Journal of Chemotherapy
ISSN: 1120-009X (Print) 1973-9478 (Online) Journal homepage: http://www.tandfonline.com/loi/yjoc20
Cefuroxime Axetil in the Treatment of Acute Otitis Media in Children G.A. Syrogiannopoulos, P.D. Goumas, F.A. Haliotis, C.G. Lygatsikas, C.D. Spyropoulos & N.G. Beratis To cite this article: G.A. Syrogiannopoulos, P.D. Goumas, F.A. Haliotis, C.G. Lygatsikas, C.D. Spyropoulos & N.G. Beratis (1992) Cefuroxime Axetil in the Treatment of Acute Otitis Media in Children, Journal of Chemotherapy, 4:4, 221-224, DOI: 10.1080/1120009X.1992.11739168 To link to this article: http://dx.doi.org/10.1080/1120009X.1992.11739168
Published online: 15 Jul 2016.
Submit your article to this journal
Article views: 1
View related articles
Citing articles: 2 View citing articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=yjoc20 Download by: [Cornell University Library]
Date: 13 July 2017, At: 21:30
Journal of Chemotherapy
Cefuroxime Axetil in the Treatment of Acute Otitis Media in Children G.A. P.D . C.G. C.D.
SYROGIANNOPOULOS * GOUMAS ** - F.A. HALIOTIS * LYGATSIKAS ** SPYROPOULOS ** - N.G. BERATIS *
Summary
--------------------------~-----
Cefuroxime axetil was evaluated for clinical efficacy and tolerance in the treatment of acute otitis media in children. Fifty-five children, 5.0 to 10.8 years, were randomly assigned to receive 250mg cefuroxime axetil every 12 hours or 50mg/kg/day amoxicillin in three divided doses. Both treatment schemes lasted for 10 days. Acute otitis media was diagnosed by the presence of erythema and/or opacity with bulging of the tympanic membrane. A tympanogram was obtained upon enrollment to the study, os well as within 2 days after completion of therapy. Fifty-one children completed the treatment protocol. The cure rate was 74.1% for cefuroxime axetil and 75.0% for amoxicillin. Clinical improvement was noted in 25.9% of children treated with cefuroxime axetil and in 25.0% of those treated with amoxicillin. There was no clinical failure in the two treatment groups. None of the children experienced relapse of acute otitis media during the month following completion of therapy. The findings indicate that cefuroxime axetil given twice daily has comparable efficacy to amoxicillin given three times daily in the treatment of children with acute otitis media. Key words: acute otitis media, cefuroxime axetil, cephalosporins.
Departments of Pediatrics* and Otolaryngology* *, University of Patras, School of Medicine, Patras, Greece. Correspondence: Panos D . Goumas, Department of Otolaryngology, University of Patras, School of Medicine, 26500 Patras, Greece. © Edizioni Ri viste Scien tifiche - Firenze
Vol. 4 - n. 4 (22 1-224) - 1992
INTRODUCTION
Cefuroxime axetil is an orally active prodrug formulation of cefuroxime, which upon absorption undergoes immediate de-esterification to free cefuroxime. Cefuroxime axetil achieves therapeutic blood levels with twice daily oral dosing 1 ' 2 • Cefuroxime possesses potent activity in vitro against Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Ehemolytic streptococci group A, which are the main pathogens associated with acute otitis media in children 3 • Preliminary clinical trials of cefuroxime axetil in the treatment of respiratory tract infections in adults and children have shown promising results 4 " 6 • The present clinical trial was designed with the following main objectives:(1) to investigate the effectiveness of cefuroxime axetil in treating children with acute otitis media; and (2) to study the tolerance of orally administered cefuroxime axetil in children; (3) to compare the efficacy and tolerance of cefuroxime axetil with that of amoxicillin, the drug of choice for initial treatment of acute otitis media with effusion 7 •
PATIENTS AND METHODS
Patient selection From January 1990 to April 1991, we performed a prospective study in children with signs and symptoms of acute otitis media (AOM). Children of both sexes, between the ages of 5 and 11 years, with the diagnosis of AOM, were eligible for the study . AOM was diagnosed by the presence of erythema and/or ISSN 1120-009X
222
G.A . SYROGIANNOPOULOS - P.D. GOUMAS - F .A. HAUOTIS - C.G . LYGATSIKAS,
opacity with bulging of the tympanic membrane. Patients were recruited from the outpatient population of the Department of Pediatrics of the University General Hospital of Patras, Patras, Greece. Exclusion criteria from the study included the following: (a) known or sus-· pected allergy to cephalosporins or penicillins; (b) administration of an antimicrobial agent during the last 7 days; (c) known impaired immunologic function and (d) hepatic disease or impaired renal function.
Treatment Patients received the usually recommended 4 • 6 10-day course of antibiotic therapy. Patients were randomly assigned to receive: (1) cefuroxime axetil 250 mg every 12 h (group A) or (2) amoxicillin 50 mg/kg/day, in three divided doses (group B): Cefuroxime axetil (Zinadol®, Glaxo Group Ltd, England) was provided as tablets of 250mg. Amoxicillin (Amoxil®, Beecham, England) was provided as a syrup containing 500mg of amoxicillin per 5-ml spoonful.
et alii
well as within 2 days after the completion of therapy. Tympanograms were performed using an Amplaid Model 720 tympanometer (Amplaid, Austria). Type A represents the normal tympanogram, showing a well-defined maximum compliance at an air -pressure differential of 0 mm H20 8 • Types As, B, and Care considered abnormal. Type As {restricted tympanagram) is characterized by normal middle ear pressure and limited compliance relative to normal mobility. Type B (flat tympanogram) is characterized by little or no change in middle ear compliance, when air pressure is varied in the external auditory canal. Type C (retracted tympanogram) is characterized by high negative pressure and normal compliance.
Statistics Statistical analyses were performed using the
r! and Student's t-tests. P values less than 0.05 were regarded as significant.
RESULTS
Clinical evaluation Children were evaluated for symptoms and physical findings on Day 1 (before treatment) and at the completion of the treatment. A telephone contact was made at 48 to 72 hours after enrollment to assess the child's clinical status and to monitor adverse effects. Clinical "success" was defined as the rapid subsiding of fever and otalgia, and the resolution of the tympanic erythema, opacity and bulging at the post-treatment evaluation. Children were considered improved if clinical signs and symptoms subsided but with incomplete resolution of evidence of infection during the treatment period. Clinical "failure" was defined as persistence or worsening of signs and symptoms of AOM during antibiotic therapy. Relapse was defined as the recurrence of signs and symptoms of AOM within 4 weeks post-treatment in a patient who exhibited cure or improvement while receiving therapy.
Tympanographic evaluation In addition to the clinical evaluation, tympanography was performed. A tympanogram was obtained upon enrollment in .the study, as
Between January 1990 and April 1991 a total of 55 children with AOM were enrolled in the study. The demographic and clinical features of the two groups of patients were similar at the initiation of therapy, with no statistically significant differences in the parameters listed in Table 1. The otoscopic and tympanographic evaluation of the children was similar in the two groups before initiation of the antibiotic treatment (Table 2). All children had bulging of the tympanic membrane on Day 1. Of the 55 children enrolled in the study, 51 completed the treatment protocol. The otosco-
TABLE
1 - Demographic and clinical features of the patients
studied. Feature Age (yr) Body weight (kg) Fever (T~ 38.0 °C) Earache
Cefuroxime axetii n = 30
Amoxicillin n = 25
7.0±1.7* 26.4 ±6.4 10**/30 29/30
7.3±2.0 24.8±7.3 12***/25 24/25
* Mean± lS.D. ** 2 additional patients had Tmax: 37.5 °C *** 3 additional patients had Tmax: 37.5 °C
223
CEFUROXIME AXETIL IN THE TREATMENT OF ACUTE OTITIS MEDIA IN CHILDREN
TABLE 2 - Otoscopic and tympanographic evaluation of the children before initiation of the antibiotic treatment.
Cefuroxime axeti1 n =30*
Examination
Amoxicillin n =25**
Otoscopy (mean ± SD) Red or yellow brane* ** Opacity*** Bulging***
mem-
Tympanogram (type)**** A As B
c
3.1 ± 0.6 2.6 ± 0.8 2.2 ± 0.8
3.5 ± 0.5 2.8 ± 0.6 3.0 ± 0.6
0/36 2/36 29/36 5/36
0/28 4/28 24/28 0/28
* 6 patients had bilateral AOM ** 3 patients had bilateral AOM *** Scale from 0 to 4 (4 is the most severe) **** See text for definitions of the tympa nogram types
pic evaluation of the children was similar in the two groups after completion of the 10-day antibiotic course (Table 3). The cure rate was 74.1% for the cefuroxime axetil group and 75.0% for the amoxicillin group. Clinical improvement was noted in 25.9% of children treated with cefuroxime axetil and in 25.0% of those treated with amoxicillin (Table 3). There was no clinical failure in the two treatment groups. None of the children experienced relapse of AOM during the month following completion of therapy.
TABLE 3 - Otoscopic and tympanographic evaluation of the children with completed 10-day treatment course.
Cefuroxime axe til n = 27*
Examination
Amoxicillin n = 24**
Otoscopy (mean ± SD) Red or yellow brane*** Opacity*** Bulgi ng***
Tympanogram (type) A As B
c
mem0.3 ± 0.6 0.1 ± 0.3 0.1 ± 0.3
0.2 ± 0.4 0.1 ± 0.3 0.1 ± 0.3
16/31 2/31 9/31 4/31
16/27' 4/27 5/27 2/27
* 4 patients had bilateral AOM ** 3 patients had bilateral AOM *** Scale from 0 to 4 (4 is the most severe)
Tolerability Cefuroxime axetil was generally well tolerated by the children. No severe side effects were noted. Two (6.7%) of the 30 patients developed mild to moderate vomiting just at the time of drug ingestion and treatment was changed to another oral antibiotic. These patients took the tablets in a crushed form for easier swallowing. None of the patients developed abdominal pain, diarrhea, skin rash or candidiasis. No side effects were noted in the group of children treated with amoxicillin.
DISCUSSION
Despite the fact that AOM is the most commonly treated pediatric infectious disease, there is still uncertainty about the best therapeutic approach to this infection. Since 1964 ampicillin, and more recently its analogues, have been the drugs of choice for the treatment of acute otitis media in children. However, the emergence of ampicillin-resistant H. influenzae and M. catarrhalis 3 as important causes of otitis media suggests that additional antibiotics should be available for the treatment of this infection. A valuable alternative, which is effective against pathogens resistant to ampicillin, is cefuroxime axetil. This antibiotic has the advantage of a bidaily dosing scheme which makes the treatment of children easier. An analysis of the data did not demonstrate a statistically significant difference between cefuroxime axetil and amoxicillin either in curing otitis media or in the time required for the acute symptoms to subside. A microbiological evaluation was not carried out by culturing nasopharyngeal swab samples, since there is a poor correlation between bacterial cultures of the nasopharynx or oropharynx and cultures of middle ear fluid s 9 • Cefuroxime axetil was generally well tolerated by the children. The two patients who developed mild to moderate vomiting just at the time of drug ingestion used to granulate the tablets and, therefore, the unpleasant taste of the medication may have caused the vomiting. It is noteworthy that no diarrhea was observed in any of the children treated with cefuroxime axetil. In conclusion, the findings show that cefuroxime axetil is an effective and in most
224
G.A. SYROGIANNOPOULOS - P.D. GOUMAS - F.A. HALIOTIS - C.G. LYGATSIKAS,
cases, a well tolerated oral cephalosporin for the treatment of AOM in children. REFERENCES ' Williams PO, Harding SM. The absolute bioavailability of oral cefuroxime axetil in male and female volunteers after fasting and after food. ] Antimicrob Chemother 1984; 13: 191-196. 'Ginsburg CM, McCracken GH, Jr, Petruska M, Olsen K. Pharmacokinetics and bactericidal activity of cefuroxime axetil. Antimicrob Agents Chemother 1985; 28: 504-507 . 'Jorgenson TH, Doern GV, Maher LA, Howell AW, Redding JS. Antimicrobial resistance among respiratory isolates of Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pneumoniae in the U.S .A. Antimicrob Agents Chemother 1990; 34: 2075-2080. 'Brodie DP, Griggs JV, Cunningham K. Comparative
et alii
study of cefuroxime axetil suspension and amoxicillin syrup in the treatment of acute otitis media in general practice. J lnt Med Res 1990; 18: 235-239. 'Yangco BG, Lowe], Nolen TM, Schleupner C, TanJS, Anthony W . A multicenter trial comparing the efficacy and safety of cefuroxime axetil and cefaclor in pneumonia of adults. Clin Ther 1990; 12: 440-446. • Pichichero M, Aronowitz GH, Gooch WM, McLinn SE, Maddern B, Johnson C, Darden PM. Comparison of cefuroxime axetil, cefaclor and amoxicillin-clavulanate potassium suspension in acute otitis media in infants and children. South Med J 1990; 83: 1174-1177. ' Klein JO. Otitis media. In: Gellis SS, Kagan BM, eds. Current pediatric therapy. 13th ed. Philadelphia: WB Saunders, 1990: 481-483. 8 Simons MR. Acoustic impedance tests. In: Goodhill V, ed. Ear diseases, deafness and dizziness. Hagerstown: Harper and Row, 1979: 185-200. 9 Bergeron MG, Ahronheim G, RichardJE et al. Comparative efficacies of erythromycin-sulfisoxazole and cefaclor in acute otitis media. Pediatr Infect Dis J 1987; 6: 654-660.
ISSN: 1120-009X (Print) 1973-9478 (Online) Journal homepage: http://www.tandfonline.com/loi/yjoc20
Cefuroxime Axetil in the Treatment of Acute Otitis Media in Children G.A. Syrogiannopoulos, P.D. Goumas, F.A. Haliotis, C.G. Lygatsikas, C.D. Spyropoulos & N.G. Beratis To cite this article: G.A. Syrogiannopoulos, P.D. Goumas, F.A. Haliotis, C.G. Lygatsikas, C.D. Spyropoulos & N.G. Beratis (1992) Cefuroxime Axetil in the Treatment of Acute Otitis Media in Children, Journal of Chemotherapy, 4:4, 221-224, DOI: 10.1080/1120009X.1992.11739168 To link to this article: http://dx.doi.org/10.1080/1120009X.1992.11739168
Published online: 15 Jul 2016.
Submit your article to this journal
Article views: 1
View related articles
Citing articles: 2 View citing articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=yjoc20 Download by: [Cornell University Library]
Date: 13 July 2017, At: 21:30
Journal of Chemotherapy
Cefuroxime Axetil in the Treatment of Acute Otitis Media in Children G.A. P.D . C.G. C.D.
SYROGIANNOPOULOS * GOUMAS ** - F.A. HALIOTIS * LYGATSIKAS ** SPYROPOULOS ** - N.G. BERATIS *
Summary
--------------------------~-----
Cefuroxime axetil was evaluated for clinical efficacy and tolerance in the treatment of acute otitis media in children. Fifty-five children, 5.0 to 10.8 years, were randomly assigned to receive 250mg cefuroxime axetil every 12 hours or 50mg/kg/day amoxicillin in three divided doses. Both treatment schemes lasted for 10 days. Acute otitis media was diagnosed by the presence of erythema and/or opacity with bulging of the tympanic membrane. A tympanogram was obtained upon enrollment to the study, os well as within 2 days after completion of therapy. Fifty-one children completed the treatment protocol. The cure rate was 74.1% for cefuroxime axetil and 75.0% for amoxicillin. Clinical improvement was noted in 25.9% of children treated with cefuroxime axetil and in 25.0% of those treated with amoxicillin. There was no clinical failure in the two treatment groups. None of the children experienced relapse of acute otitis media during the month following completion of therapy. The findings indicate that cefuroxime axetil given twice daily has comparable efficacy to amoxicillin given three times daily in the treatment of children with acute otitis media. Key words: acute otitis media, cefuroxime axetil, cephalosporins.
Departments of Pediatrics* and Otolaryngology* *, University of Patras, School of Medicine, Patras, Greece. Correspondence: Panos D . Goumas, Department of Otolaryngology, University of Patras, School of Medicine, 26500 Patras, Greece. © Edizioni Ri viste Scien tifiche - Firenze
Vol. 4 - n. 4 (22 1-224) - 1992
INTRODUCTION
Cefuroxime axetil is an orally active prodrug formulation of cefuroxime, which upon absorption undergoes immediate de-esterification to free cefuroxime. Cefuroxime axetil achieves therapeutic blood levels with twice daily oral dosing 1 ' 2 • Cefuroxime possesses potent activity in vitro against Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Ehemolytic streptococci group A, which are the main pathogens associated with acute otitis media in children 3 • Preliminary clinical trials of cefuroxime axetil in the treatment of respiratory tract infections in adults and children have shown promising results 4 " 6 • The present clinical trial was designed with the following main objectives:(1) to investigate the effectiveness of cefuroxime axetil in treating children with acute otitis media; and (2) to study the tolerance of orally administered cefuroxime axetil in children; (3) to compare the efficacy and tolerance of cefuroxime axetil with that of amoxicillin, the drug of choice for initial treatment of acute otitis media with effusion 7 •
PATIENTS AND METHODS
Patient selection From January 1990 to April 1991, we performed a prospective study in children with signs and symptoms of acute otitis media (AOM). Children of both sexes, between the ages of 5 and 11 years, with the diagnosis of AOM, were eligible for the study . AOM was diagnosed by the presence of erythema and/or ISSN 1120-009X
222
G.A . SYROGIANNOPOULOS - P.D. GOUMAS - F .A. HAUOTIS - C.G . LYGATSIKAS,
opacity with bulging of the tympanic membrane. Patients were recruited from the outpatient population of the Department of Pediatrics of the University General Hospital of Patras, Patras, Greece. Exclusion criteria from the study included the following: (a) known or sus-· pected allergy to cephalosporins or penicillins; (b) administration of an antimicrobial agent during the last 7 days; (c) known impaired immunologic function and (d) hepatic disease or impaired renal function.
Treatment Patients received the usually recommended 4 • 6 10-day course of antibiotic therapy. Patients were randomly assigned to receive: (1) cefuroxime axetil 250 mg every 12 h (group A) or (2) amoxicillin 50 mg/kg/day, in three divided doses (group B): Cefuroxime axetil (Zinadol®, Glaxo Group Ltd, England) was provided as tablets of 250mg. Amoxicillin (Amoxil®, Beecham, England) was provided as a syrup containing 500mg of amoxicillin per 5-ml spoonful.
et alii
well as within 2 days after the completion of therapy. Tympanograms were performed using an Amplaid Model 720 tympanometer (Amplaid, Austria). Type A represents the normal tympanogram, showing a well-defined maximum compliance at an air -pressure differential of 0 mm H20 8 • Types As, B, and Care considered abnormal. Type As {restricted tympanagram) is characterized by normal middle ear pressure and limited compliance relative to normal mobility. Type B (flat tympanogram) is characterized by little or no change in middle ear compliance, when air pressure is varied in the external auditory canal. Type C (retracted tympanogram) is characterized by high negative pressure and normal compliance.
Statistics Statistical analyses were performed using the
r! and Student's t-tests. P values less than 0.05 were regarded as significant.
RESULTS
Clinical evaluation Children were evaluated for symptoms and physical findings on Day 1 (before treatment) and at the completion of the treatment. A telephone contact was made at 48 to 72 hours after enrollment to assess the child's clinical status and to monitor adverse effects. Clinical "success" was defined as the rapid subsiding of fever and otalgia, and the resolution of the tympanic erythema, opacity and bulging at the post-treatment evaluation. Children were considered improved if clinical signs and symptoms subsided but with incomplete resolution of evidence of infection during the treatment period. Clinical "failure" was defined as persistence or worsening of signs and symptoms of AOM during antibiotic therapy. Relapse was defined as the recurrence of signs and symptoms of AOM within 4 weeks post-treatment in a patient who exhibited cure or improvement while receiving therapy.
Tympanographic evaluation In addition to the clinical evaluation, tympanography was performed. A tympanogram was obtained upon enrollment in .the study, as
Between January 1990 and April 1991 a total of 55 children with AOM were enrolled in the study. The demographic and clinical features of the two groups of patients were similar at the initiation of therapy, with no statistically significant differences in the parameters listed in Table 1. The otoscopic and tympanographic evaluation of the children was similar in the two groups before initiation of the antibiotic treatment (Table 2). All children had bulging of the tympanic membrane on Day 1. Of the 55 children enrolled in the study, 51 completed the treatment protocol. The otosco-
TABLE
1 - Demographic and clinical features of the patients
studied. Feature Age (yr) Body weight (kg) Fever (T~ 38.0 °C) Earache
Cefuroxime axetii n = 30
Amoxicillin n = 25
7.0±1.7* 26.4 ±6.4 10**/30 29/30
7.3±2.0 24.8±7.3 12***/25 24/25
* Mean± lS.D. ** 2 additional patients had Tmax: 37.5 °C *** 3 additional patients had Tmax: 37.5 °C
223
CEFUROXIME AXETIL IN THE TREATMENT OF ACUTE OTITIS MEDIA IN CHILDREN
TABLE 2 - Otoscopic and tympanographic evaluation of the children before initiation of the antibiotic treatment.
Cefuroxime axeti1 n =30*
Examination
Amoxicillin n =25**
Otoscopy (mean ± SD) Red or yellow brane* ** Opacity*** Bulging***
mem-
Tympanogram (type)**** A As B
c
3.1 ± 0.6 2.6 ± 0.8 2.2 ± 0.8
3.5 ± 0.5 2.8 ± 0.6 3.0 ± 0.6
0/36 2/36 29/36 5/36
0/28 4/28 24/28 0/28
* 6 patients had bilateral AOM ** 3 patients had bilateral AOM *** Scale from 0 to 4 (4 is the most severe) **** See text for definitions of the tympa nogram types
pic evaluation of the children was similar in the two groups after completion of the 10-day antibiotic course (Table 3). The cure rate was 74.1% for the cefuroxime axetil group and 75.0% for the amoxicillin group. Clinical improvement was noted in 25.9% of children treated with cefuroxime axetil and in 25.0% of those treated with amoxicillin (Table 3). There was no clinical failure in the two treatment groups. None of the children experienced relapse of AOM during the month following completion of therapy.
TABLE 3 - Otoscopic and tympanographic evaluation of the children with completed 10-day treatment course.
Cefuroxime axe til n = 27*
Examination
Amoxicillin n = 24**
Otoscopy (mean ± SD) Red or yellow brane*** Opacity*** Bulgi ng***
Tympanogram (type) A As B
c
mem0.3 ± 0.6 0.1 ± 0.3 0.1 ± 0.3
0.2 ± 0.4 0.1 ± 0.3 0.1 ± 0.3
16/31 2/31 9/31 4/31
16/27' 4/27 5/27 2/27
* 4 patients had bilateral AOM ** 3 patients had bilateral AOM *** Scale from 0 to 4 (4 is the most severe)
Tolerability Cefuroxime axetil was generally well tolerated by the children. No severe side effects were noted. Two (6.7%) of the 30 patients developed mild to moderate vomiting just at the time of drug ingestion and treatment was changed to another oral antibiotic. These patients took the tablets in a crushed form for easier swallowing. None of the patients developed abdominal pain, diarrhea, skin rash or candidiasis. No side effects were noted in the group of children treated with amoxicillin.
DISCUSSION
Despite the fact that AOM is the most commonly treated pediatric infectious disease, there is still uncertainty about the best therapeutic approach to this infection. Since 1964 ampicillin, and more recently its analogues, have been the drugs of choice for the treatment of acute otitis media in children. However, the emergence of ampicillin-resistant H. influenzae and M. catarrhalis 3 as important causes of otitis media suggests that additional antibiotics should be available for the treatment of this infection. A valuable alternative, which is effective against pathogens resistant to ampicillin, is cefuroxime axetil. This antibiotic has the advantage of a bidaily dosing scheme which makes the treatment of children easier. An analysis of the data did not demonstrate a statistically significant difference between cefuroxime axetil and amoxicillin either in curing otitis media or in the time required for the acute symptoms to subside. A microbiological evaluation was not carried out by culturing nasopharyngeal swab samples, since there is a poor correlation between bacterial cultures of the nasopharynx or oropharynx and cultures of middle ear fluid s 9 • Cefuroxime axetil was generally well tolerated by the children. The two patients who developed mild to moderate vomiting just at the time of drug ingestion used to granulate the tablets and, therefore, the unpleasant taste of the medication may have caused the vomiting. It is noteworthy that no diarrhea was observed in any of the children treated with cefuroxime axetil. In conclusion, the findings show that cefuroxime axetil is an effective and in most
224
G.A. SYROGIANNOPOULOS - P.D. GOUMAS - F.A. HALIOTIS - C.G. LYGATSIKAS,
cases, a well tolerated oral cephalosporin for the treatment of AOM in children. REFERENCES ' Williams PO, Harding SM. The absolute bioavailability of oral cefuroxime axetil in male and female volunteers after fasting and after food. ] Antimicrob Chemother 1984; 13: 191-196. 'Ginsburg CM, McCracken GH, Jr, Petruska M, Olsen K. Pharmacokinetics and bactericidal activity of cefuroxime axetil. Antimicrob Agents Chemother 1985; 28: 504-507 . 'Jorgenson TH, Doern GV, Maher LA, Howell AW, Redding JS. Antimicrobial resistance among respiratory isolates of Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pneumoniae in the U.S .A. Antimicrob Agents Chemother 1990; 34: 2075-2080. 'Brodie DP, Griggs JV, Cunningham K. Comparative
et alii
study of cefuroxime axetil suspension and amoxicillin syrup in the treatment of acute otitis media in general practice. J lnt Med Res 1990; 18: 235-239. 'Yangco BG, Lowe], Nolen TM, Schleupner C, TanJS, Anthony W . A multicenter trial comparing the efficacy and safety of cefuroxime axetil and cefaclor in pneumonia of adults. Clin Ther 1990; 12: 440-446. • Pichichero M, Aronowitz GH, Gooch WM, McLinn SE, Maddern B, Johnson C, Darden PM. Comparison of cefuroxime axetil, cefaclor and amoxicillin-clavulanate potassium suspension in acute otitis media in infants and children. South Med J 1990; 83: 1174-1177. ' Klein JO. Otitis media. In: Gellis SS, Kagan BM, eds. Current pediatric therapy. 13th ed. Philadelphia: WB Saunders, 1990: 481-483. 8 Simons MR. Acoustic impedance tests. In: Goodhill V, ed. Ear diseases, deafness and dizziness. Hagerstown: Harper and Row, 1979: 185-200. 9 Bergeron MG, Ahronheim G, RichardJE et al. Comparative efficacies of erythromycin-sulfisoxazole and cefaclor in acute otitis media. Pediatr Infect Dis J 1987; 6: 654-660.
