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PubMed1990

Disposition of roxithromycin in patients with normal and severely impaired renal function.

The disposition of roxithromycin, an investigational macrolide antibiotic, was evaluated in 20 subjects, 10 with normal renal function (creatinine clearance [CLCR] of 116 +/- 17 ml/min [mean +/- standard deviation]) and 10 with severely impaired renal function (CLCR of 10.2 +/- 2.6 ml/min) after a single 300-mg oral dose. Plasma concentration-time data were analyzed in terms of a one- or two-compartment oral absorption model utilizing nonlinear regression analysis. The terminal elimination half-life was significantly prolonged in the group with severely impaired renal function (15.5 +/- 4.7 h) compared with that of the group with normal renal function (7.9 +/- 2.5 h). Apparent total body clearance was significantly reduced in the renally impaired (25.3 +/- 10.5 ml/min) in relation to the group with normal renal function (48.8 +/- 11.1 ml/min). The first-order absorption rate constants and apparent volumes of distribution did not differ between the two groups. These data indicate that the disposition of roxithromycin is significantly delayed in subjects with CLCRs of less than 15 ml/min and suggest that the roxithromycin dosing interval be doubled for these patients.

Absorption↗
PubMed1992

Clindamycin, erythromycin, and roxithromycin inhibit the proinflammatory interactions of Pseudomonas aeruginosa pigments with human neutrophils in vitro.

The Pseudomonas aeruginosa-derived phenazine pigments pyocyanin and 1-hydroxyphenazine (1-hp) prime human neutrophils for enhanced, stimulus-activated release of superoxide and myeloperoxidase (MPO), respectively. In the present study, the modulatory potentials of the antimicrobial agents clindamycin, erythromycin, and roxithromycin (10 and 20 micrograms/ml) on the prooxidative interactions of pyocyanin and 1-hp (12.5 microM) with human neutrophils have been investigated. Clindamycin, erythromycin, and especially roxithromycin caused dose-related inhibition of the generation of superoxide by both untreated and pyocyanin-treated neutrophils during activation with either the synthetic chemotactic tripeptide N-formyl-L-methionyl-L-leucyl-L-phenylalanine (FMLP) or the calcium ionophore A23187. The antimicrobial agents also inhibited the generation of reactive oxidants by the MPO-H2O2-halide system during activation of both untreated and 1-hp-treated neutrophils by FMLP. These effects appeared to be due to drug-related interference with membrane-associated oxidative metabolism, since none of the antimicrobial agents inhibited the release of MPO by activated neutrophils, nor did they possess oxidant-scavenging properties. These data demonstrate that clindamycin, erythromycin, and especially roxithromycin antagonize the proinflammatory interactions of pyocyanin and 1-hp with neutrophils and indicate a possible therapeutic role for these antimicrobial agents in the prevention of tissue damage in diseases characterized by P. aeruginosa infection.

Clindamycin↗
PubMed1993

In vitro activity of roxithromycin against 16 species of atypical mycobacteria and effect of pH on its radiometric MICs.

The antimycobacterial spectrum of roxithromycin, a semisynthetic 14-membered ring macrolide, was determined against 28 strains belonging to 16 species of atypical mycobacteria by measuring radiometric MICs by BACTEC methodology at two different pH values, i.e., 6.8 and 7.4. The MICs obtained at pH 7.4 were 1 to 2 dilutions lower or more than those obtained at pH 6.8 for some of the species. Roxithromycin possessed promising MICs against such potential pathogens as the Mycobacterium avium complex, M. scrofulaceum, M. szulgai, M. malmoense, M. xenopi, M. marinum, M. kansasii, and rare pathogens like M. chelonei subsp. chelonei and M. chelonei subsp. abscessus but not against M. simiae. Roxithromycin showed lower MICs against M. fortuitum var. peregrinum than M. fortuitum var. fortuitum.

Hydrogen-Ion Concentration↗
PubMed1994

A randomized trial of roxithromycin in patients with acute leukemia and bone marrow transplant recipients receiving fluoroquinolone prophylaxis.

Fluoroquinolone prophylaxis in patients with profound neutropenia may be useful for preventing gram-negative bacterial infection, but it is ineffective against gram-positive bacterial infections in the bloodstream, particularly those caused by streptococci and coagulase-negative staphylococci, which appear to have emerged as significant causes of morbidity, decreased treatment efficacy, and the increased costs of empiric antimicrobial therapy. In a prospective, randomized, open trial, we evaluated the efficacy and safety of oral roxithromycin (150 mg twice daily) as additional antibacterial prophylaxis in 131 adult patients with acute leukemia and bone marrow transplant recipients receiving oral ofloxacin. In comparison with patients given ofloxacin alone, fewer patients receiving ofloxacin plus roxithromycin developed bacteremia caused by viridans group streptococci (incidence, 9 versus 0%; P = 0.03), while the incidence of bacteremia caused by other organisms, the incidence of febrile episodes from any cause, the risk of infection-associated complications (including prolonged or secondary fever, pneumonia, septic shock, need for mechanical ventilation, and/or infection-related death), and antimicrobial usage for therapy were comparable between both groups. Adverse events possibly related to the study drugs were slightly more common among the patients receiving the combination treatment (P = 0.05). Although effective for the prevention of streptococcal bacteremia, the addition of roxithromycin to a fluoroquinolone should not be used routinely as a prophylactic regimen in patients with profound neutropenia, but it might be considered and may be useful for cancer patients with a particularly high risk of streptococcal infection and related complications.

Acute Disease↗
PubMed1997

Susceptibility of penicillin-susceptible and -resistant pneumococci to dirithromycin compared with susceptibilities to erythromycin, azithromycin, clarithromycin, roxithromycin, and clindamycin.

Agar dilution with incubation in air and CO2 was used to determine the MICs of erythromycin, dirithromycin, azithromycin, clarithromycin, roxithromycin, and clindamycin for 79 penicillin-susceptible, 72 penicillin-intermediate, and 74 penicillin-resistant pneumococci (158 erythromycin-susceptible and 67 erythromycin-resistant pneumococci). MICs obtained in air were usually 1 to 3 dilutions lower than those obtained in CO2. In air, the respective MICs at which 50% (MIC50s) and 90% (MIC90s) of penicillin-susceptible, -intermediate, and -resistant strains are inhibited were as follows: erythromycin, 0.016 and 0.5, 0.03 and > 64, and 2 and > 64 microg/ml; dirithromycin, 0.03 and 0.5, 0.06 and > 64, and 8 and > 64 microg/ml; azithromycin, 0.03 and 0.5, 0.06 and > 64, and 2 and > 64 microg/ml; clarithromycin, 0.016 and 0.06, 0.03 and > 64, and 2 and > 64 microg/ml; roxithromycin, 0.06 and 2, 0.06 and > 64, and 2 and > 64 microg/ml; and clindamycin, 0.03 and 0.06, 0.06 and > 64, and 0.06 and > 64 microg/ml. The MICs of erythromycin, azithromycin, and dirithromycin were very similar; however, clarithromycin MICs were generally 1 to 2 dilutions lower and roxithromycin MICs were 1 to 2 dilutions higher than those of the other compounds tested. Strains resistant to one macrolide were resistant to all macrolides; however, not all macrolide-resistant strains were resistant to clindamycin, and 32 macrolide-resistant (MICs, > or = 28 microg/ml), clindamycin-susceptible (MICs, < or = 0.25 microg/ml) strains were encountered. Time-kill testing of six strains showed similar killing kinetics for all compounds, with 99.9% killing of all strains observed with the compounds only at or above the MIC after 24 h.

Aminoglycosides↗
PubMed1998

Roxithromycin inhibits cytokine production by and neutrophil attachment to human bronchial epithelial cells in vitro.

We evaluated the effect of roxithromycin on cytokine production and neutrophil attachment to human airway epithelial cells. Roxithromycin suppressed production of interleukin 8 (IL-8), IL-6, and granulocyte-macrophage colony-stimulating factor. It inhibited neutrophil adhesion to epithelial cells. Roxithromycin modulates local recruitment and activation of inflammatory cells, which may have relevance to its efficacy in airway diseases.

Anti-Bacterial Agents↗
PubMed2000

Effect of proinflammatory cytokines on the interplay between roxithromycin, HMR 3647, or HMR 3004 and human polymorphonuclear neutrophils.

Cytokines, the hallmarks of infectious and inflammatory diseases, modify phagocyte activities and thus may interfere with the immunomodulating properties of antibacterial agents. We have investigated whether various proinflammatory cytokines (interleukin 1 [IL-1], IL-6, IL-8, gamma interferon, tumor necrosis factor alpha [TNF-alpha], and granulocyte-macrophage colony-stimulating factor [GM-CSF]) modify two macrolide properties, i.e., inhibition of oxidant production by polymorphonuclear neutrophils (PMN) and cellular uptake. Roxithromycin and two ketolides, HMR 3647 and HMR 3004, were chosen as the test agents. TNF-alpha and GM-CSF (but not the other cytokines) decreased the inhibitory effect of HMR 3647 only on oxidant production by PMN. Fifty percent inhibitory concentrations were, however, in the same range in control and cytokine-treated cells (about 60 to 70 microgram/ml), suggesting that HMR 3647 acts downstream of the priming effect of cytokines. In contrast, the impairment of oxidant production by roxithromycin and HMR 3004 was unchanged (or increased) in cytokine-treated cells. This result suggests that HMR 3004 (the strongest inhibitory drug, likely owing to its quinoline side chain) and roxithromycin act on a cellular target upstream of cytokine action. In addition, TNF-alpha and GM-CSF significantly (albeit moderately) impaired (by about 20%) the uptake of the three molecules by PMN. The inhibitory effect of these two cytokines seems to be related to activation of the p38 mitogen-activated protein kinase. Our data also illuminate the mechanism underlying macrolide uptake: protein kinase A- and tyrosine kinase-dependent phosphorylation seems to be necessary for optimal uptake, while protein kinase C activation impairs it. The relevance of our data to the clinical setting requires further investigations, owing to the complexity of the cytokine cascade during infection and inflammation.

Anti-Bacterial Agents↗
PubMed2005

The macrolide roxithromycin impairs NADPH oxidase activation and alters translocation of its cytosolic components to the neutrophil membrane in vitro.

We have studied the interference of roxithromycin with NADPH oxidase, the key enzymatic system for oxidant production by human neutrophils. Roxithromycin alters the reconstitution of an active enzyme and impairs the translocation to the outer membrane of the cytosolic components p47-phox and p67-phox. Interestingly, in resting cells roxithromycin directly triggers the translocation of these factors without stimulating the oxidative burst.

Anti-Bacterial Agents↗
PubMed1995

Effect of roxithromycin on peripheral neutrophil adhesion molecules in patients with chronic lower respiratory tract disease.

To evaluate the effects of roxithromycin in patients with chronic lower respiratory tract disease including diffuse panbronchiolitis, we studied lymphocyte function-associated antigen-1 (LFA-1) and Mac-1, neutrophil adhesion molecules, using peripheral neutrophils from healthy volunteers and from patients with chronic lower respiratory tract disease. The number of Mac-1 expressed on neutrophils of the patients was significantly greater (0.68 +/- 0.16) than in the healthy subjects (0.45 +/- 0.14), while the number of LFA-1 expressed on neutrophils of the patients was nearly similar to that in the healthy volunteers (0.95 +/- 0.10 vs 0.89 +/- 0.11). The neutrophil numbers in bronchoalveolar lavage fluid and the number of Mac-1 expressed on peripheral neutrophils significantly decreased in all patients who responded clinically to a low dose of roxithromycin for a long period of time (56.0 +/- 25.2 vs. 22.7 +/- 19.7%, p < 0.05 and 0.70 +/- 0.16 vs. 0.59 +/- 0.08, p < 0.05, respectively), whereas roxithromycin had no effect on the quantitative expression of LFA-1 (0.96 +/- 0.14 to 1.00 +/- 0.09, not significant) in all responders.

Adult↗
PubMed1990

Effect of azithromycin, roxithromycin and erythromycin on human polymorphonuclear leukocyte function against Staphylococcus aureus.

The effect of three macrolides (azithromycin, roxithromycin and erythromycin) on the interaction in vitro of human polymorphonuclear leukocytes (PMNs) with Staphylococcus aureus was examined. The exposure of S. aureus to 0.25 MIC of roxithromycin and erythromycin but not of azithromycin significantly increased the uptake of opsonized bacteria by human PMNs. The preincubation of PMNs with 1, 10 and 25 mg/l of the three antimicrobial agents did not affect either the uptake of S. aureus or the superoxide radical production by human PMNs. At these same concentrations the three agents showed slight but not significant intracellular activity in PMNs against S. aureus. It is concluded that treatment of S. aureus with subinhibitory concentrations of roxithromycin and erythromycin enhanced phagocytosis by PMNs, but the three macrolides tested did not directly affect the functions of human PMNs against S. aureus.

Azithromycin↗
PubMed1992

The new macrolide antibiotics: azithromycin, clarithromycin, dirithromycin, and roxithromycin.

OBJECTIVE: To review the chemistry, antimicrobial spectrum, pharmacokinetics, clinical trials, adverse effects, and drug interactions of four new macrolide antibiotics: azithromycin, clarithromycin, dirithromycin, and roxithromycin. DATA SOURCES: Information was obtained from comparative clinical trials, abstracts, conference proceedings, and review articles. Indexing terms included azithromycin, clarithromycin, dirithromycin, erythromycin, roxithromycin, and macrolide antibiotics. STUDY SELECTION: Emphasis was placed on comparative clinical trials involving the new macrolide antibiotics. DATA EXTRACTION: Data from human studies published in the English language were evaluated. Trials were assessed by sample size, macrolide dosage regimen, and therapeutic response. DATA SYNTHESIS: The erythromycins have gained widespread use in treating a variety of infections. Although they are effective, limitations include the need to administer four times a day and the intolerable adverse gastrointestinal effects. Four of the more extensively studied agents, azithromycin, clarithromycin, dirithromycin, and roxithromycin, are currently being studied in patients. Based on the studies to date, the newer macrolides may offer several advantages over erythromycin, including: (1) greater antimicrobial activity against certain organisms; (2) longer elimination half-life, thus allowing less frequent administration; and (3) lower incidence of adverse gastrointestinal effects. CONCLUSIONS: The new macrolide antibiotics appear to offer an improvement over erythromycin. Definitive conclusions about the role of these drugs should await completion of ongoing clinical studies.

Anti-Bacterial Agents↗
PubMed2001

Possible roxithromycin-induced fulminant hepatic failure in a child.

A pediatric formulation of roxithromycin is a relatively new addition to the antibiotic market in Australia. A previously healthy 5-year-old boy with no significant medical history was treated with roxithromycin 50 mg twice/day for cough, fever, and anorexia. After completing a 5-day course of the agent, he developed a nonpruritic, nonurticarial, erythematous, maculopapular, generalized rash and occasional vomiting. Three days later his symptoms included jaundice, dark urine, and pale stools. Laboratory results revealed acute hepatitis, and the patient was admitted to the hospital. His hepatic function continued to deteriorate, so the boy was transferred to a tertiary pediatric hospital. His condition continued to worsen, and 6 days after transfer, he underwent liver transplantation. Clinicians should be aware of potential hepatic complications associated with the use of roxithromycin.

Anti-Bacterial Agents↗
PubMed1992

Efficacy and tolerance of roxithromycin in comparison with erythromycin stearate in patients with lower respiratory tract infections.

The efficacy and tolerance of roxithromycin 150 mg b.i.d. were compared with those of erythromycin stearate 500 mg b.i.d. in patients with lower respiratory tract infections. Out of 86 patients recruited for the study, 79 were evaluable for tolerance and 76 for efficacy. These patients were evenly distributed among the 3 investigational clinics, with 26, 25 and 28 patients, respectively. The diagnosis of lower respiratory tract infections was based on clinical, laboratory, radiological and/or physical findings and, when available, bacteriological and serological findings. The duration of treatment was 10 days, with follow-up at post-treatment visits directly after treatment and 6 weeks thereafter. The clinical outcome was satisfactory with no significant difference between the drugs. More patients reporting adverse events were on erythromycin than on roxithromycin (51.3% vs 17.5%; p = 0.003). The results suggest that roxithromycin is as effective as erythromycin stearate in the treatment of lower respiratory tract infections and causes fewer adverse effects.

Adult↗
PubMed2004

Effect of a short antibiotic treatment with roxithromycin on circulating adhesion molecules after coronary stenting: a single-center pilot trial.

BACKGROUND: The aim of this study was to assess the effect of periprocedural antibiotic treatment with roxithromycin on circulating cell adhesion molecules and restenosis after coronary stent implantation. METHODS: Case-control study enrolling 25 consecutive patients submitted to coronary stenting for stable, single-vessel coronary artery disease, treated with 300 mg roxithromycin once daily for 5 days, starting 2 days before the procedure (group R). Twenty-five patients, matched for lesion site, length and diameter, as control group (group C). The serological status for Chlamydia pneumoniae (CP) infection (IgG, ELISA) was assessed in all patients. The plasma concentrations of soluble intercellular adhesion molecule-1 (sICAM-1), E-selectin and C-reactive protein at 1 month after coronary stenting were compared with baseline values. Binary restenosis (> or = 50%) was also evaluated at 6 months. RESULTS: sICAM-1 significantly decreased at 1 month in group R vs group C (371 +/- 181 vs 573 +/- 273 ng/ml, p = 0.005). This decrease was more evident in patients with a positive serology for CP (CP+) (group R 373 +/- 131 vs group C 597 +/- 255 ng/ml, p = 0.014). Antibiotic treatment had no effects on circulating E-selectin levels at 1 month (56.7 +/- 97 vs 49.8 +/- 62 ng/ml, p = 0.54). The restenosis rate (9/50, 18%) was similar in the two groups (group R 5/25 [20%], group C 4/25 [16%]). The restenosis rate was similar in the CP+ vs CP- group (6/35 [17%] vs 3/15 [20%]). CONCLUSIONS: A short course of treatment with roxithromycin at the time of coronary stenting induces a significant reduction in the sICAM-1 levels at 1 month but apparently does not influence the restenosis rate.

Adult↗
PubMed2006

Uncontrollable prurigo nodularis effectively treated by roxithromycin and tranilast.

Treatment of prurigo nodularis (PN) is often very difficult even with strong corticosteroid dressing and other available means. Macrolide roxithromycin (RXM) is used in consideration of its immunosuppressive effects in treating several skin disorders. Tranilast (N-(3,4-dimethoxycinnamoyl) is useful for treating atopic disorders and hypertrophic scars as well, suggesting its capacity to inhibit fibroblast proliferation. More adequate and effective therapy for this disorder has been requested. We report 3 cases of uncontrollable PN treated with 300 mg/day roxithromycin and 200 mg/day tranilast. Complete and/or remarkable regression of PN was observed on treatment with roxithromycin and tranilast in combination within 4 to 6 months. The 2 agents in combination can be used effectively for the treatment of uncontrollable PN.

Adult↗
PubMed1991

[Diffusion of roxithromycin in gingival tissue].

The gingival penetration of roxithromycin was evaluated at steady-state in twenty nine patients treated by 150 mg orally every 12 h during five days. Tissue specimen were sampled at 2 h (n = 6), 4 h (n = 6), 6 h (n = 5), 8 h (n = 6) and 12 h (n = 6) after the 10th administration. One blood sample was drawn at the same times. Serum and tissue concentrations of roxithromycin were measured by high performance liquid chromatography (HPLC). Serum peak level, measured at the 4th h, reached 6.60 +/- 1.15 micrograms/ml. The tissue peak concentration was 4.63 +/- 1.84 micrograms/g at the 8th h. Between the 4th and 10th hour after administration, the tissue concentrations are above 2 micrograms/g, i.e. above roxithromycin MIC 90 against most of the encountered pathogens in stomatologic infections.

Bacterial Infections↗
PubMed1990

Quantitative effect of roxithromycin and rifampicin on mucoid cultures from directly plated sputum of cystic fibrosis patients chronically colonized with Pseudomonas aeruginosa.

A previous study has shown that non-anti-Pseudomonas aeruginosa antibiotics can modify the mucoid character, a major virulence factor in cystic fibrosis P. aeruginosa. The purpose of the present study was to investigate further this phenomenon using a quantitative approach on fresh sputum. A total of 0.1 to 0.5 ml of sputum were homogenized, decimally diluted, plated on three series of Difco Pseudomonas isolation agar containing no antibiotics, roxithromycin (16.0 microgram/ml) or Rifampicin (16.0 microgram/ml) and incubated at 35 degrees C. In each of the three series, the cfus of PA by ml of sputum were evaluated after 24h, and the entire culture of plates with confluent growth was harvested after 96h and weighed on an analytical scale according to the correlation observed between the mucosity and the density of the culture. To date, 36 sputa from twenty-nine cystic fibrosis patients known to be chronically colonized by mucoid P. aeruginosa have been submitted to the protocol; the mean weight of control, roxithromycin and rifampicin cultures was respectively 3.12 +/- 1.62, 1.90 +/- 1.67 (p less than or equal to 0.0005) and 1.83 +/- 1.24 g (p less than or equal to 0.005) in parallel with mean cfu/ml of 2.24 +/- 6.45 x 10(8) (p less than 0.03) and 1.65 +/- 4.42 x 10(8) (p greater than 0.05); a more constant reduction (greater than or equal to 20%) of mucosity (expressed as the ratio of weight of antibiotic culture/control culture x 100) was observed with rifampicin (29 vs. 23/36 sputa), whereas a more drastic reduction (greater than or equal to 80%) was observed with roxithromycin (12 vs. 4).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1990

[Roxithromycin versus doxycycline in the treatment of cervicitis. Prospective randomized multicenter study under practice-related conditions].

In a prospective randomized multicenter study Roxithromycin 150 mg or Doxycycline 100 mg was given b.i.d. p.o. for ten days to women with clinically diagnosed cervicitis. All women were seen as outpatients by one of eight licensed gynecologists in their private office in the Essen city area. With a cure and improvement rate of 100% in those women who completed therapy, Roxithromycin (n = 106) was as effective as Doxycycline (n = 104; 98%). At 90% Roxithromycin was as well tolerated as Doxycycline at 93%. Both drugs were clinically and microbiologically effective in eradicating Chlamydia trachomatis.

Adult↗