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At least 217 records · Page 12Linked to original sources

PubMed1989

Roxithromycin--a new macrolide derivative.

This ether oxim derivative of erythromycin A is an easy to absorb oral antimicrobial somewhat less effective in vitro than erythromycin. At relatively low MIC's it is active against staphylococci, streptococci, pneumococci, branhnamella and chlamydiae, higher concentrations are needed against enterococci and some strains of H. influenzae. Roxithromycin is also reported to have a very good effect on campylobacters, many anaerobic bacteria, Toxoplasma gondii, Treponema pallidum, Mycoplasma pneumoniae and Legionella pneumophilla. Its half-life in the serum of healthy individuals ranges from 9 to 16 hours. Maximum serum concentrations at 2 oral doses of 150 mg a day are reached at 3 to 4 days and vary from 5.5 to 11.1 mg/l. The distribution of roxithromycin in body tissues is excellent. In a group of 57 patients treated for various infections of clear etiology the positive therapeutic effects resulting in the state of bacteriological negativity was reached in 86% of cases. Roxithromycin can be recommended as a drug of choice in mild or less severe cases of infection caused by agents sensitive to this antimicrobial. Its excellent tolerance makes it especially well suited for use in pediatric practice.

Adult↗

PubMed1989

[Comparative in vitro bacteriostatic and bactericidal effect of 5 macrolides: roxithromycin, erythromycin, oleandomycin, josamycin and spiramycin against 284 hospital bacterial strains].

The bacteriostatic and bactericidal activities of five macrolides (roxithromycin, erythromycin, troleandomycin, josamycin and spiramycin) were tested against 284 bacterial strains belonging to various species of Gram positive (staphylococci, streptococci, pneumococci, Listeria sp, Corynebacterium sp, Bacillus sp) and Gram negative bacteria (Neisseria sp, H. influenzae, P. multocida). The activity of these compounds on the whole strains showed near results: 71.8% of susceptible strains to erythromycin and spiramycin, 70% to josamycin, 67.6% to roxithromycin, 65.5% to troleandomycin. Resisting strains were MLSB resistant cocci Gram positive, H. influenzae and P. multocida strains. Species usually less studied (nongroupable streptococci, Corynebacterium sp, Bacillus sp) were very susceptible to macrolides with MICS equal or inferior to 1 mg/l for the two last genus. A bactericidal effect was observed for 38.8% of 72 tested strains (erythromycin), 36.1% (josamycin), 34.7% (spiramycin), 31.9% (roxithromycin), 20.8% (troleandomycin). Among various tested species, this bactericidal effect concerned especially group A streptococci, N. meningitidis and Corynebacterium (except D2 and JK species).

Cross Infection↗

PubMedDate not supplied

[Double-blind and randomised parallel study of minocycline 100mg (Mynocine) vs roxithromycin 300mg (Rulid), in the treatment of seasonal acute bronchitis in clinical practice].

46 general practitioners of the vicinity of Nancy carried out a randomised, parallel and double blind study comparing the efficacity and the tolerance of two drugs: roxithromycin (Rulid) 300 mg per day, and minocycline (Mynocine) 100 mg per day in the treatment of adult acute bronchitis, in clinical practice. 124 patients were included from January 1992 to June 1992. Efficacy of the treatment was estimated by both practitioners and patients to be good and excellent at the same time in 90 to 95 per cent of cases, in the two groups. Clinical tolerance was estimated to be excellent (90 per cent of cases) in the two groups. Roxithromycine and minocycline are effective and well tolerated in the treatment of adults acute bronchitis in clinical practice. Among the two drugs, we prefer to use minocycline because it is 2.5 to 5 times less expensive than roxithromycine.

Acute Disease↗

PubMedDate not supplied

Open clinical trial of roxithromycin amongst patients of Jos University Teaching Hospital with lower and upper respiratory tract infections.

An open non-comparative clinical study to determine the efficacy and tolerance of Roxithromycin 150 mg twice daily was carried out amongst Nigerian patients with acute upper and lower respiratory tract infections. Twenty-four (24) patients (mean age 21.6 years, male 13; females 11 who completed the study presented with acute tonsillitis (33.3%, acute bronchitis (12.5%), lober pneumonia (12.5%), Otitis media (8%), acute pharyngitis (4%) and acute sinusitis (4%). Most of the patients had normal bacterial flora isolated (50.3%). Pathogens isolated included streptococcus pyogenes (21%), moraxella catarhalis (8.3%), streptococcus pneumonia (8.3%) and Klebsiella pneumonia (4%). The quick clinical response, lack of major adverse drug reactions and susceptibility of the bacterial isolates to Roxithromycin were very significant attributes of the drug. In addition, there was complete recovery in 95.8% of the patients. Roxithromycin is therefore a well tolerated and effective drug for the treatment of acute respiratory tract infections in Nigerian patients.

Acute Disease↗

PubMedDate not supplied

An open evaluation of the efficacy and safety of the new macrolide roxithromycin in the treatment of lower respiratory tract infections and pneumonia in Nigerian patients.

Roxithromycin, a new introduction into the macrolide class of antibiotics possesses favourable pharmacokinetic properties enabling a once daily dosing. This study evaluates its efficacy, safety and tolerability, previously demonstrated in Europe and North America, in Nigeria patients suffering from lower respiratory tract infections. 32 patients, aged 18-65 years with acute bronchitis/acute exacerbation of chronic bronchitis and pneumonia were administered roxithromycin 300 mg once daily. 25 patients (12 males, 13 females: aged 39.2 +/- 2.7 years) were evaluable for clinical efficacy at the end of the study. The mean duration of treatment was 6.9 +/- 0.5 days. 22 patients (88.0%) responded to therapy. Sputum culture was positive in 5 patients (20.0%): Streptococcus pneumonia and resistant Klebsiella pneumonia. Therapy was discontinued in 3 patients due to non-response. The two patients in whom Klebsiella were isolated did not show any significant clinical improvement. The third non responding patient developed empyema. Gram negative bacilli were identified in the pleural aspirate but no patients with resistant Streptococcus pneumonia improved clinically. Adverse effects were mild, transient and included nausea (4) and diarrhoea (1). The study suggests that roxithromycin is an effective and well tolerated antibacterial in the treatment of lower respiratory tract infection.

Acute Disease↗

PubMed1996

Experience with roxithromycin in visceral leishmaniasis in north Bihar.

In search of an oral drug for Visceral Leishmaniasis, 54 cases of Kala-azar were treated with roxithromycin, an orally administrable drug at a dose of 300 mg twice daily for 21 days. Thirty-nine (86.7%) were responsive (cured), 11 (28.2%) relapsed. The results appeared equally or even more effective when compared to the sodium antimony gluconate in two recent trials in Kala-azar in almost same demographic pattern. A possible synergistic action of roxithromycin and SAG was explored. Toxicities of SAG and roxithromycin are compared and discussed. Further controlled trials are needed before it can be widely used as first line drug for Indian Kala-azar in the present epidemic.

Administration, Oral↗

PubMed1997

[Prophylactic use of roxithromycin in dental procedures].

In this study roxithromycin was applied for prophylactic treatment of 104 patients (implantology, dentoalveolar surgery, risk patients etc.) underwent dental surgery. The efficacy and side effects of roxithromycin were studied. The efficacy of this antibiotic was 92%, gastrointestinal complains, as the most common side effects were obtained in 2.8% of the patients treated with roxithromycin.

Adult↗

PubMed1988

Pharmacokinetics of roxithromycin (RU 965).

This report contains the findings of five studies performed to evaluate the pharmacokinetics of roxithromycin (RU 965), a new macrolide antibiotic. Roxithromycin was given as 150- and 300-mg film-coated tablets. The drug is rapidly absorbed after oral administration. Peak plasma levels following 150- and 300-mg doses occur within two hours. Steady state is reached within four days with doses of 150 mg twice a day or 300 mg once daily. The plasma half-life is approximately 12 hours. About 10% of the dose is excreted in urine. Although dose dependency was observed for the various pharmacokinetic parameters, dose proportionality could be demonstrated only in terms of the percentage of the dose excreted in urine. The rate of absorption is not affected by age. The rate of elimination and renal clearance are decreased in healthy elderly subjects, however, these differences should not be clinically meaningful. The bioavailability of the drug is not affected to a clinically meaningful extent when it is given with milk. Less than 0.05% of the administered dose is excreted in the breast milk of lactating women. Roxithromycin was safe and well tolerated with no clinically meaningful changes in any of the safety variables in any of the five studies reported.

Adult↗

PubMedDate not supplied

Prevention of bacteremia caused by alpha-hemolytic streptococci by roxithromycin (RU-28 965) in granulocytopenic patients receiving ciprofloxacin.

We previously demonstrated that ciprofloxacin prevents infections caused by gram-negative bacilli in patients with granulocytopenia. However, in patients with intensive cytotoxic treatment leading to severe mucosal damage a high incidence of bacteremias caused by alpha-hemolytic streptococci was seen. In the present study 45 consecutive patients undergoing intensive cytotoxic treatment received a short course of roxithromycin (10 days) in addition to ciprofloxacin for prevention of bacteremias caused by alpha-hemolytic streptococci. The results of this study were compared with the results obtained in previous comparable patients receiving ciprofloxacin alone. During the days with addition of roxithromycin no infections caused by alpha-hemolytic streptococci occurred, while in the control group of 80 patients 16 bacteremias (20%) were seen. Although roxithromycin was shown to antagonize bactericidal action of ciprofloxacin on gram-negative bacilli in vitro, in vivo study based on serum bactericidal titers and on results of surveillance cultures showed no antagonistic interactions.

Acute Disease↗

PubMed1986

Evaluation of roxithromycin in the treatment of non-gonococcal urethritis in males.

One-hundred and fifty-two male patients suffering from non-gonococcal urethritis were treated with an oral dosage of 300 mg roxithromycin daily for seven days. Chlamydia trachomatis was isolated from the urethra in 53 patients (35%), and Ureaplasma urealyticum in 42 patients (28%). After treatment, 49 (92%) of the 53 patients with positive Chlamydia trachomatis cultures and 34 (81%) of the 42 patients with positive Ureaplasma urealyticum cultures had negative cultures at follow-up. A clinical cure was observed in 137 patients (90%). Ten patients (7%) showed side effects consisting of nausea, sensation of distended abdomen, headache and fatigue. Seventy-eight male patients suffering from nongonococcal urethritis were treated with an oral dosage of 2 X 150mg roxithromycin daily for seven days. Chlamydia trachomatis was isolated from the urethra in 22 patients (28%), and Ureaplasma urealyticum in 30 patients (38%). After treatment, all of the 22 patients with formerly positive Chlamydia trachomatis cultures and 23 (77%) of the 30 patients with formerly positive Ureaplasma urealyticum cultures were negative at follow-up. A clinical cure was observed in 70 patients (90%). Three patients (4%) showed side-effects consisting of nausea and headache. It is concluded that roxithromycin is a good alternative to tetracycline and erythromycin in the treatment of non-gonococcal urethritis in males.

Anti-Bacterial Agents↗

PubMed2004

Roxithromycin-induced torsades de pointes.

Roxithromycin is an oral macrolide antibiotic agent frequently used in the clinical setting. The risk of pro-arrhythmia during roxithromycin use has always been considered extremely remote. We describe a patient who developed prolongation of the QT interval and torsades de pointes under roxithromycin treatment.

Journal Article↗

PubMed1989

Micro-method for the determination of roxithromycin in human plasma and urine by high-performance liquid chromatography using electrochemical detection.

A simple and sensitive high-performance liquid chromatographic micro-method for the determination of roxithromycin in human plasma and urine is described. A dichloromethane extract of the sample was chromatographed on a C18 reversed-phase column with acetonitrile-83 mM ammonium acetate-methanol (55:23:22, v/v) adjusted to pH 7.5 with acetic acid as the mobile phase. Roxithromycin and the internal standard, erythromycin, were detected by dual coulometric electrodes operated in the oxidative screen mode. The applied cell potential of the screen electrode was set at +0.7 V and the sample electrode at +0.9 V. The intra- and inter-assay coefficients of variation were less than or equal to 7.0%. The detection limit (signal-to-noise ratio = 3) was 0.1 microgram/ml for both plasma and urine. A study of drug stability during sample storage at 4, 20 and 37 degrees C showed no degradation of roxithromycin. The method is convenient for clinical monitoring and pharmacokinetic studies.

Aminoglycosides↗

PubMed1998

Quantitative determination of the macrolide antibiotics erythromycin, roxithromycin, azithromycin and clarithromycin in human serum by high-performance liquid chromatography using pre-column derivatization with 9-fluorenylmethyloxycarbonyl chloride and fluorescence detection.

A validated, highly sensitive and precise high-performance liquid chromatographic (HPLC) method for the determination of the macrolides erythromycin, azithromycin, clarithromycin and roxithromycin in human serum is described. A diethyl ether extract, obtained from serum using a saturated sodium carbonate solution, was treated with 9-fluorenylmethyl-oxycarbonyl chloride (FMOC-Cl) for 40 min at 40 degrees C and chromatographed on a base-deactivated octadecyl column, maintained at 50 degrees C during elution, using an eluent composed of acetonitrile-hydrogenphosphate buffer, pH 7.5, with 0.125% triethylamine (3:2, v/v). Fluorescence detection was used at an excitation wavelength of 255 nm and an emission wavelength of 315 nm. Erythromycin, clarithromycin, roxithromycin and azithromycin were found to have retention times of 8.8, 15.7, 17.1 and 20.7 min, respectively. Recoveries ranging from 93 to 104% were found with reproducibility coefficients of variation of 1.1-5%. Mean correlation coefficients of 0.9997, 0.9998, 0.9996 and 0.9994 were found for the linear calibration curves (n = 2) of erythromycin (0.320-16.1 mg/l), roxithromycin (3.24-19.4 mg/l), clarithromycin (0.190-19.4 mg/l) and azithromycin (0.0988-4.94 mg/l), respectively.

Anti-Bacterial Agents↗

PubMed1987

Pharmacokinetics of roxithromycin in paediatrics.

Macrolides are well known for their high lipid solubility and good tissue penetration. The pharmacokinetic properties of roxithromycin, a new semisynthetic macrolide, appear to be very interesting in healthy adult patients. Five paediatric pharmacokinetic studies are summarized and show that the pharmacokinetic properties of roxithromycin in paediatrics are very similar to those previously reported in adults and suggest that the same dose every 12 h is appropriate in paediatrics, 2.5 mg/kg. The diffusion of roxithromycin into upper respiratory tract tissues appears to be good in children.

Child, Preschool↗

PubMed1987

Pharmacokinetics of roxithromycin in renal and hepatic failure and drug interactions.

In patients with renal insufficiency roxithromycin pharmacokinetic parameters are significantly altered. In particular, the Cmax, the AUC and the T1/2 are increased and the Clr is reduced. In alcoholic cirrhotic patients the blood half-life is dosage higher than in normals. In spite of this, in these types of patients the usual roxithromycin dosage should not be modified. Potential pharmacokinetic drug interactions that involve roxithromycin are very few and concern only disopyramide and theophylline. Theophylline concentrations should be monitored if the pretreatment blood level is greater than 15 mg/l.

Aged↗

PubMed1987

A study of the interaction of roxithromycin with theophylline and carbamazepine.

There have been reports of an interaction when theophylline and macrolides are given together, and also when carbamazepine is given with macrolides. We compared the kinetics of theophylline and carbamazepine, given alone and then in combination with roxithromycin. Roxithromycin had little effect on the pharmacokinetics of theophylline and none on carbamazepine, and roxithromycin can be given with either of the drugs without any need to alter the dose.

Adolescent↗

PubMed1987

Roxithromycin in the therapy of Streptococcus pyogenes throat infections.

Roxithromycin in two dosage regimens was compared with erythromycin in the therapy of 227 patients with throat infectious due to Streptococcus pyogenes. All three groups had the same clinical efficacy but roxithromycin 300 mg daily was less effective than erythromycin 500 mg qds in eradicating S. pyogenes while there were less antibiotic-related side effects with roxithromycin 150 mg bd than with erythromycin.

Adolescent↗

PubMed1987

Clinical evaluation of roxithromycin in odontogenic orofacial infections.

An open multicentre clinical trial was conducted in Japan to study the efficacy and safety of roxithromycin in the treatment of acute odontogenic infections. Specimens were collected by needle aspiration only from closed abscesses. The MICs were determined for the pathogens isolated by an agar dilution method. Before and after administration of roxithromycin, whenever possible, a biological safety evaluation was performed. The drug was orally administered in a dosage of 200-400 mg daily, in two divided doses, before the morning and evening meals. Evaluation was objectively performed in accordance with the 'Evaluation Criteria for the Efficacy of Antibiotics by the Japan Society of Oral Surgeons'. A total of 144 bacterial strains were isolated from 73 of the 193 analysed subjects. The proportion of the strains sensitive to roxithromycin (MIC less than or equal to 3.13 mg/l) was 85.4%. One hundred and ninety three of a total of 216 subjects were included in the final analysis. The efficacy of the drug was assessed to be 85.5%. No dose-dependent difference in the clinical effect was observed. Adverse reactions were mainly gastrointestinal disorder, seen in five of 211 subjects (2.4%), while increased hepatic transaminases were observed in two of 92 subjects (2.2%).

Bacteria, Aerobic↗