rokitamycin and Bronchitis

A new macrolide antibiotic preparation, TMS-19-Q.O tablet, was used to investigate the efficacy in the treatment of patients with respiratory tract infection, and the results obtained were as follows: Three hundred and seven cases were included in this report, and overall efficacy rate was 76.2%. Especially high clinical effect (86.0%) was observed in the treatment of patients with pneumonia including mycoplasmal pneumonia. Bacteriological effect was 87.5% in 51 cases identified as single infection of Gram-positive cocci and was 48.0% in 34 cases Gram-negative rods infection. Side effects were observed in 11 cases (3.50%): gastrointestinal disorder in 8, eruption in 2 and other in 1. Abnormality in laboratory tests was observed in 23 cases, hepatic disorder in 13, renal disorder in 3 and other laboratory tests in 7. It was considered from the results of clinical and bacteriological efficacy in different dose study that dose of TMS-19-Q should be 600 mg.

Topics: Adolescent; Adult; Aged; Anti-Bacterial Agents; Bronchitis; Child; Clinical Trials as Topic; Female; Humans; Leucomycins; Male; Middle Aged; Miocamycin; Pneumonia, Mycoplasma; Respiratory Tract Infections; Staphylococcus aureus; Streptococcus pneumoniae; Tablets; Tonsillitis

We have carried out laboratory and clinical studies on rokitamycin (RKM, TMS-19-Q). The results are summarized as follows. Serum and urinary concentrations of RKM were determined in 6 children with ages between 6 and 12 years given single oral doses of 5, 10 and 15 mg/kg. Mean serum concentrations peaked at 30 minutes after administration of 5, 10 and 15 mg/kg, and respective peak values were 0.30 microgram/ml, 0.79 microgram/ml and 1.32 micrograms/ml. Biological half-lives for 5, 10 and 15 mg/kg were 2.0 hours, 1.65 hours and 1.36 hours. The 6-hour urinary recovery ranged from 1.11% to 2.58% after administration of 5 mg/kg, and the mean 6-hour urinary recoveries were 1.35% after administration of 10 mg/kg and 2.28% after administration of 15 mg/kg. Therapeutic responses were recorded as excellent or good in 22 (73.3%) of the children, comprising 6 with tonsillitis, 2 with pharyngitis, 4 with bronchitis, 1 with bronchopneumonia, 1 with Mycoplasma pneumonia, 2 with whooping cough, 5 with streptococcal infections, 5 with Campylobacter enteritis, 3 with impetigo and 1 with SSSS. The microbiological effectiveness of RKM on identified pathogens comprising 4 strains of Staphylococcus aureus, 1 strain of Streptococcus pneumoniae, 6 strains of Streptococcus pyogenes, 4 strains of Haemophilus influenzae and 5 strains of Campylobacter spp. was not so satisfactory as evidenced by a eradication rate of 50.0%. No significant side effect due to the drug was observed in any cases. In conclusion, RKM was found to be efficacious and safe for the treatment of bacterial infections in children.

Topics: Administration, Oral; Blood Chemical Analysis; Bronchitis; Campylobacter; Child; Drug Evaluation; Drug Resistance, Microbial; Enteritis; Female; Humans; Leucomycins; Male; Miocamycin; Respiratory Tract Infections; Staphylococcus aureus; Streptococcal Infections; Streptococcus pyogenes; Tonsillitis

A clinical study on rokitamycin (RKM) dry syrup was carried out and the results obtained are summarized as follows: 1. Good clinical responses were achieved with 30-40 mg/kg/day dose of RKM dry syrup. 2. Diagnostically, acute bronchitis and bronchial pneumonia responded better than other diseases examined. 3. The efficacy rate was low in the group of patients complicated by bronchial asthma.

Topics: Administration, Oral; Adolescent; Bronchitis; Bronchopneumonia; Child; Female; Humans; Leucomycins; Male; Miocamycin

A total of 22 patients with acute pediatric infections was treated with rokitamycin (TMS-19-Q, RKM) dry syrup, a new macrolide antibiotic developed by Toyo Jozo Co., Ltd., Ohhito, Japan, to investigate its clinical efficacy. 1. A girl of an age 4 years 2 months (weighing 16.5 kg) was administered orally 10 mg/kg of RKM, and a boy of an age 8 years 7 months (weighing 24.5 kg), 15 mg/kg, and blood concentrations of RKM in these subjects were measured to investigate its absorption and excretion. Blood concentrations of the drug reached a peak of 0.84 microgram/ml in an hour after the administration in the girl, 0.72 microgram/ml in 30 minutes in the boy, with T1/2 of 0.86 and 1.82 hours, respectively. Their 6-hour cumulative urinary recovery rates were 2.79 and 2.13%, respectively. 2. A total of 20 patients was treated with RKM dry syrup. These patients included 3 with acute pharyngitis, one with acute tonsillitis, 4 with hemolytic streptococcal infections, 7 with acute bronchitis, 2 with pneumonia, another 2 with pertussis, and one with Campylobacter enteritis. The treatment was effective in 18 of them with a clinical efficacy of 90.0%. 3. Bacteriological responses to RKM dry syrup were as follows: eradication of pathogens in 5, pathogens decreased in 3, and no changes were observed in 3 of 12 patients from whom pathogens had been isolated prior to the treatment, thus the eradication rate was 45.5% with the exception of 1 patient whose bacteriological response was unknown.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Oral; Adolescent; Bronchitis; Child; Child, Preschool; Drug Evaluation; Humans; Infant; Leucomycins; Miocamycin; Pharyngitis; Respiratory Tract Infections

Laboratory and clinical studies on rokitamycin (RKM) dry syrup, a new macrolide antibiotic, were carried out in the field of pediatrics. The results are summarized as follows. 1. Plasma concentrations and urinary recovery rates after oral administration on fasting of RKM dry syrup at doses of 10 mg/kg and 20 mg/kg to 2 and 1 cases, respectively, were determined. Peak plasma levels were obtained in 30 minutes after administration of both dosages with half-lives of 1.5 to 2.2 hours. A clear-cut dose response was observed. Urinary recovery rates in the first 6 hours after administration ranged from 1.75 to 2.26%. 2. The MICs of RKM against 80 clinical isolates (Streptococcus pyogenes 9, Streptococcus pneumoniae 14, Branhamella catarrhalis 4, Haemophilus influenzae 27, Haemophilus parainfluenzae 9, Haemophilus haemolyticus 2, Haemophilus parahaemolyticus 14 and Campylobacter jejuni 1) were compared with MICs of midecamycin acetate (MOM), josamycin (JM) and erythromycin (EM). The antibacterial activity of RKM was superior to those of MOM and JM and slightly inferior to that of EM. 3. Twenty-eight pediatric patients with acute infectious diseases (acute tonsillitis 4, streptococcal infection 4, acute bronchitis 9, pneumonia 4, mycoplasmal pneumonia 2 and Campylobacter enteritis 5) were treated with RKM dry syrup at a daily dose of 12-42.9 mg/kg t.i.d. as a rule. Efficacy rates were 92.9% clinically and 58.6% bacteriologically. 4. No adverse reactions were observed. Abnormal laboratory findings were mild; thrombocytosis in 2 and eosinophilia in 1. 5. The taste and the odor of RKM dry syrup preparation were sufficiently tolerable for the pediatric patients to accept it.

Topics: Administration, Oral; Bronchitis; Campylobacter Infections; Child; Child, Preschool; Drug Evaluation; Enteritis; Humans; Leucomycins; Miocamycin; Pneumonia; Respiratory Tract Infections; Streptococcal Infections

Pharmacokinetic, bacteriological and clinical studies on a new macrolide antibiotic, rokitamycin (RKM) dry syrup for pediatric use, were done, and results as summarized below were observed: 1. Five children with ages between 6 and 10 years were administered orally with RKM at a dose level of 10 mg/kg either at 30 minutes before or 30 minutes after meal on a crossover design, and plasma concentrations and urinary excretion rates of the drug were measured. Plasma concentrations of RKM following the administration before meal were 0.50 microgram/ml at 1/2 hour, 0.43 microgram/ml at 1 hour, 0.15 microgram/ml at 2 hours, 0.03 microgram/ml at 4 hours, and not detectable at 6 hours. Plasma concentrations following the administration after meal were 0.11 microgram/ml at 1/2 hour, 0.15 microgram/ml at 1 hour, 0.09 microgram/ml at 2 hours, 0.03 microgram/ml at 4 hours, and not detectable at 6 hours. The 0-6 hour urinary recovery rates were 1.41% following the administration before meal, and 0.93% following the administration after meal. These results suggested that the drug might be absorbed more rapidly, giving a higher plasma concentration, when administered before meal than when administered after meal. Changes in plasma concentrations of RKM following the administration of 10 mg/kg before meal were similar to those of two 100 mg RKM tablets (TMS-19-Q.GC tablets) to adult patients. Therefore, it seemed optimal to administer 10 mg/kg 3 times daily at fasting to children as a rule.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Administration, Oral; Blood Chemical Analysis; Bronchitis; Child; Child, Preschool; Drug Evaluation; Enteritis; Female; Humans; Leucomycins; Male; Miocamycin; Pharyngitis; Pneumonia; Respiratory Tract Infections

We studied the absorption and excretion as well as the clinical effect of rokitamycin (RKM, TMS-19-Q) dry syrup. The results we found are summarized as follows: 1. When 3 pediatric patients were medicated orally with a single dose of 10 mg/kg of the drug, its peak concentrations of 0.75 and 0.51 microgram/ml appeared in the blood in 30 minutes after administration in 2 patients, and of 0.21 microgram/ml in 1 hour in the other patient. At 4 hours after administration, its concentration in the blood was 0.07-0.08 microgram/ml in all of the patient, and at 6 hours, it was undetectable. T1/2 values were 1.05-2.08 hours. First 6-hour urinary recovery rates of the drug in the first 2 patients were 1.52 and 1.11%, respectively. 2. Twenty-four patients with 25 diseases were medicated with 7.14-12.5 mg/kg of the drug 3-4 times daily for 4-10 days. The patients consisted of 12 with tonsillitis, 7 with bronchitis, 3 with colitis, one each with Haemophilus influenzae pneumonia, mycoplasmal pneumonia, and pertussis. Clinical responses to the treatment were excellent in 7, good in 13, and poor in 5, with an efficacy rate of 80.0%. Bacteriologically, of 17 isolates whose changes were followed, 8 were eradicated, 1 decreased, and 8 remained unchanged, with an eradication rate of 47.1%. 3. No adverse reactions to the drug were observed in any of these patients, while abnormal laboratory test values observed were slight eosinophilia and also slight elevations of S-GOT and S-GPT in one of the patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Oral; Bronchitis; Child; Child, Preschool; Drug Evaluation; Enteritis; Female; Humans; Infant; Leucomycins; Male; Miocamycin; Pneumonia, Mycoplasma; Tonsillitis

The usefulness of a new macrolide antibiotic rokitamycin (RKM, TMS-19-Q) was evaluated in the field of pediatrics. 1. Twenty seven patients were enrolled in the study. One patient was excluded from the study because the illness was due to a viral infection. They included 14 boys and 13 girls with ages 7 months to 9 years 11 months. 2. The patients were treated with RKM at daily doses ranging 19.2-41.1 mg/kg, divided into 3 equal portions. The administration was done orally at fasting, lasting 2-15 days, with total doses of 22.2-500.0 mg/kg. 3. The patients were diagnostically classified into the following categories: 9 with acute pharyngitis, 15 with acute bronchitis, and one each with pneumonia, purulent lymphadenitis and Campylobacter enteritis. 4. The clinical response to the treatment was good or excellent in 22 of the patients with an overall efficacy rate of 81.5%. An efficacy rate of 88.9% was achieved for the patients with acute pharyngitis, 80.0% for those with acute bronchitis, and 100% for the patient with purulent lymphadenitis and the patient with Campylobacter enteritis. From the patient with pneumonia whose response was evaluated "fair" was Haemophilus influenzae isolated by culturing pharyngeal material. This organism was found resistant to RKM by the disk method. 5. Bacteriological responses were as follows; of 26 isolates presumed to be pathogens, 9 were eradicated, 5 decreased, 7 unchanged and 5 unknown, with an eradication rate of 42.9%. 6. Neither adverse reactions nor abnormal changes in laboratory findings were observed with the medication in any patients during and after the end of the treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Bacterial Infections; Bronchitis; Child; Child, Preschool; Drug Evaluation; Enteritis; Female; Humans; Infant; Leucomycins; Lymphadenitis; Male; Miocamycin; Pharyngitis; Pneumonia