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Hartmut Derendorf - One of the best experts on this subject based on the ideXlab platform.
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pharmacokinetics of Cefpodoxime in plasma and subcutaneous fluid following oral administration of Cefpodoxime proxetil in male beagle dogs
Journal of Veterinary Pharmacology and Therapeutics, 2011Co-Authors: Vipul Kumar, Rajanikanth Madabushi, M B B Lucchesi, Hartmut DerendorfAbstract:Kumar, V., Madabushi, R., Lucchesi, M. B. B., Derendorf, H. Pharmacokinetics of Cefpodoxime in plasma and subcutaneous fluid following oral administration of Cefpodoxime proxetil in male beagle dogs. J. vet. Pharmacol. Therap.34, 130–135. Pharmacokinetics of Cefpodoxime in plasma (total concentration) and subcutaneous fluid (free concentration using microdialysis) was investigated in dogs following single oral administration of prodrug Cefpodoxime proxetil (equivalent to 5 and 10 mg/kg of Cefpodoxime). In a cross over study design, six dogs per dose were utilized after a 1 week washout period. Plasma, microdialysate, and urine samples were collected upto 24 h and analyzed using high performance liquid chromatography. The average maximum concentration (Cmax) of Cefpodoxime in plasma was 13.66 (±6.30) and 27.14 (±4.56) μg/mL with elimination half-life (t1/2) of 3.01 (±0.49) and 4.72 (±1.46) h following 5 and 10 mg/kg dose, respectively. The respective average area under the curve (AUC0–∞) was 82.94 (±30.17) and 107.71 (±30.79) μg·h/mL. Cefpodoxime was readily distributed to skin and average free Cmax in subcutaneous fluid was 1.70 (±0.55) and 3.06 (±0.93) μg/mL at the two doses. Urinary excretion (unchanged Cefpodoxime) was the major elimination route. Comparison of subcutaneous fluid concentrations using pharmacokinetic/pharmacodynamic indices of fT>MIC indicated that at 10 mg/kg dose; Cefpodoxime would yield good therapeutic outcome in skin infections for bacteria with MIC50 upto 0.5 μg/mL while higher doses (or more frequent dosing) may be needed for bacteria with higher MICs. High urine concentrations suggested Cefpodoxime use for urinary infections in dogs.
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Tissue penetration of Cefpodoxime into the skeletal muscle and lung in rats.
European Journal of Pharmaceutical Sciences, 2005Co-Authors: Ping Liu, Bernd Obermann, Alistair I. Webb, Richard Fuhrherr, Hartmut DerendorfAbstract:Abstract Purpose: The aim of this study was to investigate the pharmacokinetics of Cefpodoxime in interstitial tissue fluids (skeletal muscle and lung) in rats by microdialysis, and to examine the relationship between free drug levels in plasma and in tissues. Methods: Cefpodoxime was administered to anesthetized male Wistar rats as single intravenous bolus of 10 or 20 mg/kg and constant infusion of 260 μg/h with a loading dose. The protein binding of Cefpodoxime in rat plasma was determined using ultrafiltration. Results: The average protein binding of Cefpodoxime in rat plasma was 38%. The half-lives in plasma, muscle and lung were similar (approximately 5 h). After constant rate infusion, the free concentrations in the muscle and the lung were almost identical, but lower than total and free plasma concentrations. The data were modeled simultaneously using a two-compartmental body model. Conclusions: Free interstitial levels of Cefpodoxime in muscle and lung tissue are very similar. Since muscle is more accessible than lung, free muscle concentrations may serve as a good surrogate for unbound concentrations in lung.
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Tissue penetration of Cefpodoxime and cefixime in healthy subjects.
Journal of clinical pharmacology, 2005Co-Authors: Ping Liu, Markus Müller, Maria B. Grant, Bernd Obermann, Hartmut DerendorfAbstract:Microdialysis is a technique that allows the measurement of free antibiotic concentrations in different tissues, which are responsible for the antibacterial activity at the infection site. In an open, randomized, 2-way crossover study in healthy volunteers, the muscle penetration of orally administered Cefpodoxime (400 mg) and cefixime (400 mg) was compared using microdialysis. The results show that the total plasma concentration-time profiles of each antibiotic were similar; the area under the curve for Cefpodoxime was 22.4 +/- 8.7 versus 25.6 +/- 8.5 mg/L*h for cefixime. However, tissue penetration was twice as high for Cefpodoxime (area under the curve 15.4 +/- 5.1 mg/L*h) as for cefixime (area under the curve 7.3 mg/L*h). This degree of tissue distribution is consistent with their protein binding of 21% for Cefpodoxime and 65% for cefixime. After equilibration, the unbound tissue concentrations of both antibiotics were similar to their unbound plasma concentrations. Pharmacokinetic modeling was applied to describe the pharmacokinetic profiles in plasma and muscle. The study demonstrates that Cefpodoxime shows greater tissue penetration than cefixime.
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Tissue penetration of Cefpodoxime into the skeletal muscle and lung in rats.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences, 2005Co-Authors: Ping Liu, Bernd Obermann, Alistair I. Webb, Richard Fuhrherr, Hartmut DerendorfAbstract:The aim of this study was to investigate the pharmacokinetics of Cefpodoxime in interstitial tissue fluids (skeletal muscle and lung) in rats by microdialysis, and to examine the relationship between free drug levels in plasma and in tissues. Cefpodoxime was administered to anesthetized male Wistar rats as single intravenous bolus of 10 or 20 mg/kg and constant infusion of 260 microg/h with a loading dose. The protein binding of Cefpodoxime in rat plasma was determined using ultrafiltration. The average protein binding of Cefpodoxime in rat plasma was 38%. The half-lives in plasma, muscle and lung were similar (approximately 5 h). After constant rate infusion, the free concentrations in the muscle and the lung were almost identical, but lower than total and free plasma concentrations. The data were modeled simultaneously using a two-compartmental body model. Free interstitial levels of Cefpodoxime in muscle and lung tissue are very similar. Since muscle is more accessible than lung, free muscle concentrations may serve as a good surrogate for unbound concentrations in lung.
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Interstitial tissue concentrations of Cefpodoxime
Journal of Antimicrobial Chemotherapy, 2002Co-Authors: Ping Liu, Markus Müller, Maria B. Grant, Bernd Obermann, Alistair I. Webb, Hartmut DerendorfAbstract:Microdialysis is a technique that allows the measurement of concentrations of free antibiotic in tissue. The free antibiotic concentration is responsible for the antibacterial effect at the target site. We used microdialysis in animal and human studies to investigate the tissue penetration of Cefpodoxime. In the animal study, total plasma and free muscle and lung concentrations of Cefpodoxime were measured after male Wistar rats had received either 10 mg/kg or 20 mg/kg i.v. Cefpodoxime over 5 h or a continuous i.v. infusion of 260 microg/h Cefpodoxime after a loading dose of 6 mg/kg. Free muscle concentrations of Cefpodoxime were similar to free lung concentrations and therefore provided a surrogate measure of Cefpodoxime concentrations at the pulmonary target site. In an open, randomized, two-way crossover, single-dose study in six healthy male volunteers, total plasma and free muscle concentrations were measured after a single oral dose of Cefpodoxime 400 mg or cefixime 400 mg. The total plasma concentrations of each antibiotic were similar and higher than free muscle concentrations. The tissue penetration of Cefpodoxime was, however, greater than that of cefixime, as shown by two-fold higher peak free muscle concentrations after dosing with Cefpodoxime than with cefixime (2.1 mg/L versus 0.9 mg/L). In addition, the area under the curve for tissue (AUC(t)) of Cefpodoxime (400 mg) was more than double that of cefixime (400 mg), based on free antibiotic concentrations (15.4 mg x h/L versus 7.3 mg x h/L). These findings indicate that, taking into account pharmacokinetic/pharmacodynamic considerations, Cefpodoxime is likely to be more efficacious than cefixime, due to its greater tissue penetration.
Ping Liu - One of the best experts on this subject based on the ideXlab platform.
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Tissue penetration of Cefpodoxime into the skeletal muscle and lung in rats.
European Journal of Pharmaceutical Sciences, 2005Co-Authors: Ping Liu, Bernd Obermann, Alistair I. Webb, Richard Fuhrherr, Hartmut DerendorfAbstract:Abstract Purpose: The aim of this study was to investigate the pharmacokinetics of Cefpodoxime in interstitial tissue fluids (skeletal muscle and lung) in rats by microdialysis, and to examine the relationship between free drug levels in plasma and in tissues. Methods: Cefpodoxime was administered to anesthetized male Wistar rats as single intravenous bolus of 10 or 20 mg/kg and constant infusion of 260 μg/h with a loading dose. The protein binding of Cefpodoxime in rat plasma was determined using ultrafiltration. Results: The average protein binding of Cefpodoxime in rat plasma was 38%. The half-lives in plasma, muscle and lung were similar (approximately 5 h). After constant rate infusion, the free concentrations in the muscle and the lung were almost identical, but lower than total and free plasma concentrations. The data were modeled simultaneously using a two-compartmental body model. Conclusions: Free interstitial levels of Cefpodoxime in muscle and lung tissue are very similar. Since muscle is more accessible than lung, free muscle concentrations may serve as a good surrogate for unbound concentrations in lung.
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Tissue penetration of Cefpodoxime and cefixime in healthy subjects.
Journal of clinical pharmacology, 2005Co-Authors: Ping Liu, Markus Müller, Maria B. Grant, Bernd Obermann, Hartmut DerendorfAbstract:Microdialysis is a technique that allows the measurement of free antibiotic concentrations in different tissues, which are responsible for the antibacterial activity at the infection site. In an open, randomized, 2-way crossover study in healthy volunteers, the muscle penetration of orally administered Cefpodoxime (400 mg) and cefixime (400 mg) was compared using microdialysis. The results show that the total plasma concentration-time profiles of each antibiotic were similar; the area under the curve for Cefpodoxime was 22.4 +/- 8.7 versus 25.6 +/- 8.5 mg/L*h for cefixime. However, tissue penetration was twice as high for Cefpodoxime (area under the curve 15.4 +/- 5.1 mg/L*h) as for cefixime (area under the curve 7.3 mg/L*h). This degree of tissue distribution is consistent with their protein binding of 21% for Cefpodoxime and 65% for cefixime. After equilibration, the unbound tissue concentrations of both antibiotics were similar to their unbound plasma concentrations. Pharmacokinetic modeling was applied to describe the pharmacokinetic profiles in plasma and muscle. The study demonstrates that Cefpodoxime shows greater tissue penetration than cefixime.
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Tissue penetration of Cefpodoxime into the skeletal muscle and lung in rats.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences, 2005Co-Authors: Ping Liu, Bernd Obermann, Alistair I. Webb, Richard Fuhrherr, Hartmut DerendorfAbstract:The aim of this study was to investigate the pharmacokinetics of Cefpodoxime in interstitial tissue fluids (skeletal muscle and lung) in rats by microdialysis, and to examine the relationship between free drug levels in plasma and in tissues. Cefpodoxime was administered to anesthetized male Wistar rats as single intravenous bolus of 10 or 20 mg/kg and constant infusion of 260 microg/h with a loading dose. The protein binding of Cefpodoxime in rat plasma was determined using ultrafiltration. The average protein binding of Cefpodoxime in rat plasma was 38%. The half-lives in plasma, muscle and lung were similar (approximately 5 h). After constant rate infusion, the free concentrations in the muscle and the lung were almost identical, but lower than total and free plasma concentrations. The data were modeled simultaneously using a two-compartmental body model. Free interstitial levels of Cefpodoxime in muscle and lung tissue are very similar. Since muscle is more accessible than lung, free muscle concentrations may serve as a good surrogate for unbound concentrations in lung.
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Interstitial tissue concentrations of Cefpodoxime
Journal of Antimicrobial Chemotherapy, 2002Co-Authors: Ping Liu, Markus Müller, Maria B. Grant, Bernd Obermann, Alistair I. Webb, Hartmut DerendorfAbstract:Microdialysis is a technique that allows the measurement of concentrations of free antibiotic in tissue. The free antibiotic concentration is responsible for the antibacterial effect at the target site. We used microdialysis in animal and human studies to investigate the tissue penetration of Cefpodoxime. In the animal study, total plasma and free muscle and lung concentrations of Cefpodoxime were measured after male Wistar rats had received either 10 mg/kg or 20 mg/kg i.v. Cefpodoxime over 5 h or a continuous i.v. infusion of 260 microg/h Cefpodoxime after a loading dose of 6 mg/kg. Free muscle concentrations of Cefpodoxime were similar to free lung concentrations and therefore provided a surrogate measure of Cefpodoxime concentrations at the pulmonary target site. In an open, randomized, two-way crossover, single-dose study in six healthy male volunteers, total plasma and free muscle concentrations were measured after a single oral dose of Cefpodoxime 400 mg or cefixime 400 mg. The total plasma concentrations of each antibiotic were similar and higher than free muscle concentrations. The tissue penetration of Cefpodoxime was, however, greater than that of cefixime, as shown by two-fold higher peak free muscle concentrations after dosing with Cefpodoxime than with cefixime (2.1 mg/L versus 0.9 mg/L). In addition, the area under the curve for tissue (AUC(t)) of Cefpodoxime (400 mg) was more than double that of cefixime (400 mg), based on free antibiotic concentrations (15.4 mg x h/L versus 7.3 mg x h/L). These findings indicate that, taking into account pharmacokinetic/pharmacodynamic considerations, Cefpodoxime is likely to be more efficacious than cefixime, due to its greater tissue penetration.
Marie T. Borin - One of the best experts on this subject based on the ideXlab platform.
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Cefpodoxime pharmacokinetics in children: effect of food.
The Pediatric infectious disease journal, 1998Co-Authors: Gregory L. Kearns, Richard F Jacobs, Susan M. Abdel-rahman, Thomas G. Wells, Marie T. BorinAbstract:Background. Cefpodoxime, an oral third generation cephalosporin antibiotic, is used for the treatment of acute upper respiratory tract infection caused by susceptible bacteria in children 5 months to 12 years of age. We report the results of a randomized two-way crossover study designed to characterize the disposition of a single dose (10 mg/kg) of Cefpodoxime proxetil oral suspension in children, under fed and fasted conditions. Methods. Seventeen children (8.4 months to 12.2 years old, seven female) participated in this study. Each subject received a single 10-mg/kg dose of Cefpodoxime proxetil oral suspension, after a predose fast and again coadministered with food. Repeated blood samples (n = 10) were obtained during 12 h postdose and Cefpodoxime was quantified from plasma by high performance liquid chromatography. Plasma concentration vs. time data were curve fit for each subject with a nonlinear weighted least squares algorithm, and pharmacokinetic parameters were determined from the polyexponential estimates. Results. Cefpodoxime disposition was best characterized using a one-compartment open model with first order absorption. The area under the plasma concentration vs. time curve, C max and K e were not significantly different between fed and fasted conditions. However, T max was significantly prolonged (fed = 2.79 ± 1.10 h vs. fasted = 1.93 ± 0.54 h) and K a was significantly smaller (fed = 0.42 ± 0.14 h -1 vs. fasted = 0.81 ± 0.72 h -1 ) in the fed state. Conclusions. Administration of Cefpodoxime in the presence of food affected the rate but not the extent of absorption. Cefpodoxime proxetil oral suspension can be administered without regard to meals in children 6 months to 12 years of age.
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The bioavailability of Cefpodoxime proxetil tablets relative to an oral solution
Biopharmaceutics & drug disposition, 1995Co-Authors: Marie T. Borin, Kristi K. Forbes, George S. HughesAbstract:The bioavailability of Cefpodoxime proxetil tablets relative to an oral solution of Cefpodoxime proxetil in a sucrose/alcohol/citric acid vehicle was studied in 11 healthy volunteers in a randomized, crossover study. Fasted subjects took one Cefpodoxime proxetil 100 mg tablet or 50 mL of a 2 mg mL-1 Cefpodoxime proxetil oral solution on two separate occasions. In a third study period, all subjects took a 100 mg dose of the oral solution with a high-fat meal to investigate the effect of food on Cefpodoxime proxetil absorption from the oral solution. Serial blood samples were obtained over a 24 h period, and urine was collected for 48 h after dosing. Cefpodoxime concentrations in plasma and in urine were determined using HPLC methods. The bioavailability of Cefpodoxime proxetil tablets relative to the oral solution was 82%, as determined from AUC ratios. There was no difference in the rate of Cefpodoxime absorption between dosage forms. Food had no effect on the extent of drug absorption from the oral solution but did result in delayed absorption. These results suggest that complete dissolution of Cefpodoxime proxetil is critical for optimal bioavailability.
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Effect of food on absorption of Cefpodoxime proxetil oral suspension in adults.
Antimicrobial agents and chemotherapy, 1995Co-Authors: Marie T. Borin, Kristi K. ForbesAbstract:The effect of a high-fat meal on absorption of a 200-mg dose of Cefpodoxime proxetil oral suspension was evaluated in 20 healthy, male volunteers in a randomized, two-way crossover study. The concentrations of Cefpodoxime in plasma and in urine were determined by sensitive and specific high-performance liquid chromatography methods. The area under the plasma drug concentration-time curve, time to peak concentration, and urinary excretion of Cefpodoxime were significantly greater (P < or = 0.05) after administration of Cefpodoxime proxetil oral suspension with food than under fasting conditions. However, the difference in the areas under the curve between fed and fasted treatments was only 11%, and application of the two one-sided tests procedure showed bioequivalence between treatments for this parameter. The slight increase in the extent of drug absorption and the slower rate of absorption which results when Cefpodoxime proxetil is given with food are unlikely to be of clinical importance.
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Pharmacokinetics of Cefpodoxime Proxetil in Healthy Young and Elderly Volunteers
Journal of clinical pharmacology, 1994Co-Authors: Marie T. Borin, Kristi K. Forbes, James J. Ferry, George S. HughesAbstract:The influence of age on the pharmacokinetics of Cefpodoxime was evaluated in 12 elderly (ages 65-85 years) and 12 weight- and sex-matched young (ages 20-33 years) subjects, each of whom received two Cefpodoxime proxetil 200-mg tablets every 12 hours for 14.5 days. Serial blood samples and urine were collected after the first dose on day 1, after the morning dose on day 8, and after the last (morning) dose on day 15. Plasma and urine samples were assayed for Cefpodoxime concentrations using HPLC methods. Within each age group, mean pharmacokinetic parameters determined on day 1 were similar to corresponding values on days 8 and 15, indicating that Cefpodoxime does not accumulate after twice-daily dosing of Cefpodoxime proxetil. Based on this result, parameters were pooled across days in each age group. No significant differences were observed between healthy and elderly volunteers in area under the plasma concentration-time curve for the 12-hour dosing interval, peak plasma concentration, or time to peak concentration. Mean urinary excretion and renal clearance of Cefpodoxime were significantly lower in elderly subjects. Differences in renal clearance were attributed to the corresponding age-related reduction that was noted in creatinine clearance values, whereas the lower urinary excretion of Cefpodoxime probably reflected slightly reduced systemic drug absorption in the elderly. Differences in these parameters between groups were less than 30%, and were unlikely to be of clinical importance. The data indicate that dose adjustment of Cefpodoxime in elderly subjects having normal (age-adjusted) creatinine clearance values is not required.
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Disposition of Cefpodoxime proxetil in hemodialysis patients.
Journal of clinical pharmacology, 1992Co-Authors: Marie T. Borin, George S. Hughes, Judy S. Kelloway, Bruce E. Shapiro, Charles E. HalstensonAbstract:The disposition of Cefpodoxime after single, oral 200-mg doses of Cefpodoxime proxetil (Cefpodoxime equivalents) was investigated in an open-Jabel study of six patients with end-stage renal disease currently maintained on hemodialysis. Subjects were randomly assigned to one of two treatment groups, which differed in the sequence of the interdialytic and intradialytic periods. Doses were separated by at least 2 weeks. Blood samples were serially collected for 48 hours after each treatment; if obtainable, urine was also collected over this same period. During the intradialytic period, hemodialysis was scheduled to begin approximately 3 hours after dosing, and dialysate was collected before and until the end of dialysis. Average Cefpodoxime elimination half-life for the interdialytic period was 18.0 ± 6.5 hours; apparent total body clearance was 28.6 ± 13 mL/minute. The half-life during hemodialysis, 2.66 ± 0.74 hours, was considerably shorter than that after hemodialysis, 19.2 ± 3.5 hours, in the intradialytic period of the study. Hemodialysis clearance of Cefpodoxime was 120 ± 31 mL/minute, which was 57.1 ± 13% and 71.7 ± 25% of the hemodialysis clearance for urea nitrogen and creatinine, respectively. The 2.86 ± 0.25 hour hemodialysis session removed 22.4 ± 2.9% of the administered dose, as assessed by Cefpodoxime recovery in dialysate. A maximum rebound in Cefpodoxime plasma concentration of 0.41 ± 0.33 mcg/mL was observed, at about one-half hour after the end of hemodialysis. Based on these results, dosage adjustment is not required, but extension of the dosing interval is warranted. The recommended dosing interval for Cefpodoxime proxetil in patients with end-stage renal disease is three times a week, after hemodialysis.
Wesley Mark Todd - One of the best experts on this subject based on the ideXlab platform.
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Randomized double-blind trial of the comparative efficacy and safety of Cefpodoxime proxetil and cefaclor in the treatment of acute community-acquired pneumonia
Current Therapeutic Research, 1994Co-Authors: Jon A. Green, Thomas Butler, Wesley Mark ToddAbstract:Abstract A randomized, controlled, double-blind, double-dummy, multicenter study compared the efficacy and safety of Cefpodoxime proxetil with that of cefaclor in the outpatient treatment of community-acquired pneumonia. A total of 325 patients received 7 to 14 days of either 200 mg of Cefpodoxime as Cefpodoxime proxetil twice daily (n = 216) or 500 mg of cefaclor three times daily (n = 109). All study criteria were met by 125 patients (Cefpodoxime, 77; cefaclor, 48). Streptococcus pneumoniae and Haemophilus influenzae were the most commonly identified pathogens. Of 198 pathogenic bacteria isolated from sputum, Cefpodoxime susceptibility was tested in 178 and cefaclor susceptibility in 181. Isolates were more susceptible to Cefpodoxime than to cefaclor ( P = 0.001): 94% were susceptible to Cefpodoxime and 82% to cefaclor; 3% were moderately susceptible to Cefpodoxime and 5% to cefaclor; 3% were resistant to Cefpodoxime and 13% were resistant to cefaclor. Clinical outcome in the two treatment groups was similar: 77% of Cefpodoxime-treated patients and 71% of cefaclor-treated patients were cured; 19% of Cefpodoxime-treated and 25% of cefaclor-treated patients improved; and 4% of patients in each group were considered treatment failures. Gastrointestinal complaints were the most frequently reported drug-related adverse event (10%) in the Cefpodoxime group, and dermatologic problems (5%) were the most commonly encountered drug-related adverse event in the cefaclor group. Overall frequencies of drug-related adverse events were similar (16% for Cefpodoxime vs 14% for cefaclor) in the two groups. Cefpodoxime proxetil was as effective and as well tolerated as cefaclor in the outpatient treatment of community-acquired pneumonia.
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Cefpodoxime proxetil vs penicillin v in pediatric streptococcal pharyngitis tonsillitis
Pediatric Infectious Disease Journal, 1993Co-Authors: Adnan S Dajani, Susan L Kessler, Robert Mendelson, Donald L Uden, Wesley Mark ToddAbstract:This multicenter, randomized, parallel treatment, observer-blinded study was designed to evaluate the safety and efficacy of Cefpodoxime proxetil (5 mg/kg twice daily for 10 days) compared with penicillin V (13.4 mg/kg three times daily for 10 days) for treatment of Group A streptococcal pharyngitis and tonsillitis in pediatric patients. Clinical and microbiologic results were evaluated before therapy, during therapy (Study Days 3 to 5), at the end of therapy (Study Days 14 to 18) and at long term follow-up (Study Days 30 to 32). Both drugs were well-tolerated in 578 patients evaluable for safety. Mild gastrointestinal complaints were noted in 6.7% of 386 Cefpodoxime-treated patients and in 5.2% of 192 penicillin-treated patients. In 413 patients evaluable for efficacy, both treatment regimens resulted in comparably favorable clinical outcome; cure rates were 83.8% for 275 Cefpodoxime-treated patients and 77.5% for 138 penicillin-treated patients. However, eradication of S. pyogenes at end of therapy was significantly higher with Cefpodoxime (93.1%) than with penicillin (81.2%) (P < 0.01). Cefpodoxime proxetil provides an effective alternative to penicillin V for the treatment of streptococcal pharyngitis and tonsillitis.
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Cefpodoxime proxetil compared with amoxicillin-clavulanate for the treatment of otitis media.
The Journal of pediatrics, 1992Co-Authors: Paul M. Mendelman, Mark A. Del Beccaro, Samuel E. Mclinn, Wesley Mark ToddAbstract:In a multicenter, randomized, investigator-blinded trial, patients were randomly selected to receive either Cefpodoxime proxetil or amoxicillin-clavulanate potassium orally for the treatment of acute suppurative otitis media. Petients were seen before, during, and at the end of therapy, and 2 to 3 weeks after completion of therapy. A total of 229 patients, 153 receiving Cefpodoxime and 76 receiving amoxicillin-clavulanate were entered into the study; all patients were examined to determine drug safety. A total of 146 patients, 98 in the Cefpodoxime group and 48 in the amoxicillin-clavulanate group, completed the study and were examined to determine drug efficacy. End-of-therapy microbiologic eradication rates in assessable patients were 92% for Cefpodoxime and 86% for amoxicillin-clavulanate ( p =0.14; 95% confidence interval (CI) on difference: −4.4%, 19.2%). End-of-therapy clinical response rates for assessable patients were as follows: cured, 68% for Cefpodoxime and 65% for amoxicillin-clavulanate; improved, 24% for Cefpodoxime and 23% for amoxicillin-clavulanate; and falled, 8% for Cefpodoxime and 13% for amoxicillin-clavulanate ( p =0.57; 95% CI: −8.4%, 16.5%). Recurrence rates at long-term follow-up were 24% for Cefpodoxime-treated patients and 25% for those given amoxicillin-clavulanate. Both drugs were well tolerated; 20.9% of those given Cefpodoxime and 31.6% of amoxicillin-clavulanate-treated patients had drug-related adverse medical events ( p =0.102; 95% Cl: −23.9%, 2.6%). Gastrointestinal complaints were the most frequently reported drug-related side effect in both groups: 11.8% of Cefpodoxime-freated patients and 21.1% of those given amoxicillin-clavulanate ( p =0.076; 95% Cl: −20.8%, 2.2%). Drug-related dermatologic side effects (e.g., diaper rash, pruritus, urticaria) were reported in 7.8% of Cefpodoximetreated patients and 14.5% of those who received amoxicillin-clavulanate ( p =0.160; 95% Cl: −16.6%, 3.3%). Our findings suggest that clinical efficacy for Cefpodoxime administered twice daily is equivalent to that of amoxicillin-clavulanate administered three times a day.
C A Greenwald - One of the best experts on this subject based on the ideXlab platform.
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comparison of oral Cefpodoxime proxetil and penicillin v potassium in the treatment of group a streptococcal pharyngitis tonsillitis the Cefpodoxime pharyngitis study group
Clinical Therapeutics, 1991Co-Authors: R J Brown, D H Batts, G S Hughes, C A GreenwaldAbstract:Ninety-three patients with a diagnosis of acute pharyngitis/tonsillitis due to Streptococcus pyogenes were randomly assigned to receive 100 mg of Cefpodoxime proxetil orally with food every 12 hours or 250 mg of penicillin V potassium orally on an empty stomach every six hours. Treatment efficacy was evaluated in 30 Cefpodoxime-treated and 33 penicillin-treated patients. After 10 days of treatment, S pyogenes was eradicated from the throat culture in 29 of the 30 Cefpodoxime-treated patients and in 30 of the 33 penicillin-treated patients. Twenty days after treatment termination, infection recurred in one patient of each treatment group. Clinical cure or improvement was found in 97% of the patients in each group. Adverse medical events occurred in nine of the 48 Cefpodoxime-treated patients and in four of the 45 penicillin-treated patients; these were probably related to the study drug in seven and two patients, respectively. The most common adverse events were nausea (in three Cefpodoxime and one penicillin patient) and diarrhea (in three and two). No patient showed colitis related to Clostridium difficile. No clinically significant abnormal laboratory test results were found in either treatment group. It is concluded that Cefpodoxime proxetil is as effective and safe as penicillin V potassium in the treatment of pharyngitis due to S pyogenes.
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Comparison of oral Cefpodoxime proxetil and penicillin V potassium in the treatment of group A streptococcal pharyngitis/tonsillitis. The Cefpodoxime Pharyngitis Study Group.
Clinical therapeutics, 1991Co-Authors: R J Brown, D H Batts, G S Hughes, C A GreenwaldAbstract:Ninety-three patients with a diagnosis of acute pharyngitis/tonsillitis due to Streptococcus pyogenes were randomly assigned to receive 100 mg of Cefpodoxime proxetil orally with food every 12 hours or 250 mg of penicillin V potassium orally on an empty stomach every six hours. Treatment efficacy was evaluated in 30 Cefpodoxime-treated and 33 penicillin-treated patients. After 10 days of treatment, S pyogenes was eradicated from the throat culture in 29 of the 30 Cefpodoxime-treated patients and in 30 of the 33 penicillin-treated patients. Twenty days after treatment termination, infection recurred in one patient of each treatment group. Clinical cure or improvement was found in 97% of the patients in each group. Adverse medical events occurred in nine of the 48 Cefpodoxime-treated patients and in four of the 45 penicillin-treated patients; these were probably related to the study drug in seven and two patients, respectively. The most common adverse events were nausea (in three Cefpodoxime and one penicillin patient) and diarrhea (in three and two). No patient showed colitis related to Clostridium difficile. No clinically significant abnormal laboratory test results were found in either treatment group. It is concluded that Cefpodoxime proxetil is as effective and safe as penicillin V potassium in the treatment of pharyngitis due to S pyogenes.