Amoxicillin potassium clavulanate uses

The drug stability at room temperature was determined preparing three different plasma samples of each drug concentration and then injecting the samples immediately into the HPLC system. The samples were kept at room temperature and were injected again after 8 h. The concentrations measured at time zero and after 8 h were compared to determine whether there were changes in the concentrations with time.

The difference in the drug concentrations in the two analyses was always less than 10%.

When the samples were kept at room temperature for 8 h, no changes in the drug concentration was evident thus indicating the stability of amoxicillin in the plasma samples at room temperature.

The stability of the drug in frozen plasma was investigated by the analysis of samples obtained from three volunteers. The first analysis was performed at the beginning of the study and the second analysis was performed at the end of the study.

The samples were stored at -20° C between the analyses.

The difference in the drug concentration in all samples in the two analyses was always less than 10% in each sample.

There was no change in the drug concentration in frozen plasma during storage at -20° during the study period, indicating stability of amoxicillin in frozen plasma. The lower limit children's amoxicillin price of quantification (LLOQ) was estimated by analyzing samples with known amounts of amoxicillin, at progressively lower concentrations, starting at the lower end of the calibration curves.

The limit of quantification of amoxicillin in this assay was 0.5 µg/ml. The retention time of the drug in the standard and the study samples were identical.

There were no peaks for endogenous compounds that appeared at the same retention time for amoxicillin in the chromatograms for six different blank plasma samples.

The concentration of amoxicillin in the plasma (µg/ml) at different time points following administration of either one Amoxicare ® tablet (1000 mg amoxicillin) or two Amoxil ® (500 mg amoxicillin each) were plotted for each volunteer.

The area under the curve of plasma drug concentration (AUC) versus time (t), from zero to t (AUC 0>t ), was calculated from the drug concentration by the linear trapezoidal rule, using the relationship; where, C n is the drug concentration at any time (t n ).

The area under the curve from t h to infinity was obtained from the relationship: where, C t is the concentration of amoxicillin at the t-hour time point (last determined concentration), K e is the elimination rate constant in a particular individual. The elimination rate constant (K e ) was calculated from the slope of the straight part of log C versus t plot, where the slope of the straight line equals (-k/2.303).

To obtain this value, the data were plotted as log plasma concentration versus time (to ensure linearity of the terminal phase of the profile) and the best fitting line was determined by the method of least square. The total area under the curve from zero to infinity (AUC 0>? ) was calculated as the sum of the areas obtained.

Following the oral administration of drugs, the plasma concentration generally reaches a single, well-defined peak (C max ) at the time of T max .

C max is an important kinetic index for drug safety and can be viewed as a measure of maximal exposure.

Particularly, C amoxicillin 875 mg potassium clavulanate 125 max has important roles in clinical pharmacological investigations, including bioequivalence, T max has been considered as a simple measure for comparative absorption and disposition rate constants.

C max and T max can be estimated either directly or indirectly. In the first case, one can record the maximal observed concentration and the corresponding time. In the second case, a pharmacokinetic model can be fitted to the measurements and the predicted maximum evaluated[7]. The maximum amoxicillin plasma concentration (C max ) and the corresponding time of peak plasma concentration (T max ) were taken directly from the slope of the semi-logarithmic plot of the terminal phase of the plasma concentration-time curve calculated by linear regression.

The elimination half–life (T 1/2 ) was derived by dividing ln2 by the elimination rate constant K e . The areas under the amoxicillin plasma concentrations time curves from (AUC 0-8 ) and the area to the infinity (AUC 0-? ) were calculated by using the linear trapezoidal method.

Extrapolation to infinity was obtained by adding the value C t /K e to the calculated AUC 0-8 (where C t is the last detectable concentration of amoxicillin).

For the purpose of bioequivalence analysis, one-way analysis of variance (ANOVA procedure) was used to assess the effect of formulations, periods, sequences and subjects on AUC 0-8 , AUC 0-? , and C max . The statistical analysis was performed using Minitab Statistical package version 13 IBM PC (Minitab Inc. The alternate HPLC-UV method described and used here for amoxicillin quantification provided the required sensitivity, specificity and high sample throughput required for pharmacokinetic studies.

2 are shown three representative chromatograms of amoxicillin. Particularly, blank plasma sample chromatogram, blank plasma spiked with amoxicillin (20 µg/ml) chromatogram and plasma sample amoxicillin 2 grams of volunteer #14R obtained after 1.5 h from administration, are reported.

Both amoxicillin formulations (one Amoxicare ® 1000 mg/tablet, and two Amoxil ® 500 mg/capsule) were well tolerated at the administered dose by all the subjects; unexpected incidents possibly influencing the outcome of the study did not occur.

All volunteers were discharged from the hospital in good health conditions. Both medications were quantifiable at the first sampling time in all the volunteers.

3 shows mean amoxicillin plasma concentrations as a function of time after the oral administration of 1000 mg of amoxicillin of both brands over the 8 h truncated sampling period.

3 shows that both formulations were matching in terms of plasma drug concentration - time curves.

Detailed descriptive statistics of the major mean pharmacokinetic parameters including AUC0 -8 , AUC 0-? , C max , T max , K e and T 1/2 for the test and reference formulations are summarized in Table 2. PHARMACOKINETIC PARAMETERS CALCULATED FOR AMOXICILLIN AFTER A SINGLE ORAL DOSE ADMINISTRATION * Amoxicillin Prices and Coupons. Amoxicillin is used to treat a wide variety of bacterial infections.

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Comparison of Clarithromycin and Amoxicillin/Clavulanic Acid for Community-Acquired Pneumonia in an Era of Drug-Resistant Streptococcus pneumoniae. Pablo Bonvehi, Katherine Weber, Todd Busman, Dee Shortridge, Gerard Notario. Objective: To compare the safety and efficacy of clarithromycin and amoxicillin/clavulanic acid in patients with community-acquired pneumonia due to penicillin-resistant and/or macrolide-resistant Streptococcus pneumoniae, by selecting clinical investigators who practice in study populations from geographic areas in which a high incidence of resistant strains is reported by surveillance. Design and setting: Prospective, randomised, investigator-blinded, multicentre study conducted in 45 sites in primary-care and referral centre settings. Patients and interventions: 327 ambulatory patients diagnosed with radio-graphically confirmed community-acquired pneumonia administered clarithromycin 500mg immediate-release or amoxicillin/clavulanic acid 875mg/125mg twice daily for 7 days.

Main outcome measures and results: Similarly high clinical cure amoxicillin and clavulanate potassium 625mg rates were observed among evaluable patients in both treatment groups at the test-of-cure visit (28-35 days post-treatment): 92% (114/124) for clarithromycin and 91% (117/129) for amoxicillin/clavulanic acid.

pneumoniae strains isolated pretreatment, four (5%) were classified as resistant to macrolides (one mefA, two ermB, and one ermB + mefA ) and eight (9%) had reduced susceptibility to penicillin. The overall eradication rate for pathogens isolated from bacteriologically and clinically evaluable patients was 91% for clarithromycin and 93% for amoxicillin/clavulanic acid, and 89% and 92%, respectively, for S.

The rates of resolution and/or improvement in clinical signs and symptoms and radiological improvement were similar with clarithromycin to those with amoxicillin/clavulanic acid, as was overall incidence of adverse events. Conclusion: A 7-day course of clarithromycin immediate-release was similar to amoxicillin/clavulanic acid based on high rates (>90%) of clinical cure, radiological improvement and pathogen eradication among ambulatory-care patients with community-acquired pneumonia.

As the resistance rate at baseline was low, no conclusion could be made about clarithromycin's efficacy for infections caused by macrolide-resistant S. Community-acquired pneumonia is a common infection associated with significant morbidity and mortality. More than 4 million cases of community-acquired pneumonia occur each year in the US, resulting in about 10 million physician visits, >1 million hospitalisations, and an estimated cost of $US23 billion.

[1,2,3,4] The mortality rate ranges from 36% in those requiring hospitalisation and care in the intensive care unit.

[5] Among cases in which a bacteriological aetiology is identified, Streptococcus pneumoniae is a common cause of community-acquired pneumonia, [6] especially in the elderly, under conditions of crowding (e.g. military camps), and in those with comorbid medical conditions (e.g. alcoholism, chronic cardiovascular disease, chronic obstructive airway disease, immunoglobulin deficiency, haematological malignancy and HIV infection).

pneumoniae has become increasingly resistant to penicillin over the last three decades.

[8,9,10,11] Equally disturbing is the observation that penicillin-resistant pneumococcal strains are frequently resistant to other classes of drugs (e.g. pneumoniae to penicillin and macrolides has varied not only over time, but also by geographic region and country. [17,18,19] According to data collected in the PROTEKT (Prospective Resistance Organism Tracking and Epidemiology for Ketolide Telithromycin) study, a multinational (25 countries) surveillance programme established to monitor antimicrobial susceptibility, 25% of 1521 pneumococcal strains collected in Europe during 1999-2000 were resistant to erythromycin, with resistance rates of 16% in Turkey, 29% in Spain and 43% in Italy.

Macrolide resistance rates in Argentina, Mexico and the US were 11%, 28% and 31%, respectively. [18] Because a bacterial aetiology is determined in only about half of the cases of community-acquired pneumonia, [20] treatment is often initiated empirically. With this in mind, several medical societies and infectious diseases groups have issued treatment guidelines for community-acquired pneumonia, based on considerations of the most common infecting pathogens, their antibacterial susceptibility patterns, and antimicrobial activity of various antibacterials against these pathogens. [9,21,22,23,24,25] According to these guidelines, a macrolide (e.g.

amoxicillin/clavulanic acid) with good activity against pneumococci is an appropriate empirical choice for treating out-patients with uncomplicated community-acquired pneumonia.

This study was designed to compare the safety and efficacy of clarithromycin and amoxicillin/clavulanic acid in patients with community-acquired pneumonia due to penicillin-resistant and/or macrolide-resistant S. pneumoniae, by selecting clinical investigators who practice in study populations from geographic areas in which a high incidence of resistant strains is reported.

Azithromycin (3 days) better than amoxicillin-clavulanate (10 days) for sinusitis?

Henry DC, Riffer E, Sokol WN, Chaudry NI, Swanson RN.

Randomized double-blind study comparing 3- and 6-day regi - mens of azithromycin with a 10-day amoxicillin-clavulanate regimen for treatment of acute bacterial sinusitis. Via, MD Department of Family and Community Medicine, Scott & White Memorial Hospital, Texas A & M University System Health Science Center College of Medicine, Temple, Tex. BACKGROUND: Sinusitis is frequently treated with 7- to 14-day courses of antibiotics in primary care; however, several trials have shown success with shorter reg-imens.

This randomized controlled trial compared treatment efficacy using azithromycin for 3 and 6 days with amoxicillin-clavulanate for 10 days. POPULATION STUDIED: This manufacturer-sponsored, multicenter study, performed in the United States, enrolled 941 adults with acute bacterial sinusitis, defined clinically as presence of either purulent nasal discharge or facial pain, pressure, or tightness for more than 7 but fewer than 28 days, as well as an abnormal plain radiograph.

Patients were excluded if they had hypersensitivity to macrolides or penicillins, were receiving systemic antibiotic therapy within 2 weeks prior to enrollment, or had a history of chronic sinusitis.

STUDY DESIGN AND VALIDITY: This was a double-blind randomized controlled study. Subjects were assigned to receive azithromycin 500 mg/d for 3 days (AZM-3), azithromycin 500 mg/d for 6 days (AZM-6), or amoxicillin-clavulanate 500 mg/125 mg 3 times daily for 10 days (AMC). The subjects were assessed clinically at baseline, by telephone at day 4, and again clinically at days 10 and 28.

Analysis of data was potassium clavulanate uses done on an intention-to-treat basis. OUTCOMES MEASURED: The primary outcome was cure at the end of trial (28 days), defined as resolution of signs and symptoms to the level that existed prior to the occurrence of the acute illness. Secondary outcomes were adverse reaction to medication and compliance.