OBJECTIVES: Currently established first line therapy of acute (presumed bacterial) rhinosinusitis (ARS) consists of 10 to 14 days of oral amoxicillin or cephalosporins. This study compared the clinical efficacy and tolerance of cefcapene pivoxil (CP) and amoxicillin-clavulanate (AMC) in patients with ARS. METHODS: A randomized, open labeled, double-blinded trial of ARS patients over 15 years of age was performed. Patients diagnosed with ARS received paranasal sinus X-rays and nasal endoscopies and 2 weeks of either CP (150 mg, 3 times/ day) or AMC (625 mg, amoxicillin 500 mg, 3 times/day). All patients revisited the clinic on days 7, 14, and 28 for evaluation of changes in symptoms, endoscopy, and monitoring of any adverse reactions. Demographics, clinical characteristics and drug efficacy were also compared between the two groups. RESULTS: Among the 60 initially enrolled patients (CP 30, AMC 30), 5 patients in the CP group and 6 in the AMC group were excluded due to poor compliance. There were no significant differences in demographic data including age, sex, initial signs and symptoms, endoscopic and X-ray findings between the two groups. Rates of improvement after 2 weeks were 96% and 95.8% in the CP and AMC group, respectively. Sinus symptoms were changed significantly after 2 and 4 weeks, however, there was no difference between groups (P=0.41). The most common adverse reaction was gastrointestinal complication, diarrhea occurred in 1 patient in the CP group and 6 in the AMC group (P=0.04). CONCLUSION: CP and AMC were both effective in treating ARS. The difference of treatment outcome was not found between the two groups, however, gastrointestinal complications were less prevalent in the CP group.
Amoxicillin ; Amoxicillin-Potassium Clavulanate Combination ; Bacterial Infections ; Cephalosporins ; Clavulanic Acid ; Compliance ; Demography ; Diarrhea ; Double-Blind Method ; Endoscopy ; Humans ; Sinusitis ; Treatment Outcome

Augmentin is a formulation of amoxycillin trihydrate and potassium clavulanate, a fused beta-lactam molecule produced by the fermentation of straptomyces clavuligerus. Most clinically important resistance is due to the production by bacteria of antibiotic destroying enzymes. In the case of penicillins and cephalospolins these enzymes are termed beta-lactamse as they destroy the beta-lactam ring of these antibiotics completely inactivating them. The presence of clavulanic acid extends the spectrum of amoxycillin to include beta-lactamse producing strains of common pathogens such as Staphylococcus, H influenza, E. coli, Neisseria spp, Proteus spp, Salmonella and Shigella. On clinical study of Augmenting in the field of Genitourinary tract infection cases. We selected randomly 30 patients, 20 males and 10 females, age from 21 to 71, in the period from October, 1985 to February, 1986. Among the total 30 patients, 15 were uncomplicated urinary tract infection and 15 were complicated urinary tract infection. Of the 15 patients with uncomplicated urinary tract infection, 14 patients had not bacteriuria after therapy and 1 patient was not changed. The clinical efficacy rate was 93.4%. Of the 4 patients with persistent infection, 2 patients had resistant P. aeruginosa, and 2 patients had S marcescens persistantly. The clinical efficacy rate was 73.4%. In 2 cases, mild diarrhea was developed, but medication was not stopped. The liver and renal function were normal range before and after treatment.
Amoxicillin ; Amoxicillin-Potassium Clavulanate Combination* ; Anti-Bacterial Agents ; Bacteria ; Bacteriuria ; beta-Lactams ; Clavulanic Acid ; Diarrhea ; Female ; Fermentation ; Humans ; Influenza, Human ; Liver ; Male ; Neisseria ; Penicillins ; Proteus ; Reference Values ; Salmonella ; Shigella ; Staphylococcus ; Urinary Tract Infections

UV - spectrophotometric (UV) and high performance liquid chromatographic methods (HPLC) were described in determining amoxicillin and clavulanic acid in pharmaceutical preparations. Spectrophotometrically, amoxicillin was determined by measuring the absorbance values at 320 nm in buffer-CuS04 solution (pH 5.2) for amoxicillin and at 313 nm in imidazol solution (pH 6.8) for clavulanic acid. Beer's Law was obeyed in range 12 - 32mg. ml-1 for amoxicillin and 12 - 22 mg. ml-1 for clavulanic acid. The simultaneous HPLC method depended upon using a reserved phase RP18 column at ambient temperature with a mobile phase consisting of methanol - phosphate solution pH 4.4 (4:96) at a flow rate 1ml.min-1. Quantitation was achieved by UV detection at 220 nm. Calibration curve was linear over the concentration range 50-150 mg. ml-1 for amoxicillin and 15-35 mg. ml-1 for clavulanic acid. Both spectrophotometry and HPLC method showed good linear correlation, precision and accuracy. The obtained results from spectrophotometry and HPLC method showed no significant difference. Both methods were successfully applied to the assay of commercial tablets. The procedures were rapid, simple and suitable for quality control applications
Pharmaceutical Preparations ; Amoxicillin ; Clavulanic Acid

A urinary tract infection (UTI) is a collective term for infections that involve any part of the urinary tract. It is one of the most common infections in local primary care. The incidence of UTIs in adult males aged under 50 years is low, with adult women being 30 times more likely than men to develop a UTI. Appropriate classification of UTI into simple or complicated forms guides its management and the ORENUC classification can be used. Diagnosis of a UTI is based on a focused history, with appropriate investigations depending on individual risk factors. Simple uncomplicated cystitis responds very well to oral antibiotics, but complicated UTIs may require early imaging, and referral to the emergency department or hospitalisation to prevent urosepsis may be warranted. Escherichia coli remains the predominant uropathogen in acute community-acquired uncomplicated UTIs and amoxicillin-clavulanate is useful as a first-line antibiotic. Family physicians are capable of managing most UTIs if guided by appropriate history, investigations and appropriate antibiotics to achieve good outcomes and minimise antibiotic resistance.
Adult ; Aged ; Amoxicillin ; administration & dosage ; Amoxicillin-Potassium Clavulanate Combination ; Anti-Bacterial Agents ; Clavulanic Acid ; administration & dosage ; Cystitis ; drug therapy ; Drug Resistance, Microbial ; Escherichia coli ; Escherichia coli Infections ; drug therapy ; epidemiology ; Female ; Humans ; Incidence ; Male ; Middle Aged ; Primary Health Care ; Risk Factors ; Urinary Tract Infections ; drug therapy ; epidemiology

A simple, rapid, sensitive, precise and accurate high-performance liquid chromatographic (HPLC) method with ultraviolet detection at wavelength of 205nm has been validated for the simultaneous determination of amoxicillin and clavulanic acid in human serum. Serum samples were deproteinized with methanol. The separation of 2 obtained compounds was achieved using a reversed phase C8 column and a mobile phase, consisting of acetonitrile-phosphate solution. The calibration curves were linear over the concentration range of 0.625 – 10 g.ml-1 for amoxicillin and 0.3125 – 5 g.ml-1 for clavulanic acid. The quantitative limits are 0.625 and 0.3125 g.ml-1 for amoxicillin and clavulanic acid. Analytical recoveries from human serum ranged from 93 to 96% for both components. This method was fully validated. It allows the simultaneous assay of amoxicillin and clavulanic acid in biomedical applications. This method has been successfully applied to a pilot pharmacokinetic study in 3 healthy volunteers after a single oral administration of amoxicillin and clavulanic acid combination
Amoxicillin ; Clavulanic Acid ; Serum ; Chromatography, High Pressure Liquid

BACKGROUND: This study was designed to evaluate the ability of the Vitek and MicroScan ESBL test by comparing with NCCLS ESBL phenotypic confirmatory test by disk diffusion and to know the frequency of ESBL producers in the Seoul Veterans Hospital. METHODS: A total of 1,261 isolates(Escherichia coli 705, Klebsiella pneumoniae 502, K. oxytoca 54) from 883 patients were included in ESBL screening test by Vitek (494 strains) and MicroScan (767 strains). After excluding repetitive isolates from same patients, NCCLS ESBL confirmatory test was performed for 197 ESBL screening positives and 184 ESBL screening negatives. RESULTS: The overall frequency of ESBL screening positives was 22.3% (by MicroScan 26.2%, by Vitek 15.6%), and that of NCCLS ESBL positives was 18.9%(18.3% in E. coli, 21% in K. pneumoniae). MicroScan and Vitek ESBL test showed 100% and 92.3% sensitivity, 77.1% and 95.5% specificity, respectively. Among the 158 NCCLS ESBL positives, 17.7% showed clavulanic acid effect in cefotaxime only, 10.1% in ceftazidime only, and 72.2% in both. MicroScan Neg ComboPanel Type 21 test revealed that 91.4% of suspicious ESBL producers flagged by one or two antimicrobials were erroneous. In contrast, 96.2% of strains flagged by all five antimicrobials were correct. CONCLUSION: Suspicious ESBL producers by MicroScan showing three or four antimicrobial flags should be retested by NCCLS ESBLconfirmatory test. But strains with two or less flags and strains with all 5 flags can be reported as Non-ESBL producers and ESBL producers, respectively.
Cefotaxime ; Ceftazidime ; Clavulanic Acid ; Diffusion ; Hospitals, Veterans ; Humans ; Klebsiella pneumoniae ; Mass Screening ; Sensitivity and Specificity ; Seoul

To elucidate the role of plasmid-mediated AmpC-type B-lactamases in clinical practice, cefoxitin-resistant isolates of E. coli (19 strains) and K. pneumoniae (7 strains) from three hospitals in Korea were studied. All of the 26 isolates produced at least one j3-lactamase and 16 (62%) isolates produced AmpC-type B-lactamases poorly inhibited by clavulanic acid. In 16 such isolates, 4 kinds of AmpC enzymes were detected; the pI 8.0 AmpC enzyme in 11 isolates, the pI 8.9 in 3 isolates of E. coli, the pI 8.5 in 1 isolate of E. coli, and the pI 7.8 in 1 isolate of K pneumoniae. The pI 8.0 and 7.8 AmpC enzymes had an apparent molecular mass of 38 kDa and the pI 8.5 and 8.9 AmpC enzymes had a molecular mass of 35 kDa. Cefoxitin resistance was transmissible in six E. coli and three K pneumoniae strains due to a common AmpC-type B-lactamase with a pl of 8.0. This enzyme was confirmed to be CMY-1 B-lactamase by Southern blotting and PCR analysis. Four E. coli isolates produced large amounts of AmpC-type j3-1actamase. They were chromosomal AmpC hyperproducers carrying some alterations in the promoter and attenuator regions of the ampC chromosomal gene. The pI 7.8 AmpC enzyme is currently under study. In conclusion, this study showed that the CMY-1 plasmid-mediated cephamycinase play an important role in cephamycin resistance of K. pneumoniae and E. coli clinical isolates in Korea.
beta-Lactamases* ; Blotting, Southern ; Cefoxitin ; Clavulanic Acid ; Korea ; Pneumonia* ; Polymerase Chain Reaction

At the Venereal Disease Clinic of Choong-ku Public Health Center in Seoul ]03 male patients with uncomplicated gonococcal urethritis were allocated randomly into one of 2 treatment regimens and 101 patients were followed. All 51 patients, including PPNG infections, treated with clavulanate-potentiated amoxycillin, 375 mg, PO, t.i.d. for 5 days recovered(100%), Two(4%) of 50 patients treated with clavulanate-potentiated amoxycillin, 3. 25g, PO plus probenecid, lg, PO failed to recover. These cases were 2 of 25 Penicillinase Froducing Neisseria gonorrhoeae(PPNG) infections(failure rate of 8%) and all 25 non-PPNG infections recovered(100%). It is suggested that both of these clavulanate-potentiated amoxycillin regimens ha.ve similarly good effect with minimal side effects in the treatment of gonococcal urethritis and, because of high rate of PPNGs among circulating N, gonorrhoeae, they can be recommended as the first line treatment for gonorrhoa ir Korea.
Amoxicillin* ; Clavulanic Acid* ; Humans ; Korea ; Male* ; Neisseria ; Penicillinase ; Probenecid ; Public Health ; Seoul ; Sexually Transmitted Diseases ; Urethritis*

OBJECTIVETo establish a chromatography-based method for simultaneous analysis of the concentrations of amoxicillin and clavulanate potassium in human blood.

METHODSWith paracetamol as the internal control, human plasma samples, after treatment with methanol for protein sedimentation and centrifugation, were loaded for analysis with high-performance liquid chromatography (HPLC). HPLC analysis was carried out using a C18 column (5 µm, 4.6 mm×150 mm) with the mobile phase of acetonitrile-PBS (0.05 mol/L) of 10:90 (pH 2.3), UV detection wavelength of 220 nm, flow rate of 1.0 ml/min, and column temperature of 25 degrees celsius;.

RESULTSThe retention time of acetaminophen for potassium clavulanate, amoxicillin sodium and the internal control was 5.3, 7.2, and 8.5 min, respectively, and no interference by the endogenous impurities in the plasma samples was found. Amoxicillin sodium showed a good linearity within the concentration range of 0.52-4.16 µg/ml (r(2)=0.9996), and potassium clavulanate had a good linearity within the range of 0.266-2.14 µg/ml (r(2)=0.9998). The minimum detectable concentrations of amoxicillin sodium and potassium clavulanate were 0.065 µg/ml and 0.066 µg/ml, respectively. The relative recoveries of amoxicillin sodium were 95.9%-96.5% (n=5), and those of clavulanate potassium were 92.5%-98.8% (n=5); the intra- and inter-day RSD of amoxicillin sodium was 1.84%-6.4% and 2.1%-7.8%, as compared to that of potassium clavulanate of 3.57%-8.6% and 1.8%-9.1%, respectively.

CONCLUSIONThis method is simple, accurate, sensitive, specific and reproducible for analyzing the concentrations of amoxicillin and clavulanate potassium simultaneously in human plasma.

BACKGROUND: Accurate detection of extended spectrum beta-lactamase (ESBL) is important because ESBLs producing organisms may appear susceptible to oxyimino-beta-lactams in standard susceptibility tests, but are considered to be clinically resistant to these drugs. Conventional antimicrobial susceptibility test methods do not reliably detect ESBL production. Molecular techniques and NCCLS broth dilution method, which detect ESBL production, may be time consuming, expensive and technically difficult to perform. The purpose of this study is to evaluate the clinical usefulness of NCCLS ESBL phenotypic confirmatory test by disk diffusion method. METHODS: For 96 Escherichia coli and 49 Klebsiella pneumoniae isolates collected between December 2000 to February 2001, double disk synergy test, NCCLS ESBL screening and phenotypic confirmatory test by disk diffusion test were performed. The ESBL producer was defined as organism showed an increase in the zone diameter of > or = 5 mm for either antimicrobial agent such as cefotaxime and ceftazidime tested in combination with clavulanic acid versus its zone when tested alone. RESULTS: The sensitivity of NCCLS ESBL phenotypic confirmatory test were as follows: cefotaxime/clavulanic acid disk; 100% in K. pneumoniae and 83% in E. coli, and ceftazidime/clavulanic acid disk; 94% in K. pneumoniae and 67% in E. coli, respectively. Among the organisms with positive to NCCLS ESBL phenotypic confirmatory test, the detection rate of antimicrobial agents in double disk synergy test were as follows: K. pneumoniae; cefotaxime (84%), aztreonam (74%), and ceftazidime (52%), and E. coli; cefotaxime (44%), ceftazidime (44%), and aztreonam (39%). CONCLUSIONS: The NCCLS ESBL phenotypic confirmatory test by disk diffusion method is easy, rapid, and sensitive method, suitable for routine use in the clinical laboratory.
Anti-Infective Agents ; Aztreonam ; beta-Lactamases* ; Cefotaxime ; Ceftazidime ; Clavulanic Acid ; Diffusion ; Escherichia coli* ; Escherichia* ; Klebsiella pneumoniae* ; Klebsiella* ; Mass Screening ; Pneumonia