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An open comparative study of azithromycin versus cefaclor in the treatment of patients with upper respiratory tract infections.

Azithromycin and cefaclor were compared for the treatment of acute otitis media, streptococcal pharyngitis/tonsillitis, or sinusitis in an open multicentre study conducted in 530 adults. At the end of therapy (day 11-15), 228/245 (93%) patients treated with azithromycin 500 mg once daily for 3 days and 233/241 (97%) treated with cefaclor 250 mg given three times daily for 10 days were considered to have responded satisfactorily (cured or improved). In bacteriologically evaluable patients with pharyngitis/ tonsillitis, Streptococcus pyogenes was eradicated in 116/117 (99%) azithromycin- and in 115/119 (97%) cefaclor-treated patients at day 11-15; one patient in each group had become reinfected after initial eradication of the pathogen. When followed up on day 25-30, S. pyogenes infection had recurred in 5/105 (5%) azithromycin and 4/108 (3%) cefaclor patients who had responded satisfactorily at day 11-15, and whose baseline pathogen had been eradicated. Of these patients, two in the azithromycin and one in the cefaclor group also relapsed clinically; the others remained asymptomatic. Patients tolerated both treatments well; treatment-related adverse events were recorded in 11% of the 267 azithromycin- and 10% of the 263 cefaclor-treated patients assessed for safety. One azithromycin patient and five cefaclor patients withdrew because of adverse events. The results of the study show that a 3-day regimen of azithromycin, given once daily, is as effective and well tolerated as a multiple-daily, 10-day cefaclor regimen for the treatment of upper respiratory tract infections in adults.

Acute Disease↗

Rapid elimination of cefaclor from the cerebrospinal fluid is mediated by a benzylpenicillin-sensitive mechanism distinct from organic anion transporter 3.

The purpose of this study was to investigate the carrier-mediated elimination of cephalosporins from the cerebrospinal fluid (CSF) via the choroid plexus. Cefaclor and cefalexin are structural analogs with similar lipophilicity, differing by only one functional group (cefaclor, -Cl; cephalexin, -CH(3)), and they are substrates of rat peptide transporter PEPT2 with similar transport activities. However, cefaclor was cleared from the CSF more rapidly than cefalexin after intracerebroventricular administration (the elimination rate constants were 0.11 and 0.050 min(-1), respectively). The elimination of cefaclor from the CSF was inhibited by benzylpenicillin, but not by glycylsarcosine (GlySar), whereas GlySar, but not benzylpenicillin, had an inhibitory effect on the elimination of cefalexin from the CSF. The uptake of cefaclor by the freshly isolated rat choroid plexus was saturable, with a K(m) value of 250 muM, and the uptake clearance corresponding to saturable components accounts for the major part of the in vivo clearance from the CSF (17 versus 26 mul/min, respectively). The uptake of cefaclor by the choroid plexus was inhibited by benzylpenicillin, but not by GlySar. However, the inhibitory effect of benzylpenicillin was weaker than expected from its own K(m) value, and furthermore, organic anion transporter (Oat)3 substrates (cimetidine or p-aminohippurate) had no effect. These results suggest that cefaclor and cefalexin are eliminated from the CSF by different transporters, and rapid elimination of cefaclor from the CSF is accounted for by a benzylpenicillin-sensitive mechanism distinct from Oat3. A slight modification of a single chemical group of cephalosporins can greatly affect the contribution of the transporters involved, and their duration in the CSF.

Animals↗

Comparison of once daily cefpodoxime proxetil suspension and thrice daily cefaclor suspension in the treatment of acute otitis media in children.

An open-labeled and randomized trial was conducted to compare the efficacy and safety of once daily cefpodoxime proxetil suspension (10mg/kg/day) and thrice daily cefaclor (45mg/kg/day) in the treatment of acute otitis media in children. A total of 57 children aged from 6 months to 9 years were enrolled; 23 were treated with cefpodoxime and 34 with cefaclor. Satisfactory clinical outcome, either cure or improvement, was achieved at the end of treatment in 90% of patients in the cefaclor group and 95% of patients in the cefpodoxime group (p > 0.05). Clinical recurrence was identified at the follow-up visits in one case of the cefaclor group (3%), and none in the cefpodoxime group (p > 0.05). These drugs were well tolerated by 14/21 (67%) in the cefpodoxime-treated group and 27/32 (84%) in the cefaclor-treated group. The incidence of adverse events was slightly higher in the cefpodoxime group than in the cefaclor group, however the difference did not reach statistical significance (p > 0.05). The daily cost of once-daily cefpodoxime was lower than that of thrice-daily cefaclor. We conclude that cefpodoxime administered once daily is as effective and safe as cefaclor administered thrice daily in the treatment of acute otitis media in children. The less dosing frequency and lower daily price of cefpodoxime provide additional benefits.

Acute Disease↗

In vitro activity and pharmacokinetics of cefaclor in normal volunteers and patients with renal failure.

In both Mueller-Hinton agar (MHA) and antibiotic medium no. 1 (AB1) cefaclor was more active than cephalothin or cephalexin against Enterobacteriaceae. Its activity was equivalent to cephalexin against S. aureus in MHA. Cefaclor was particularly active against P. mirabilis. The activity of this antibiotic was greated in AB1 than in MHA. The inoculum effect was pronounced for cefaclor when compared with cephalothin, but cefaclor retained greater activity even against the higher inoculum. In volunteers with normal renal function, cefaclor produced slightly lower blood levels than those reported for cephalexin. Absorption after eating was decreased and delayed. Despite severe renal failure, substantial urine levels of antibiotic were still achieved. In contrast to cephalexin, plasma half-life for cefaclor was only moderately prolonged by renal failure (two-to-threefold) and only minimally shortened by haemodialysis. Adequate concentrations of cefaclor in sputum, active against common respiratory pathogens, could not be consistently demonstrated after the oral administration of a 1 gram dose of cefaclor.

Adult↗

Evaluation of cefaclor.

The chemistry, pharmacology, pharmacokinetics, bacterial spectrum, clinical use, dosage, adverse reactions, and dosage forms and cost of cefaclor are reviewed. Cefaclor, a congener of cephalexin monohydrate, is a new semisynthetic cephalosporin antibiotic. It is well absorbed when given orally on an empty stomach; absorption is delayed by the presence of food. Although metabolism may play a role in the disposition of cefaclor, elimination is primarily renal. Cefaclor's spectrum of activity is similar to that of cefalexin, including a wide range of gram-negative and gram-positive bacteria; in particular, Escherichia coli, Klebsiella spp., Proteus mirabilis, Salmonella spp., and Haemophilus influenzae are more susceptible to clinically achievable concentrations of cefaclor than cephalexin. Cefaclor has been demonstrated to be effective against beta-lactamase-producing H. influenzae resistant to ampicillin, but further studies are needed to establish the clinical significance of this activity. Efficacy of cefaclor has been demonstrated in urinary tract, upper and lower respiratory tract, and skin and soft tissue infections in adults and children as well as in pediatric otitis media. Adverse reactions, mostly gastrointestinal, are generally mild and occur in few patients. Usual doses are 250-500 mg every eight hours in adults and 20--40 mg/kg/day in children, although this pediatric dose may be two low for otitis media. Clinical superiority of cefaclor over less expensive antibiotics has not been demonstrated.

Adult↗

Diffusion disk susceptibility testing with cefaclor.

The reliability of the standardized 30-mug cephalothin disk and that of an experimental 30-mug cefaclor disk in predicting probable clinical susceptibility to cefaclor were compared. Quantitative determinations of cefaclor susceptibility were measured by the World Health Organization International Collaborative Study agar dilution procedure; diffusion disk tests were performed by the standardized U.S. Food and Drug Administration disk test. The cephalothin disk erred in predicting probable susceptibility in 52% of isolates of Enterococcus spp. resistant to 16 mug or less of cefaclor per ml; the cefaclor disk did not. The cephalothin disk erred in correctly predicting susceptibility in only 20% of cefaclor-susceptible isolates of Enterobacter spp.; the cefaclor disk correctly predicted susceptibility for 70%. These results indicate the need for further evaluation of a separate cefaclor disk for use in susceptibility testing with this new cephalosporin.

Cephalosporins↗

Cefaclor in treatment of otitis media and pharyngitis in children.

The safety and efficacy of cefaclor were compared with amoxicillin trihydrate in the treatment of 130 cases of otitis media, and with penicillin V potassium in 88 cases of streptococcal pharyngitis in two single-blind controlled studies. Patients with otitis media received approximately 40 mg/kg/day of cefaclor or amoxicillin trihydrate for ten days to three weeks; patients with pharyngitis received 20 mg/kg/day of cefaclor or penicillin V potassium for ten days. Overall, patients who received cefaclor for otitis media had fewer acute failures and better total success, especially in cases caused by Haemophilus influenzae; however, the difference between cefaclor and amoxicillin was not statistically significant. There also was no significant difference between the clinical effectiveness of cefaclor and penicillin in the treatment of streptococcal pharyngitis. Cefaclor was well tolerated with no serious side effects.

Amoxicillin↗

In vitro activity of Ro 15-8074 and Ro 19-5247 in comparison to cefaclor and cefalexin.

805 clinical isolates were investigated for their in vitro sensitivity against Ro 15-8074 and Ro 19-5247 in comparison to cefaclor and cefalexin in a serial dilution test on solid medium. Ro 19-5247 had the strongest activity of all drugs tested against streptococci (except Streptococcus faecalis) and was as active as cefaclor and cefalexin against most strains of Staphylococcus aureus. Ro 19-5247 was the only oral cephalosporin active against Bordetella pertussis. It was on average 160 times more active than cefaclor against Haemophilus influenzae. In its activity against enterobacteria Ro 19-5247 was always superior to cefaclor and cefalexin. Only a few strains of Enterobacter aerogenes, Enterobacter cloacae, Klebsiella pneumoniae, Proteus vulgaris and Serratia marcescens were resistant to Ro 19-5247 as were all strains of Enterobacter agglomerans and Klebsiella ozaenae. Ro 15-8074 was inactive against staphylococci but ten times more active than cefaclor and cefalexin against Streptococcus pyogenes. There was no difference in the activity against Streptococcus pneumoniae and Streptococcus agalactiae. Against Haemophilus influenzae Ro 15-8074 acted 12 times stronger than cefaclor and 100 times stronger than cefalexin. The activity against enterobacteria corresponded to that of Ro 19-5247. Ro 15-8074 was also active against most strains of Enterobacter cloacae and Proteus vulgaris which were resistant to cefaclor and cefalexin.

Bacteria↗

Multicenter evaluation of azithromycin and cefaclor in acute lower respiratory tract infections.

This was a randomized, third-party-blinded, multicenter study that compared once-daily azithromycin (500 mg on day 1, followed by 250 mg on days 2-5) to cefaclor (500 mg three times daily for 10 days) in the treatment of patients with acute bronchitis or pneumonia. A total of 546 patients were entered into the study and 272 patients were evaluable for efficacy analysis. Of these, 249 (176 azithromycin, 73 cefaclor) had bronchitis and 23 (15 azithromycin, 8 cefaclor) had pneumonia. The combined clinical cure and improvement rate, as determined by the investigator, was 96% for azithromycin and 94% for cefaclor, with 88% bacteriologic eradication in both treatment groups. The elimination of Haemophilus influenzae was significantly better with azithromycin (94.5%) than with cefaclor (61.1%) (p less than 0.001; Fisher's exact two-tail test). The two antibiotics were well tolerated during this study; the incidence of side effects reported was similar for azithromycin and cefaclor. Approximately two thirds of the side effects were mild. Only minor abnormalities in the screening laboratory tests were noted. This study shows that a 5-day course of once-daily azithromycin is as effective as a 10-day three times daily course of cefaclor in the treatment of patients with acute lower respiratory tract infections.

Azithromycin↗

Loracarbef (LY163892) versus cefaclor in the treatment of bacterial skin and skin-structure infections in an adult population.

Loracarbef (LY163892), a member of the class of beta-lactam antibiotics known as carbacephems, is characterized by a high level of chemical stability and a broad spectrum of antibacterial activity that persists in the presence of beta-lactamase. The efficacy and safety of loracarbef, 200 mg (twice daily), and cefaclor, 250 mg (three times daily) (one patient received 178 mg of cefaclor suspension, three times daily), were compared in a randomized, double-blind, multicenter trial conducted in adults with skin and skin-structure infections due predominantly to Staphylococcus aureus. Examination within 72 hours after the completion of therapy indicated a favorable clinical response in 84 (93.3%) of the 90 loracarbef-treated patients evaluable for efficacy and in 79 (95.2%) of the 83 evaluable patients treated with cefaclor. Pathogens were eradicated in 83 (92.2%) of the patients in the loracarbef group and 74 (89.2%) of those in the cefaclor group. Only four adverse events--headache/migraine, diarrhea, abdominal pain, and nausea--occurred in greater than 2% of the total study population. The overall incidence of adverse events in the 201 loracarbef-treated and 192 cefaclor-treated patients evaluated for safety was 19.9% and 24.5%, respectively. Adverse events that required hospitalization or discontinuation of treatment occurred in four patients in the cefaclor group but in none of those treated with loracarbef. There were no statistically significant differences in the clinical or bacteriologic response or the incidence of side effects between the two treatment groups. These findings indicate that loracarbef given twice daily is comparable in safety and efficacy to cefaclor given three times daily in the treatment of adults with skin and skin-structure infections.

Adolescent↗

Comparison of oral cefpodoxime proxetil and cefaclor in the treatment of skin and soft tissue infections.

This multicenter, randomized, double-blind study was designed to compare the safety and efficacy of cefpodoxime proxetil and cefaclor in the treatment of skin and soft tissue infections. Patients were aged > or = 12 years with acute (< or = 7 days duration), single-site skin or skin-structure infections. The 7- to 10-day treatment regimens were cefpodoxime proxetil (400 mg cefpodoxime) orally with food twice a day with cefaclor-matched placebo (orally, fasting, three times a day); or cefaclor (Ceclor; 500 mg anhydrous equivalent) orally, fasting, three times a day, with cefpodoxime-matched placebo (orally with food twice a day). Clinical progress and cultures were evaluated upon admission to the study; on study days 7-10 and 15-18; and 2-3 weeks after treatment. Cefpodoxime had lower minimum inhibitory concentrations against the majority of Staphylococcus species than did cefaclor. Both treatments were highly effective (99% pathogen eradication and 86% cure rate). These high eradication rates were not unexpected in this study of minor infections in which patients with resistant pathogens were excluded. Cefaclor had a higher failure rate [2 (4%) of 57], than did cefpodoxime [2 (1%) of 139; p not significant]. Most patients in both groups completed treatment as planned: 185 (74%) of 249 cefpodoxime-treated patients and 91 (75%) of 122 cefaclor-treated patients. Both treatments were well tolerated and considered safe and effective in the treatment of skin and skin structure infections. However, the twice-a-day dosing regimen for cefpodoxime proxetil compared with the three-times-a-day regimen for cefaclor may result in better patient compliance.

Administration, Oral↗

Serum sickness-like reactions to cefaclor.

In this study, we evaluated whether the high number of reports of serum sickness to cefaclor was present in every country and year, and whether these figures from voluntary reporting facilitated an estimation of the relative risk. A nested case-control study was performed with reports of all suspected adverse reactions (ADR) to cefaclor, amoxicillin and cephalexin in the period 1968-1987, as reported to the WHO Collaborating Center for International Drug Monitoring from the U.S.A., the U.K., Sweden, Canada and Germany. The ADR-reporting odds ratio was defined as the ratio of the odds of the number of ADR-reports of serum sickness to cefaclor and amoxicillin or cephalexin and the odds of similar reports of non-serum sickness to cefaclor and amoxicillin or cephalexin. The ADR-reporting odds ratio adjusted for country, age, gender, origin of the report and year of marketing was 12.4 for cefaclor vs amoxicillin and 18.5 for cefaclor vs cephalexin. In children (< 15 years of age) and in adults (> 15 years of age), the relative risk of developing serum sickness of cefaclor vs amoxicillin was estimated at 13.9 (95% confidence interval (95% CI): 6.0-32.2) and 2.9 (95% CI: 0.9-9.4) respectively in the U.S.A., and at 15.1 (95% CI: 7.2-31.5) and 5.5 (95% CI: 2.0-15.0) respectively in the other four countries together. In this study, the ADR-reporting odds ratio facilitated a valid estimation of the relative risk.

Adolescent↗

Cefdinir versus cefaclor in the treatment of uncomplicated urinary tract infection.

OBJECTIVE: This multicenter, double-blind, randomized, parallel-group study was conducted in Europe, South Africa, and Australia to compare the clinical and microbiologic efficacy and the tolerability of a cephalosporin antibiotic, cefdinir, with those of cefaclor in the treatment of uncomplicated urinary tract infection. METHODS: Patients were randomized in a 1:1 ratio to 5 days of treatment with either cefdinir 100 mg BID or cefaclor 250 mg TID. RESULTS: A total of 661 patients were randomized to treatment. They were 90% female, with a median age of 44 years. There were no clinically important differences between groups in terms of demographic characteristics or symptoms on admission. The most frequently isolated pathogens in admission urine cultures were Escherichia coli (383 patients), Proteus mirabilis (20 patients), Staphylococcus saprophyticus (14 patients), and Klebsiella pneumoniae (9 patients). Of the admission pathogens with documented susceptibility results, significantly more were resistant to cefaclor (6.7%) than to cefdinir (3.7%; P < 0.003). Significantly more admission isolates of E. coli were resistant to cefaclor (5.1%) than to cefdinir (2.0%; P < 0.007). A total of 383 patients were assessable for efficacy, 196 in the cefdinir group and 187 in the cefaclor group. Clinical cure rates and microbiologic response rates for cefdinir and cefaclor were statistically equivalent at 5 to 9 days posttherapy (test-of-cure visit), using a 95% CI approach. The rate of treatment-related adverse events was higher in cefdinir-treated patients (20.2%) than in cefaclor-treated patients (13.0%; P = 0.025), mainly due to the greater frequency of diarrhea in the former group. However, only 4 patients (1.2%) discontinued cefdinir treatment due to diarrhea. CONCLUSION: Empiric therapy with cefdinir appears to be a reasonable choice for patients with uncomplicated urinary tract infection in whom cephalosporin treatment is indicated.

Adolescent↗

Studies on the bioequivalence of second generation cephalosporins: cefaclor capsules and suspension.

The aim of the present studies, performed in two different groups of volunteers, was to prove the bioequivalence of 500 mg cefaclor (CAS 70356-03-5) test and reference capsules (Losefar 500 mg Capsules as test and an originator product as reference; study 1) and cefaclor 250 mg/5 mL test and reference suspensions (Losefar 250 mg/5 mL Granules oral suspension as test and an originator product as reference; study 2). Each study was conducted according to an open, randomized, single-dose, two-period cross-over design in healthy volunteers with a wash-out period from 7 to 14 days. Blood samples were taken up to 8 h post dosing, and concentrations of cefaclor were determined by HPLC method. In the first study, the 90% confidence intervals for intra-individual ratios of AUC0-t and Cmax of cefaclor were 0.99-1.08 for AUC0-t and 0.82-1.06 for Cmax, and thus within the acceptance ranges for bioequivalence trials. The 90% confidence interval for intra-individual ratios of AUC0-t and Cmax of cefaclor administered as suspensions were 1.10-1.19 and 1.02-1.21, respectively. These values were also within the acceptance range. Concerning the secondary parameter tmax the 90% confidence interval for the intra-individual differences for cefaclor were between -0.13 - 0.13 in the first and between 0.00 - 0.13 in the second study, respectively. In the light of the results of the studies reported here it can be concluded that cefaclor test formulations, i.e. capsules and suspension are bioequivalent to the respective reference formulations.

Adolescent↗

A comparative study of the efficacy, safety and tolerability of azithromycin and cefaclor in the treatment of children with acute skin and/or soft tissue infections.

An open, multicentre study was carried out in 200 paediatric patients between 6 months and 12 years of age with skin and/or soft tissue infections (mild-to-moderate dermatological conditions and abscesses) to compare the efficacy and safety of azithromycin and cefaclor oral suspensions. Patients were randomly assigned to receive either azithromycin (10 mg/kg once daily for 3 days) or cefaclor (20 mg/kg/day in three divided doses for 10 days). The clinical efficacy of both treatments was comparable: 92/98 (94%) of the evaluable azithromycin patients were cured or improved as were 93/98 (95%) of those treated with cefaclor. Before treatment, 74 pathogens were isolated from 60 of the azithromycin- and 80 pathogens from 66 of the cefaclor-treated patients. In the azithromycin group, 70/74 (95%) pathogens were eradicated, as were 79/80 (99%) pathogens in the cefaclor group. All 200 patients were evaluable for safety analyses. Both drugs were well tolerated, with a low incidence of side-effects: 3/100 (3%) in the azithromycin group and 2/100 (2%) in the cefaclor group. No patient in either treatment group withdrew from the study because of adverse events. In conclusion, azithromycin is as effective and as well tolerated as cefaclor in the treatment of children with skin and/or soft tissue infections.

Acute Disease↗

Interactions of amoxicillin and cefaclor with human renal organic anion and peptide transporters.

Amoxicillin and cefaclor are two of the widely used beta-lactam antibiotics in the treatment of urinary tract infections. Both drugs are eliminated mainly by the kidney and rely on renal excretion to exert their antibacterial activities in the urinary tract. Previous studies have suggested the involvement of organic anion and oligopeptide transporters in membrane transport of beta-lactams. The objective of the current study was to examine the kinetics of amoxicillin and cefaclor interactions with human renal transporters human organic anion transporter 1 (hOAT1), human peptide transporter 1 (hPepT1), and human peptide transporter 2 (hPepT2) in detail, both as substrates and as inhibitors. Using fluorescence protein tagging and cell sorting, we established Madin-Darby canine kidney cell lines stably expressing highly functional hOAT1, hPepT1, and hPepT2. Amoxicillin and cefaclor inhibited hOAT1-mediated [(3)H]para-aminohippuric acid uptake (K(i) = 11.0 and 1.15 mM, respectively). However, our uptake study revealed that neither drug was transported by hOAT1. Amoxicillin and cefaclor competitively inhibited hPepT2-mediated [(3)H]glycylsarcosine uptake (K(i) = 733 and 65 muM, respectively), whereas much lower affinity for hPepT1 was observed with both antibiotics. Direct uptake studies demonstrated that amoxicillin and cefaclor were transported by hPepT1 and hPepT2. Kinetic analysis showed that hPepT2-mediated uptake of both drugs was saturable with K(m) of 1.04 mM for amoxicillin and 70.2 muM for cefaclor. hPepT2, and to a lesser extent hPepT1, may play an important role in apical transport of amoxicillin and cefaclor in the renal tubule. hOAT1, in contrast, is not involved in basolateral uptake of these antibiotics.

Amoxicillin↗

Pharmacokinetics of cefaclor in renal failure: effects of multiple doses and hemodialysis.

The pharmacokinetics of cefaclor were characterized in 15 functionally anephric patients on hemodialysis. Each patient received a 500-mg oral dose of cefaclor every 8 h for 10 days. Multiple serum drug levels were measured by bioassay on day 0 (no hemodialysis), day 10 during hemodialysis, and as single determinations 1 h after administration on days 1, 3, and 5. Analysis of cefaclor kinetics in these 15 patients along with kinetics from 24 previously studied patients showed that weight was the best single predictor of volume of distribution. The corrected creatinine clearance (calculated from serum creatinine, age, and sex) proved to be the best predictor of drug half-life (r = 0.969). Thus, a single serum creatinine test provided a better estimated of cefaclor half-life than a 24-h urine collection. Cefaclor was cleared with an average serum half-life of 2.9 h without hemodialysis and 1.5 h during hemodialysis. Cefaclor serum levels measured 1 h after administration on days 0, 1, 3, and 5 showed no evidence of accumulation. Thus, cefaclor may be administered orally in multiple doses without accumulation in functionally anephric patients. In patients on dialysis, dosage interval or quantity should be increased to compensate for doubled drug clearance dialysis.

Administration, Oral↗

Amoxicillin-clavulanic acid versus cefaclor in the treatment of urinary tract infections and their effects on the urogenital and rectal flora.

In a double-blind randomized study, amoxicillin-clavulanic acid (AM-CL) was compared with cefaclor for the treatment of acute urinary tract infections in 107 college women. A total of 53 patients received amoxicillin (250 mg) and clavulanic acid as the potassium salt (125 mg), and 54 received cefaclor (250 mg); each drug was administered every 8 h for 10 days. The cure rates at 1 and 4 weeks after treatment were 96 and 78%, respectively, in the AM-CL group and 92 and 75%, respectively, in the cefaclor group (P greater than 0.10). After AM-CL treatment, the prevalence of amoxicillin-resistant Escherichia coli significantly increased in the rectal flora. Also, the frequency of bacterial resistance to amoxicillin, AM-CL, and cefaclor increased among the urinary pathogens causing subsequent urinary tract infections (P less than 0.05). There were no adverse reactions in the cefaclor group; however, six patients in the AM-CL group (12%) experienced diarrhea, nausea, or vomiting (P less than 0.05). Elevated transaminase enzyme levels were observed in 23% of the patients in the AM-CL group and in 6% of the patients in the cefaclor group (P less than 0.05). Symptomatic Candida vaginitis developed in 16 and 13% of the patients in the AM-CL and cefaclor groups, respectively (P greater than 0.10).

Adolescent↗