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Volume 49, Issue 11
Displaying 1-7 of 7 articles from this issue
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YOSHIKIYO TOYONAGA, TOSHIHIDE ISHIHARA, HIRONORI NAKAMURA1996 Volume 49 Issue 11 Pages 981-993
Published: November 25, 1996
Released on J-STAGE: May 17, 2013
JOURNAL FREE ACCESSAzithromycin (AZM), a new macrolide antibiotic, in fine granules and in capsules was studied for pharmacokinetic and clinical evaluations.
1. Antibacterial activities MIC profile of AZM was as follows: 0.78-1.56 μg/ml against Staphylococcus aureus, ≤0.025-0.10 μg/ml against Streptococcus pyogenes, 0.10-0.39 and 6.25 μg/ml against Streptococcus pneumoniae, 0.025-0.39μg/ml against Moraxella (Branhamella) catarrhalis, 0.39-3.13 μg/ml against Haemophilus influenzae, and 0.20-6.25μg/ml against Haemophilus parainfluenzae.
2. Absorption and excretion The elimination half-life of AZM after its administration at 10 mg/kg/day for three days was 28.1-46.1 hours. The cumulative urinary excretion rate in the first 120 hours after start of treatment was 4.01-8.47%.
3. Clinical evaluation
AZM was given to 76 pediatric patients to treat following infections: pharyngitis in seven, tonsillitis in 11, bronchitis in 11, pneumonia in 19, Mycoplasma pneumonia in eight, scarlet fever in 13, infective enteritis in one, SSTI in four, and otitis media in two. Effectiveness of AZM was assessed in 75 patients and the drug was rated “excellent” or “good” in 71 resulting in an efficacy rate of 94.7%. 87.0% of the 46 cases indicated that AZM had eradicated bacteria identified before the treatment.
One patient complained of moderate diarrhea which disappeared after treatment of antidiarrheic. Abnormal laboratory changes were reported in 12 patients in the following: decreased leukocytes in eight, increased eosinophils in two, increased platelet count in one, and increased GPT in one. All cases of abnormality was deemed mild in severity and clinically insignificant.View full abstractDownload PDF (1409K) -
AKIHISA OKUMURA, KUNIYOSHI KUNO1996 Volume 49 Issue 11 Pages 994-1003
Published: November 25, 1996
Released on J-STAGE: May 17, 2013
JOURNAL FREE ACCESSAzithromycin (AZM), a new macrolide antibiotic, in fine granules and in capsules was administered at a standard dose of 10 mg/kg once daily for 3 days to pediatric patients with bacterial infections. AZM was studied for its pharmacokinetic and clinical evaluation.
1. AZM possessed potent activity against Gram-positive bacteria and Gram-negative bacteria that had been clinically isolated.
2. Plasma samples were collected from two patients diagnosed as having pneumonia or enteritis, and urine samples were collected from one patient diagnosed as having pneumonia for drug level determination. The drug concentrations in plasma were 0.095 and 0.204 μg/ml just before the end of treatment, and 0.017 and 0.096.μg/ml at 48 hours post-treatment. The drug concentrations in urine were 5.16.μg/ml and 5.63μg/ml during a period between 24 and 48 hours and between 48 and 72 hours after the start of treatment, respectively.
3. The drug was found effective in 37 of 38 cases with various pediatric infections. AZM treatment eradicated bacteria in 17 of 30 strains (56.7% ).
4. One patient complained of mild vomiting, while abnormal laboratory test results indicating mild eosinophilia were reported in four cases.View full abstractDownload PDF (1030K) -
YOHNOSUKE KOBAYASHI, MINORU KINO, HIROHIKO HIGASHINO, JUNJI TAKAYA, YO ...1996 Volume 49 Issue 11 Pages 1004-1012
Published: November 25, 1996
Released on J-STAGE: May 17, 2013
JOURNAL FREE ACCESSAzithromycin (AZM), 10% fine granules or 100 mg capsules, were given orally to 27 children with various pediatric infections. The results of the study are shown below.
1. Pharmacokinetic investigation
We studied plasma and urinary concentrations after 100 mg AZM capsules were given.
One patient received 8.3 mg/kg of AZM once a day for 3 days, and AZM concen tration in plasma was 0.033 μg/ml 48 hours after the final dosing.
Doses of 8.3 and 12.5 mg/kg body weight of A ZM were respectively given to two patients once daily for 3 days. As a result, AZM concentrations in urine during a period between 96 and 120 hours post-dosing were 1.67 and 4.53.Eg/ml, respectively, and urinary excretion rate in 120 hours after the first dosing was 10.54% in the patient that was given 12.5 mg/kg.
2. Clinical investigation
Clinical efficac ies were examined in 24 patients. Excellent results were obtained in 7 patients,good results in 14 patients, hence the clinical efficacy rate was 87.5%.
Bacteriologically, Haemophilus influenzae strains isolates from 2 patients were eradicated in 1 and decreased in the other.
Safety was evaluated in 26 patients. An adverse reaction was observed in 1 patient (urticaria). Abnormal laboratory test results were observed in 2 patients, decreased WBC in 1 and elevation of eosinophils in the other.
The above results suggest that AZM is a useful oral antibiotic for pediatric patients with infection with susceptible organisms.View full abstractDownload PDF (867K) -
SEIKYO FURUKAWA, TAKASHIGE OKADA1996 Volume 49 Issue 11 Pages 1013-1023
Published: November 25, 1996
Released on J-STAGE: May 17, 2013
JOURNAL FREE ACCESSFine granule preparation of azithromycin (AZM), a new macrolide antibiotic, was given to treat various infections in pediatric patients.
Efficacies of AZM in a total of 21 patients (tonsillitis in six, bronchitis in five, pneumonia in five, impetigo contagiosa in three, staphylococcal scalded skin syndrome in one and bacterial enterogastritis in one) were rated “excellent” in 11 patients and “good” in eight. The remaining two cases were not included in the evaluation.
AZM eradicated all strains of infection-causative bacteria identified in the 21 patients: Staphylococcus aureus in two, Streptococcus pneumoniae in four, Moraxella (Branhamella) catarrhalis in four, Haemophilus influenzae in six, Haemophilus parainfluenzae in three and Mycoplasma pneumoniae in one.
One patient complained of mild diarrhea, while two patients showed increases in eosinophils as abnormal laboratory changes.View full abstractDownload PDF (887K) -
TAISUKE OKADA, YUMIKO MACHIDA, MIKIYA FUJIEDA, YOSEI SHIMAZAKI, TAKANO ...1996 Volume 49 Issue 11 Pages 1024-1029
Published: November 25, 1996
Released on J-STAGE: May 17, 2013
JOURNAL FREE ACCESSAzithromycin (AZM), an oral macrolide antibiotic drug, was studied for its efficacy and pharmacokinetics in the treatment of pediatric patients with respiratory tract infections. The results of the study are presented.
Fifteen pediatric patients in an age range between 1 and 10 years were given 8.9 to 14.7 mg/kg body weight of AZM once daily for 3 to 4 days. Pharmacokinetics of AZM in three patients were examined. AZM concentration in plasma was 0.037 μg/ml at 72 hours after final dosing, while urine concentration was 10.9 μg/ml measured during a period between 72 and 96 hours post-dosing. Fourteen patient cases were included in analysis of drug efficacy for AZM. AZM was found “markedly effective” in all seven patients with pneumonia, and “effective” in all three patients with acute bronchitis, two patients with mycoplasmal pneumonia, and one patient with tonsillitis. In one patient with mycoplasmal bronchitis, AZM was found slightly effective. The efficacy rate was 92.9% (13/14). The study found one case of side effect, moderate diarrhea. No laboratory abnormality was documented.
In conclusion, an antibiotic AZM was found useful in a treatment of pediatric respiratory tract infections.View full abstractDownload PDF (630K) -
YASUSHI ISHIDA, KAICHI KIDA, HIROSHI MATSUDA1996 Volume 49 Issue 11 Pages 1030-1038
Published: November 25, 1996
Released on J-STAGE: May 17, 2013
JOURNAL FREE ACCESSAzithromycin (AZM) was studied for its concentrations in plasma and urine, efficacy and safety.
1. Plasma and urine samples were collected from one patient diagnosed as having Mycoplasma pneumonia for drug level determination. The drug was given once daily at 9.7 mg/kg body weight for three days. The drug concentrations in plasma was 0.149 μg/ml in 12 hours after the st art of the treatment, and 0.095 μg/ml at the point of 24 hours after the end of the treatment. Urinary recovery rate up to 72 hours post-dosing was 6.39%.
2. The effectiveness of AZM was assessed in 19 patients with following diagnoses: pharyngitis in two patients, bronchitis in four, pneumonia in seven and Mycoplasma pneumonia in six. The drug was rated “excellent” in 11, “good” in seven, “poor” in one, resulting in an efficacy rate of 94.7%.
3. AZM eradicated two strains of Streptococcus pyogenes and Streptococcus pneumoniae identified in patients.
4. T he AZM MIC's were 0.39μg/ml against Staphylococcus aureus, 0.20 μg/ml against S. pneumoniae,≤0.0008.μg/ml against Mycoplasma pneumoniae.
5. One patient complained of mild diarrhea, while another showed a slight increase in eosinophils, suggesting an abnormal laboratory change.
In conclusion, AZM was found useful in treatment of pediatric infections.View full abstractDownload PDF (916K) -
YUICHI OHTSUKA, YUTAKA HARADA, YOSHIRO TSUJI, YUTAKA UEHARA, TOSHIHIKO ...1996 Volume 49 Issue 11 Pages 1039-1048
Published: November 25, 1996
Released on J-STAGE: May 17, 2013
JOURNAL FREE ACCESSAzithromycin (AZM) is a new oral macrolide antibiotic drug. AZM either in 10% finegranules form or in 100 mg capsule form was studied for its pharmacokinetics and treatment efficacy in pediatric patients with various infections.
1. Pharmacokinetics
Plasma and urine samples were collected from four patients with pharyngitis and post-dosing drug levels were determined. The drug was given once daily at 10 mg/kg body weight for 3 days. The drug concentrations found in plasma at 96 hours after the first dosing (48 hours after the final dosing) lay in a range of 0.02 and 0.04 μg/ml and in urine at 120 hours after the first dosing (72 hours after the final dosing) in a range between 3.2 and 7.7 μg/ml.
AZM was found in two patients but no effect was o bserved on blood levels of theophylline determined between 48 and 96 hours after the first dosing in the treatment of underlying bronchial asthma.
2. Clinical study results Clinical studies of AZM was carried out in 25 pediatric patients with bacterial infections that mainly affected the respiratory tract. The patients received either 10% fine granules at 10 or 20 mg/kg body weight or 100 mg capsules at 10 mg/kg body weight once daily over 3 to 6 days.
The drug was found markedly effective in six patients, moderately effective in thirteen patients, while the investigators could not assess the drug efficacy in six patients. Although no side effect was reported in the study, two patients experienced slight decrease in WBC.View full abstractDownload PDF (918K)
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