Of 1045 patients, 589 were evaluable for efficacy. At baseline, most patients had moderate or severe cough and sputum production as well as rhonchi, wheezing, and dyspnea. The microbiologic eradication rates by pathogen were 90% with once-daily cefdinir, 85% with twice-daily cefdinir, and 88% with twice-daily cefuroxime. The corresponding values for microbiologic eradication rate by patient were 90% (once-daily cefdinir), 85% (twice-daily cefdinir), and 86% (twice-daily cefuroxime). The respective clinical response rates by patient were 81%, 74%, and 80%. There were no significant differences in the incidence of drug-related adverse events or discontinuations due to adverse events. Diarrhea was the most frequent complaint.
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SDCAP and SDCAGA showed improved solubility and dissolution profiles owing to amorphization and formation of solid dispersions with hydrophilic carriers. The improved stability of amorphous CA in solid dispersions compared to ACA alone was attributed to hydrogen bonding interactions involving the amide of CA with the carbonyl of polyvinyl pyrrolidone in SDCAP, whereas in SDCAGA the interactions were at multiple sites involving the amide and carbonyl of CA with the carbonyl and hydroxyl of Gelucire 50/13. However, SDCAGA showed superior bioavailability compared to SDCAP, ACA and CA.
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Sixty-six centers in 11 countries (Belgium, Canada, Czech Republic, Germany, Hungary, Ireland, Israel, Poland, Portugal, South Africa, and the United Kingdom).
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One hundred two subjects with immediate reactions to cephalosporins and positive skin test results to the responsible drugs underwent serum specific IgE assays with cefaclor and skin tests with different cephalosporins. Subjects were classified in 4 groups: group A, positive responses to 1 or more of ceftriaxone, cefuroxime, cefotaxime, cefepime, cefodizime, and ceftazidime; group B, positive responses to aminocephalosporins; group C, positive responses to cephalosporins other than those belonging to the aforementioned groups; and group D, positive responses to cephalosporins belonging to 2 different groups. Group A subjects underwent challenges with cefaclor, cefazolin, and ceftibuten; group B participants underwent challenges with cefuroxime axetil, ceftriaxone, cefazolin, and ceftibuten; and group C and D subjects underwent challenges with some of the aforementioned cephalosporins selected on the basis of their patterns of positivity.
A few antibiotics (i.e. metronidazole, clindamycin and ciprofloxacin) are available in both parenteral and oral formulations, and have good bioavailability, ensuring equivalent systemic drug concentrations. During a 4-year period subsequent to the initiation of a parenteral to oral (IV-PO) stepdown programme for metronidazole and clindamycin, Vancouver General Hospital saved approximately $C85 000. However, many parenteral antibacterials lack an oral formulation, requiring oral stepdown to a different antibacterial with a similar spectrum of activity. Alternatively, the oral formulation of a parenteral antibacterial may have poor bioavailability (i.e. cefuroxime axetil, ampicillin, cloxacillin, erythromycin, and tetracycline) and it is not possible to maintain equivalent systemic drug concentrations. While rigid criteria are not applicable to all clinical scenarios, the general criteria for oral stepdown include the following: the patient 1) continues to need an antibiotic; 2) is clinically stable; 3) is capable of tolerating the oral dosage form; and 4) has no factors present (e.g. gastrointestinal abnormalities or drug interactions) that would adversely affect oral bioavailability. A review of subsequent IV-PO stepdown programmes at Vancouver General Hospital revealed that 1) not all patients receiving parenteral therapy are candidates for oral stepdown; 2) oral stepdown is delayed in a large proportion of treatment courses; 3) oral stepdown is not occurring in many patients for whom it is deemed appropriate; and 4) in a very few treatment courses stepdown may occur prematurely and may contribute to clinical deterioration.(ABSTRACT TRUNCATED AT 250 WORDS)
Oral cephalosporins, after 25 years of use, continue to present the clinician with a therapeutic challenge. The older agents have been extensively prescribed for ambulatory adult and pediatric patients with a wide variety of infections caused by gram-positive and some gram-negative organisms. The newer agents, cefaclor, cefuroxime axetil, and cefixime, have increased in vitro activity against beta-lactamase-secreting strains of Haemophilus influenzae and Branhamella catarrhalis which has made them more popular for the treatment of otitis media and respiratory tract infections in children. The new agents are also more active against most gram-negative organisms. However, clinical trials have failed to show a clear-cut superiority over older, proven therapy when used to treat infections of the respiratory tract, middle ear, skin and soft tissue, urinary tract, and bone and joints when caused by sensitive organisms. Published reports of clinical trials continue to support the recommendation that oral cephalosporins, especially the newer and more expensive agents, be reserved for second- or third-line therapy when amoxicillin, penicillin V, or trimethoprim/sulfamethoxazole have either failed or produced patient intolerance. Erythromycin/sulfisoxazole and amoxicillin/clavulanate potassium are equally efficacious and also less expensive than cefaclor, cefuroxime axetil, and cefixime and could be considered second-line therapy prior to the use of the newer cephalosporins for infections in the ambulatory patient.
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To present a predictive model of allergenicity based on a structure-activity relationship analysis of beta-lactam antibiotics using appropriate skin testing procedures.
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We conclude that in patients with urine proven sterile prior to ESWL there is no need for antibiotic prophylaxis.
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This trial compared the efficacy and safety of a 10-day treatment course of cefaclor and cefuroxime axetil in the treatment of acute otitis media with effusion in children who failed therapy with amoxicillin. This was an investigator-blind, randomized, parallel treatment group study. To be included, patients must have received treatment with a standard clinical regimen of amoxicillin for at least 48 hours and not more than 10 days, with the last dose within 72 hours of randomization. Patients who met the entry criteria were randomly assigned to one of two antibiotic treatment groups. Cefaclor and cefuroxime axetil suspensions were administered twice daily for a total daily dose of 40 mg/kg and 30 mg/kg, respectively. Physical examination, pneumatic otoscopy and tympanogram were performed to evaluate efficacy to therapy. Therapeutic equivalence was established by ruling out a difference (cefaclor minus cefuroxime axetil) of 15% in percentages of clinical success (cure plus improvement). Safety evaluation was performed by assessment of clinical adverse events. In the intent-to-treat analysis post-therapy (1-6 days after completion of therapy), 96 of 104 (92.3%) cefaclor-treated patients had clinical success compared to 90 of 101 (89.1%) cefuroxime axetil patients. The 95% confidence limits on the difference between proportions of favorable outcomes (cefaclor minus cefuroxime axetil) was from -4.8% to +11.2%. At termination of the study (day 10-16 after completion of therapy), 86 of 104 (82.7%) cefaclor patients and 84 of 101 (83.2%) cefuroxime axetil patients had favorable clinical outcomes (95% confidence interval: -10.8% to +9.9%). Thirty-two (30.8%) of the 104 patients in the cefaclor treatment group reported at least one adverse event, with rhinitis reported in 9 (8.7%) patients and cough increased in 7 (6.7%) patients. Thirty-six (35.6%) of the 101 patients in the cefuroxime axetil treatment group reported at least one event, with diarrhea reported in 11 (10.9%) of patients and rhinitis in 10 (9.9%) patients. Cefaclor and cefuroxime axetil were equally effective in the treatment of patients with acute otitis media with effusion who had failed therapy with amoxicillin. Significantly fewer patients treated with cefaclor reported diarrhea, which is the most frequently reported adverse event in children treated with antibiotics for this disease.
Toxic epidermal necrolysis (TEN) is one of the most threatening adverse reactions to various drugs. No case of concomitant occurrence TEN and severe granulocytopenia following the treatment with cefuroxime has been reported to date. Herein we present a case of TEN that developed eighteen days of the initiation of cefuroxime axetil therapy for urinary tract infection in a 73-year-old woman with chronic renal failure and no previous history of allergic diathesis. The condition was associated with severe granulocytopenia and followed by gastrointestinal hemorrhage, severe sepsis and multiple organ failure syndrome development. Despite intensive medical treatment the patient died. The present report underlines the potential of cefuroxime to simultaneously induce life threatening adverse effects such as TEN and severe granulocytopenia. Further on, because the patient was also taking furosemide for chronic renal failure, the possible unfavorable interactions between the two drugs could be hypothesized. Therefore, awareness of the possible drug interaction is necessary, especially when given in conditions of their altered pharmacokinetics as in case of chronic renal failure.