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PubMed1990

Randomised double-blind study of norfloxacin and cefadroxil in the treatment of acute pyelonephritis.

In a coordinated, double-blind multi-centre trial, adults with symptoms of acute pyelonephritis were randomly assigned to receive a two-week course of oral treatment with either 400 mg norfloxacin twice daily or 1 g cefadroxil twice daily. Of 197 patients enrolled in the study, 140 could be evaluated for drug efficacy and 193 for drug safety. Norfloxacin gave a significantly higher bacteriological cure rate than cefadroxil, both at 3 to 10 days (98% versus 65%; p less than 0.0001; 95% confidence interval (CI) for difference in proportions 21-46%) and up to eight weeks (87% versus 48%; p less than 0.0001; 95% CI 25-54%) after cessation of treatment. The differences between the two regimens were most pronounced in men and in patients with complicating factors such as diabetes mellitus and urinary tract abnormalities. The clinical response during treatment did not differ between the two groups, but symptomatic recurrences at follow-up were more common in the cefadroxil group (28% versus 3%; p less than 0.0001; 95% CI 14-36%). Adverse events were more often reported by patients receiving cefadroxil (39% versus 22%; p = 0.011; 95% CI 4-30%) and consisted mainly of gastrointestinal disturbances and vulvo-vaginitis. In terms of bacteriological and clinical efficacy and safety, a two-week course of norfloxacin was superior to a two-week course of cefadroxil for oral treatment of community-acquired acute pyelonephritis.

Acute Disease↗
PubMed1985

Transport of cefadroxil, an aminocephalosporin antibiotic, across the small intestinal brush border membrane.

The transport characteristics of cefadroxil, an aminocephalosporin antibiotic, across the brush border membrane of rat small intestine were investigated by a rapid filtration technique. The uptake of cefadroxil was not affected by Na+ gradient, suggesting the absence of a cotransport system between cefadroxil and Na+ in the brush border membrane. The uptake was slightly inhibited by HgCl2 pretreatment and stimulated by the countertransport effect, where cyclacillin played a role as an elicitor. These results suggest the existence of a carrier-mediated transport system for cefadroxil in the brush border membrane, which is shared with cyclacillin. Papain treatment increased the specific transport activities for the antibiotic. This may be the first step of purification of the cefadroxil transport carrier.

Animals↗
PubMed1986

Once daily therapy for streptococcal pharyngitis with cefadroxil.

To determine if a single daily dose of cefadroxil would be effective in the treatment of group A beta-hemolytic streptococcal (GABHS) pharyngitis, 196 patients with GABHS pharyngitis were randomly assigned to receive either penicillin V 250 mg three times daily or cefadroxil 30 mg/kg once daily, for 10 days. Outcome was measured by the ability to isolate GABHS from the upper respiratory tract 18 to 24 hours after the onset of therapy, the impact on the clinical course, and the bacteriologic treatment failure rate. There was no significant difference in the number of patients in the cefadroxil and penicillin V treatment groups with throat cultures positive for GABHS at the 18 to 24-hour follow-up visit (0% and 2%, respectively), and the clinical responses of the patients in the two treatment groups were similar. Of the 99 patients in the three times daily penicillin V group, six (6%) had strains of GABHS isolated on one of the follow-up cultures that were identical to the strains isolated from their initial throat cultures and were considered to have bacteriologic treatment failures. Of the 96 patients in the once daily cefadroxil group, two (2%) were considered to have bacteriologic treatment failures. A single daily dose of cefadroxil appears to be as effective in the treatment of GABHS pharyngitis in this population as penicillin V given three times daily.

Adolescent↗
PubMed2000

The effect of pore formers on the controlled release of cefadroxil from a polyurethane matrix.

The effect of various pore formers on the controlled release of an antibacterial agent from a polymeric device was examined in order to develop a novel biomaterial that prevents bacterial adhesion and growth on its surface. Cefadroxil was chosen as the model antibiotic and was incorporated into a polyurethane matrix by the solvent-casting method. Polyethylene glycol (PEG) 1450, D-mannitol, or bovine serum albumin (BSA) was used as a pore former. The amount of cefadroxil released from various formulations at 37 degrees C was measured by HPLC. The morphological change of matrices before and after release studies was investigated by scanning electron microscopy (SEM). The duration of antimicrobial activities of matrices against Escherichia coli and Bacillus subtilis was evaluated by measuring the diameters of the inhibition zone. Changing the weight fraction and particle size of the pore formers/drug mixtures could control the release of cefadroxil from the matrix. The release rate of cefadroxil increased as the loading dose of the pore former increased (15<20<25%). Cefadroxil released from these devices exhibited antibacterial activity for 5-6 days. These results imply that an antibiotic-loaded polymeric device that could prevent bacterial infection on its surface can be formulated using appropriate pore formers.

Bacteria↗
PubMed2004

Comparative bioavailability of two cefadroxil products using serum and urine data in healthy human volunteers.

1. The aim of the present study was to assess the bioequivalence of two cefadroxil products, namely Ultracef (a reference product) in the form of a 500 mg capsule (produced by Bristol-Myers Squibb Laboratories, Princeton, NJ, USA) and Roxil (a test product) in the form of a 500 mg capsule (produced by Tabuk Pharmaceutical Manufacturing, Tabuk, Saudi Arabia). 2. The study was performed under US Food and Drug Administration (FDA) guidelines (http://www.fda.gov/cder) on 24 healthy male subjects. Both products were administered orally as a single dose (1 x 500 mg capsule) separated by a 1 week washout period. Following oral administration, blood and urine samples were obtained and analysed for cefadroxil concentrations using a sensitive and specific HPLC assay. 3. There were no statistically significant differences between the two products in either the mean concentration-time profiles or the cumulative urinary excretion of cefadroxil at various times. Similarly, no statistical significance was observed in the pharmacokinetic parameters reflecting rate and extent of drug absorption. The relative extent of drug absorption, assessed by calculating the area under the curve (AUC) ratio for Roxil/Ultracef for 10 h and for infinity was 0.94 with 90% confidence limits (CL) of 0.91-0.98. In agreement with serum data, the average ratio (Roxil/Ultracef) of the cumulative amount of cefadroxil excreted in urine 10 h after the dose was found to be 0.97, with 90% CL of 0.88-1.05. The CL of the AUC and cumulative urinary excretion ratios are within the FDA accepted limits for bioequivalent products (0.80-1.25). 4. These findings show that serum and urine data of cefadroxil are in agreement and indicate that Roxil (the test product) and Ultracef (the reference product) are bioequivalent in terms of the rate and extent of drug absorption.

Adolescent↗
PubMed1987

Randomized, single-blind evaluation of cefadroxil and phenoxymethyl penicillin in the treatment of streptococcal pharyngitis.

A total of 150 children from two pediatric practices with clinical and bacteriologic evidence of acute group A beta-hemolytic streptococcal (GABHS) pharyngitis randomly received cefadroxil monohydrate (75 children) or phenoxymethyl penicillin (75 children). Cefadroxil was given once daily, while penicillin was given three times daily. The treatment groups were similar in age, sex, race, illness severity, and acute GABHS symptomatology. Throat cultures were routine 3 to 5 days after the start of therapy and 2 and 14 days after the end of therapy. The bacterial cure rates were 90% (62 of 69) for cefadroxil-treated patients and 76% (52 of 68) for penicillin-treated patients. This difference was significant (P less than 0.04). The clinical response was satisfactory in 91% of cefadroxil-treated patients and 89% of penicillin-treated patients. We conclude that once-daily cefadroxil is at least as effective as three-times-daily penicillin in producing bacteriologic eradication and clinical symptomatic improvement in children with GABHS pharyngitis.

Cefadroxil↗
PubMed1986

Cefadroxil. A review of its antibacterial, pharmacokinetic and therapeutic properties in comparison with cephalexin and cephradine.

Cefadroxil is an oral cephalosporin which is similar to cephalexin and cephradine in structure and spectrum of antibacterial activity, but has different pharmacokinetic properties. Not only does cefadroxil exhibit a longer serum half-life, and thus a prolonged duration of activity, but it is virtually unaffected by simultaneous food intake. The concentrations of cefadroxil attained in body tissues and fluids are also higher and more sustained than those of cephalexin and cephradine. These characteristics permit the administration of cefadroxil during meals on a once-daily or twice-daily basis, thus encouraging patient compliance which often determines the successful management of out-patient infections. Many studies have established the efficacy of the administration of once- or twice-daily cefadroxil, compared with regimens of cephalexin or cephradine given 4 times daily, in the management of infections in the respiratory tract, urinary tract, skin and soft tissues, and bones and joints.

Cefadroxil↗
PubMed1986

A comparative study of cefadroxil and co-trimoxazole in patients with lower respiratory tract infections.

The most common causative pathogens in lower respiratory disease are S. pneumoniae, H. influenzae and S. pyogenes. Cefadroxil and co-trimoxazole, both orally administered broad spectrum antibiotics, are effective against these organisms when given in a twice-daily regimen. In this open randomised study, 42 patients with lower respiratory tract infections received cefadroxil 1 g or co-trimoxazole 1 double-strength tablet every 12 hours for a mean duration of 11 and 13 days, respectively. Pathogens were isolated in the pre-treatment sputum of 51% of patients given cefadroxil and in 25% of those who received co-trimoxazole. Similar overall cure rates were observed after treatment with cefadroxil (67%) and co-trimoxazole (60%); sputum purulence was similarly diminished by both drugs (91% and 85%, respectively). Neither antibiotic caused serious side effects. Thus, in a convenient twice-daily regimen, cefadroxil and co-trimoxazole are comparably effective in treating lower respiratory tract infections.

Cefadroxil↗
PubMedDate not supplied

Therapy for pharyngitis and tonsillitis caused by group A beta-hemolytic streptococci: a meta-analysis comparing the efficacy and safety of cefadroxil monohydrate versus oral penicillin V.

A meta-analysis was conducted to compare the efficacy and safety of oral cefadroxil monohydrate (30 mg/kg QD or 15 mg/kg BID) with that of oral penicillin V (8, 10, or 15 mg/kg BID, TID, or QID) in the treatment of group A beta-hemolytic streptococcal (GABHS) pharyngitis and tonsillitis treated for 10 days. A simple random effects model was used for combining the efficacy and safety results of nine comparative trials performed in the United States. A total of 1646 patients aged < or = 19 years were considered evaluable; 1406 patients were evaluable using revised bacteriologic criteria, and 1499 patients were considered fully evaluable for safety. The results demonstrate significantly better response rates (P < 0.05) with cefadroxil monohydrate than with penicillin V for overall cure (91.8% versus 81.3%), bacteriologic cure (92.6% versus 81.4%), and bacteriologic recurrence (4.2% versus 10.5%); clinical cure rates were statistically similar (90.5% versus 90.2%). Revised bacteriologic criteria analysis revealed bacteriologic cure rates of 95.8% versus 88.7% (P < 0.05) and bacteriologic recurrence rates of 4.9% versus 7.1% (P = NS) for cefadroxil monohydrate and penicillin V, respectively. Adverse events related to drug administration occurred infrequently and did not differ significantly between treatment groups (P > 0.05). Compliance with cefadroxil monohydrate was at least as good as with penicillin V. Penicillin is currently the drug of choice in the treatment of GABHS pharyngitis and tonsillitis. Based on the information described in this large meta-analysis, cefadroxil monohydrate is an excellent alternative to oral penicillin V in the treatment of GABHS pharyngitis and tonsillitis.

Administration, Oral↗
PubMed1991

[Bactericide activity of cefadroxil comparated with amoxicillin-clavulanic acid, cefaclor and josamycin].

Betalactamase-producing organisms are responsible for an increasing number of ENT and lower respiratory tract infections. Or cephalosporins and the combination of amoxicillin with the beta-lactamase inhibitor clavulanic acid are alternatives to ampicillin therapy. The killing activity of cefadroxil on the organisms most often responsible for ENT and respiratory infections was evaluated in vitro using a viable bacteria count method, comparatively with cefaclor, josamycin, and amoxicillin-clavulanic acid. Killing activity was found to be time-dependent for all the antimicrobial agents studied. Cefadroxil exhibited the same bactericidal effect on Streptococcus pyogenes and S. pneumoniae than the other agents. Haemophilus influenzae and an increasing number of Pneumococcus strains were resistant to josamycin which is therefore not appropriate for first-line therapy. As compared with amoxicillin and amoxicillin-clavulanic acid, cefadroxil was less active on H. influenzae and more active on Staphylococcus aureus. Production of beta-lactamase failed to influence the killing activity of cefadroxil. These bacteriologic data, together with results of pharmacologic studies (long half-life and good penetration within tissues) can explain the clinical successes obtained with cefadroxil in ENT and lower respiratory tract infections.

Amoxicillin↗
PubMed1991

[Bactericidal effect of cefadroxil, amoxicillin alone or in combination with clavulanic acid in sera of healthy volunteers].

Determination of minimal inhibitory concentrations (MICs) provides data on the susceptibility or resistance of a bacteria; however, in susceptible bacteria this parameter is not predictive of effectiveness of the antimicrobial agent. Bactericidal activities of cefadroxil, of amoxicillin, and of the amoxicillin-clavulanic acid combination on bacteria commonly found in ENT and lower respiratory tract disease were studied comparatively. The antibiotics were given by the oral route to six healthy volunteers. With beta-lactamase-producing and non-beta-lactamase-producing strains of Escherichia coli, amoxicillin produced MICs consistent with susceptibility but failed to exhibit a bactericidal effect, whereas cefadroxil was bactericidal. Combination of amoxicillin with an inhibitor did not modify this activity on E. coli and failed to produce a bactericidal effect on Klebsiella pneumoniae similar to that seen with cefadroxil. Amoxicillin with and without clavulanic acid exhibited comparable effectiveness on Streptococcus pyogenes and S. Pneumoniae. The bactericidal effect of cefadroxil on S. pneumoniae was of similar magnitude but shorter duration than that of amoxicillin. Cefadroxil and the amoxicillin-clavulanic acid combination had similar bactericidal effects against Staphylococcus aureus. These antibiotics exhibited a time-dependent effect on Gram positive microorganisms. These pharmacodynamic data, together with measures of bactericidal activity, may be very helpful for selecting the appropriate antibiotic and dosage.

Amoxicillin↗
PubMed1985

Comparative efficacy of cefadroxil and cefaclor in the treatment of skin and soft-tissue infections.

A ten-day, randomized, open-label study was conducted to compare the efficacy of 1,000 mg of cefadroxil once daily and 250 mg of cefaclor TID in 200 black patients with skin and soft-tissue infections caused by microorganisms sensitive to these cephalosporins. Statistically, the clinical results with each drug were not significantly different: 91% efficacy with cefadroxil and 95% efficacy with cefaclor. The important difference between cefadroxil and cefaclor is the remarkably longer half-life of cefadroxil, which makes once-a-day dosing possible and offers greater patient convenience and the likelihood of better compliance. In an analysis of compliance, only 2% of the patients in the cefadroxil group (20 capsules given to each patient) returned unused capsules; 77% in the cefaclor group (30 capsules given to each patient) returned unused capsules.

Adult↗
PubMed1980

[Pharmacokinetics of cefadroxil in rats: comparison of fasting and non-fasting (author's transl)].

A single dose 50 mg/kg of cefadroxil was administered orally to rats in fasting and non-fasting. In both fasting and non-fasting, the serum levels of cefadroxil were higher than those of cephalexin. In fasting, the biological half-life (T 1/2) of cefadroxil was longer than that of cephalexin. This indicates its prolonged durable action. Ingestion of cefadroxil with food affected the serum level less than that of cephalexin with food, and the serum levels of cefadroxil in non-fasting were same as those of cephalexin in fasting.

Administration, Oral↗
PubMed1980

Tissue and fluid concentrations of cefadroxil monohydrate.

In summary, there are several tissues and fluids in which the penetration of cefadroxil appears to be superior to that of other antibiotics, including other cephalosporins. A possible explanation for this relates to the characteristic solubility of cefadroxil in both aqueous and lipid solvents. A study comparing IV, IM and PO administration of cefadroxil appears to support this thesis. Clinically, based on work which shows that patients who had higher concentrations of antibiotic in sputum made a faster recovery, cefadroxil may have an advantage since sputum is one of the fluids in which the drug appears to have superior and earlier penetration. In addition, in comparison with cephalexin, penetration of skin-blister fluid by cefadroxil was superior, suggesting an advantage in treating disorders of the skin and skin structures, such as impetigo. The possibility of different dosage requirements for male and female patients, based on the difference in the availability of lipid deposit sites, cannot be considered clinically significant at this time.

Blister↗
PubMedDate not supplied

Cefadroxil reduces the production of IgE in a 3 year old asthmatic with juvenile rheumatoid arthritis.

Cefadroxil, a cephalosporin, had been prescribed to children with superinfected atopic dermatitis, and was shown to improve both the infection, the clinical status and induced a dramatic lowering of the serum total IgE levels. Further studies have confirmed the IgE immunomodulating properties of cefadroxil. We report the case of a 3 year old asthmatic child who was hospitalized for superimposed pneumonia and was included in a study evaluating cefadroxil. The child was also suffering of juvenile rheumatoid arthritis. After treatment with cefadroxil and oral salbutamol, the child fully recovered. The initially elevated serum IgE (day 1:556 IU/ml) dropped to normal values (day 21: 52 IU/ml), while the production of IgE in vitro by peripheral blood B cells was normalized. We suggest that one mechanism of action of cefadroxil is the stimulation of production of gamma interferon in patients with atopic disorders; this mechanism interferes with the IL-4 primary signal, as well as with other second signals recognized for the synthesis of IgE. Gamma interferon may also prove beneficial for the control of juvenile rheumatoid arthritis.

Albuterol↗
PubMed1997

In vitro susceptibility of clinical isolates of Mycobacterium tuberculosis to cefadroxil--a cephalosporin antibiotic.

The bactericidal activity (BA) of cefadroxil, a semisynthetic cephalosporin antibiotic, against M. tuberculosis H37Rv was studied in Middlebrook 7H9 medium. Cefadroxil showed good BA (average fall of viable counts = log10 0.32 colony forming units/ml/day) against the log phase culture of M. tuberculosis H37Rv. Its minimal inhibitory concentration (MIC) and minimal bactericidal concentration (MBC) were found to be 15 micrograms/ml or less. The MIC of cefadroxil for 29 clinical isolates of M. tuberculosis and a laboratory strain, M. tuberculosis H37Rv was also determined by agar dilution method using Middlebrook 7H11 agar as a screening procedure. The MIC of cefadroxil was found to be 10 micrograms/ml or less for M. tuberculosis H37Rv and 16 (55.1%) of 29 clinical isolates tested. The MIC for 3 of 10 drug sensitive and 9 of 19 drug resistant isolates was 40 or more, a concentration much higher than the peak plasma concentration (28 micrograms/ml) attained in human beings. The higher MIC observed in 12 of 29 clinical isolates irrespective of their susceptibility pattern requires further studies to assess the usefulness of cefadroxil in the treatment of tuberculosis.

Cefadroxil↗
PubMed1977

Cefadroxil, a new broad-spectrum cephalosporin.

Cefadroxil is a new semisynthetic cephalosporin with a broad antibacterial spectrum and a high chemotherapeutic potential when administered orally. The inhibitory activity of this compound was similar to that of cephalexin and cephradine when tested against 602 clinical isolates on Mueller-Hinton medium. In the oral treatment of experimental infections of mice, cefadroxil was more effective than cephalexin against Streptococcus pyogenes, and comparably effective against Streptococcus pneumoniae, Staphylococcus aureus, and several gram-negative species. Administered orally to mice, at doses ranging from 25 to 100 mg/kg, cefadroxil attained peak concentrations in the blood similar to those of cephalexin. At a dose of 200 mg/kg, however, higher peak levels were noted with cefadroxil than with cephalexin. In regard to other properties which were investigated, the behavior of cefadroxil compared favorably to that of cephalexin.

Animals↗
PubMed1992

Column liquid chromatography and microbiological assay compared for determination of cefadroxil preparations.

A reversed-phase column liquid chromatographic method was developed for the assay of cefadroxil in bulk drugs and pharmaceutical preparations. An equation was derived showing a linear relationship between peak-area ratios of cefadroxil to dimethylphthalate (internal standard) and the cefadroxil concentration over a range of 0.02-0.8 mg/ml (r = 0.9999). Standard addition recoveries were generally greater than 97.7%. The coefficients of variation in the within-day assay were between 0.36 and 0.65, and in the between-day assay was 0.71%. The column liquid chromatographic assay results were compared with those obtained from a microbiological assay, which indicated that the proposed method is a suitable substitute for the microbiological method for potency assays and stability studies of cefadroxil preparations.

Bacillus subtilis↗