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PubMed1991

[Pharmacokinetic, bacteriological and clinical studies on cefdinir fine granules in the field of pediatrics].

The Pharmacokinetics and clinical effectiveness of cefdinir (CFDN, FK482) were examined in pediatric patients. The results are summarized as follows. 1. Plasma concentrations and urinary excretions of CFDN after administration of 5% fine granules were investigated on 4 children at a dose level of 6 mg/kg. Average plasma concentrations peaked at 4 hours after administration at 0.99 micrograms/ml with a half-life of 2.12 hours. The first 24-hour urinary recovery rates of CFDN in 3 children averaged 22.0%. 2. CFDN was given to 24 children (11 with pharyngitis, 3 with tonsillitis, 8 with scarlet fever, 1 with urinary tract infection and 1 with enteritis due to Salmonella); 15 were treated with 5% fine granules and 9 with 10% fine granules at daily doses of about 10 mg/kg in 2 to 3 divided portions. Clinical effects were excellent in 16, good in 7 and not evaluable in 1, with an overall efficacy rate of 100%. 3. Identified causative organisms were 12 strains of Streptococcus pyogenes, 4 of Haemophilus influenzae, 5 of Haemophilus parainfluenzae, 1 of Escherichia coli, and 1 of Salmonella. Bacteriological effects were rated as "eradicated" for 19 strains, "unchanged" for 4 with an eradication rate of 82.6%. 4. No side effects were observed. As for abnormal laboratory test results, a transient decrease of white blood cells was observed in 1 patient. 5. The CFDN fine granule preparations were preferably accepted by the children. 6. The fine granular preparations of CFDN, a new oral antibiotic, were useful for the treatment of bacterial infections in pediatrics.

Administration, Oral↗
PubMed1990

[Pharmacokinetic and clinical studies of cefdinir in pediatric field].

Cefdinir (CFDN) was evaluated for its efficacy and safety. The following results were obtained. 1. Pharmacokinetic study: CFDN was evaluated pharmacokinetically in 4 male children aged 9 to 13. CFDN was given orally to 3 children at a dose of 3 mg/kg. Peak plasma levels of 0.71 microgram/ml, 0.78 microgram/ml and 0.45 microgram/ml were attained in the 3 children, respectively, at 4 hours after dosing. Half-lives of CFDN in serum were 1.78 hours, 1.48 hours and 2.23 hours, respectively. The 12-hour urinary recovery rates of CFDN were 17.4%, 28.1% and 6.2%. When CFDN was given orally to the remaining child at a dose of 6 mg/kg, the peak plasma level was attained at 4 hours after dosing with a level of 1.16 micrograms/ml. T 1/2 was 1.78 hours. The 12-hour urinary recovery rate of CFDN was 15.0%. 2. Clinical study: CFDN 5 percent fine granules were given to 26 patients with infections; 2 with pneumonia, 4 with acute bronchitis, 1 with chronic bronchitis, 12 with pharyngitis, 4 with scarlet fever, 1 with otitis media and 2 with skin and soft tissue infections. Therapeutic responses were "excellent" in 15, "good" in 8, "fair" in 1 and "poor" in 2, with an efficacy rate of 88.5%. 3. Adverse reactions: As for adverse reactions, diarrhea was noted in 1 patient. It was concluded that CFDN is a useful drug for the treatment of the bacterial infections in pediatrics.

Administration, Oral↗
PubMed1990

[Pharmacokinetic and clinical studies on cefdinir fine granules in children].

A new oral cephem, cefdinir (CFDN) was evaluated for its efficacy, safety and pharmacokinetics in 13 children. The results are summarized as follows. Plasma concentration peaked at 3-4 hours after administration of 3 mg/kg of CFDN with Cmax ranging from 0.57-0.89 microgram/ml except 1 case in which the absorption of the drug was poor. Recovery rates in urine averaged at 13.4%, with a large individual variation. Ten children with 12 bacterial infections were treated with 9 mg/kg/day of CFDN fine granule. Clinical responses were good in 10 patients and fair in 1 patient, with an efficacy rate of 90.9%. No clinical adverse reactions nor abnormal laboratory findings were encountered.

Administration, Oral↗
PubMed1990

[A clinical study on cefdinir in pediatrics].

Clinical evaluations of cefdinir (CFDN, FK482) were carried out. The obtained results are summarized as follows. 1. Clinical responses to CFDN of 43 patients with pediatric infections were excellent in 23, good in 15, fair in 4 and poor in 1. The overall efficacy rate was 88%. 2. Bacteriologically, the eradication rate for 34 isolates presumed to be pathogens was evaluated and the eradication rate was 85.3%. 3. Side effects observed were diarrhea in 4 of 48 patients. The incidence was 8.3%. Abnormal laboratory findings were an elevation of GOT, an elevation of eosinophils and an increase in platelet counts. The results suggested that CFDN might be a very useful and safe drug for the treatment of pediatric infections.

Administration, Oral↗
PubMed1990

[Pharmacokinetics and clinical effects of cefdinir 5% fine granules in pediatrics].

Cefdinir (CFDN), a newly developed oral cephalosporin in 5% fine granular form, was administered to 10 boys at 1 hour before meal (in the fasting state) and concentrations of the drug in plasma and urine and its urinary recovery rates were determined. The subjects were divided into 2 groups of 5 boys each; one group received 3 mg/kg of CFDN, and the other, 6 mg/kg. To 6 of the 10 children the drug was administered in the two different dose levels using the cross-over method. To study clinical and bacteriological effects of this drug, a mean dose of 4.6 mg/kg t.i.d. was administered for 8 days on the average to 40 children with various infections; pharyngitis (4 cases), tonsillitis (2), acute bronchitis (2), pneumonia (8), scarlet fever (6), acute purulent otitis media (1), urinary tract infection (12), impetigo (2), phlegmon (1), lymphadenitis (1) and subcutaneous abscess (1). MICs were determined for 6 drugs including CFDN, cefaclor, cefixime (CFIX), methicillin, cloxacillin (MCIPC), amoxicillin (AMPC) against 13 strains of 6 species freshly isolated from children receiving CFDN. An inoculum size of 10(6) cfu/ml was used in the MIC-determinations. Adverse reactions and abnormal laboratory findings attributable to this drug were also examined in these patients. The results obtained are summarized as follows. 1. Mean plasma peak levels of CFDN were observed at 3 hours after administration in both the 3 mg/kg and 6 mg/kg groups with mean peak values of 0.68 and 1.35 micrograms/ml, respectively. Mean half-lives were 2.06 hours in the 3 mg/kg group and 1.61 hours in the 6 mg/kg group, and mean AUCs were 3.5 in the former and 6.5 micrograms.hr/ml in the latter. Thus, dose-response between the 2 doses was observed in plasma levels and AUCs. 2. To 3 patients, CFDN was given in the two different doses using the cross-over method. Mean plasma peak levels of CFDN were 0.71 and 1.31 micrograms/ml in the doses of 3 mg/kg and 6 mg/kg, respectively. Half-lives were 1.39-2.90 hours in the 3 mg/kg group and 1.21-1.48 hours in the 6 mg/kg group, with AUCs of 3.4-3.7 and 4.1-7.5 micrograms.hr/ml, respectively.(ABSTRACT TRUNCATED AT 400 WORDS)

Administration, Oral↗
PubMed1990

[Clinical and pharmacokinetic evaluation of cefdinir in children].

Thirty children were treated with cefdinir (CFDN) for the evaluation of its clinical efficacy and side effects. Their ages ranged from 1 to 9 years. The dosage of CFDN ranged from 8.1 to 15.9 mg/kg/day with the treatment continued for 2 to 10 days. Twenty-eight of the 30 patients were evaluated for clinical efficacy; 10 patients with tonsillitis, 3 with scarlet fever, 4 with lower respiratory infections, 2 with otitis media, 2 with cervical lymphadenitis, 3 with urinary tract infections and 4 with skin and soft tissue infections. The remaining 2 patients who had viral diseases were included in the evaluation for side effects. Clinical responses were excellent in 14 patients, good in 12, fair in 1 and poor in 1 with an efficacy rate of 92.9%. Diarrhea was noted in one of the 30 patients. A pharmacokinetic study on CFDN was performed in 8 fasting patients whose ages ranged from 3 to 7 years. Serum concentrations of CFDN peaked at 0.59 to 1.76 micrograms/ml (mean 1.13 microgram/ml) at 2 hours after dosing of 3 mg/kg in 4 patients, and 0.89 to 2.49 micrograms/ml (mean 1.49 micrograms/ml) 2 or 3 hours after dosing of 6 mg/kg in the other 4 patients. The 8-hour urinary excretion rates were 16.0% to 21.3% (mean 17.4%) in 4 patients given a dose of 3 mg/kg and 10.9 to 21.1% (mean 15.5%) in 4 patients given a dose of 6 mg/kg.

Administration, Oral↗
PubMed1990

[Clinical studies on cefdinir in pediatric infections].

Pharmacokinetic, bacteriological and clinical studies on cefdinir (CFDN), a newly developed oral cephalosporin, were performed on children with infections. The pharmacokinetics was examined in 3 patients. The peak plasma concentrations were 1.97 micrograms/ml, 0.84 microgram/ml and 1.67 micrograms/ml in the 3 patients. The 0 to 6 or 8-hour urinary excretion rates were 22.2%, 18.1%, and 32.7%, respectively. These results were similar to those in adult patients. Clinical response to CFDN was evaluated in 21 patients, 4 patients with pharyngitis (an efficacy rate of 100%), 7 with tonsillitis (85.7%), 1 with bronchitis (excellent), 1 with pneumonia (fair), 6 with scarlet fever (100%), 1 with staphylococcal scaled skin syndrome (good) and 1 with urinary tract infection (good). Thus, an overall efficacy rate of 90.5% was achieved. With regard to microbiological effect on pathogens, 14 of the 15 strains identified as pathogens were eradicated, with an eradication rate of 93.3%. The safety was evaluated in a total of 23 cases. Diarrhea, elevated eosinophil count and elevated S-GPT were observed in one patient each. The side effect and abnormalities in laboratory tests were not serious, however. It was concluded that CFDN, with its excellent antibacterial effect, was an efficacious and safe drug for the treatment of pediatric infections.

Administration, Oral↗
PubMed1990

[Laboratory and clinical studies on cefdinir in pediatric field].

Pharmacokinetic and clinical studies on cefdinir (CFDN) capsule and fine granules in children were performed and the following results were obtained. 1. Plasma level and urinary excretion of CFDN were determined in 10 children with ages 7 to 13 years given single doses of 2.3 to 7.5 mg/kg. Six of the 10 children received the drug orally before meal and the other 4 after meal. Plasma concentration peaked at 2 to 4 hours in the children administered the drug before meal, and at 3 to 4 hours in those given the drug after meal. The 8-hour urinary recovery rate was 18.8%. 2. Clinical efficacies were evaluated in 23 children with bacterial infections. The children were given the drug orally at dose levels of 3.3 to 6.3 mg/kg 3 times a day. Clinical effects of CFDN were excellent in 7 and good in others, hence the overall clinical efficacy rate was 100%. 3. Bacteriologically, 18 of the 19 strains of causative organisms identified were eradicated, with an overall bacteriological eradication rate of 94.7%. 4. As for side effects, loose stool was observed in 1 case, but it disappeared in a few days. In laboratory tests a slight elevation of GOT and GPT were observed in 1 case, but no additional treatment was needed. 5. CFDN is a useful oral antibiotic for the treatment of bacterial infections in pediatric field.

Administration, Oral↗
PubMed1990

[A clinical evaluation of cefdinir in pediatric infections].

Cefdinir (CFDN), a new oral cephalosporin, was administered to 10 patients with various infections and the following results were obtained. 1. Clinical responses in 10 patients (1 patient with rhinitis, 2 with sinusitis, 1 with pharyngitis, 1 with tonsillitis, 4 with scarlet fever and 1 with abscess) were excellent in 6 and good in 4 with an efficacy rate of 100%. 2. Eleven species of bacteria were isolated (3 of Staphylococcus aureus, 6 of Streptococcus pyogenes and 2 of Haemophilus influenzae) and all of them were eradicated by the treatment with CFDN. 3. No side effects or abnormal laboratory test values were noted. None of the patients refused to take the drug.

Administration, Oral↗
PubMed1990

[Clinical evaluation of a new oral cephem, cefdinir, in children].

Cefdinir (CFDN, FK482) was evaluated for its safety, efficacy and pharmacokinetics in 28 children. CFDN was effective in 100% of 22 evaluable cases with respiratory, middle ear, urinary or soft tissue infections. From the clinical response, adverse effects and the pharmacokinetic results, daily dose of 9-18 mg/kg, administered in 3 divided portions is suggested. Increase of dose will be associated with increase of gastrointestinal side effects. The data suggest that CFDN is safe and effective when used in children with infections caused by susceptible bacteria including Staphylococcus aureus.

Administration, Oral↗
PubMed1990

[Clinical studies on cefdinir granules in pediatric field].

Cefdinir (CFDN, FK482) granules, a new oral antibiotic for children, were given to children with infections. The results obtained are summarized as follows. 1. The plasma level of CFDN peaked at 0.38-0.88 microgram/ml in 2-3 hours after administration of the drug at a dose of 3 mg/kg. Meanwhile, the plasma level peaked at 1.85 micrograms/ml in 3 hours after administration of 6 mg/kg. The plasma level was higher in the 6 mg/kg group than that in the 3 mg/kg group, thus a dose response was clearly observed. 2. The 8 hour urinary excretion accounted for 10.3-17.4% of administered amount of the drug in children with 3-6 mg/kg dosage. 3. CFDN granules were administered to a total of 42 children with upper or lower airway infections or with urinary tract infections at daily doses of 9.0-20.7 mg/kg in 3 divided portions. The clinical efficacy was "excellent" in 28 patients, "good" in 13, and "fair" in 1, hence an efficacy rate of 97.6% was obtained. 4. Bacteria identified from various diseases were 29 strains of 9 species, and the eradication rate was 82.8%. 5. No. side effects were noted in any of the children. Laboratory test results showed an abnormality in 1 case each with a rise of platelet count and eosinophilia.

Administration, Oral↗
PubMed1990

[Clinical evaluation of cefdinir in pediatric field].

We studied the clinical efficacy of cefdinir (CFDN), a new oral cephalosporin, in 18 children with ages 2 years and 4 months to 11 years and 4 months with pediatric infections. The diagnoses consisted of respiratory tract infections in 15 cases, impetigo in 2 and balanoposthitis in 1. Clinical efficacies were excellent in 11 patients and good in 7, with an efficacy rate of 100%. Bacteriologically, 9 (64.3%) of the 14 strains of clinical isolates were eradicated. No side effects nor abnormal laboratory findings were observed. We have concluded that CFDN is a useful antibiotic for the treatment of mild to moderate pediatric infections.

Administration, Oral↗
PubMed1990

[Clinical study on cefdinir in pediatric field].

We studied pharmacokinetics and clinical effects of cefdinir (CFDN), a newly developed oral cephalosporin, and the following results were obtained. 1. Pharmacokinetics of CFDN in 2 patients were investigated. The 2 patients with ages of 8 years (36.5 kg, body weight) and 6 years (26.5 kg, body weight) were administered with 3 mg/kg of fine granules of CFDN on empty stomachs. Peak plasma levels of CFDN were 0.85 microgram/ml in one patient and 0.56 microgram/ml in the other. The 8-hour urinary recovery rate was 21.6% of the administered dose in one and was not calculable in the other. 2. Clinical effects of CFDN were studied in 25 children with various infectious diseases: 11 with acute pharyngitis, 1 with acute tonsillitis, 2 with acute laryngitis, 3 with acute bronchitis, 2 with acute bronchopneumonia, 4 with scarlet fever, 1 with acute otitis media, 1 with acute lymphadenitis. The efficacy rate was 96% (24/25), and the bacteriological eradication rate was 83.3% (10/12). 3. No side effects were noted. Clinical laboratory test values were investigated in 14 patients. There were no seriously abnormal laboratory test findings except a slight elevation of eosinophile and GPT.

Acute Disease↗
PubMed1990

[Laboratory and clinical studies on cefdinir in pediatric field].

Clinical trials of cefdinir (CFDN) in pediatric infections were carried out. Results are summarized as follows. 1. Mean half-lives of CFDN in serum in children when administered on an empty stomach were 1.24 hours (3 mg/kg per os) and 1.85 hours (6 mg/kg per os). 2. Mean 8 hour urinary excretion rates of CFDN were 19.0% (3 mg/kg/per os) and 10.5% (6 mg/kg per os). 3. CFDN was administered to 28 children with various infections: 12 patients with tonsillitis, 8 with bronchitis, 2 with pneumonia, 4 with urinary tract infections, 1 staphylococcal scalded skin syndrome and 1 with impetigo. The overall efficacy rate was 89.3%. 4. Diarrhea was noted in 1 patient. Abnormal laboratory test values encountered were eosinophilia in 2 patients, thrombocytosis in 1.

Adolescent↗
PubMed1990

[Studies on FK482 (Cefdinir). III. Synthesis and structure-activity relationships of 7 beta-[(Z)-2-aryl-2-hydroxyiminoacetamido]-3-vinyl-3- cephem-4-carboxylic acid derivatives].

The synthesis, antibacterial activity and oral absorption of the 7 beta-[(Z)-2-aryl-2-hydroxyiminoacetamido]-3-vinylcephalosporins (Ia--e) are described. All of these compounds exhibited excellent activity against Staphylococcus aureus. Against Gram-negative bacteria FK482 exhibited more excellent activity than the other compounds (Ia--e). These compounds except Ie showed good oral absorption. The relationship between the oral absorption rates and the lipophilicity of these cephalosporins is discussed.

Animals↗
PubMed1992

[A new oral cephem, cefdinir: its structure-activity relationships and biological profile].

This article reviews structure-activity relationships and biological properties of a new oral cephem, cefidinir (CFDN). It also describes a hypothesis concerning the absorption mechanism from the intestine. Antibacterial activities and the oral absorption efficiencies were studied with regard to 3-vinyl cephalosporins with various 7-acyl side chains. From the study, 2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetyl group was selected and various 3-substituents were screened. As a result, it was found that the vinyl compound, CFDN, showed excellent antibacterial activity and good oral absorption in rats. In vitro and in vivo antibacterial activities, the affinity for PBPs and the stability to beta-lactamases revealed that CFDN had well balanced antimicrobial activities against Gram-positive and Gram-negative bacteria and good biological properties. The pharmacokinetics of CFDN in healthy volunteers showed that serum concentration and half life were good enough to make CFDN an effective therapeutic agent. The mechanism of intestinal absorption of CFDN and related oral cephems are discussed and a hypothesis for molecular recognition by the carrier protein in the intestine is proposed.

Animals↗