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Dirithromycin is a recently developed oral antibiotic, and has been shown to be effective in the treatment of respiratory tract, skin and soft tissue infections. Dirithromycin is administered once daily which may contribute to patient compliance. In this paper we review the data from studies conducted in Europe, USA, Israel and South Africa over a six-year period to assess the safety and efficacy of dirithromycin in the treatment of a variety of acute infectious illnesses, and to compare it with structurally related antibiotics (erythromycin base, roxithromycin, and miocamycin) given orally. A total of 7437 patients have been enrolled from a total of 66 studies and trials, 4263 (57.3%) treated with dirithromycin and 3174 (42.7%) treated with a comparator antibiotic. Patients received either 500 mg dirithromycin (two tablets once daily), 1000 mg erythromycin base (250 mg qid), 300 mg roxithromycin (150 mg bid), or 1200 miocamycin (600 mg bid); the length of therapy ranged from 7 to 14 days. These studies have shown that dirithromycin has a safety profile similar to the comparator agents. The most frequently reported adverse events for both dirithromycin and comparator treatment groups were gastrointestinal in nature. The majority (99%) of adverse events reported from patients treated with dirithromycin were considered mild or moderate in severity. Early discontinuation of antibiotic therapy was infrequent (3-4%) in both treatment groups, and considered to be possibly drug-related in 2-3% of the population. The safety profile of dirithromycin in elderly patients was comparable to that recorded in the overall patient population. The incidence and nature of abnormal clinical laboratory evaluation were similar in dirithromycin and comparator groups. Notable alterations in laboratory tests of haematological or hepatic function were infrequent and were not associated with clinical manifestations. Routine monitoring of standard clinical laboratory tests in patients prescribed dirithromycin does not appear to be necessary.
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Twenty pregnant women inadvertently exposed to roxithromycin during early pregnancy were identified and prospectively followed-up. For comparison, 170 pregnant women matched by age and gravidity, not being exposed to any potential teratogenic agent during pregnancy, were recruited as controls. All gestations were confirmed by ultrasound examination, and participants were followed-up until delivery. Newborns were examined by a neonatologist.
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Rothmann-Makai syndrome (lipogranulomatosis subcutanea) is a rare variant of Weber-Christian disease, but lacks visceral involvements and systemic manifestations. We herein report the case of a 56-year-old Chinese woman with this disorder who complained of subcutaneous tender nodules over her extremities, trunk, and face of 2 years' duration. She was firstly treated with 300 mg of oral roxythromycin for 8 weeks and subsequently treated with 400 mg of oral clarithromycin for the next 8 weeks. However, no significant effect was observed. She was then administered 200 mg of oral minocycline hydrochloride. After 1 week, her skin symptoms rapidly improved and no relapse has been observed in a follow-up period of 3 months. Considering that tetracycline antibiotics, but not macrolide antibiotics, inhibit the activity of pancreatic lipase in vitro, the efficiency of tetracycline antibiotics may be a clue to clarifying the pathogenesis of this disorder.
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Roxithromycin was as effective as conventional doxycycline or chloramphenicol in children with scrub typhus and may be safer to use.
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In the present study, in vitro interactions between nitroimidazoles, macrolides and omeprazole in binary and ternary mixtures were examined by measuring their enthalpy of solution (delta(sol)H) using a calorimetric technique. A comparison of the enthalpy of solution of the pure drugs with those of binary and ternary mixtures at pH 2 and 6 was made to indicate the magnitude of interaction between them. The delta(sol)H for all the nitroimidazoles is endothermic at pH 2 and 6 but both the macrolides show exothermic behavior, whereas the enthalpy of solution of omeprazole changes from -40.52 to 4.35 kJmol(-1) as the pH changes from 2 to 6. The results have been quantified by determining the excess enthalpy of solution for both binary and ternary systems. The small deviations from ideality for all the binary systems are attributed to various non-bonding interactions between different functional groups on both the drug molecules. The results suggest compatibility of drug pairs in their binary mixtures. However, ternary mixtures show somewhat larger interactions. The magnitude of interaction enthalpy of a ternary mixture comprising tinidazole, clarithromycin and omeprazoles which are available as a marketed kitshas been calculated to be significant, suggesting that the three drugs cannot be co-formulated.
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The anti-inflammatory changes observed in IL-10-deficient mice resulted from the efficacy of RXM as an immunosuppressant as well as from its efficacy as an antibiotic. According to our findings, RXM would seem to have significant potential as a preventive and/or therapeutic agent for IBD.
Lower respiratory tract infections--acute bronchitis and community acquired pneumonia (CAP)--are important causes of morbidity in Australia. Acute bronchitis is often treated with antibiotics, although the cause is usually viral. Community acquired pneumonia may be fatal, particularly in the elderly, therefore appropriate assessment and management is essential.
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Since infection of endothelial or smooth muscle cells with Chlamydia pneumoniae increased expression of tissue factor and plasminogen activator inhibitor I (PAI-1), C. pneumoniae might be involved in triggering acute thrombotic events in patients with coronary artery disease. Therefore, we explored a potential relationship between IgG-seropositivity to C. pneumoniae and early thrombotic events after coronary stent placement.
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The 150- and 300-mg single-dose pharmacokinetics of roxithromycin were investigated in 12 healthy subjects in a crossover study. Serum concentrations were determined by high-performance liquid chromatography (HPLC) and microbiologic assay (MA). Peak serum levels as measured by HPLC were 6.7 +/- 2.6 (150 mg) and 11.0 +/- 2.2 micrograms/ml (300 mg) and did not differ significantly from the values obtained by MA. Mean serum roxithromycin levels 12 hr after the 150-mg dose and 24 hr after the 300-mg dose were 2.50 and 2.55 micrograms/ml, respectively. HPLC analysis of a comparable macrolide, clarithromycin, showed peak serum levels of 1.2 +/- 0.6 and 2.3 +/- 0.6 micrograms/ml after oral dosing with 250 and 500 mg in the same subjects. The 14-OH metabolite reached a level that was 50% and 40%, respectively, of that of the parent compound. Roxithromycin showed a prolonged elimination half-life compared with clarithromycin and its 14-OH metabolite. Mean values of 14.6, 3.5, and 5.5 hr, respectively, indicate the need for less frequent dosing of roxithromycin.
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Of the 109 mycoplasma positive cases in 2001, 86.2% were infected with Ureaplasma urealyticum (Uu), 3.8% with Mycoplasma hominis (Mh), 10.1% with both Uu and Mh; and of the 134 mycoplasma positive cases in 2003, Uu infection accounted for 79.1%, Mh infection 4.48% and Uu and Mh infection 16.4%. Compared with 2001, the drug-resistance rates to roxithromycin, azithromycin, levofloxacin, ofloxacin and clindamycin rose obviously in 2003; but the drug-resistance rates to josamycin, minomycin and doxycycline did not change significantly. As far as the drug sensitivity rate is concerned, josamycin ranked the first, and doxycycline the second.
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The azalide antibiotic azithromycin and the newer macrolides, such as clarithromycin, dirithromycin and roxithromycin, can be regarded as 'advanced-generation' macrolides compared with erythromycin, the first macrolide used clinically as an antibiotic. Their pharmacokinetics are characterized by a combination of low serum concentrations, high tissue concentrations and, in the case of azithromycin, an extended tissue elimination half-life. Azithromycin is particularly noted for high and prolonged concentrations at the site of infection. This allows once-daily dosing for 3 days in the treatment of respiratory tract infections, in contrast to longer dosage periods required for erythromycin, clarithromycin, roxithromycin and agents belonging to other classes of antibiotics. The spectrum of activity of the advanced-generation macrolides comprises Gram-positive, atypical and upper respiratory anaerobic pathogens. Azithromycin and the active metabolite of clarithromycin also demonstrate activity against community-acquired Gram-negative organisms, such as Haemophilus influenzae. Advanced-generation macrolides, and in particular azithromycin, are highly concentrated within polymorphonuclear leucocytes, which gravitate by chemotactic mechanisms to sites of infection. Following phagocytosis of the pathogens at the infection site, they are exposed to very high, and sometimes cidal, intracellular concentrations of antibacterial agent. Pharmacodynamic models and susceptibility breakpoints derived from studies with other classes of drugs, such as the beta-lactams and aminoglycosides, do not adequately explain the clinical utility of antibacterial agents that achieve high intracellular concentrations. In the case of azithromycin, attention should focus on tissue pharmacokinetic and pharmacodynamic concepts.
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We studied a novel disease occurred among cultured Carassius auratus gibelio at a farm located in Yancheng City, Jiangsu Province.