cefroxadine and Respiratory-Tract-Infections

In this multicentre trial, 1072 hospitalized children, 573 boys and 499 girls (847 of whom were aged less than 6 years), affected by respiratory tract (376 patients) or ENT (696 patients) infections were treated for 10 days with cefroxadine per os, at an average dose of 650 mg/day (325 mg every 12 h corresponding to 25 mg/kg b.w.). Most patients (1047; 97.7%) completed the trial, while 25 patients were withdrawn from the study (20 patients for viral diseases and 5 for side-effects). Of the patients affected by respiratory tract infections, 361 completed the trial and 342 of them (94.7%) were cured in 6.0 days on average. Of the patients affected by ENT infections, 686 completed the trial and 649 of them (94.6%) were also cured in an average of 6.0 days. In the two groups the signs and symptoms of the disease significantly (p less than 0.001) decreased by the end of the study. Some patients (80; 7.6%) complained of side-effects, mainly gastric discomfort (4.9%), skin rash (2.2%) and glossitis (0.5%). In conclusion, cefroxadine exerts a satisfactory antibacterial action with only a few days of treatment, and it appears to be very well tolerated.

Topics: Bacterial Infections; Cephalosporins; Cephradine; Child; Child, Preschool; Female; Humans; Infant; Infant, Newborn; Male; Otorhinolaryngologic Diseases; Respiratory Tract Infections

The in vitro susceptibilities of various causative organisms recently isolated from patients with primary respiratory tract infections to BRL 25000 (a formulation of amoxicillin, 2 parts, and potassium clavulanate, 1 part), amoxicillin (AMPC), cefaclor (CCL), cephalexin (CEX), cefadroxil (CDX) and cefroxadine (CXD) were determined. beta-Lactamase producing strains were detected by nitrocefin chromogenic method and PCG acidometric method. The frequency of isolation of beta-lactamase production in strains of S. aureus, H. influenzae, B. catarrhalis and K. pneumoniae was 92%, 18%, 36% and 98%, respectively. Against S. aureus strains with MIC values to AMPC of less than or equal to 100 micrograms/ml and CEX of less than or equal to 25 micrograms/ml BRL 25000 showed MIC values in the range 0.39-6.25 micrograms/ml with inocula of 10(6) CFU/ml, while BRL 25000 required 12.5-100 micrograms/ml of concentrations for inhibition of the strains with MIC values to AMPC of greater than 100 micrograms/ml and CEX of greater than or equal to 25 micrograms/ml. Against S. pyogenes and S. pneumoniae BRL 25000 showed MIC values in the range less than 0.024-0.10 micrograms/ml with inocula of 10(6) CFU/ml, which is much more active than CCL, CEX, CDX and CXD and slight less active than AMPC. Against H. influenzae and B. catarrhalis BRL 25000 showed MIC values in the range 0.20-6.25 micrograms/ml with inocula of 10(6) CFU/ml, which showed most potent activity among the agents tested. The activity of BRL 25000 against K. pneumoniae was approximately equal to that of CCL and superior to that of AMPC, CEX, CDX and CXD.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria; beta-Lactamases; Cefaclor; Cefadroxil; Cephalexin; Cephradine; Clavulanic Acids; Drug Combinations; Drug Evaluation; Humans; Respiratory Tract Infections

Topics: Anti-Bacterial Agents; Cephalosporins; Cephradine; Humans; Otorhinolaryngologic Diseases; Respiratory Tract Infections

Basic and clinical evaluations of cefroxadine were carried out in children, and the following results were obtained. 1. Cefroxadine 20 mg/kg was administered to 9 children with heart disease for the prophylaxis against infections before undergoing cardiocatheterization and cardioangiography, and serum levels were determined. Peak levels reached after 30 minutes in 4 of the 9 cases, with a mean peak level of 22.5 mcg/ml and after 1 hour in 5 cases, with a mean peak level of 16.2 mcg/ml. Half life was 3.1 hours in the former group in a 6-hour blood sampling (1.04 hours in a 2-hour sampling) while in the latter group it was 1.37 hours. 2. Clinical responses were evaluated in 56 children comprising 23 cases of pharyngitis, 8 of tonsillitis, 13 of scarlet fever, 10 of urinary tract infections and 2 of impetigo. Fifty of these cases had excellent and good responses showing a efficacy rate of 89.3%. 3. From 42 of the cases, 43 strains were isolated as causative organisms. Major organisms included 27 strains of S. pyogenes, 9 of E. coli and 3 of S. aureus. As for bacteriological responses, all strains were eradicated. 4. No severe side effects were observed except for diarrhea of 1 cases and eosinophilia of 2 cases. Furthermore, no children refused to take cefroxadine dry syrup.

Topics: Cephalosporins; Cephradine; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Female; Humans; Infant; Male; Respiratory Tract Infections; Urinary Tract Infections

The clinical and pharmacokinetic studies of cefroxadine (CXD) dry syrup were conducted, and the following results were obtained. 1. A single dose of CXD either 10 mg/kg or 20 mg/kg was given to 2 patients each, and serum levels were peaked in the range of about 10 to 11 microgram/ml. 2. About 30 mg/kg of CXD per day was administered to 47 infants and children (37; upper and lower respiratory tract infection, 3; urinary tract infection, 7; Others) aged from 6 months to 8 years and 1 month weighing 8 to 29 kg, and a 97.8% (44 out of 45) of clinical response was obtained except for 2 cases whose efficacies were uncertain. 3. As the drug-induced side effects, only transient loose stool was observed in 2 cases. This, however, allowed to continue the treatment.

Topics: Cephalosporins; Cephradine; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Female; Humans; Infant; Male; Respiratory Tract Infections

Cefroxadine dry syrup was administered to 57 children with acute febrile respiratory tract infections and 2 children with scarlet fever in the dose of 40 mg/kg/day q.i.d. for 2 approximately 7 days. 65 strains of organism were isolated as pathogen from the 59 patients, and 50 of the 65 strains (76.9%) showed bacteriologically good responses. Clinically, 55 children (93.2%) had good response. Out of 63 strains isolated from the 57 cases with respiratory infections, 48 strains (76.2%) showed good bacteriological response. As for the type of pathogen, all strains of Staphylococcus aureus, 86.4% of Streptococcus haemolyticus and 90.0% of Streptococcus pneumoniae had good response, but as for Haemophilus influenzae it was only 47.6%. In one child, Streptococcus pneumoniae appeared during cefroxadine treatment in addition to the preexisting Haemophilus influenza. From the 4 children having no response for their respiratory infections, H. influenzae were isolated in 3 cases and Streptococcus haemolyticus was isolated in 1 case, before starting the treatment. As for side effects, mild diarrhea developed in only 3 children.

Topics: Cephalosporins; Cephradine; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male; Respiratory Tract Infections; Scarlet Fever

Clinical evaluation was carried out on cefroxadine dry syrup (containing 100 mg of cefroxadine per 1 g) for child use, and the following results were obtained. 1. Serum levels: Peak serum levels at 1 hour after single administration of CXD 100 mg (9.1 mg/kg) to a 4-year old child (11kg) and 300 mg (12.8 mg/kg) to a 8-year old child (23.5 kg) were 20.32 microgram/ml and 18.75 microgram/ml, respectively. They declined to 0.78 microgram/ml and 0.88 microgram/ml respectively after 6 hours and to undetectable levels after 8 hours. Half-life was 1 hour and 1.2 hours, respectively. CXD has shown the same concentration pattern as CEX, except for the fact that serum levels were peaked after 30 minutes and not detectable after 6 hours. 2. Clinical responses: CXD was administered, for 7 days, to 33 children with scarlet fever in the dosage of greater than or equal 20 approximately less than 60 mg/kg/day (7 children in greater than or equal to 20 approximately 30 mg/kg/day, 21 in greater than or equal to 30 approximately less than 40 mg/kg/day and 5 in greater than or equal to 40 approximately less than 60 mg/kg/day). Clinical responses were excellent in 19 cases and good in 14 cases, with an efficacy rate of 100%. All strains of group A Streptococcus isolated from the pharynx of 22 children were eradicated within 24 hours. In 1 case each of acute pharyngitis, acute tonsillitis, acute laryngotracheitis and staphylococcal scalded skin syndrome, the dosage of greater than or equal to 30 approximately less than 45 mg/kg/day produced a 100% good clinical response and eliminated the causative pathogens. 3. Side effect: Only 2 cases of eosinophilia were observed in hematologic study as well as in hepatic and renal function tests before and after administration.

Topics: Cephalosporins; Cephradine; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Female; Humans; Infant; Male; Respiratory Tract Infections; Scarlet Fever