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Odontogenic infections are the primary infections caused by indigenous oral bacteria, when a factor changes their perfect equilibrium. We studied 30 samples from patients with odontogenic infections that were submitted to therapy with roxithromycin. Our results showed that 79% of aerobic and 71% of anaerobic bacteria, responsible for odontogenic infections, were sensitive to roxithromycin.
New macrolide antibiotic, roxithromycin (erythromycin--like group), was tested in treatment of chlamydial genital infection in women. In comparison with doxycycline, roxithromycin showed higher clinical efficiency with fewer sides effects.
Two patients, a women of 70 and a man of 75 years old, who were using phenprocoumon chronically, and were monitored by a regional thrombosis service, received a macrolide antibiotic, clarithromycin and roxithromycin respectively, for an airway infection. Both patients developed a serious increase in hypocoagulability, requiring administration of phytomenadione and temporary decreases in phenprocoumon dose. There were no bleeding complications. After the antibiotics were discontinued, the original dosage of phenprocoumon was needed again. It is suggested that in these patients the macrolide antibiotics may have potentiated the effect of phenprocoumon, perhaps as a result of inhibition of phenprocoumon transformation by liver enzymes. In patients receiving chronic treatment with phenprocoumon, coagulation parameters should be regularly checked if they are given a macrolide antibiotic such as clarithromycin, roxithromycin or erythromycin.
An open clinical study to assess the efficacy and tolerance of Roxithromycin 150 mg twice daily was carried out amongst Nigerian patients with upper and lower respiratory tract infections at Plateau Hospital Jos. Twenty-two patients aged between 13 and 86 years comprising of twelve women, seven men and three children completed the study. 18 (81.8%) had bronchopulmonary infections, 3 (13.6%) had tonsillitis and 1 (4.6%) had otitis media. Pathogens isolated included streptococcus Pneumonia (22.7%), Streptococcus pyogenes (13.6%), Bramhella Catarrhalis (9.1%), Haemophilus influenzae (9.1%), Staphylococcus Aureus (4.6%), Klebsiella species (4.6%), Pseudomonas Aeruginosa (4.6%). There was 88.2% bacteriological cure and patients responded fast, with no major adverse reactions. Roxithromycin is therefore concluded to be an effective well tolerated drug for treatment of respiratory tract infections in Nigerians.
In this pilot trial, 18 patients participated in an investigation in which the combined therapy of co-trimoxazole and roxithromycin in late Lyme borreliosis was tested. The study has been performed as a result of earlier case reports in "The Lancet" where this combination has been used successfully in order to thwart late Lyme disease. The authors show that 76% of the patients recovered completely. In 2 patients, symptoms could be resolved with i.v. penicillin and 2 did not respond to any antibiotic therapy. These results show that oral therapy of co-trimoxazole and roxithromycin in combination provides similar results as i.v. antibiotics in earlier studies.
BRONCHIAL SUPERINFECTIONS: Macrolides are first-line antibiotics for acute bronchitis and infectious complications of chronic bronchitis. PROVEN EFFICACY: Data in the literature on roxithromycin treatment in respiratory tract infections demonstrate to clinical and bacteriological efficacy at high doses comparable with other available antibiotics. ANTIBIOTIC STRATEGY: These results are explained by the bioavailability of roxithromycin, its antibacterial spectrum, and its pharmacokinetic features (high serum peak, high intracellular and extracellular concentrations).
Roxithromycin protected mice against a lethal infection with the extremely virulent RH strain and the C56 strain of Toxoplasma gondii. Therapy initiated 2 h after infection with 2 X 10(3) or 2 X 10(4) RH or C56 tachyzoites protected more than 80% of the mice, compared with 0% of untreated controls (p less than 0.001). Paradoxically, Toxoplasma gondii was isolated more frequently (greater than 80%) in treated mice surviving infection with the less virulent strain (C56) than those surviving infection with the more virulent RH strain (less than 25%). Furthermore, in vitro studies revealed that roxithromycin at dosages up to 250 micrograms/ml had no effect on the proliferation of Toxoplasma gondii in murine peritoneal macrophage cultures.
The effects of a new macrolide antibiotic (Roxithromycin) and one of its major metabolite (RU 39001) on rat hepatic drug metabolizing enzymes were compared to those of erythromycin, erythralosamine and troleandomycin (TAO) both in vitro and in vivo. In contrast to erythromycin, erythralosamine and TAO, roxithromycin and its metabolite RU 39001 exhibit: (i) a very poor affinity for rat liver cytochrome P-450, (ii) an unability to be metabolized into a stable inhibitory metabolite-cytochrome P-450 complex and (iii) a decreased ability to induce liver cytochrome P-450 PCNE, an isozyme implicated in drug associations involving some macrolide antibiotics.
Roxithromycin (RU 28965) is a new semi-synthetic derivative of erythromycin. Its antibacterial activity is of the same order as that of other macrolides, although its MIC's against Legionella pneumophila are lower. In double-blind comparative studies there was no significant difference in therapeutic effectiveness between roxithromycin and the reference antibiotics tested. However, this new macrolide exhibits exceptional pharmacological properties (prolonged half-life, excellent tissue penetration and intracellular activity), and it is very well tolerated both clinically and biochemically.
BACKGROUND: CDE (cyclophosphamide, doxorubicin, etoposide) is one of the standard chemotherapy regimens in the treatment of small-cell lung cancer (SCLC), with myelosuppression as dose-limiting toxicity. In this trial the impact of prophylactic antibiotics on incidence of febrile leucopenia (FL) during chemotherapy for SCLC was evaluated. PATIENTS AND METHODS: Patients with chemo-naïve SCLC were randomized to standard-dose CDE (C 1,000 mg/m2 day 1, D 45 mg/m2 day 1, E 100 mg/m2 days 1-3. i.v., q 3 weeks, x5) or to intensified CDE chemotherapy (125% dose, q 2 weeks, x4, with filgrastim 5 microg/kg/day days 4-13) to assess the impact on survival (n = 240 patients). Patients were also randomized to prophylactic antibiotics (ciprofloxacin 750 mg plus roxithromycin 150 mg, bid. days 4-13) or to placebo in a 2 x 2 factorial design (first 163 patients). This manuscript focuses on the antibiotics question. RESULTS: The incidence of FL during the first cycle was 25% of patients in the placebo and 11% in the antibiotics arm (P = 0.010; 1-sided), with an overall incidence through all cycles of 43% vs. 24% respectively (P = 0.007; 1-sided). There were less Gram-positive (12 vs. 4), Gram-negative (20 vs. 5) and clinically documented (38 vs. 15) infections in the antibiotics arm. The use of therapeutic antibiotics was reduced (P = 0.013; 1-sided), with less hospitalizations due to FL (31 vs. 17 patients, P = 0.013: 1-sided). However, the overall number of days of hospitalization was not reduced (P = 0.05; 1-sided). The number of infectious deaths was nil in the antibiotics vs. five (6%) in the placebo arm (P = 0.022; 2-sided). CONCLUSIONS: Prophylactic ciprofloxacin plus roxithromycin during CDE chemotherapy reduced the incidence of FL, the number of infections, the use of therapeutic antibiotics and hospitalizations due to FL by approximately 50%, with reduced number of infectious deaths. For patients with similar risk for FL, the prophylactic use of antibiotics should be considered.
Erythromycin and especially roxithromycin (1.25-20 micrograms/mL) stimulated neutrophil migration in vitro. Both antibiotics selectively inhibited superoxide generation by neutrophils activated with the N-formylated leukotactic tripeptide FMLP, the calcium ionophore A23187 and the pharmacologic agent benoxaprofen, while the responses initiated by the tumor promotor PMA and opsonized zymosan were unaffected. Neutrophil autooxidation during exposure to FMLP was also decreased by both antibiotics. The antimicrobial agents did not scavenge superoxide. Likewise, the interactions of [3H]FMLP with specific receptors on neutrophils, FMLP-activated degranulation and intracellular calcium fluxes, the activity of cytosolic protein kinase C and the release of [3H]arachidonate from calcium ionophore-stimulated neutrophils were all unaffected by the antibiotics. Erythromycin and roxithromycin in particular appear to enhance neutrophil migration by an antioxidant mechanism that is not due to inhibition of transductional events involved in the activation of NADPH-oxidase or to oxidant scavenging properties.
One hundred isolates of Haemophilus influenzae including 50 beta-lactamase producing, five ampicillin-resistant non-beta-lactamase producing and five beta-lactam tolerant strains were tested for susceptibility (MICs and MBCs) to ampicillin, aztreonam, carumonam, cefixime, cefaclor, cefamandole, cefotaxime, imipenem, enoxacin, ciprofloxacin, roxithromycin, erythromycin, chloramphenicol, and co-trimoxazole, by a microdilution broth method. Cefotaxime, enoxacin and ciprofloxacin with MIC90 and MBC90 of less than 0.03 mg/l) were the most active antimicrobial agents tested. Cefixime, carumonam, aztreonam, and co-trimoxazole (MIC90 and MBC90 less than 0.25 mg/l) showed good activity against most strains. Roxithromycin and erythromycin had limited antibacterial activity (MIC90, 8 and 4 mg/l respectively). There were no chloramphenicol-resistant strains. Five beta-lactamase-negative strains were resistant to ampicillin, cefaclor and cefamandole but susceptible to other beta-lactams tested. Different patterns of tolerance were observed: four of five tolerant strains were tolerant to ampicillin and cefamandole, three to cefixime, cefaclor and cefotaxime, one to aztreonam. One tolerant strain was a beta-lactamase producer. Two other strains were tolerant only to co-trimoxazole.
As tissue distribution studies have become increasingly important aspects of the assessment of new antimicrobials, roxithromycin distribution has been evaluated in experimental models and in human tissues and body fluids. High levels were achieved in respiratory tract tissues and fluids and in the male and female genital tract. In most experiments the local concentrations of roxithromycin were as high as that in serum, reaching 4-6 mg/l (or mg/kg) or more. These high levels were generally stable and an equilibrium was reached between central and extra-vascular compartments. These data provide important information which may be clinically relevant.
In a double blind randomised investigation in 76 patients, roxithromycin (150 mg bd) and doxycycline (200 mg once daily) were compared in two groups of patients who were well-matched for age, sex, body weight, diagnosis, duration and severity of disease and associated pathological conditions, with infected skin conditions. Clinical effectiveness was 92% for roxithromycin and 82% for doxycycline, and bacteriological effectiveness also 92% and 82% respectively, the differences not being statistically significant.
Roxithromycin sachets of 50 mg were given to 304 infants and children, aged 2 months to 14 years, suffering from respiratory and skin infections treated in 25 hospitals in France and one in Greece. The dosage range was from 2.5 to 5.0 mg/kg/12 h and the mean duration of therapy was 8.9 days. The cure rate was 89% of the 266 children evaluable for clinical efficacy and 90.3% of the 50 bacteriologically identified cases. The overall bacteriological efficacy was 82%. The antibiotic was well accepted by the 90% of the 304 children, while in 6.9% an adverse effect was reported, mainly vomiting. There were no toxic effects. Roxithromycin should be considered as an effective and safe oral antibiotic to treat children with upper and lower respiratory tract and skin infections due to common pathogens.
The in-vitro activity of roxithromycin against Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma hominis, Ureaplasma urealyticum, Treponema pallidum, Gardnerella vaginalis and Haemophilus ducreyi is reviewed. Roxithromycin demonstrated equivalent activity to erythromycin against N. gonorrhoeae, C. trachomatis, M. hominis, U. urealyticum, G. vaginalis and H. ducreyi. In a rabbit model for syphilis, potentially useful activity against T. pallidum has been demonstrated.
Roxithromycin (RU 28965), an ether oxime derivative of erythromycin, protected mice against a lethal infection with the virulent RH strain of Toxoplasma gondii. Therapy begun 24 h before, 2 h after, and 24 h after infection with 2 X 10(3) tachyzoites protected 90, 80, and 50% of the mice, compared with 0% of untreated controls (P less than 0.05 to 0.001). Toxoplasma was isolated in less than 20% of surviving roxithromycin-treated mice.
A new macrolide (A-56268) was found to be approximately twice as active as erythromycin and four to eight times more active than roxithromycin. All three macrolides were similar in their potency against anaerobes. Human plasma enhanced the antistaphylococcal activity of A-56268 and erythromycin but reduced the activities of roxithromycin and clindamycin.