Augmentin scientific update |
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ur J Clin Pharmacol. 2007 May 12;
Gras-Le Guen C, Boscher C, Godon N, Caillon J, Denis C, Nguyen JM, Kergueris MF, Roze JC.
Pediatric and Neonatal Critical Care Division,Department of Perinatology, Hopital Mere Enfant, Centre Hospitalier Universitaire, 38 Bd J Monnet, 44099, Nantes, Cedex, France.
Therapeutic amoxicillin levels achieved with oral administration in term neonates.
Role of oral administration in Therapeutic amoxicillin levels in neonates AIMS: The standard treatment of neonatal group B Streptococcus infection is intravenous amoxicillin for 10 days. We
investigated whether effective serum amoxicillin concentrations could be reached by switching to oral amoxicillin
after 48 h of intravenous administration in full-term neonates with group B Streptococcus infection. METHODS: Over
2 years, we included 222 full-term neonates who had early onset group B streptococcal disease responsive to 48 h of
intravenous amoxicillin, at which point they were asymptomatic and fed orally. They were switched to oral
amoxicillin (300 or 200 mg/kg per day in four divided doses). Steady-state serum amoxicillin concentrations were
determined 48 h later by high-performance liquid chromatography; values >/=5 mg/l were considered effective.
RESULTS: Mean gestational age was 39.32 +/- 1.5 weeks ,and mean birth weight was 3,422 +/- 533 g; 29 newborns were
bacteremic. Median serum amoxicillin concentration on oral therapy was 31,.15 (range 11-118) and 25.80 (range
5-84.8) with 300 and 200 mg/kg per day, respectively. None of the infants had a concentration <5 mg/l (p < 0.001).
Gastrointestinal tolerance was satisfactory; 216 patients were discharged at 5 days of age, and none was readmitted
within the 3-month follow-up. CONCLUSION: Early switching to the oral route in asymptomatic full-term newborns with
early onset group B streptococcal disease maintained serum amoxicillin concentrations within our predefined
therapeutic range (error risk<0.001). This strategy may hold potential for reducing treatment invasiveAvandianess
and shortening hospital length of stay.
Int J Clin Pract. 2007 May;61(5):873-6.
Benninger M.
Henry Ford Health System, Detroit, MI, USA.
Guidelines on the treatment of ABRS in adults.
Treatment for of ABRS in adults, guidelines. Acute bacterial rhinosinusitis (ABRS) is a common reason for healthcare visits, and one of the more common reasons
for the use of antibiotics. In an effort to improve the diagnosis and appropriate therapy of ABRS, several
guidelines have been developed. Current guidelines recommend extended-spectrum cephalosporins as one of the
first-line options for the treatment of this condition. In addition, most cephalosporins recommended by recent
guidelines (e.g. cefuroxime axetil, cefpodoxime proxetil and cefdinir) are unlikely to be associated with
cross-reactivity with penicillins, and may be considered effective alternatives to amoxicillin in adults who are
allergic to penicillin.
J Antimicrob Chemother. 2006 Sep 26;
Chierakul W, Wangboonskul J, Singtoroj T, Pongtavornpinyo W, Short JM, Maharjan B, Wuthiekanun V, Dance DA, Teparrukkul P, Lindegardh N, Peacock SJ, Day NP, Chaowagul W, White NJ.
Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Pharmacokinetic and pharmacodynamic assessment of co-amoxiclav in the treatment of melioidosis.
A review on Pharmacokinetic and pharmacodynamic of co-amoxiclav in the treatment of melioidosis. OBJECTIVES: We conducted a prospective pharmacokinetic study of oral co-amoxiclav in patients with melioidosis to determine the optimal dosage and dosing interval in this potentially fatal infection. PATIENTS AND METHODS: Serial plasma concentrations were measured after administration of two 1 g tablets of Augmentin(R) (1750 mg of amoxicillin and 250 mg of clavulanate) to 14 adult patients with melioidosis. Monte Carlo simulation was used to predict the concentration of each drug following multiple doses of co-amoxiclav at different dosages and dose intervals. The proportion of the dose-interval above MIC (T > MIC) was calculated from 10 000 simulated subject plasma concentration profiles together with chequerboard MIC data from 46 clinical isolates and four reference strains of Burkholderia pseudomallei. RESULTS: The median (range) observed maximum plasma concentrations of amoxicillin and clavulanate were 11.5 (3.3-40.2) mg/L and 5.1 (0.8-12.1) mg/L, respectively. The median (range) elimination half-lives were 94 (73-215) and 89 (57-140) min, respectively. Simulation indicated that co-amoxiclav 1750/250 mg given at 4, 6, 8 or 12 hourly dosing intervals would be associated with a T > MIC of MIC of >/=90% were 95.8%, 78.6%, 50.2% and 10.8%, respectively. CONCLUSIONS: The dosing interval for co-amoxiclav (750/250 mg) in melioidosis should not be greater than 6 h.
JAMA. 2005 Feb 23;293(8):949-55.
Hooton TM, Scholes D, Gupta K, Stapleton AE, Roberts PL, Stamm WE.
Department of Medicine, School of Medicine, University of Washington, Seattle, USA.
Amoxicillin-clavulanate vs ciprofloxacin for the treatment of uncomplicated cystitis in women: a randomized trial.
A randomized trial on Amoxicillin-clavulanate vs ciprofloxacin in the treatment of uncomplicated cystitis in women. The high prevalence of resistance to trimethoprim-sulfamethoxazole and other antimicrobials among Escherichia coli causing acute cystitis in women has led to increased use of alternative antibiotics. One such antibiotic, amoxicillin-clavulanate, has not been well studied.
OBJECTIVE: To compare the efficacy of a 3-day regimen of amoxicillin-clavulanate to that of a 3-day regimen of ciprofloxacin in the treatment of acute cystitis in women. The primary study hypothesis was that the amoxicillin-clavulanate and ciprofloxacin treatment groups would differ in clinical cure.
DESIGN, SETTING, AND PATIENTS: Randomized, single-blind treatment trial of 370 women, aged 18 to 45 years, with symptoms of acute uncomplicated cystitis and a urine culture with at least 10(2) colony-forming units of uropathogens per milliliter from a university student health center or a health maintenance organization.
INTERVENTIONS: Women were randomly assigned to receive amoxicillin-clavulanate (500 mg/125 mg twice daily) or ciprofloxacin (250 mg twice daily) for 3 days and were followed up for 4 months. MAIN OUTCOME MEASURES: The main outcome measure was clinical cure. Secondary study outcomes of interest were microbiological cure and vaginal E coli colonization at the 2-week follow-up visit. RESULTS: Clinical cure was observed in 93 (58%) of 160 women treated with amoxicillin-clavulanate compared with 124 (77%) of 162 women treated with ciprofloxacin (P<.001). Amoxicillin-clavulanate was not as effective as ciprofloxacin even among women infected with strains susceptible to amoxicillin-clavulanate (65 [60%] of 109 women in the amoxicillin-clavulanate group vs 114 [77%] of 149 women in the ciprofloxacin group; P = .004). The difference in clinical cure rates occurred almost entirely within the first 2 weeks after therapy. Microbiological cure at 2 weeks was observed in 118 (76%) of 156 women treated with amoxicillin-clavulanate compared with 153 (95%) of 161 women treated with ciprofloxacin (P<.001). At this visit, 45% of women in the amoxicillin-clavulanate group compared with 10% in the ciprofloxacin group had vaginal colonization with E coli (P<.001).
CONCLUSIONS: A 3-day regimen of amoxicillin-clavulanate is not as effective as ciprofloxacin for the treatment of acute uncomplicated cystitis, even in women infected with susceptible strains. This difference may be due to the inferior ability of amoxicillin-clavulanate to eradicate vaginal E coli, facilitating early reinfection.
Antimicrob Agents Chemother. 2005 Mar;49(3):908-15.
Berry V, Hoover J, Singley C, Woodnutt G.
GlaxoSmithKline, Collegeville, PA, USA.
Comparative bacteriological efficacy of pharmacokinetically enhanced amoxicillin-clavulanate against Streptococcus pneumoniae with elevated amoxicillin MICs and Haemophilus influenzae.
A review on the bacteriological effectiveness of pharmacokinetically improved amoxicillin-clavulanate vs Streptococcus pneumoniae with elevated amoxicillin MICs and Haemophilus influenzae. A new pharmacokinetically enhanced formulation of amoxicillin-clavulanate (2,000 mg of amoxicillin/125 mg of clavulanate twice a day; ratio 16:1) has been designed, with sustained-release technology, to allow coverage of bacterial strains with amoxicillin-clavulanic acid MICs of at least 4/2 mug/ml. The bacteriological efficacy of amoxicillin-clavulanate, 2,000/125 mg twice a day, ratio 16:1, was compared in a rat model of respiratory tract infection versus four other amoxicillin-clavulanate formulations: 8:1 three times a day (1,000/125 mg), 7:1 three times a day (875/125 mg), 7:1 twice a day (875/125 mg), and 4:1 three times a day (500/125 mg); levofloxacin (500 mg once a day); and azithromycin (1,000 mg on day 1 followed thereafter by 500 mg once a day). Bacterial strains included Streptococcus pneumoniae, with amoxicillin-clavulanic acid MICs of 2/1 (one strain), 4/2, or 8/4 microg/ml (three strains each), and Haemophilus influenzae, one beta-lactamase-positive strain and one beta-lactamase-negative, ampicillin-resistant strain. Animals were infected by intrabronchial instillation. Antibacterial treatment commenced 24 h postinfection, with doses delivered by computer-controlled intravenous infusion to approximate the concentrations achieved in human plasma following oral administration. Plasma concentrations in the rat corresponded closely with target human concentrations for all antimicrobials tested. Amoxicillin-clavulanate, 2,000/125 mg twice a day, ratio 16:1, was effective against all S. pneumoniae strains tested, including those with amoxicillin-clavulanic acid MICs of up to 8/4 microg/ml and against beta-lactamase-producing and beta-lactamase-negative ampicillin-resistant H. influenzae. These results demonstrate the bacteriological efficacy of pharmacokinetically enhanced amoxicillin-clavulanate 2,000/125 mg twice a day (ratio 16:1) against S. pneumoniae with amoxicillin-clavulanic acid MICs of at least 4/2 microg/ml and support clavulanate 125 mg twice a day as sufficient to protect against beta-lactamase in this rat model.
Eur J Obstet Gynecol Reprod Biol. 2005 Mar 1;119(1):21-6.
Keuchkerian SE, Sosa CG, Fernandez A, Alonso JG, Laborde A, Cuadro JC.
Department of Obstetrics and Gynecology, Pereira Rossell Hospital, School of Medicine, University of Uruguay, Montevideo, Uruguay.
Effect of amoxicillin sulbactam in threatened preterm labour with intact membranes: a randomised controlled trial.
A study on randomized controlled trial on the efficacy of amoxicillin sulbactam in threatened preterm labour having intact membranes. Objective: To determine whether treatment with amoxicillin-sulbactam in women with threatened idiopathic preterm labour will prolong the gestation and reduce preterm birth rates in a Latin-American population. Methods: A double-blind, placebo-controlled, randomized trial was conducted in 96 women who were hospitalized for preterm labour between 24 and 34 weeks of gestation at the Pereira Rossell Hospital, in Montevideo, Uruguay. The primary outcome measure was prematurity. The sample size was calculated a priori based on the hospital database. Statistical analyses were performed using the t-test, chi square, weighted mean difference (WMD) and relative risk (RR) with their confidence intervals (95% CI). Analysis by intention-to-treat. Results: Out of 47 patients assigned for antibiotics, 43 completed the treatment. There were no significant statistical differences between antibiotics and placebo group in prematurity (RR:1.04, 95% CI: 0.59, 1.84), prolongation of pregnancy (WMD:0.23, 95% CI: -0.96, 1.42) and other perinatal outcomes. Conclusion: Antibiotics did not prove to have benefits in improving perinatal outcomes in this Latin American population.
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Drug category:Antibacterial and antiviral agent
 Augmentin scientific update
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