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Of a total of 22,455 adverse medicine reaction (AMR) reports there were 943 reports of liver injury (4.2%). Two hundred and five drugs were associated with hepatic reactions. The top 20 drugs accounted for 57% of all liver reactions. Fifty-seven percent were reported in females. Hepatotoxicity was most commonly reported among patients 50-80 years old. Liver reactions were associated with a 3.3% mortality, but were responsible for 7.4% of all fatal occurrences. There was a steady increase in the number of reports over the 21 years. Although the largest number of reports of liver injury were received between 1988 and 1994, mortality was lowest during this period. There were substantial differences in the medicines associated with hepatic reactions during each of the three periods, although erythromycin was the commonest cause throughout. Erythromycin was associated with two deaths. Halothane and perhexilene were the most frequent cause of death and were two of the most important causes of liver injury during the first and second periods. Diclofenac, Augmentin and flucloxacillin were important causes of hepatotoxicity during period 3 but were not associated with a fatal outcome.
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The primary endpoint, clinical response at the test-of-cure visit in the bacteriologic eligible population, was achieved in 80.5% of children in the azithromycin ER group and 84.5% of children in the amoxicillin/clavulanate group (difference-3.9%; 95% confidence interval-10.4, 2.6). Bacteriologic eradication was 82.6% in the azithromycin ER group and 92% in the amoxicillin/clavulanate group (p=0.050). Children who received amoxicillin/clavulanate had significantly higher rates of dermatitis and diarrhea, a greater burden of adverse events, and a lower rate of compliance to study drug compared to those who received azithromycin ER.
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We evaluated the incidence of Haemophilus influenzae resistance to selected antimicrobials used in Canada. From 1985 to 1987, 2503 H. influenzae isolates obtained in 14 hospitals across Canada were sent to the Centre hospitalier de l'université Laval (CHUL) for identification, serotyping, biotyping and testing for beta-lactamase production. Susceptibility tests were done with the use of 12 antibiotics. Of the strains 424 (16.9%) produced beta-lactamase; the proportion varied from 12.8%, in Newfoundland, to 19.6%, in Ontario. Of the strains 18.3% were type b; 19.4% of those produced beta-lactamase. Almost 82% of the strains were not type b. The proportion of beta-lactamase-producing strains varied according to the isolation site, from 15.3% in the respiratory tract to 25.6% in the blood. The overall level of resistance was 19.3% to ampicillin, 24.2% to erythromycin, 3.8% to trimethoprim-sulfamethoxazole, 1.7% to amoxicillin-potassium clavulanate, 1.4% to cefaclor, 1.3% to tetracycline, 1.0% to rifampin, 0.7% to cefuroxime and 0.1% to cefamandole. Disc diffusion susceptibility testing revealed 64 strains (2.6%) that did not produce beta-lactamase but were resistant to ampicillin and 9 (0.4%) that produced beta-lactamase but were susceptible to ampicillin. The results of beta-lactamase production tests were identical regardless of whether the tests were done by the CHUL or by the other hospitals, but there was a marked difference in the susceptibility test results between the CHUL and the other centres. Our results suggest that the level of resistance of H. influenzae to antibiotics is increasing in Canada and that the initial choice of drug therapy may have to be modified.
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Patients' signs and symptoms were assessed by physical examination and by both physician and parental forced-choice questionnaires 1, 3, and 24 months after treatment. The decision to proceed to surgery or to continue expectant management was made for all patients by the same physician, based on reported symptoms and physical findings.
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Treatment failure occurred in 18.6% of the children who received amoxicillin-clavulanate, as compared with 44.9% of the children who received placebo (P<0.001). The difference between the groups was already apparent at the first scheduled visit (day 3), at which time 13.7% of the children who received amoxicillin-clavulanate, as compared with 25.3% of those who received placebo, had treatment failure. Overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio, 0.38; 95% confidence interval [CI], 0.25 to 0.59; P<0.001) and the need for rescue treatment by 81% (6.8% vs. 33.5%; hazard ratio, 0.19; 95% CI, 0.10 to 0.36; P<0.001). Analgesic or antipyretic agents were given to 84.2% and 85.9% of the children in the amoxicillin-clavulanate and placebo groups, respectively. Adverse events were significantly more common in the amoxicillin-clavulanate group than in the placebo group. A total of 47.8% of the children in the amoxicillin-clavulanate group had diarrhea, as compared with 26.6% in the placebo group (P<0.001); 8.7% and 3.2% of the children in the respective groups had eczema (P=0.04).
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In a previous prospective multicenter study in Spain, we found that OXA-1 and inhibitor-resistant TEM (IRT) β-lactamases constitute the most common plasmid-borne mechanisms of genuine amoxicillin-clavulanate (AMC) resistance in Escherichia coli. In the present study, we investigated the population structure and virulence traits of clinical AMC-resistant E. coli strains expressing OXA-1 or IRT and compared these traits to those in a control group of clinical AMC-susceptible E. coli isolates. All OXA-1-producing (n = 67) and IRT-producing (n = 45) isolates were matched by geographical and temporal origin to the AMC-susceptible control set (n = 56). We performed multilocus sequence typing and phylogenetic group characterization for each isolate and then studied the isolates for the presence of 49 virulence factors (VFs) by PCR and sequencing. The most prevalent clone detected was distinct for each group: group C isolates of sequence type (ST) 88 (C/ST88) were the most common in OXA-1 producers, B2/ST131 isolates were the most common in IRT producers, and B2/ST73 isolates were the most common in AMC-susceptible isolates. The median numbers of isolates per ST were 3.72 in OXA-1 producers, 2.04 in IRT producers, and 1.69 in AMC-susceptible isolates; the proportions of STs represented by one unique isolate in each group were 19.4%, 31.1%, and 48.2%, respectively. The sum of all VFs detected, calculated as a virulence score, was significantly higher in AMC-susceptible isolates than OXA-1 and IRT producers (means, 12.5 versus 8.3 and 8.2, respectively). Our findings suggest that IRT- and OXA-1-producing E. coli isolates resistant to AMC have a different and less diverse population structure than AMC-susceptible clinical E. coli isolates. The AMC-susceptible population also contains more VFs than AMC-resistant isolates.
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A prospective, randomized, open study was performed in 199 patients at the Leyenburg Hospital comparing amoxycillin/clavulanate (AMX/CL) with cefuroxime plus metronidazole (CR/MN) in the prophylaxis of infection following gynaecological surgery. AMX/CL was given as a single dose of 2200 mg i.v. at the start of the operation. CR/MN, 750/500 mg i.v. was administered 3 times within 24 h, beginning at the start of the operation. The study group consisted of patients undergoing either a vaginal hysterectomy, a vaginal hysterectomy with cysto/rectocele repair or a secondary caesarean section. There were no statistically significant differences in demographic characteristics, duration of surgery or anaesthetic method between the two groups. Postoperatively, 10.6% of patients developed a urinary tract infection, and febrile temperatures were found in 9.0% of patients. There were no statistically significant differences between the two treatment groups. Other complications were found in less than 1% of the study population, equally distributed between the two regimens. In this study there was a low overall percentage of infection after gynaecological surgery. AMX/CL was as effective as CR/MN as a perioperative prophylactic treatment and has the dual advantage of a single dose and lower cost.
Briefly, SCAPs were cultured and subjected to either no drug treatment or various concentrations including TAP, DAP, modified TAP (ciprofloxacin, metronidazole and cefaclor), Augmentin (Champs Pharmacy, San Antonio, TX), or Ca(OH)(2). Viable stem cells counts were obtained using an automated method of detecting trypan blue dye at 3 days after treatment.
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The risk of fistula formation is a major concern after incision and drainage of an anorectal abscess.
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Large general hospital in Dublin.
Polypharmacy is common, and may modify mechanisms of drug-induced liver injury. We examined the effect of these drug-drug interactions on liver safety reports of four drugs highly associated with hepatotoxicity. In the WHO VigiBase™, liver event reports were examined for acetaminophen, isoniazid, valproic acid, and amoxicillin/clavulanic acid. Then, we evaluated the liver event reporting frequency of these 4 drugs in the presence of co-reported medications. Each of the 4 primary drugs was reported as having more than 2000 liver events, and co-reported with more than 600 different medications. Overall, the effect of 2275 co-reported drugs (316 drug classes) on the reporting frequency was analyzed. Decreased liver event reporting frequency was associated with 245 drugs/122 drug classes, including anti-TNFα, opioids, and folic acid. Increased liver event reporting frequency was associated with 170 drugs/82 drug classes; in particular, halogenated hydrocarbons, carboxamides, and bile acid sequestrants. After adjusting for age, gender, and other co-reported drug classes, multiple co-reported drug classes were significantly associated with decreased/increased liver event reporting frequency in a drug-specific/unspecific manner. In conclusion, co-reported medications were associated with changes in the liver event reporting frequency of drugs commonly associated with hepatotoxicity, suggesting that comedications may modify drug hepatic safety.
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A randomized, double-blind, double-dummy, multicenter international study was conducted to assess the clinical and bacteriologic response, safety, and compliance of a single 60-mg/kg dose of azithromycin extended-release (ER) versus a 10-day regimen of amoxicillin/clavulanate 90/6.4 mg/kg per day in children with acute otitis media at high risk of persistent or recurrent middle ear infection.
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The aim of the present study was to evaluate the effect of non-surgical periodontal therapy with the adjunct of a selected antibiotic in subjects diagnosed with refractory periodontal disease. 21 subjects were selected for the study; all had a history of periodontal surgery, tetracycline therapy, and regular maintenance by a periodontist. When disease activity was detected, a bacterial sample was taken and a whole plaque susceptibility test was performed. Before the outcome of the susceptibility test the subjects were assigned to either antibiotic or placebo therapy. All subjects received scaling and rootplaning prior to antibiotic or placebo therapy. Based on the susceptibility test, subjects in the antibiotic group were treated either with Augmentin or clindamycin. The results demonstrated that in subjects with refractory periodontal disease there was no significant difference (N.S.) in the proportion of sites losing attachment before and after treatment (11.3% and 12.4%, respectively) over a 2-year post therapy observation period. However, the proportion of sites showing gain of attachment increased from 0.9% before therapy to 5.1% (p = 0.029) following selective antibiotic therapy when combined with scaling and rootplaning. The remainder of sites showed no change between pre- and post-therapy monitoring periods. The progression of attachment loss in the active sites could not be completely stopped over the entire 2-year period. After 12-15 months following therapy, there was a tendency towards new loss of attachment and an increase of pocket depth. However, all 4 subjects treated with placebo drug demonstrated continuous deterioration and had to be retreated. Although the proportion of sites losing attachment decreased from 5.1% to 2.3% (N.S.), the proportion of sites gaining attachment also decreased from 2.0% to 1.0% (N.S.). The results suggest that scaling and rootplaning together with selected antibiotic therapy repeated every 12-15 months may be beneficial for these subjects although it may not completely stop progressive attachment loss.
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Under certain permissive circumstances, normally occurring fusiform bacteria and Borrelia spirochetes can result in a symbiotic overgrowth that leads to necrotic oral ulcers (stomatitis), gingivitis, and periodontitis. These lesions are collectively known as oral fusospirochetosis and may be under-appreciated in patients with HIV infection and AIDS. Fusospirochetal oral ulcers in patients with HIV are often large, necrotic, and malodorous; they respond completely to penicillin. We report 3 patients with HIV infection and fusospirochetal ulcerative stomatitis and review the clinical presentation, microbiologic diagnosis, potential pathogenesis, and treatment of these lesions.
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This multicenter, randomized, single-blind study compared the efficacy and safety of a new, twice-daily formulation of amoxycillin/clavulanate (Augmenting) with the standard three-times-daily formulation. Children with a clinical diagnosis of acute otitis media, aged between 2 months and 12 years, received either amoxycillin/clavulanate 45/6.4 mg/kg/day twice-daily (b.d.) (range 38.3/5.5-76.2/10.9 mg/kg/day) or amoxycillin/clavulanate 40/10 mg/kg/day three-times-daily (t.d.s.) (range 25/6.25-56/14 mg/kg/day) for 7 or 10 days. Patients were evaluated during therapy (Days 3-5), at the end of therapy (Days 7-12) and at follow-up (Days 38-42). At the end of therapy, for the intent-to-treat and per-protocol populations, respectively, clinical success (cure) was achieved by approximately 94% of patients in both treatment groups. A successful bacteriological response at the end of therapy (Visit 3) was documented in 7/9 patients (77.8%) in the twice-daily group and in 11/13 patients (84.6%) in the three-times-daily group. At follow-up (Visit 4), 93.3% of patients in the twice-daily group and 87.9% in the three-times-daily group continued to have a clinically successful response. Both treatment regimens were well tolerated, with most adverse events being of a mild-moderate and transient nature. The most common treatment-related adverse event was diarrhea, occurring in 7.2% of patients in the twice-daily group and in 10.7% of the three-times-daily group. In total, 173 patients (82.8%) in the twice-daily group and 151 patients (73.3%) in the three-times-daily group were compliant with medication. In conclusion, this study confirms that b.d. amoxycillin/clavulanate is an effective treatment for pediatric acute otitis media and demonstrates that the b.d. and t.d.s. formulations of amoxycillin/clavulanate produce equivalent efficacy. Furthermore, there was a trend towards a higher level of compliance and a lower incidence of drug-related adverse events in the twice-daily compared with the three-times-daily treatment group.
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Osteopetrosis is a heterogeneous disorder characterized by abnormal bone remodeling and increased bone density primarily due to defective osteoclast resorption. The diagnosis is based on a history of numerous fractures and radiological findings indicative of osteosclerosis, usually sufficient for a definitive diagnosis. We present a quite rare case of osteopetrosis complicated by recurrent episodes of maxillomandibular osteomyelitis associated with cutaneous fistulization and purulent nasal discharge. We used intravenous antibiotic therapy and necrotic bone debridement that prevented the appearance of acute infections over a 3-year follow-up, but the complete healing of the case was not achieved.
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A 40-year-old woman was admitted to the hospital for an acute outbreak of multiple pustular lesions with an underlying erythematous base affecting cheeks and chin. These lesions were referred to as "aching". The patient had been taking amoxicillin-clavulanic acid (3 g a day) over the past three days for oral prophylaxis for dental treatment. Given the possible allergic reaction to the drug administered and the extension of the pustular lesions over all face and neck during the following four days, we replaced the amoxicillin-clavulanic acid with another antibiotic with wide range (ciprofloxacin). Resolution of the pustular lesions occurred within ten days and was accompanied by light scarring and pigmentation. On the basis of the close relationship between the administration of amoxicillin-clavulanic acid and the development of the disease, in combination with a rapid, acute resolution as soon as this treatment was interrupted, and all the histologic findings, we consider this to be an unusual type of acute generalized pustular eruption (AGEP) recently defined as acute localized pustular eruption (ALEP) due to amoxicillin-clavulanic acid.
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Drug-induced liver injury (DILI) is a rare but potentially serious idiosyncratic reaction. By using candidate gene and genome-wide association studies, replicated associations for DILI susceptibility with HLA genes and genes relevant to drug metabolism have been detected, mainly since 2000. The HLA associations include a strong association between flucloxacillin-induced injury and the class I allele B*5701 and weaker associations for co-amoxiclav and ximelagatran DILI with the class II genotype. These associations suggest an injury mechanism involving an immune response, possibly to a complex of drug or metabolite and protein. For genes relevant to drug metabolism, the best replicated association is between isoniazid DILI and NAT2 slow acetylation. Homozygosity for GSTM1 null and/or GSTT1 null alleles also seems to be a risk factor for DILI, with associations described independently for several drugs. Other not-yet-replicated associations have been described for genes relevant to drug metabolism and oxidative stress and cytokine genes.
Despite the implementation of strategies aiming at improving antimicrobial utilisation, inappropriate use remains an increasing problem with important consequences on both antibiotic resistance and hospital costs.
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The nasal septum abscess is a rare and serious infection because of the complications which can be generated. The authors report a new case of nasal septum abscess to probably from dental origin.
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Pristinamycin 3 G daily for 4 days is as effective and well tolerated as co-amoxiclav 2G daily for 8 days in the treatment of AECB.
Fecal Enterobacteriaceae were enumerated onto EMB agar containing amoxicillin (AMX). A total of 173 CF isolates and 41 sibling isolates were grouped into seven Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS) clusters and identified through 16S rRNA and rpoB sequence analysis.
A retrospective analysis was conducted to assess the cost-effectiveness of four intravenous antibiotic treatment regimens in the treatment of severe community-acquired pneumonia (CAP) in adults in a private hospital setting. The study compared some third-generation cephalosporin regimens with a second-generation cephalosporin and an amoxicillin/clavulanic acid (co-amoxiclav) regimen to investigate published South African treatment guidelines from a pharmaco-economic point of view.
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We assessed children at age 7 years born to the 4221 women who had completed the ORACLE II study and who were eligible for follow-up with a structured parental questionnaire to assess the child's health status. Functional impairment was defined as the presence of any level of functional impairment (severe, moderate, or mild) derived from the mark III Multi-Attribute Health Status classification system. Educational outcomes were assessed with national curriculum test results for children resident in England.
The study population consisted of 2 groups of women who had previously been enrolled in a randomized clinical trial: group A was not treated, and group B was treated. All women were scheduled for follow-up visits every 6 months, or more frequently if symptoms arose. Microbiological evaluation was performed only in symptomatic women. All women were followed up for a mean of 38.8 months to analyze data from urine cultures and antibiograms.
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Clinical symptoms and signs decreased significantly in both treatment groups during phase I (p < 0.01). There was a trend to greater improvement in the patients treated with flunisolide, but only the decrease in turbinate swelling/obstruction was statistically significant at the end of phase I when compared with placebo (p = 0.041). Patients' global assessment of overall effectiveness of treatment was higher for flunisolide than placebo after phase I (p = 0.007) and after phase II (p = 0.08). Maxillary sinus radiographs showed improvement in both treatment groups during phase I (p < 0.004) with somewhat greater regression of abnormal findings in patients treated with flunisolide after phase II (p = 0.066). However, 80% of radiographs were still abnormal at the end of phase I. All types of inflammatory cells were significantly decreased in nasal cytograms in patients treated with flunisolide in comparison with those treated with placebo. Flare-up of sinusitis during phase II occurred in 26% of with those treated with placebo. Flare-up of sinusitis during phase II occurred in 26% of patients treated with flunisolide and 35% of those treated with placebo and tended to be more severe in the latter, although these differences were not statistically significant. Adverse events, mainly gastrointestinal symptoms and headache, were similar in both groups and more frequent in phase I than in phase II, (42 vs 15 patients); these side effects were probably due to the antibiotic.
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The authors recovered S. aureus from 20 of 429 surfaces (4.7 percent). Most isolates were resistant to penicillin but none were resistant to the other antibiotics. No isolate carried the mecA gene encoding resistance to methicillin. The authors considered one site to be highly contaminated (> 200 colony-forming units [CFUs]), but all other sites that tested positive yielded fewer than 5 CFUs.
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To compare the efficacy and tolerability of clarithromycin extended-release (ER) to amoxicillin/ clavulanate in patients diagnosed with acute bacterial sinusitis.
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PMNs from renal transplant recipients showed a diminished phagocytic activity with reduced phagocytosis and bactericidal activity against intracellular Klebsiella pneumoniae, compared to that seen with PMNs from healthy subjects. Co-amoxiclav significantly elicited the functions of PMNs from uremic patients, resulting in an increased percentage of ingested klebsiellae and in a higher bactericidal effect (98-99%), compared with the drug-free control system. When PMNs were collected from renal transplant recipients treated with co-amoxiclav a significant high increase in both phagocytosis and killing activity were detected, showing the co-amoxiclav capability of "restoring" even in vivo the depressed primary functions of PMNs.