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The failure rate of primary empirical anti-infective treatment of community-acquired pneumonia is reported to range between 2 and 7%. These patients are subject to a greater risk of intensive medical treatment and a higher mortality rate than patients who respond to primary treatment. We investigated 63 patients in a "real life scenario" who were admitted to the hospital after failure of primary outpatient therapy for community-acquired pneumonia. Thirty-three patients received intravenous standard therapy (betalactam 14, macrolide 3, levofloxacin 6, doxycycline 1, combinations 9 patients) while 30 patients were treated with intravenous moxifloxacin. The oral antibiotic pretreatment that failed most frequently was clarithromycin (n = 25), followed by amoxicillin/clavulanic acid (n = 16), cefixime (n = 10), cefuroxime/axetil (n = 5), doxycycline (3), cefpodoxime, and ciprofloxacin (2 each). There were no differences between the two groups in respect of age, gender, numbers of patients in nursing homes, numbers of patients with different underlying diseases (chronic bronchitis, coronary heart disease, diabetes mellitus, smoking, etc.), severity of pneumonia at the time of admission, numbers of patients requiring intensive care, and lethality. The group that underwent standard therapy experienced failure of the empirical intra-hospital antibiotic therapy more often during therapy [10 (30%) patients vs 2 (6%) in the moxifloxacin group, p = 0.009] and clinical failure of treatment on day 28 after initiation of therapy [7 (21%) patients vs 2 (6%) in the moxifloxacin group, p = 0.003]. In cases of failure of empirical preclinical antibiotic treatment for community-acquired pneumonia, subsequent intrahospital treatment with moxifloxacin is more successful than standard therapy in our study reflecting a "real life scenario".
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The data showed the flow-through cell to be unequivocally the most robust dissolution method for the nanoparticulate system. Furthermore, the dissolution profiles conform closely to the classic Noyes-Whitney model, indicating that the increase in dissolution rate as particles become smaller results from the increase in surface area and solubility of the nanoparticles.
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Biphasic floating minitablets of cefuroxime axetil were prepared by melt granulation technique using two different grades of gelucire namely 50/13 and 43/01 to maintain constant plasma drug concentration. Loading dose of cefuroxime axetil was formulated as immediate release (IR) minitablets by using hydrophilic grade of gelucire 50/13. Maintenance dose was formulated as floating sustained release (SR) minitablets by using hydrophobic grade of gelucire 43/01. The prepared IR and SR granules were subjected to micromeritic studies and scanning electron microscopy. Fourier transform infrared spectroscopy (FT-IR) study revealed that drug and selected carriers were compatible. In vitro dissolution study of optimized IR minitablets showed more than 85% of loading dose dissolved within 30 min. Optimized SR minitablets showed zero lag time with floating duration more than 12 h. The drug release from SR minitablets was linear with square root of time with non-Fickian diffusion-controlled release. The optimized batch of minitablets was filled into 0 size hard gelatin capsule. In vitro dissolution study for capsule showed an immediate burst release followed by SR up to 12 h. There is no significant change in dissolution data after storage at 40 °C and 75% RH for three months. Microbiological assay of dissolution samples of optimized minitablets filled in capsules showed proportionate increase in inhibition of growth against Escherichia coli up to 12 h samples. In vivo bioavailability study in albino rabbits showed three times improvement in oral bioavailability.
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Cefuroxime is a second generation cephalosporin antibiotic with a broad spectrum activity against Gram positive and Gram negative bacteria. The purpose of this research work was to evaluate the pharmaceutical quality standards of four different brands of cefuroxime axetil 125 mg tablets with different price ranges purchased from retail pharmacies of Pakistan. The brands were tested for physicochemical evaluation and in vitro dissolution studies in different medium like 0.07N HCl, distilled water, 0.1N HCl of pH 1.2 and phosphate buffers of pH 4.5 and pH 6.8. Statistical analysis, model dependent (zero order, first order, Korsmeyer-Peppas, Hixson-Crowell, Weibull) and model independent (Difference f1, similarity f2) approaches were applied to multiple dissolution profile of all brands. All brands were found to be similar with reference and meeting the compendial quality standard. Inter brand variation was observed in disintegration time and assay which was resulted in significant differences (P<0.05) in drug release data and Weibull was observed as best fill model.
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Patients with AECOPD and without radiographic evidence of pneumonia were enrolled and randomized to either levofloxacin 500 mg daily or cefuroxime 250 mg twice daily in the mildmoderate exacerbation group, or 500 mg twice daily in the severe exacerbation group, for seven days. Clinical efficacy and microbiologic response were evaluated 5-7 days after the last dose.
Studies regarding the cross-reactivity and tolerability of alternative cephalosporins in large samples of subjects with an IgE-mediated hypersensitivity to cephalosporins are lacking.
A simple rapid spectrophotometric method has been developed for estimation of cefuroxime axetil from bulk drug and tablet dosage form by using 1-nitroso-2-napthol and sodium hydroxide. The method is based on the formation of yellow-orange coloured complex of drug with 1-nitroso-2-napthol having absorbance maxima at 424 nm. The Beer's law is obeyed in the concentration range of 10-50 mug/ml of the drug but more precisely it obeys in the range of 10- 30 mug/ml. The slope and intercept values are 0.0101 and 0.0838, respectively. Results of analysis of this method were validated statistically and by recovery studies. The method is applied to the marketed tablet formulation. Result of analysis of tablet formulation given as percentage of label claim +/-standard deviation is 99.17+/-1.57. The precision and accuracy was examined by performing recovery studies and was found to be 99.50+/-1.82. Sandell's correlation coefficient is calculated as 0.4434. The developed method is simple, sensitive and reproducible and can be used for routine analysis of cefuroxime axetil from bulk and tablet dosage form.
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Otitis media is a common childhood disease with a spectrum of pathology ranging from acute, painful infection to persistent middle ear effusion to chronic negative middle ear pressure and development of cholesteatoma. Amoxicillin remains the initial empiric drug of choice with TMP-SMZ or erythromycin-sulfisoxazole used for penicillinallergic patients or for amoxicillin therapy failures. Amoxicillin-clavulante, cefuroxime axetil (no elixir form available) or cefixime may then be tried keeping in mind relative costs, side effects, dosing frequency and drug formulation. Prophylactic amoxicillin or sulfisoxazole at one-half the usual daily dose given once a day throughout the URI season is effective in reducing the number of episodes of AOME. Prolonged sulfonamide use should be carefully monitored. Tympanostomy tube insertion is indicated for frequently recurring otitis media and for persistent middle ear effusions. Adenoidectomy is an adjunctive procedure shown to be effective in children requiring a second set of tubes for recurrent infections or for children four years old or older with persistent middle ear fluid. Tympanoplasty may be necessary to prevent ossicular chain damage due to severe cases of MEVD or to repair non-healing perforations. Cholesteatomas must be surgically removed and may require elaborate reconstructive techniques.
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A randomized, double-blind, double-dummy, three-arm parallel design, multicentre study was conducted among adult patients with acute exacerbation of chronic bronchitis (AECB) in order to compare the efficacy and safety of two different doses of levofloxacin with cefuroxime axetil. A total of 832 patients were randomized to receive oral levofloxacin (250 mg od or 500 mg od) or oral cefuroxime axetil (250 mg bd) for 7-10 days. The primary efficacy analysis was based on the clinical response in patients with bacteriologically confirmed AECB, determined 5-14 days after the end of therapy (per-protocol population). Of 839 patients enrolled (at 71 centres in 14 countries), seven were not treated, giving an intention-to-treat (ITT) population of 832. In total, 281 patients received levofloxacin 250 mg, 280 received levofloxacin 500 mg and 271 received cefuroxime axetil. The cure rates in the ITT population were: levofloxacin 250 mg, 70% (196/281); levofloxacin 500 mg, 70% (195/280); cefuroxime axetil, 61% (166/271); those in the per-protocol population were: 78% (121/156), 79% (108/137) and 66% (88/134), respectively. Both doses of levofloxacin were at least as effective as cefuroxime axetil and were active against the main pathogens of clinical relevance (Haemophilus influenzae, Streptococcus pneumoniae and Moraxella catarrhalis). All three treatment regimens were equally well tolerated. In conclusion, the results show that levofloxacin (250 mg and 500 mg) od is effective and well tolerated in the treatment of AECB in adult patients.
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In the presence of wound infection from snakebite injury in Hong Kong, first line empirical antibiotics include amoxicillin/clavulanic acid plus levofloxacin. Prophylactic antibiotics may be considered in selected cases of Chinese cobra (N. atra) bite, otherwise prophylactic antibiotics are not recommended in snakebite unless tissue necrosis is present.
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A total of 311 patients presenting with uncomplicated gonorrhoea were entered into a comparative randomized open-label study and given single-dose treatment with either oral cefuroxime axetil (CAE) or intramuscular procaine penicillin (PP). Neisseria gonorrhoeae was eliminated from 129 (98%) of 131 evaluable patients treated with CAE and 127 (98%) of 129 evaluable patients treated with PP. None of the 4 treatment failures (3 male and 1 female) were caused by beta-lactamase-producing isolates. Both treatments were well tolerated with minor adverse events reported in 3 (2%) of CAE treated patients. We conclude that CAE is an effective, well tolerated treatment for uncomplicated gonorrhoea which has the convenience and acceptability of single-dose oral therapy.
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The choice of antimicrobials did not influence the duration of middle ear effusion, which was much shorter than had been thought previously. Children with unilateral AOM were cured much more quickly than those with bilateral AOM.