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Clinical effect of cefadroxil (CDX) against urinary tract infections was reported herein. CDX, a daily dose of 0.75 g t.i.d., has been applied for the treatment of (I) 40 cases with simple UTI for average 6.4 days and (II) 47 cases with the complicated UTI for average 8.9 days. Rates of effectiveness were obtained 95% in (I) and 57% in (II). Side effects were noted in 10 cases (9.3%) out of total 107 cases.
Cefadroxil (CDX), a new semisynthetic cephalosporin derivative, was administered to 20 patients with acute or chronic otolaryngological infections and following results were obtained. Of 11 cases with acute infections such as acute otitis media, acute otitis externa and postoperative maxillary cyst, excellent, good and fair results were obtained in 10 cases, the efficacy ratio being 91%, while the efficacy ratio in 9 cases with chronic infections such as chronic pharyngolaryngitis and chronic otitis media was 56%. CDX is, therefore, extremely effective for acute otolaryngological infections. No severe side effect was observed, although there were 2 cases with minor adverse effects, one with drug induced eruption and the other with stomatitis.
The newly developed cefadroxil (CDX) dry syrup in a mean daily dose of 32.9 mg/kg t.i.d. or q.i.d. was administered to children for a period of 8 days on the average; viz. a total of 64 cases consisting of 39 cases of tonsillitis, 2 of tonsillitis complicated with otitis media, 1 of bronchitis, 1 of pneumonia, 14 of scarlet fever, and 7 of urinary tract infections; and its clinical and bacteriological effects, and adverse reactions were examined, leading to the following results. 1. The clinical effects were "good" or "excellent" in any of 39 cases of tonsillitis, 2 of tonsillitis complicated with otitis media, 1 of pneumonia, 14 of scarlet fever, and 7 of urinary tract infections, and "fair" only in a case of bronchitis, showing the high efficacy of 98.4%. 2. The clinical effects by daily dose were compared only in the great cases of tonsillitis between the 2 daily dose groups of 30 mg/kg or below and 31 to 40 mg/kg, and both groups showed "good" or "excellent" results, but the latter group revealed that the excellent rate was greater by 20.8% than that of the former group. 3. The frequency of daily administration was 3 times or 4 times and the cases of 4 times administration were few in any disease. In comparison of clinical effects between the 3 times group and the 4 times group in the whole cases, no significant difference was observed between both groups but it is desirable to make the 4 times administration in view of the pharmacokinetics. 4. The bacteriological effects could be judged in 15 cases, namely bacteria were eradicated in 14 cases and unchanged in 1 case, showing a good result of the eradication rate as 93.3%. 5. No adverse reaction was observed and the laboratory test values showed eosinophilia in 7 cases (15.9%) and abnormal elevations of GPT in 1 case (4.5%), of GOT and GPT in 2 case (9.1%), of LDH in 1 case (4.8%) and of BUN in 1 case (4.8%), but 4 of the 7 cases with eosinophilia seemed attributable to underlying diseases or objective diseases. From the above it can be said that this preparation is a useful drug in mild bacterial diseases.
The present paper reports the results which were obtained in a clinical trial of cefadroxil (CDX), a new oral cephalosporin, in the pediatric field. (1) A total of 20 patients with infectious diseases including 9 urinary tract infection, 7 acute tonsillitis, 2 scarlet fever, 1 pyodermia and 1 recurrent bronchitis were treated with CDX. Of the 20 cases, the clinical response was excellent in 15 cases (75%), good in 4 cases (20%), and fair in 1 case (5%). (2) Efficacy classified by causative organisms was as follows; E. coli, 100%; S. pyogenes, 87.5%. (3) Neither adverse reactions nor abnormal laboratory results were observed.
The authors have carried out the laboratory and clinical studies of cefadroxil (CDX). The results were as follows; The sensitivity was measured by plate dilution method on 27 strains of S. aureus and E. coli, 26 strains of K. pneumoniae isolated from patients. The distribution of sensitivity of S. aureus was 3.13-12.5 microgram/ml and the peak of distribution was 3.13 microgram/ml and 6.25 microgram/ml, of E. coli was 6.25 microgram/ml by 10(8) cells/ml. And the distribution of sensitivity of K. pneumoniae was 6.25-25 microgram/ml and its peak was 6.25 microgram/ml by 10(8) cells/ml. CDX were given orally at dose of 10 mg/kg to 3 children. The serum levels of CDX were 10.5 +/- 1.78 microgram/ml, 15.8 +/- 3.25 microgram/ml, 12.0 +/- 0.41 microgram/ml and 3.9 +/- 0.9 microgram/ml at 0.5, 1, 2, 4 hours after administration respectively, and was 2.3 +/- 0.48 microgram/ml at 6 hours. The urinary excretion rate was 55.6% up to 8 hours after administration. CDX were administered to 39 cases of pediatric infectious disease (26 cases with tonsillitis, 5 cases with enterocolitis, 3 cases with UTI, 2 cases with impetigo, each one case with bronchitis, cervical lymphadenitis and epididymitis). And CDX were given 25.0-65.2 mg/kg daily. Clinical results obtained were above good in all cases. No side effects were observed in any cases, except for one case, with diarrhea, 6 cases with the elevation of serum transaminase and 1 case with eosinophilia.
The pharmacokinetics of 7-[D-(-)-alpha-amino-alpha-(4-hydroxyphenyl)-acetamido]-3-methyl-3-cefen-4-carboxylic acid (cefadroxil) were studied in rabbits with normal renal function and with varying degrees of experimentally caused renal impairment. All the animals included in the survey received a single i.v. dose of 30 mg/kg of the antibiotic. The following variations may be observed in the parameters established for the rabbits with altered renal function with respect to the rabbits with normal renal function: alpha, beta,K12, K21, K13, Vc and Vp decrease, and t 1/2 alpha, t 1/2 beta, and (AUC) infinity o increase. Linear relationships are established between the plasma urea and creatinine values, indices of the degree of renal function, and log k13. There is an increase in biliary excretion in rabbits with renal impairment and a linear relationship between the percentage of the antibiotic excreted and the plasma urea and a creatinine values. In rabbits with normal renal function a linear relationship may be found between the elimination rate of the drug in urine and the plasma concentration of the antibiotic.
(1) Cefadroxil powder for syrup was administered in 24 cases of respiratory tract infection and urinary tract infection, and the efficacy was obtained in 21 cases, effective ratio being 87.5%. (2) Clinical effect could be obtained satisfactorily at a daily dose of 10-15 mg/kg divided into 3 times after each meal. (3) As to the side effect, GOT and GPT rose in 1 case, and stomatitis in 1 case, though the patients returned to normal after discontinuation of the drug. (4) Haemophilus appeared by pharyngeal culture after administration of the drug, and attention should be paid on an alteration of pharyngeal flora.
MIC of cefadroxil (CDX) against A group beta-Streptococcus was distributed between 0.05-0.2 microgram/ml, that is, more susceptible than cephalexin (CEX) an cefaclor (CCL), and susceptible to tetracycline (TC), erythromycin (EM), lincomycin (LCM) resistant strains. Serum level was higher than CCL administered orally at the same dose, and urinary excretion ratio after oral administration was good similarly to CEX and CCL. Patients treated were mostly scarlet fever and upper respiratory tract infections as acute tonsillitis and lacunar tonsillitis. They responded well to CDX at a daily dose of 30 mg/kg divided into 3-4 times. All cases of scarlet fever became normal temperature within 2 days. Among 14 cases in which A group beta-hemolytic Streptococcus was detected by pharyngeal sputum culture at admission, 11 cases became negative on the 1st day. This result was superior to CEX, when this drug was administered orally at a daily dose of 40-60 mg/kg, bacteria became negative at the ratio of 73.3% on the 2nd day. CDX was effective for acute tonsillitis, lacunar tonsillitis, acute bronchitis, impetigo and maxillary lymphadenitis in which numerous A group beta-Streptococcus, Staphylococcus aureus and Haemophilus influenzae were proven, as well as for acute urinary tract infection due to Escherichia coli. Clinical results of CDX in totalling 69 cases were excellent in 63 cases, good in 6 cases, efficacy ratio being 100%. No local nor systemic side effects were observed in 69 cases including maximum 11 days' treatment, as well as no effect was noticed on hepatic and renal functions. From the above results, it was concluded that satisfactory treatment results may be obtained with CDX dry syrup for children at a daily dose of 20-50 mg/kg divided into 3-4 times in acute infections due to CDX susceptible pathogens.
Clinical efficacy was studied with cefadroxil powder for syrup in 35 pediatric patients including 20 acute tonsillitis and pharyngitis, 6 scarlet fever, 2 cervical lymphadenitis and 7 urinary tract infections. The results indicated a 97% effectiveness when 'excellent' and 'good' ratings were combined. A mild skin rash was observed in 1 patient.
In a randomized crossover study, the pharmacokinetics of two new cephalosporin antibiotics, cefaclor (CCL), and cefadroxil (CDX), were determined after oral administration of 1000 mg (capsules) on an empty stomach in 12 normal subjects in comparison to cephalexin (CEX). Serum concentrations were measured during a period of 8 h and urine recovery during 24 h. The significant parameters of bioavailability of an orally administered substance were determined. The maximum serum concentrations (ymax) were 38.8 +/- 8.1 mg/l (CEX), 34.6 +/0 7.8 mg/l (CCL), 33.0 +/- 5.4 mg/l (CDX); the areas under the curve were 93.0 +/- 14.8 h . mg/l (CEX), 74.5 +/- 9.9 h . mg/l (CCL), and 108.5 +/- 18.4 h . mg/l (CDX). In a further crossover study with 6 subjects, 1000 mg CEX and CDX were given during a standard breakfast. The ymax of CEX decreased to 23.1 +/- 6.6 mg/l in contrast to CDX with an unchanged ymax of 32.7 +/- 3.4 mg/l.
The antibacterial activity of some ureido, acylureido and carbamoylureido derivatives of cephalexin and cefadroxil, prepared in our laboratories, as compared to parent compounds is reported. Only the 7-[D-alpha-(imidazolidin-2-one-1-ylcarbonylamino)-alpha-phenylacetamido]-3-methyl-3-cephem-4-carboxylic acid (IV d) and the 7-[D-alpha-(imidazolidin-2-one-1-ylcarbonylamino)-alpha-p-hydroxyphenylacetamido]-3-methyl-3-cephem-4-carboxylic acid (V c) showed some antibiotic activity. However we found no activity improvement against Pseudomonas strains (contrary to the results obtained in similar penicillin derivatives) and a lower beta-lactamase resistance.
We compared efficacy of cefadroxil and generic and proprietary cephalexin in treatment of pyoderma in dogs. Forty-four dogs were randomly assigned to receive 1 of the 3 preparations at 22 to 35 mg/kg body weight, every 12 hours. Dogs were examined at the conclusion of treatment period and assessed as to degree of improvement. All 3 cephalosporins were effective and safe antibiotics for the treatment of pyoderma in dogs.
The in vitro activity of loracarbef, penicillin V, cefaclor and cefadroxil against log and stationary phase cultures of group A streptococci was compared. MICs and MBCs were determined with the broth dilution method and by a modified agar plate dilution technique where the beta-lactams were inactivated after the MICs were determined allowing inhibited but not killed organisms to grow on further incubation. The MICs of loracarbef and the two cephalosporins were 16-32 times higher than those of penicillin V. In plate dilution the MBC/MIC ratios of all agents were < or = 2 for log phase cultures. With stationary phase cultures, especially in the broth dilution test, the MBC/MIC ratios of loracarbef and the two cephalosporins were > or = 32 for a large number of strains. The phenotype response of stationary phase cultures to beta-lactam antibiotics may not only be related to the physiological status of the streptococci, to the culture conditions and to the beta-lactam under test. The present investigation indicated that the phenotypic response was also an intrinsic property of certain strains.
BL-S 578 (Cefadroxil) is a new orally active semisynthetic cephalosporin antibiotic with broad-spectrum antibacterial activity. The new compound was evaluated in vitro in comparison with cephalexin. Some properties studies such as, antibacterial activity, binding with serum proteins and stability in acid and neutral solution at 37 degrees C for both cephalosporins were similar. In experimental infections of mice, the protective action of BL-S 578 was more effective than cephalexin against Staphylococcus aureus and Streptococcus pneumoniae. BL-S 578 was more resistant than cephalexin to the beta-lactamases produced by Klebsiella pneumoniae and Escherichia coli.
Pharmacokinetics of cefadroxil, a new orally semisynthetic cephalosporin, was studied in 5 subjects with normal renal function and in 20 patients with varying degrees of renal insufficiency. All subjects received 1,000 mg per os in a single dose and the elimination phase was studied. In healthy subjects, elimination half-life (T1/2) was 1.39 +/- 0.06 h. Apparent volume of distribution was 0.305 liters/kg and area under the serum concentration versus time curve AUC was 82.94 +/- 19.98 microgram . h/ml. Peak level averaged 25.72 +/- 4.68 microgram . ml-1 and occurred at 1.20 +/- 0.45 h postingestion. 93.0 +/- 3.6% of the dose was recovered in urine during the first 24 h. Renal and serum clearance averaged 166.7 and 172.4 ml . min-1/1.73 m2, respectively. In patients with renal insufficiency, T1/2 increased to 25.49 h in severe chronic renal failure. Renal impairment did not significantly modify volume of distribution. During a 6- to 8-hour hemodialysis session, antibiotic serum concentrations decreased by 75.4 +/- 5.6%. Dosage schedules could be suggested on the basis of these pharmacokinetic results.
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