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Query: UMLS:C0032285 (pneumonia)
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To evaluate pharmacokinetics and clinical efficacy of flomoxef (6315-S, FMOX) in neonates, FMOX was administered to 21 neonates. With 20 mg/kg and 40 mg/kg of intravenous drip-infusion of FMOX 60 minutes, half lives (T 1/2's) was 64.9 minutes and 130.3 minutes, respectively, and when 20 mg/kg of FMOX was infused intravenously to 2 cases, half lives were 70.8 minutes and 110.1 minutes, respectively. When 45-100 mg/kg of FMOX was administered to 17 neonates with infections (pneumonia 8, sepsis 1, sepsis suspected 2, intrauterine infection 2, urinary tract infection 2, omphalitis 2), the efficacy rate was 88.2% (15 of 17). No adverse reactions were observed clinically in the 21 neonates. Transient elevation of eosinophilia was observed in 1 case and transient elevation of S-GOT and S-GPT 1 in another. These results suggest that FMOX is an effective and safe antibiotic to use in neonates.
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PMID:[Pharmacokinetic and clinical evaluations of flomoxef in neonates]. 178 76

Flomoxef sodium (FMOX) was evaluated experimentally and clinically in neonates. 1. Serum concentrations and urinary excretions of the drug were examined after a bolus intravenous injection at 20 mg/kg to 22 neonates 1-30 days after birth (durations of pregnancy 31-43 weeks, weights at birth 1,650-4,040 g) and 5 infants 50-95 days after birth (durations of pregnancy 33-40 weeks, weights at birth 1,720-3,308 g). Serum concentrations were 10.8-67.6 micrograms/ml (mean 32.7 +/- 2.8 micrograms/ml) and 25.1-52.0 micrograms/ml (mean 38.9 +/- 4.3 micrograms/ml) in the neonates and the infants, respectively, at their peaks (0.5 hour value), decreased thereafter with half-lives of 0.96-5.59 hours (mean 2.20 +/- 0.26 hours value), and 0.97-1.54 hours (mean 1.22 +/- 0.12 hours value), respectively. Serum levels decreased to 0.2-17.1 micrograms/ml (mean 2.9 +/- 0.6 micrograms/ml) and N.D. -1.1 micrograms/ml (mean 0.4 +/- 0.2 micrograms/ml) after 8 hours, respectively. The urinary recovery rates of the drug in the first 8 hours after administration were 15.0-96.0% (mean 53.7 +/- 4.9%) and 29.9-73.3% (mean 62.4 +/- 9.4%) in the neonates and in the infants, respectively. 2. FMOX was administered to 78 neonates (durations of pregnancy 31-42 weeks, weights at birth 1,420-3,860 g) in whom bacterial infections were established or suspected, and clinical, bacteriological, and side effects were evaluated. In 47 neonates examined (1 with sepsis, 3 with acute upper respiratory infections, 18 with acute pneumonia, 1 with umbilical infection, 1 with impetigo, 4 with acute urinary tract infections, 1 with acute otitis externa, 1 with periproctal abscess, and 17 with intrauterine infections), the treatment was markedly effective in 41, and effective in 6, with an overall efficacy rate of 100%. The bacterilogical effects of the drug on 3 strains of Staphylococcus aureus, 1 strain of Streptococcus pneumoniae, 1 strain of Streptococcus agalactiae, 9 strains of Escherichia coli, and 2 strains of Haemophilus influenzae which were responsible for these infections were all rated as "eradicated". Moreover, the drug, administered with or without prophylactic intentions showed complete prophylactic effects in all 27 cases tested. No side effects were observed in any of the patients. Concerning abnormal clinical laboratory results, increases in GOT were noted in 2, eosinophilia in 1, and thrombocytosis in 1, but these abnormalities were invariably mild and the normalized in 1 patient without treatment. The results suggest that FMOX is useful and safe also in neonates.
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PMID:[Laboratory and clinical evaluations of flomoxef sodium in neonates]. 178 77

Laboratory and clinical studies were performed on a new oxacephem antibiotic, flomoxef (FMOX, 6315-S). In vitro antibacterial activity of FMOX was evaluated in comparison to latamoxef (LMOX), cefmetazole (CMZ), cefazolin (CEZ) using clinically isolated strains of Gram-negative and Gram-positive bacteria. Antibacterial activities of FMOX were stronger than LMOX, CMZ, CEZ against Escherichia coli, Klebsiella but only slightly effective against Staphylococcus aureus. This antibiotic drug was administered to 5 patients consisting of 2 cases with pneumonia, one each with pyelonephritis, chronic bronchitis and urinary tract infection. The drug was given in 1 g drip infusion twice a day for 8 to 13 days. Clinical efficacies of FMOX were excellent in 1 case, good in 2, fair in 1, and unevaluable in 1. As for bacteriological effect of FMOX, organisms were eradicated in 3 cases. No side effect was noted and there was no abnormal change in laboratory findings.
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PMID:[Laboratory and clinical studies of flomoxef]. 332 64

Pharmacokinetical, bacteriological and clinical studies of flomoxef (FMOX, 6315-S), a new cephem antibiotic, were conducted in the pediatric field. 1. Mean drug concentrations in the blood after intravenous one shot injection of FMOX 20 mg/kg to 5 children (aged 5-8 years) were 39.7 micrograms/ml at 1/4 hour, 24.1 micrograms/ml at 1/2 hour, 12.2 micrograms/ml at 1 hour, 4.7 micrograms/ml at 2 hours, 1.1 microgram/ml at 4 hours, and 0.3 microgram/ml at 6 hours. The mean half-life in blood was 0.65 hour. Mean concentrations in urine was 3,558 micrograms/ml during 0-2 hours after intravenous injection, 568 micrograms/ml during 2-4 hours, and 117 micrograms/ml during 4-6 hours. The mean 6-hour urinary recovery rate was 72.8%. 2. Clinically, FMOX was administered to 32 children (5 months to 9 years) with infections, i.e. 29 with pneumonia, 1 each with acute purulent tonsillitis, acute purulent lymphadenitis and cellulitis. The treatment was excellent in 24 cases and good in 8. Thus, the efficacy rate was 100%. 3. The bacteriological effect of FMOX was investigated using 11 clinical isolates which were considered to be causative organisms, i.e. 1 strain of Staphylococcus aureus, 1 strain of Streptococcus pneumoniae, 8 strains of Haemophilus influenzae and 1 strain of Haemophilus parainfluenzae. Except one strain (H. influenzae) which was just decreased, all the bacteria were eliminated. 4. No side effect was found at all. As abnormal laboratory findings, elevation of GOT was found in 1 case, thrombocytosis in 2, and eosinophilia in 1 but all the changes were slight and were normalized by the time of re-examination. The above results suggest that FMOX is a useful and safe drug for the pediatric practice just as in the adult field.
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PMID:[Pharmacokinetical, bacteriological and clinical studies of flomoxef in the pediatric field]. 343 Jul 14

Bacteriological and clinical studies with flomoxef (FMOX, 6315-S), a new oxacephem antibiotic, were carried out in the field of pediatrics and the results obtained are summarized as follows: 1. The antimicrobial activity of FMOX against clinically isolated organisms was determined. FMOX had a good antimicrobial activity against Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae and especially against Staphylococcus aureus (including methicillin resistant S. aureus). 2. Mean serum concentrations of FMOX following intravenous bolus injection of 20 and 40 mg/kg (in 7 and 4 cases, respectively) were 35.3 and 77.7 micrograms/ml at 15 minutes after administration with mean serum half-lives (T1/2) of 0.75 and 0.95 hours and mean urinary recovery rates up to 6 hours after administration were 71.9 and 65.1%, respectively. 3. Twenty-five pediatric patients (19 cases of pneumonia, 1 case of pyothorax and 5 cases of urinary tract infection) were treated with FMOX in doses ranging from 50 to 138 mg/kg divided into 3 or 4 times a day. The rate of clinical effectiveness was 100% and the bacterial elimination rate was 90.6%. 4. No adverse reactions were observed. Abnormal laboratory findings were eosinophilia in 1, thrombocytosis in 2 and slight elevations of GOT and GPT in 3 patients. These results indicate the usefulness and the safety of FMOX in the treatment of bacterial infections in the pediatric field.
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PMID:[Bacteriological and clinical studies of flomoxef in the field of pediatrics]. 343 Jul 15

Flomoxef (FMOX, 6315-S), a newly synthesized antibiotic which belongs to the oxacephem group, was clinically evaluated for its efficacy and safety in 17 patients with ages ranging from 1 month to 9 year-8-month who had bacterial infections. The results obtained were summarized as follows. 1. A pharmacokinetic study following 20 mg/kg FMOX administration by intravenous bolus injection showed that the half-life of FMOX (beta phase) was 39.8 minutes and the urinary excretion of FMOX in the first 6 hours was 76.5%. 2. FMOX was administered to 3 patients with pneumonia, 8 patients with bronchopneumonia, 2 patients with tonsillitis, 2 patients with pyelonephritis, one patient each with cervical lymphadenitis, and pustulosis associated with severe varicella at daily dosage levels of 61.9 approximately 87.2 mg/kg, divided into 3 or 4 administrations by intravenous bolus injection or by 30 minutes drip infusion. The clinical results of these 17 patients were as follows; excellent: 14 patients, good: 2 patients, poor: 1 patient. The efficacy rate was 94.1%. 3. No clinical adverse reaction was observed in any of the 17 patients. Neutropenia, eosinophilia, a slight elevation of GPT and slight elevations of GOT & GPT were observed in 1, 1, 1, and 2 patients, respectively. No abnormality in coagulation system was observed in any of 10 evaluable patients. 4. MICs of FMOX against 13 strains isolated from patients were as follows. MIC against 2 out of 3 strains of Streptococcus pneumoniae was 0.20 micrograms/ml and that of the remaining 1 strain was 0.39 micrograms/ml.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:[Clinical studies of flomoxef in the field of pediatrics]. 343 Jul 17

We have carried out laboratory and clinical studies on flomoxef (FMOX, 6315-S). The results were summarized as follows. FMOX was given by 5-minute intravenous administration to 3 children at a single dose of 20 mg/kg. After the intravenous administration, mean serum levels of FMOX were 110.1 +/- 30.95 micrograms/ml at the end of injection, 44.4 +/- 10.55 micrograms/ml at 15 minutes, 11.0 +/- 1.72 micrograms/ml at 1 hour and 0.42 +/- 0.17 microgram/ml at 6 hours. The mean half-life was 1.14 +/- 0.30 hours. The mean urinary excretion rate was 68.8 +/- 17.4% up to 6 hours after the intravenous administration. FMOX was given by 30-minute drip infusion to 2 children at a single dose of 20 mg/kg and to 3 children at a single dose of 40 mg/kg. After the 30-minute drip infusion, mean peak serum levels of FMOX obtained for the 2 dose levels were 45.5 +/- 0.45 micrograms/ml and 87.4 +/- 18.35 micrograms/ml at the end of injection, respectively, and mean half-lives were 0.63 +/- 0.23 hours and 0.70 +/- 0.27 hours, respectively. The mean urinary excretion rate was 53.4 +/- 6.1% up to 6 hours after the 30-minute drip infusion of 40 mg/kg FMOX. Treatment with FMOX was made in 24 cases of pediatric bacterial infections; 5 cases of purulent tonsillitis, 2 cases of bronchopneumonia, 12 cases of pneumonia, and 1 case each of lymphadenitis, pyothorax, purulent meningitis, cellulitis, and abscess. Results obtained were excellent in 15 cases and good in 9 cases. No significant side effect due to the drug was observed in any cases.
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PMID:[Laboratory and clinical studies of flomoxef in the pediatric field]. 343 Jul 18

Flomoxef (FMOX, 6315-S), a new parenteral oxacephem antibiotic was investigated for its clinical efficacy and pharmacokinetics. The results obtained are summarized below. 1. Twenty-eight patients were treated with 39-152 mg/kg per day of FMOX by intravenous administration. Diagnosis of patients were pneumonia in 15 patients, acute upper respiratory tract infection in 5, acute enterocolitis in 3, urinary tract infection in 2 and cholangitis, suppurative lymphadenitis and suspicious sepsis in 1 patient each. Clinical effect was excellent in 7 cases, good in 8, fair in 5, poor in 2 and 6 cases were excluded because therapy periods were too short and other antibiotics were used together. Efficacy rate was 68% and the rate of bacterial disappearance was 83%. 2. Rash was found in 5 cases and thrombocytosis was found in 1 out of 28 cases. However, no severe adverse reaction was encountered. 3. The peak serum level of FMOX was 51.0 micrograms/ml after 20 mg/kg of drip infusion for 30 minutes and the half-life was 17.2 minutes in alpha-phase and 58.2 minutes in beta-phase.
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PMID:[Clinical and pharmacokinetics evaluation of flomoxef in pediatrics]. 343 Jul 19

Flomoxef (FMOX, 6315-S), a new parenteral oxacephem antibiotic, was studied bacteriologically and clinically. 1. The MIC and MBC values of FMOX and cefuzonam (CZON) were determined against strains of Staphylococcus aureus recently isolated from clinical materials. In MICs against methicillin- and cefazolin (CEZ)-sensitive strains, FMOX and CZON were almost equivalent. In MBC, FMOX showed lower values than CZON. Against resistant strains, both MIC and MBC values indicated that FMOX was superior to CZON, and particularly, values showed large differences in MBC. 2. FMOX was administered intravenously at doses of 20.0-35.1 mg/kg 3 or 4 times daily to 17 children aged 2 months to 8 years. The therapeutic effect was determined in 16 cases (pneumonia 9 cases, pyothorax 1, urinary tract infection 2, staphylococcal scalded skin syndrome 1, cellulitis 2 and arthritis 1). One remaining case was unevaluable and later found to be mycoplasmal pneumonia. The effect was determined as excellent in 10 cases and good in 6 cases. All the causative organisms detected in these evaluable cases were eliminated. 3. There were no symptoms or findings that suggested the occurrence of side effects of the drug in any of the 17 cases. With regard to laboratory values, a slight elevation of GPT was found in 1 case only. 4. In a case with pyothorax, the concentration of the drug in the pleural fluid determined on the day following the initiation of treatment was 18.2 micrograms/ml at 30 minutes after intravenous injection of the drug at 33 mg/kg. The concentration was 46.7 times as high as the MIC (0.39 micrograms/ml) against the causative organism S. aureus. 5. Two doses of FMOX were intravenously administered at the dose of 50 mg/kg to a female infant ventriculoperitoneal shunt infection which had been treated with other drugs. In this case showing relatively low cell counts of 171-240/mm3 in the ventricular fluid, concentrations of the drug measured by HPLC were as low as 0.53 and 0.98 micrograms/ml 1 hour after intravenous injection of the drug. 6. The above results suggested that FMOX is a new antibiotic drug easy to use and effective for the treatment of general infections in children.
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PMID:[Bacteriological and clinical studies of flomoxef in the pediatric field]. 343 Jul 20

Pharmacokinetic and clinical studies were performed on flomoxef (FMOX, 6315-S), a new oxacephem antibiotic, as follows. 1. Pharmacokinetics Serum concentrations of FMOX were measured in 2 cases given 20 mg/kg bolus injection. In the 2 cases, peak concentrations of the drug were 44.3 and 197 micrograms/ml at 15 minutes, T1/2 (beta) were 0.76 and 0.47 hour and AUC were 44.8 and 169.5 micrograms.hr/ml, respectively. Urinary recovery rates for these cases during 6 hours were 83.1 and 54.9%, respectively. The extremely high peak serum concentration in one case may be attributed to dehydration. 2. Clinical efficacy FMOX was administrated intravenously to 12 patients, 6 with pneumonia, 2 with cellulitis, 1 each with bronchitis, tonsillitis, purulent lymphadenitis and subcutaneous abscess, in doses of 55.0-120.0 mg/kg (average 82.2 mg/kg) t.i.d. for 4-13 days (average 6.2 days). The overall efficacy rate was 100%, with excellent responses in 10 and good in 2. Bacteriological efficacy was excellent; 4 of 5 strains were eradicated and 1 strain was decreased. No clinical side effect was observed. Laboratory abnormality was observed in 1 case with transient eosinophilia. The above results suggested that FMOX would be an useful antibiotic for treating pediatric bacterial infections.
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PMID:[Pharmacokinetic and clinical experience with flomoxef in bacterial infection in children]. 343 Jul 21


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