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PubMed1999

Cefaclor into the millennium.

We review the discovery and development of the cephalosporins and subsequently cefaclor. Cefaclor is active against a wide range of commonly encountered bacterial pathogens, acting by inhibiting cell wall synthesis. Its in vitro activity compares favourably with other beta-lactam antibiotics. Its pharmacokinetic properties indicate that an 8-hourly dosing schedule is appropriate. In addition a delayed release formulation allowing twice daily dosage has been developed. The efficacy of both formulations of cefaclor has been verified by many clinical trials. Cefaclor has been widely used in infections of the respiratory tract (including otitis media), urinary tract and soft tissues. The results of therapy are summarized. The low incidence of adverse events is highlighted and the beneficial influence of this on compliance is described. Finally, the pharmaco-economics of cefaclor are considered.

Bacterial Infections↗
PubMed1982

A double-blind study of cefaclor and amoxycillin in home and hospital-acquired infections.

Eighty-seven patients admitted to hospital for a variety of reasons and who had, or subsequently developed, an infection were treated with either cefaclor or amoxycillin, 150 mg 3-times daily, on a double-blind basis. Two patients were excluded from te final analysis as the infecting organisms would normally be resistant to both antibiotics. Forty (93%) patients treated with cefaclor and 40 (95.2%) treated with amoxycillin responded satisfactorily. Of the patients with a hospital-acquired infection, 93.3% of the cefaclor group and 94.3% of the amoxycillin group responded satisfactorily. The differences between the groups were not significant. A greater number of organisms were sensitive to cefaclor, confirming its broader spectrum of activity. It is concluded that cefaclor is a useful first-line antibiotic which could be particularly useful in hospital-acquired infections.

Amoxicillin↗
PubMed1986

Cefadroxil compared with cefaclor in the treatment of streptococcal pneumonia in adults.

103 young male Black African gold-miners with pneumococcal pneumonia confirmed by culture or serology were randomly assigned to receive the long acting oral cephalosporin cefadroxil 1 g every 12 hours or cefaclor 500 mg every 8 hours for 10 days. Clinical cures were obtained in 94% of the group who received cefadroxil and in 94% of the cefaclor group. Similarly, the causative organism S. pneumoniae was eradicated in 98% and 96% of patients who received cefadroxil and cefaclor, respectively. Minimal side effects occurred in both groups, although 1 patient withdrew from therapy with cefaclor because of severe diarrhoea. Thus, cefadroxil and cefaclor both displayed effective antimicrobial activity with low toxicity in the treatment of pneumococcal pneumonia.

Adult↗
PubMed1993

Roxithromycin versus cefaclor in lower respiratory tract infection: a general practice pharmacoeconomic study.

An economic evaluation comparing roxithromycin 150mg twice daily and cefaclor 250mg thrice daily in the treatment of lower respiratory tract infections (LRTI) was undertaken as part of a randomised clinical trial in New Zealand general practice. The observed statistically significant difference in adverse events, withdrawal rates and extra treatment courses in favour of roxithromycin in the clinical study was translated into medical cost savings. Treatment failures, withdrawals or adverse events resulted in additional costs for 11 of 120 (9%) patients receiving roxithromycin and 19 of 118 (16%) patients receiving cefaclor. In these cases (treatment failures, withdrawals, adverse effects) additional antibiotics and general practitioner visits were required 3 times more often and the cost of additional medication for treating failure or adverse effects was 3 times higher for patients treated with cefaclor than for patients receiving roxithromycin. The total direct medical cost per patient treated with roxithromycin was $NZ9.37 lower (on an incremental basis) than for patients treated with cefaclor, despite a higher drug acquisition cost. An estimate of $NZ656 000 per year in total savings in direct medical costs could be made in New Zealand if roxithromycin were to replace all cefaclor prescriptions in the treatment of LRTI.

Cefaclor↗
PubMed1999

Selection of treatment of cefaclor-associated urticarial, serum sickness-like reactions and erythema multiforme by emergency pediatricians: lack of a uniform standard of care.

BACKGROUND: Serum sickness-like reactions (SSLR) and erythema multiforme are common adverse effects of cefaclor therapy and can be associated with significant morbidity. No standardized evidence-based protocol for the optimal treatment of drug-induced SSLR exists. OBJECTIVES: To define the standard of care used by physicians treating adverse reactions associated with cefaclor. METHODS: A retrospective review of the medical records of children discharged from a pediatric emergency room with a diagnosis of adverse events to cefaclor was conducted. Charts of patients were reviewed to determine which therapy was prescribed. RESULTS: During the study period, 74 cases of adverse events attributed to cefaclor presented to the emergency department. SSLR were the most common pattern of adverse events seen (31 cases, 42%), followed by urticarial reactions (26 cases, 35%) and erythema multiforme (17 cases, 23%). An antihistamine was the treatment most often prescribed (88%) for erythema multiforme. Significantly more children with SSLR than with erythema multiforme or urticaria were treated with prednisone, either alone or in combination (P<0.05). CONCLUSIONS: The treatment most often prescribed for serious cefaclor-associated erythema multiforme was an antihistamine. In the case of SSLR, an antihistamine and prednisone were most commonly used. Prospective randomized, controlled trials are needed to define the role of various therapeutic agents and to determine the optimal therapy for SSLR and other serious adverse drug reactions.

Cefaclor↗
PubMed1999

Cefaclor af versus amoxycillin/clavulanate in acute bacterial exacerbations of chronic bronchitis: a randomised multicentre study.

Cefaclor and amoxycillin/clavulanate are active against Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis and Staphylococcus aureus--pathogens commonly associated with acute exacerbations of chronic bronchitis (AECB). This randomised, parallel-group, single-blind, multicentre study investigated the comparative efficacy and safety of 7-day treatment regimens of cefaclor AF (750 mg b.d. [n = 73]) and amoxycillin/clavulanate (875/125 mg b.d. [n = 72]) in AECB. A favourable clinical response was obtained in 95.9% of patients on cefaclor AF and 97.2% of patients on amoxycillin/clavulanate. There were no statistically significant differences between the groups for improvement in clinical response measured by pulmonary peak expiratory flow (PPEF), or for common symptoms associated with AECB. Both agents were well tolerated, with no statistically significant differences in overall safety; however, nausea and vomiting, and abdominal pain, the most frequently occurring adverse events in the amoxycillin/clavulanate group, were not reported in the cefaclor group. In conclusion, cefaclor AF and amoxycillin/clavulanate have similar efficacy and safety profiles in the treatment of AECB.

Adult↗
PubMed2004

[Comparison of pharmacokinetics/pharmacodynamics of cefdinir, cefpodoxime proxetil and cefaclor against common bacteria of community acquired infections].

OBJECTIVE: To compare the pharmacokinetics/pharmacodynamics property of cefdinir, cefpodoxime proxetil and cefaclor against common bacteria of community acquired infections and evaluate the recommended regimens. METHODS: The antibacterial activities of 3 agents against 238 clinical isolates were determined by standard agar dilution test and the pharmacokinetics of these antibiotics in male healthy volunteers were conducted in Latin-square manner. The time over MIC (T > MIC) of serum antibiotic concentrations were calculated with pharmacokinetic equation and MIC. RESULTS: The value of MIC90 s cefdinir against these bacterial strains except penicillin non-sensitive pneumococci were 0.031-1 mg/L. Cefpodoxime held similar antibacterial activity with cefdinir, but was less potent against staphylococci. Cefaclor had much higher MIC values than other two drugs. After oral administration of 250 mg cefaclor, the drug concentration quickly reached peak concentration of 4.95 mg/L +/- 2.41 mg/L and the eliminative half time was 0.69 h +/- 0.6 h; the Tmax, Cmax and T1/2beta of cefdinir and cefpodoxime after oral administration of 100 mg were 2.5 h +/- 0.48 h, 0.81 mg/L +/- 0.19 mg/L, 1.73 h +/- 0.3 h and 2.38 h +/- 0.43 h, 1.12 mg/L +/- 0.28 mg/L, 1.92 h +/- 0.55 h, respectively. T > MIC of cefdinir in thrice daily administration were longer than 40% of medication interval against most of the tested isolates; no T > MIC period was found in cefpodoxime against staphylococci and the T > MICs of cefaclor after 250 mg oral administration were shorter than expected values against most bacteria. CONCLUSION: With powerful antibacterial activity, the T > MICs of cefdinir after 100 mg oral administration can meet with the clinical requirement in most infections; PK/PD value of cefpodoxime proxetil against staphylococci is lower than expectancy and 250 mg cefaclor 3 times daily is not enough to the treatment of common community acquired infections, the regimens of cefpodoxime proxetil and cefclor should be furtherly optimized.

Anti-Bacterial Agents↗
PubMedDate not supplied

Loracarbef versus cefaclor in the treatment of cystitis and asymptomatic bacteriuria.

In this double-blind study, 333 patients (16 males, 317 females) with cystitis or asymptomatic bacteriuria were randomly assigned to receive 200 mg of loracarbef once daily (n = 164; mean age, 36 years) or 250 mg of cefaclor thrice daily (n = 169; mean age, 37 years) for seven days. Cystitis was diagnosed in 97.8% of the evaluable loracarbef-treated patients and 94.4% of the evaluable cefaclor-treated patients. Clinical and bacteriologic responses were assessed in 92 loracarbef-treated patients and 107 cefaclor-treated patients. At the five- to nine-day posttreatment evaluation, a clinical cure was found in 84.5% of the loracarbef-treated patients and in 79.4% of the cefaclor-treated patients and improvement in 3.3% and 7.5%, respectively. The pathogen was eliminated in 76.1% and 72.9%, respectively; new pathogens were identified in 4.3% and 4.7%, respectively; and the original pathogen was not eliminated or recurred in 19.6% and 21.5%, respectively. Nausea was the most frequently reported adverse event (in 4.5% of all patients). The results indicate that both loracarbef and cefaclor are safe and effective in the treatment of uncomplicated urinary tract infections.

Adolescent↗
PubMedDate not supplied

Cefprozil versus cefaclor in the treatment of mild to moderate skin and skin-structure infections. The Cefprozil Multicenter Study Group.

In a multicenter study, 598 patients with skin or skin-structure infections were randomly assigned to receive 500 mg of cefprozil once daily (or 20 mg/kg once daily) or 250 mg of cefaclor three times daily (or 20 mg/kg daily in three equal doses) for 5 to 10 days. Treatment was evaluated in 212 cefprozil-treated patients and in 210 cefaclor-treated patients. The patients were aged 2 to 99 years (mean, 28 years) and their primary diagnoses were impetigo (in 99 patients), pyoderma (in 98), superficial abscess (in 70), and cellulitis (in 64). A satisfactory clinical response was found in 93% of the cefprozil-treated patients and in 92% of the cefaclor-treated patients, the pathogens were eradicated in 91% and 89%, and overall treatment was rated effective in 87% of both groups. Adverse clinical events were reported by 5% of the patients in both groups; one cefprozil-treated patient and three cefaclor-treated patients withdrew from treatment because of adverse events. It is concluded that cefprozil administered once daily is as effective and safe as cefaclor administered three times daily in the treatment of mild to moderate skin and skin-structure infections.

Abscess↗
PubMed1988

Blinded comparison of cefuroxime to cefaclor for lower respiratory tract infections.

Cefuroxime axetil was compared with cefaclor for the therapy for lower respiratory tract infections. Sixty-one patients were randomized to receive the following drug dosages: (1) cefuroxime axetil, 250 mg orally every 12 hours (21 patients); (2) cefuroxime axetil, 500 mg orally every 12 hours (21 patients); and (3) cefaclor, 500 mg orally every eight hours (19 patients). Of these 61 patients, 80% were male, with a mean age of 59.5 years; 56% had acute pneumonia, and the remainder had an acute bronchitis. Causative pathogens included typical respiratory tract pathogens. Overall, 23 of 27 patients with bronchitis were clinically cured at the end of therapy. Thirty-one of 34 pneumonias were clinically cured or improved at the end of therapy; the three pneumonia treatment failures occurred in the lower dose cefuroxime (n = 2) and cefaclor (n = 1) treatment groups. Overall, bacteriologic cure occurred in 86% of patients treated with 500 mg of cefuroxime axetil compared with 60% of cefaclor-treated patients. Adverse clinical effects were uncommon. From this study, it was concluded that cefuroxime given every 12 hours is at least as clinically efficacious as cefaclor; it is a new oral cephalosporin with pharmacologic and bacterial spectrum advantages over many older agents.

Acute Disease↗
PubMed1987

Cefuroxime axetil in the treatment of uncomplicated UTI: a comparison with cefaclor and augmentin.

Cefuroxime axetil (CAE) is an acetoxyethyl ester prodrug of cefuroxime. The efficacy and safety of cefuroxime axetil was studied in a randomized general practice trial in urological infections where cefuroxime axetil 250 mg b.d. was compared with amoxycillin/clavulanate (Augmentin, AUG) 375 mg t.d.s. A randomized trial was then performed in hospital outpatients, who received cefuroxime axetil 250 mg b.d. or cefaclor (CCL) 250 mg t.d.s. Of 140 clinically assessable patients, 108 were cured and 28 improved on cefuroxime axetil (97% success) compared with 75 cured and 13 improved out of 89 on Augmentin (99% success) and 31 cured and 7 improved out of 38 patients treated with cefaclor (97% success). Bacteriology was assessable in 101 patients given cefuroxime axetil (72% cleared), 61 of those given Augmentin (70% cleared) and 27 out of 28 (96%) given cefaclor. As expected, the predominant pathogen was E. coli, accounting for 61% of isolates overall. Drug-related adverse events occurred in 10% of patients given cefuroxime axetil, including diarrhoea in 4%. Eleven percent of patients given Augmentin suffered adverse events (5% diarrhoea) and 5% of those given cefaclor. Superinfections occurred in 4 cefaclor patients (2 Pseudomonas aeruginosa, 1 Candida, 1 E. coli) compared with 2 on cefuroxime axetil (1 Candida, 1 E. coli). Uncomplicated UTI accounted for 92% of cases in the G.P. trial and 82% of cases in the hospital trial. Cefuroxime axetil may be used safely and effectively to treat uncomplicated UTI at a dose of 250 mg b.d.

Adolescent↗
PubMed1985

Comparative treatment trial of augmentin versus cefaclor for acute otitis media with effusion.

A total of 150 children with acute otitis media were randomly allocated to treatment with amoxicillin-potassium clavulanate (Augmentin) or with cefaclor. Each drug was given in a daily dosage of approximately 40 mg/kg in three divided doses for ten days. Tympanocentesis done before treatment yielded specimens that contained pneumococcus or Haemophilus sp or both in 67% of specimens. Viridans group streptococci were isolated from 10% of specimens and Branhamella catarrhalis from 6%. Patients were scheduled for follow-up examinations at midtreatment, end of therapy, and at 30, 60, and 90 days. Of the 150 children, 130 were evaluable. Five of 60 patients (8%) treated with cefaclor were considered therapeutic failures because of persistent purulent drainage and isolation of the original pathogen or suprainfection. There were no failures among patients treated with Augmentin (P = .019). Rates of relapse, recurrent acute otitis media with effusion, and persistent middle ear effusion were comparable in the two groups of patients. Diaper rash, or loose stools, or both were significantly more common in children treated with Augmentin (34%) than in those taking cefaclor (12%), but in no case was it necessary to discontinue medication because of these mild side effects (P = .002). Cefaclor therapy was discontinued in one patient because of severe abdominal pain and vomiting. In this study, treatment with Augmentin was superior to treatment with cefaclor in the acute phase of acute otitis media with effusion, but Augmentin produced more adverse effects. The rates of persistent middle ear effusion and recurrent acute otitis media with effusion were comparable with the two regimens.

Acute Disease↗
PubMed1983

Influence of amoxycillin and cefaclor on the colonization resistance of oropharynx.

A randomized, double-blind, controlled trial was carried out to compare amoxycillin and cefaclor in the treatment of respiratory tract infections in general practice. Their effect on the microflora of the oropharynx, their clinical effectiveness, side-effects and the incidence of superinfections were monitored. Amoxycillin and cefaclor were given three times daily in a dosage of 375 and 250 mg, respectively, for 7 days. In 72 patients treated with amoxycillin, the oropharynx became colonized with resistant Gram-negative rods in 24, with Pseudomonas in 1, with Staphylococcus aureus in 3 and with yeasts in 2 patients. In 67 patients treated with cefaclor only 2 patients became colonized with Gram-negative rods. In the amoxycillin group, 5 superinfections developed within 4 weeks after treatment. No superinfection occurred after treatment with cefaclor. Clinically, cefaclor was more effective than amoxycillin and showed fewer side-effects.

Adolescent↗
PubMedDate not supplied

Global surveillance of bacterial susceptibility to cefaclor: 1988-1990.

In vitro data on bacterial susceptibility to cefaclor were collected from clinical trials conducted in 15 European countries, South Africa, Canada, and the United States. Among the respiratory pathogens, 94% of Haemophilus influenzae, 98.6% of Streptococcus pneumoniae, 98.8% of Streptococcus pyogenes, and 98.1% of Moraxella catarrhalis were susceptible to cefaclor. Over 90% of the tested isolates of the most common urinary tract pathogen, Escherichia coli, were susceptible to cefaclor. Virtually all of the pathogens that may infect skin and soft tissues, S pyogenes and Staphylococcus aureus (methicillin-susceptible strains), were cefaclor susceptible. These data confirm that the major pathogens in bacterial infections of the upper and lower respiratory tract, of the skin and related structures, and of the urinary tract remain susceptible to cefaclor after more than 13 years of widespread clinical use.

Bacteria↗
PubMedDate not supplied

Comparative pharmacokinetics of oral ceftibuten, cefixime, cefaclor, and cefuroxime axetil in healthy volunteers.

STUDY OBJECTIVE: To compare the pharmacokinetics of ceftibuten, cefixime, ceturoxime axetil, and cefaclor after oral administration. DESIGN: Randomized, four-period, crossover study. SETTING: Hospital-based clinical research center. SUBJECTS: Healthy adult men and women volunteers. INTERVENTIONS: Single 400-mg doses of cefixime and ceftibuten, and 500-mg doses of cefuroxime axetil and cefaclor. MEASUREMENTS AND MAIN RESULTS: Serum concentrations were determined by high-performance liquid chromatography methods. The mean oral clearances of cefixime, cefuroxime axetil, and cefaclor were similar, ranging from 20.4-27.0 L/hour; clearance of ceftibuten was approximately 4-fold less, 5.45 L/hour. The serum half-lives of ceftibuten (2.35 hrs) and cefixime (2.38 hrs) were prolonged compared with those of cefuroxime axetil (1.30 hrs) and cefaclor (0.693 hr). These agents also differed in terms of time to maximum concentration, time to peak plasma level, area under the curve, and apparent volume of distribution, the last reflecting differences in biovailability. CONCLUSION: Ceftibuten had a relatively high time to maximum concentration and long half-life, resulting in a 3.5-fold higher area under the curve than cefixime, cefuroxime axetil, and cefaclor. These pharmacokinetic data can be used as a basis to compare the four oral cephalosporins; however, comparative susceptibility data must also be considered.

Administration, Oral↗
PubMedDate not supplied

[Non-comparative open study of the efficacy and tolerance of cefaclor in the prevention of urinary tract infections in children].

Cefaclor has been investigated as an additional prophylactic agent in the UTI. It is active against virtually all common urinary pathogens, is well absorbed in the upper gastrointestinal tract, is well tolerated and safe. The Authors have carried out a clinical trial of the prophylactic use of cefaclor in the prevention of recurrent urinary tract infection in children. We studied 52 children (25 females and 27 males, median age 7 +/- 19 months) with UTI, investigated by imaging (sonography, micturating cystourethrography, renal scintigraphy) and by urodynamic studies. We found vesicoureteral reflux in 37 cases, primitive megaureter in 6 cases, in 1 patient duplication of the collecting system in 1 patient and substenosis of ureteropelvic junction in 1 case. In the others 5 cases the UTI were associated with bladder disfunction and finally in 1 case the UTI occurred in absence of urinary malformations. All patients received cefaclor, as prophylaxis, at the dosage of 10-20 mg/kg/die, administrated as a single bedtime dose. The mean time of treatment with cefaclor was 8 +/- 3,48 months. We observed an optimal compliance in all patients, also in the first year of life. In only two out of 52 patients, during the prophylaxis, we found documented bacteriuria. We stopped treatment in two cases because of an adverse effect (in both children has been demonstrated a cutaneous rash). In conclusion our study shows that cefaclor is an effective, well tolerated and safe agent in the UTI prophylaxis, also in the first year of life, when it seems to offer an optime alternative to other agents.

Cefaclor↗
PubMed1978

Treatment of acute otitis media of infancy with cefaclor.

The emergence of ampicillin-resistant Haemophilus as a clinical problem in otitis media necessitates a search for alternative, effective therapy. An orally absorbable cephalosporin derivative, cefaclor, is equally effective in vitro against ampicillin-susceptible and -resistant Haemophilus and against other bacteria that cause acute otitis media. Two dosage schedules of cefaclor (40 and 60 mg/kg/day) were evaluated in 95 infants with acute otitis media. Bacterial origin was determined by a culture of tympanocentesis fluid. Success rates using the smaller dosage were inferior to those using the larger dosage. Results of therapy for pneumococcal and Haemophilus infection with 60 mg/kg/day were comparable to those previously found with amoxicillin trihydrate or with combinations of trisulfapyrimadines with erythromycin or penicillin V. One patient with an ampicillin-resistant Haemophilus infection responded well to cefaclor and did not have a relapse. Cefaclor was well tolerated and caused an acceptably low incidence of minor, adverse effects. Cefaclor deserves further testing as a candidate for preferred status as a single-drug treatment of acute otitis media.

Acute Disease↗
PubMed1993

Cefaclor vs amoxicillin in the treatment of acute, recurrent, and chronic sinusitis.

BACKGROUND: The treatment of acute, recurrent, and chronic sinusitis remains controversial because of the presence of a wide variety of aerobic and anaerobic bacteria in the sinuses. DESIGN: This double-blind, randomized trial compared cefaclor with amoxicillin in the treatment of acute, recurrent, and chronic maxillary sinusitis using clinical evaluation, roentgenography, and microbiologic evaluation of antral aspirates. SETTING: Outpatient office of five otorhinolaryngologists in Salt Lake City, Utah. PATIENTS: One hundred eight adult patients with acute, recurrent, or chronic maxillary sinusitis. INTERVENTION: Oral treatment with cefaclor (500 mg) twice daily or amoxicillin (500 mg) three times daily for 10 days. MAIN OUTCOME MEASURE: Clinical response to treatment with cefaclor vs amoxicillin. RESULTS: Fifty-six patients with acute sinusitis, 25 with recurrent sinusitis, and 15 with chronic sinusitis were evaluable. Although multiple organisms were common in each group, patients with acute sinusitis were more likely to have Haemophilus influenzae or Streptococcus pneumoniae, and patients with recurrent or chronic sinusitis were more likely to have anaerobes in sinus aspirate. Whether treated with cefaclor or amoxicillin, clinical improvement occurred in 86% of patients with acute sinusitis and 56% of patients with recurrent sinusitis. Patients with chronic sinusitis were too few to allow statistical analysis of the differences in outcome between them and patients with recurrent or acute sinusitis. Resistance of the cultured organisms to the study drug used was unrelated to treatment outcome. CONCLUSIONS: The rate of clinical improvement was high in patients with acute sinusitis but was less favorable in those with recurrent and chronic disease regardless of the study drug used. The susceptibility of organisms isolated to the study drugs was unrelated to outcome.

Acute Disease↗