Amoxicillin 250g

The elimination half–life (T 1/2 ) was

derived

For the

purpose

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 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

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

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 rates were observed

among

for

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

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

[17,18,19] According to data collected in the

PROTEKT

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 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.

RESULTS: The groups were similar at baseline, and 93.1% followed up at 28 days.

In the intention-to-treat population (920 patients), clinical success at 28 days was equivalent among AZM-3 (71.5%), AZM-6 (74.1%), and AMC (71.5%).

Subjects treated with AMC reported a higher incidence of treatment-related adverse events than AZM-3 (51.1% vs 31.1%; P =.001; number needed to treat [NNT]=5) or AZM-6 (51.1% vs 37.6%; P =.001; NNT=7).

Diarrhea was the most frequently reported adverse event, occurring in 17% to 21% of patients treated with azithromycin and 32% of patients treated with AMC. Compliance was significantly better in the AZM groups compared with the AMC group (AZM-3: 99.2%; AZM-6: 93.9%; and AMC: 82.1%). Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Listing a study does not mean it has been evaluated by the U.S.

Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Study Details Tabular View No Results Posted Disclaimer How to Read a Study Record. To evaluate the clinical efficacy of pristinamycin at a dose of 2g x 2/day for 2 days then 1g x 3/day for 5 to 7 days versus amoxicillin 1g x3 /day for 7 to 9 days, 5 to 9 days after the end of treatment.

To evaluate the clinical efficacy in a subpopulation bacteriologically documented at inclusion and according to procalcitonin level. To evaluate the efficacy of treatments against pneumococcus.

To evaluate the rate of relapse and mortality 30±2 days after treatment is started. Condition or disease Intervention/treatment Phase Pneumonia Drug: PRISTINAMYCIN XRP7263 Drug: Amoxicillin Drug: Amoxicillin Placebo Drug: PRISTINAMYCIN Placebo Phase 4.

Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 500 participants Allocation: Randomized Intervention

Model

Talk with your doctor and family members or friends about deciding to join a study.

To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No. Male or female more than 18 years old with a presumed bacterial acute community acquired pneumonia presenting a PORT score of II or III (Fine II or III).

The acute community acquired

pneumonia

within

At least 4 functional and/or clinical symptoms from among the following: Fever characterized by a temperature of more than 38.5 at least once within 24h prior to inclusion. Tachypnoea Chest pain A characteristic sign on percussion and/or auscultation associated with a pulmonary condensation focus.

Patients having received systemic antibiotic therapy of over 24 hours within the week preceding the start of study treatment. Associated neoplasm (active cancer [of whatever type, solid or haematological] or diagnosed within the year other than basocellular skin cancer).

Severe or very severe chronic obstructive pulmonary disease (COPD) (GOLD3 and GOLD4). History of bacterial pneumonia in the past 12 months.

Bronchopulmonary diseases likely to interfere with the assessment of the therapeutic response.

Known hypersensitivity to streptogramins, penicillin and other betalactamines or excipients of the treatments studied. History of severe skin reaction after taking pristinamycin or amoxicillin. Kidney disease (chronic kidney failure or creatinine clearance ?30 mL/minute). Patients treated with allopurinol, colchicine, immunosuppressants (cyclosporin, tacrolimus, mycophenolate mofetil, methotrexate, biotherapies) oral anticoagulants in the previous 6 months or during the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. AMOXIL (amoxicillin) Capsules, Tablets, or Powder for Oral Suspension.

Formulations of AMOXIL contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms.