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A specific, sensitive and rapid liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) method has been developed and validated for the determination of azithromycin in human plasma. After deproteinizing the plasma sample with methanol, azithromycin and internal standard (IS: roxithromycin) were separated using a mobile phase comprised of acetonitrile : ammonium acetate buffer (50 mM, containing 0.05% acetic acid)=85:15 on a Hypersil GOLD C18 column (50 mm×2.1 mm ID, dp 1.9 μm). Detection was performed with a tandem mass spectrometer by selective reaction monitoring (SRM) through electrospray ionization. Target ions were monitored at [M+H]+ m/z 749.5→591.5 and 837.7→679.5 in positive electrospray ionization (ESI) mode for azithromycin and IS respectively. Linearity was established for the range of concentrations 2-800 ng/mL with a coefficient of correlation (r) of 0.9996. The lower limit of quantification (LLOQ) was identifiable and reproducible at 2.0 ng/mL. Both intra- and inter-batch standard deviations were less than 15%. The validated method was successfully applied to study the comparative bioavailability of azithromycin for suspension in test vs. reference in healthy Chinese volunteers through the statistical comparison of pharmacokinetic parameters obtained with the two formulations.
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A. actinomycetemcomitans was highly susceptible to both fluoro-quinolones (MIC90 of 0.006 microgram/mL of ciprofloxacin and 0.032 microgram/mL of moxifloxacin). Good susceptibilities were found for ampicillin/sulbactam and doxycycline (MIC90 of 0.75 microgram/mL and 1 microgram/mL, respectively), and moderate susceptibilities for azithromycin (MIC90 of 3 microgram/mL). Most strains were resistant to metronidazole and roxithromycin. Cluster analysis revealed two larger clusters of A. actinomycetemcomitans strains with the smaller cluster assembling isolates with significantly higher MICs of most antibiotics.
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Macrolides may cause severe drug interactions due to the inhibition of metabolizing enzymes. Transporter-mediated uptake of drugs into cells [e.g., by members of the human organic anion transporting polypeptide (OATP) family] is a determinant of drug disposition and a prerequisite for subsequent metabolism. However whether macrolides are also inhibitors of uptake transporters, thereby providing an additional mechanism of drug interactions, has not been systematically studied. The human OATP family members OATP1B1 and OATP1B3 mediate the uptake of endogenous substances and drugs such as antibiotics and HMG-CoA reductase inhibitors (statins) into hepatocytes. In this study we investigated the potential role of these uptake transporters on macrolide-induced drug interactions. By using sulfobromophthalein (BSP) and the HMG-CoA reductase inhibitor pravastatin as substrates, the effects of the macrolides azithromycin, clarithromycin, erythromycin, and roxithromycin and of the ketolide telithromycin on the OATP1B1- and OATP1B3-mediated uptake were analyzed. These experiments demonstrated that the OATP1B1- and OATP1B3-mediated uptake of BSP and pravastatin can be inhibited by increasing concentrations of all macrolides except azithromycin. The IC50 values for the inhibition of OATP1B3-mediated BSP uptake were 11 microM for telithromycin, 32 microM for clarithromycin, 34 microM for erythromycin, and 37 microM for roxithromycin. These IC50 values were lower than the IC50 values for inhibition of OATP1B1-mediated BSP uptake (96-217 microM). These macrolides also inhibited in a concentration-dependent manner the OATP1B1- and OATP1B3-mediated uptake of pravastatin. In summary, these results indicate that alterations of uptake transporter function by certain macrolides/ketolides have to be considered as a potential additional mechanism underlying drug-drug interactions.
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Data from human studies published in the English language were evaluated. Trials were assessed by sample size, macrolide dosage regimen, and therapeutic response.
We hypothesized that bacterial biofilm formation could be an important factor that make some infection intractable. Interaction of P. aeruginosa biofilm with antibactial agents was examined in vitro.
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Twenty-two healthy women participated in a study to determine whether roxithromycin (a new macrolide antibiotic agent) obtunds the activity of a triphasic oral contraceptive. The duration of the study was four menstrual cycles. Medication was given as follows: (1) cycle 1, no medication to demonstrate ovulation; (2) cycle 2, triphasic oral contraceptive daily to suppress ovulation; (3) cycle 3, triphasic oral contraceptive daily plus roxithromycin, 150 mg b.i.d.; and (4) cycle 4, triphasic oral contraceptive daily plus rifampin, 300 mg daily. Sonography of the ovaries was performed on day 13, and serum progesterone was measured on day 21 of each cycle. Elevated progesterone indicated ovulation. The presence of a maturing follicle supported this finding. All volunteers ovulated in the first cycle and no volunteers ovulated in the second and third cycles. However, 11 women ovulated when rifampin and the triphasic oral contraceptive were given concomitantly. The findings suggest there is no reason to believe that roxithromycin interferes with the efficacy of oral contraceptives.
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To evaluate the therapeutic effect of Roxithromycin (RXM), we studied 56 chronic sinusitis patients with nasal polyps using computed tomography (CT) and electron microscopy in addition to conventional clinical assessment. The paranasal sinus of subjects was observed clinically before and after daily administration of RXM at 300 mg for 3 months all underwent allergy testing for possible complications of allergic rhinitis based on subjective symptoms and objective findings. Improvement after RXM treatment was seen in 50.3% based on subjective symptoms and 59.1% based on objective findings. Overall improvement was seen in 53.6%. In 41 cases (73.2%) of all patients with chronic sinusitis and complications of allergic rhinitis, no significant difference was seen between patients with and without complications (53.7% in those with complications and 53.3% in those without). In CT analysis the paranasal sinus in 51.8% of all posttreated patients showed obvious improvement. In electron microscopy in chronic sinusitis patients with complications of allergic rhinitis, pretreated ethmoidal sinus tissues showed high mucous epithelial cell apoptosis in addition to common histological lesions, while posttreatment patients showed only eosinophil apoptosis in the interstitium and no apoptotic epithelial cells. We divided ethmoidal sinus lesions in patients without complications into 3 types and evaluated them as follows: In type 1, pretreated ethmoidal sinus tissues showed plasma cell infiltration and posttreatment cell apoptosis. In type 2, pretreated tissues showed lymphocyte and plasma cell infiltration and posttreated showed only some lymphocytes and no plasma cells. In type 3, proliferation of fibroblasts, most of which showed apoptosis, was seen in addition to apoptotic epithelial cells before treatment, while after treatment, these lesions remained with some apoptotic bodies phagocytosed by macrophages. In type 3 patients relapsed after surgery. Our findings indicate that RXM treatment had a significant therapeutic effect on chronic sinusitis with nasal polyps with and without complications of allergic rhinitis. We clarify the morphological mechanism of therapeutic effect of RXM on each type of ethmoidal sinus lesion divided by light and electron microscopy.
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To investigate the impact of treatment with low dose roxithromycin on clinical symptoms and CT scores in patients with stable bronchiectasis.
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We evaluated the effects of a new semisynthetic macrolide antibiotic, roxithromycin, on the bronchial hyperresponsiveness to histamine in children with asthma. Twelve hospitalized asthmatic children, aged 11 to 15 years (mean age, 12.9 years), were enrolled in this study. They were treated with 150 mg of roxithromycin once a day orally for 8 weeks without any side effects. The PC20 value 4 or 8 weeks after the administration of roxithromycin increased significantly over the initial values (p < 0.05, p < 0.01, respectively). No significant change was observed in serum theophylline concentrations during this study. Serum cortisol level in the morning did not change after the administration of roxithromycin for 4 weeks. These results suggest that administration of roxithromycin may act favorably in the treatment of childhood asthma.
Elevated antibodies against Chlamydia pneumoniae have been associated with coronary artery disease. In patients undergoing percutaneous coronary angioplasty, we therefore investigated the effect of roxithromycin on symptomatic restenosis and determined antichlamydial antibodies as well as inflammatory and immunological parameters.
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Tiamulin and a number of macrolides were evaluated as to their ability in forming metabolic-intermediate (MI) complexes with cytochrome P450 in liver microsomes from rabbits bred for meat production. Complex formation, which occurred only in preparations where the expression of P450 3A was increased as the result of rifampicin pre-treatment and with different kinetics, was in the order tiamulin > erythromycin > TAO approximately roxithromycin approximately tylosin and did not take place with tilmicosin and spiramycin. Most of the tested compounds underwent an oxidative N-dealkylation and a good relationship could be found between the rate of N-dealkylase activity in induced preparations and the aptitude in generating MI complexes. Although the results from in vitro studies should be interpreted with caution, it is suggested that the potential for in vivo drug interactions also exists in the rabbit for tiamulin and for four out of the six tested macrolides.
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We investigated the distributions of 12 antibiotics (viz., sulfonamides, macrolides, and trimethoprim) in the water from the Mekong Delta, Vietnam, and compared them with those in the Tamagawa River, Japan. In Vietnam, only a few antibiotics (viz., sulfamethoxazole, sulfamethazine, trimethoprim, and erythromycin-H2O) were detected in the river and canals from urban and rural sites, at concentrations of 7-360 ng/L. This contrasts with the results from the Japanese urban river, where more antibiotics (sulfamethoxazole, sulfapyridine, trimethoprim, erythromycin-H20, azithromycin, clarithromycin, and roxithromycin) were detected at concentrations ranging from 4to 448 ng/L. The concentrations of sulfonamides in the Mekong Delta were comparable to those in the Tamagawa River, whereas macrolide concentrations were lowerthanthose in the Tamagawa River. The ubiquitous occurrence of sulfamethazine, used as a veterinary medicine, in the waters in Vietnam at relatively high concentrations (15-328 ng/L) was unique. Extremely high concentrations of sulfamethazine [(18.5-19.2) x 10(3) ng/L] were detected in pig farm wastewaters, and relatively high concentrations were observed in canals near chicken and pig farms. All these data suggested the potential utility of sulfamethazine as a molecular marker of livestock-source contamination. The present study demonstrated widespread inputs of veterinary medicines to waters in Vietnam.
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Antibiotic sensitivity of 21 Campylobacter strains isolated from humans, monkeys and birds with diarrhea was assayed and the findings are presented. It was shown that all the isolates were highly sensitive to ofloxacin, pefloxacin, ciprofloxacin, josamycin, pipemidinic acid and amoxyclav (a combination of amoxycillin and clavulanic acid). The predominating majority of the strains were resistant to rifampicin, amoxycillin and phosphomycin. The majority of the cultures were sensitive to erythromycin and roxithromycin while some of the isolates were resistant to them which could be used as an additional biological characteristic of Campylobacter cultures and considered in choosing agents for antibiotic therapy.
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The susceptibility of the obligate intracellular chlamydiae was studied in primary coronary endothelial cells, smooth muscle cells and immortalized epithelial cells. Minimal inhibitory concentrations (MICs) were determined for ofloxacin, levofloxacin, trovafloxacin, moxifloxacin, erythromycin, azithromycin, roxithromycin, rifapentin and rifampin.