[Study on the use of cefotiam in neonates].
Pharmacokinetic and clinical studies were carried out regarding the use of cefotiam (CTM) in the treatment of infections in newborn infants. Absorption and excretion: CTM was administered by bolus intravenous injection at a dose of 20 mg/kg to 9 newborns ranging in age from 1 to 28 days (gestational age, 34-40 weeks; birth weight, 2,000-3,380 g) and 6 infants aged 30 to 87 days (gestational age, 33 approximately 40 weeks; birth weight, 2,100-3,600 g) and its serum concentration and urinary excretion were determined. In the newborns, mean serum concentrations were 43.3 micrograms/ml at 1/4 hour, 36.7 microgram/ml at 1/2 hour, 27.8 micrograms/ml at 1 hour, 17.7 micrograms/ml at 2 hours, 8.8 micrograms/ml at 4 hours and 4.8 micrograms/ml at 6 hours, and in the infants, they were 44.5 micrograms/ml, 31.2 micrograms/ml, 19.1 micrograms/ml, 7.6 micrograms/ml, 2.2 micrograms/ml and 0.7 micrograms/ml at the above sampling times, respectively. Mean half-lives were 1.92 hours for the newborns and 0.96 hour for the infants, and mean urinary recoveries within 6 hours were 41.2% and 50.1% for the newborns and the infants, respectively. Taking individual differences into account, serum peak levels (at 1/4 hour) in newborns were very similar to each other irrespective of age (days after birth), and did not appear to be greatly different from those in infants. Half-lives, however, became shorter with aging, and the half-life of the serum CTM level in infants of about 1 month old should be close to those in young children or school-age children. From these observations, it is suggested to establish a standard regimen in which CTM is administered at a dose of 20 mg/kg once or twice a day to newborns within 3 days after birth, twice or 3 times a day to those aged 4 to 7 days, and 3 or 4 times a day to those aged 8 days or older. Clinical study: The CTM was administered to 11 patients with acute pneumonia, 2 patients each with suspected septicemia and with bullous impetigo, 1 patient with purulent lymphadenitis, 3 patients with idiopathic respiratory distress syndrome and 1 patient with pneumothorax, and its clinical effect was investigated. Excellent responses were observed in 12 of the 15 evaluated cases,good responses in 2, and a poor response in 1, thus an overall clinical effectiveness was 93.3%.(ABSTRACT TRUNCATED AT 400 WORDS)
Iwai
N
N
Taneda
Y
Y
Shibata
M
M
Mizoguchi
F
F
Nakamura
H
H
Katayama
M
M
Tauchi
N
N
Kawamura
M
M
Ozaki
T
T
Ichikawa
T
T
D000042:Absorption; D000208:Acute Disease; D002439:Cefotaxime / Q000031:analogs & derivatives* / Q000378:metabolism / Q000627:therapeutic use; D015310:Cefotiam; D005260:Female; D006207:Half-Life; D006801:Humans; D007231:Infant, Newborn; D007700:Kinetics; D008297:Male; D011014:Pneumonia / Q000188:drug therapy* / Q000378:metabolism
D015310:Cefotiam; D002439:Cefotaxime