cefmenoxime and Infant--Premature--Diseases

Pharmacokinetic and clinical studies on cefmenoxime (CMX) in neonates and premature infants were conducted. The results are summarized as follows. 1. Intravenous administration of CMX at 20 mg/kg, via bolus injection or 1-hour drip infusion, produced at sufficiently high blood concentration. As it is the case with other cephem antibiotics, the half-life varied with age and tended to become shorter with aging. 2. There were intergroup differences in urinary recovery of the drug, but urinary concentrations were generally high. 3. In the clinical evaluation, 12 out of 15 cases which were evaluable for efficacy were rated "excellent" or "good". 4. Side effects were evaluated in 27 cases. A bleeding tendency was found in 1 case, eosinophilia in 1 case, elevated GOT in 1 case, and positive PIVKA II in 4 cases. It is, therefore, concluded that CMX is a highly useful drug for the treatment of bacterial infections in neonates and premature infants.

Topics: Bacterial Infections; Cefmenoxime; Drug Evaluation; Female; Humans; Infant, Newborn; Infant, Premature, Diseases; Male

Serum concentrations and urinary recovery rates of cefmenoxime (CMX) were determined in 41 mature and premature infants (with ages 0-24 days) after one shot intravenous injection of 10, 20 (1-hour intravenous drip infusion was also carried out) or 30 mg/kg for treatment and prophylaxis of various infections. Because the number of cases included was small, a comparison study was conducted by classifying them into 3 groups; 3 days or younger, 4 to 7 days, and 8 days or older, rather than dividing them into groups of mature and premature infants. Clinical evaluation was conducted in 7 male and 1 female cases 1 to 29 days old, whose diseases comprised 1 case each with septicemia, purulent otitis media and phlegmonous cellulitis, 3 with pneumonia and 2 with urinary tract infection. 1. Changes in serum concentrations and urinary recovery rates (1) Intravenous bolus injection of 10 mg/kg: Serum concentrations of the drug in the 3 age groups peaked at 28.9, 29.5 and 29.1 micrograms/ml, respectively, all at 30 minutes after the drug administration, and thereafter gradually declined. The mean level in the 3rd group was the lowest at 1.9 micrograms/ml at 6 hours. Average serum half-lives of CMX were shorter in older subjects, 3.0, 1.9 and 1.4 hours, respectively in the 3 groups. Urinary recovery rates were relatively high, 68.9 to 84.9% in the 3 cases examined during the first 6 hours, and 15.4 to 66.2% during the first 2 hours. (2) Intravenous bolus injection of 20 mg/kg: Serum concentrations of the drug in the 3 groups peaked at 65.2, 60.5 and 65.8 micrograms/ml, respectively, all at 30 minutes after the drug administration, with no significant differences noted among the groups. The levels gradually declined thereafter in all groups, but remained rather high at 20.1, 6.5 and 9.5 micrograms/ml, respectively, at 6 hours. Average serum half-lives of CMX were 3.5, 1.7 and 1.9 hours, respectively. The inversion of values obtained between the 2nd and 3rd groups appears to be attributable to that all of the 3rd group were premature infants, and the body weight of 2 cases of them were less than 2,000 g each. Urinary recovery rates ranged widely from 37.0 to 89.4% in the 4 cases examined during the first 6 hours. (3) One-hour intravenous drip infusion of 20 mg/kg: Serum concentrations of the drug in the 3 groups peaked at 57.7, 60.2 and 72.4 micrograms/ml, respectively, all at the termination of the drug infusion.(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Bacterial Infections; Cefmenoxime; Cellulitis; Drug Evaluation; Female; Humans; Infant, Newborn; Infant, Premature, Diseases; Male; Otitis Media, Suppurative; Pneumonia; Sepsis; Urinary Tract Infections

Cefmenoxime (CMX) was evaluated for its absorption and excretion as well as for therapeutic effectiveness in neonates and premature infants. The following results were obtained. 1. Serum concentrations of the drug were examined in 3 premature infants 1 to 11 days old upon intravenous administration of about 10 mg/kg body weight (1st group), in 2 premature infants 18 and 32 days old and 1 neonate 17 days old upon intravenous administration of about 20 mg/kg (2nd group), and in 1 neonate 15 days old with meningitis upon intravenous administration of 45.2 mg/kg. Concentrations of CMX at 30 minutes after administration were 43, 29 and 27 micrograms/ml, respectively, in the 1st group, 46, 37 and 44 micrograms/ml, respectively, in the 2nd group and 208 micrograms/ml in the other neonate, and appeared to be dose-dependent. Concentrations of CMX at 6 hours after administration were 18.2, 6.6 and 8.1 micrograms/ml, respectively, in the 1st group, 9.6, 11 and 1.35 micrograms/ml, respectively, in the 2nd group and 5.2 micrograms/ml in the other subject. Serum half-lives were, respectively, 4.59, 2.85 and 3.48 hours in the 1st group, 2.52, 2.73 and 1.14 hours in the 2nd group and 1.0 hour in the other subject. Urinary recovery rates during the first 6 hours after administration were 45.8, 87.0, 50.2 and more than 100% in 4 cases examined. Two of these cases, in which recovery rates were 45.8 and 50.2%, were premature infants of low birth weight. Spinal fluid concentrations of the drug at 80 to 90 minutes after dosing to 1 neonate with purulent meningitis (causative organism presumed: Escherichia coli) given 48.3 mg/kg tended to decline gradually with the recovery of the disease, 3.8, 1.72 and 1.32 micrograms/ml on the 2nd, 6th and 8th day, respectively. 2. The drug was given to 9 neonates 0 to 24 days old. The therapeutic effectiveness on bacterial infections was evaluated in 7 cases (10 diseases) including 1 disease of purulent meningitis presumably caused by E. coli, 4 of septicemia caused by E. coli, Staphylococcus aureus and Streptococcus agalactiae (1, 2 and 1, respectively), 3 of urinary tract infection caused by E. coli, Serratia and Enterococcus faecalis (1 each), 1 of purulent parotitis caused by S. aureus and 1 of pneumonia (causative organism was unknown). Therapeutic efficacies were assessed as "Excellent" in all of meningitis, septicemia and urinary tract infection cases, and "Good" in 1 each of purulent parotitis and pneumonia cases.(ABSTRACT TRUNCATED

Topics: Bacterial Infections; Cefmenoxime; Drug Evaluation; Female; Humans; Infant, Newborn; Infant, Premature, Diseases; Male

Cefmenoxime (CMX) was administered by intravenous bolus injection to a total of 23 neonates and premature babies with aged 1 to 26 days at a dose of 10 or 20 mg/kg and their plasma and urine concentrations and urinary recovery rates were determined up to 6 hours after administration. In addition, for the treatment of bacterial infections, diagnosed or suspected, or for the prophylaxis of bacterial infections, the drug was administered to a total of 27 neonates, premature babies and infants, with ages of 0 day to 3 months. It was possible to evaluate therapeutic efficacy and prophylactic efficacy in 15 cases and 7 cases, respectively. In these cases, side effects and bacteriological effects and, in some of them, changes in laboratory test values were also investigated. The obtained results are summarized below. 1. At a dose level of 10 mg/kg (n = 7), peak plasma concentrations at 5 minutes after administration, were 42.6 microns/ml in neonates with ages of 15 to 21 days and 45.9 microns/ml in those with ages of 22 to 28 days in a group of less than 2,500 g b.w. (birth weight), and 36.9 microns/ml in neonates with ages of 4-7 days and 38.9 microns/ml in those of 8-14 days in the other group of greater than of equal to 2,500 g b.w., indicating no large differences among the 4 subgroups (each of the above concentration values is either the value for an individual when only one neonates was involved or a mean value when 2 or more neonates were involved. The same applies hereinafter). Though 1 exceptional case showed a biphasic change, its cause is unknown. Half-lives in the above-mentioned 4 subgroups were 1.5, 1.6, 2.4 and 1.9 hours, respectively. The half-life of 2.4 hours in 1 patient with an age of 5 days of the greater than or equal to 2,500 g b.w. group was longer than in any of the other 3 subgroups. 2. At 20 mg/kg (n = 16) dosage level, mean peak plasma concentrations were 63.8 microns/ml in the infants of 0-3 days, 68.1 microns/ml in those of 8-14 days and 59.4 microns/ml in those of 15-21 days in the group of less than 2,500 g b.w., and 109.9 microns/ml in the neonates aged 8-14 days and 79.7 microns/ml in those of 15-21 days in the group greater than or equal to 2,500 g b.w.(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Bacterial Infections; Cefmenoxime; Drug Evaluation; Female; Humans; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Male; Maxillary Sinusitis; Pneumonia; Sepsis; Urinary Tract Infections