozil their number declined to 11 and 42, respectively (P< 0.001).

Topics: Amoxicillin-Potassium Clavulanate Combination; Antibiosis; Cefprozil; Cephalosporins; Child, Preschool; Drug Therapy, Combination; Female; Gram-Negative Bacteria; Gram-Positive Cocci; Humans; Infant; Male; Nasopharynx; Otitis Media

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.

Topics: Adult; Bronchitis; Cefprozil; Cephalosporins; Child; Child, Preschool; Female; Humans; Male; Otitis Media; Serum Sickness; Sinusitis

We compared the in-vitro activities of cefprozil, a novel oral cephalosporin, and of loracarbef, a new oral carbacephem, with other agents against middle ear fluid isolates obtained from children with acute otitis media. These included Streptococcus pneumoniae, Haemophilus influenzae and Branhamella catarrhalis. Cefprozil activity (MIC50 and MIC90) against S. pneumoniae was 0.25 and 0.50 mg/l; against H. influenzae 8 and 16 mg/l; against B. catarrhalis 2 and 2 mg/l. Loracarbef activity (MIC50 and MIC90) against S. pneumoniae was 1 and 2 mg/l; against H. influenzae 8 and 16 mg/l; against B. catarrhalis 1 and 8 mg/l. Cefprozil was four-fold more active against S. pneumoniae than loracarbef but similar to amoxycillin, amoxycillin/clavulanate, cefaclor, cefixime, cefuroxime and trimethoprim/sulfamethoxazole (TMP/SMX). Against H. influenzae, cefprozil was similar to loracarbef and other agents through less active than TMP/SMX and cefixime. Against B. catarrhalis, cefprozil was four-fold more active than loracarbef, cefaclor and cefixime but similar to the comparative antibiotics. Cefprozil and loracarbef activities were unaffected at pH 6 and 8 or in the presence of human serum, but there was a major diminution of activity for both agents at pH 5 and at inoculum sizes greater than or equal to 10(7) cfu/ml. Cefoprozil and loracarbef have consistent activity against middle ear pathogens and further pharmacokinetic and clinical studies appear warranted.

Topics: Acute Disease; Cefprozil; Cephalosporins; Ear, Middle; Haemophilus influenzae; Moraxella catarrhalis; Otitis Media; Streptococcus pneumoniae