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Biomedical subjects

R J Royer

Publications and source records attributed to R J Royer.

At least 19 recordsLinked to original sources
PubMed2000

The link between sunshine and phototoxicity of sparfloxacin.

AIMS: To test the association between reporting rates for sparfloxacin-induced phototoxicity and sunlight u.v. exposure, and the effects of regulatory action. METHODS: The reporting rates for phototoxicity with sparfloxacin to the French Pharmacovigilance System or to the Drug Manufacturer were compared with concurrent national mean u.v. exposure obtained from Météo-France, before and after the regulatory restrictions and warnings. RESULTS: There were 371 severe phototoxic reaction reports during the first 9 months of marketing (reporting rate of 0.4 per thousand treated patients), approximately four to 25 times that reported for other fluoroquinolones. The reporting rate correlated highly (r = 0.873, P < 0.001) with the mean monthly u.v. exposure from sunlight (from Météo-France). Regulatory action including warnings for physicians, and restricted indications dramatically decreased the number of reports, but not the reporting rate. CONCLUSIONS: This is the first demonstration of a strong association between sunlight exposure in a population and drug-induced phototoxicity. Regulatory action had no effect on the reporting rate (individual exposed patient risk), though it solved the public health issue.

Adolescent↗
PubMed1996

Penetration of pefloxacin and its desmethyl metabolite into the uroepithelium after a 800-mg single oral dose in human patients.

Penetration of pefloxacin into the uroepithelium was studied in 20 patients (10 men and 10 women) receiving a single oral dose of 800 mg. Samples of serum, urine, and uroepithelium were taken 1.8 h (mean) after the dose. Pefloxacin and its active metabolite, norfloxacin, were assayed by liquid chromatography, and the microbiologically active compounds were quantified by a microbiological assay. Both procedures were correlated (r > 0.7); nevertheless, slight differences detected in concentrations depended on the levels of norfloxacin achieved in the biological samples. The serum and tissue concentrations were higher than the concentration of bactericide (4 micrograms.ml-1), except in one case. The uroepithelium concentration of pefloxacin was proportional to the serum concentration (r = 0.79). The urinary concentrations ranged from 1.2 micrograms.ml-1 to 82.4 micrograms.ml-1. The mean norfloxacin/pefloxacin ratios were 3% in serum, 8% in uroepithelium, and 44% in urine. The mean uroepithelium/serum concentration ratios were 1 for pefloxacin and 2.3 for norfloxacin. This result shows that, at a time close to that of the maximum concentration, there is good penetration of pefloxacin and norfloxacin into the uroepithelium.

Administration, Oral↗
PubMed1995

Double-blind randomized multicentre trial of acamprosate in maintaining abstinence from alcohol.

A prospective placebo-controlled, randomized double-blind study of Acamprosate at two dose levels in alcohol-dependent patients followed up for 12 months was performed. After detoxification, each of the 538 patients included was randomly assigned to one of three groups: 177 patients received placebo, 188 received Acamprosate at 1.3 g/day (low dose group) and 173 received 2.0 g/day (high dose group) for 12 months. This was followed by a single blind 6 month period on placebo. The patients' mean age was 43.2 +/- 8.6 years. Their mean daily alcohol intake was high (nearly 200 g/day) and of long duration (9.5 +/- 7.1 years). Abstinence figures followed the order high dose > low dose > placebo. The difference was significant at 6 months (P < or = 0.02) but not at 12 months (P = 0.096). The number of days of continuous abstinence after detoxification was 153 +/- 197 for the high-dose group versus 102 +/- 165 for the placebo group (P = 0.005), with the lose-dose group reporting 135 +/- 189 days. Clinic attendance was significantly better in the Acamprosate groups than in the placebo group at 6 months (P = 0.002) and 12 months (P = 0.005). During the 6-month post-treatment period, no increased relapse rate or residual drug effect was observed. The side effect profile for Acamprosate was good compared with controls with only diarrhoea being reported more frequently (P < 0.01). This study confirms the pharmacological efficacy of Acamprosate and its good acceptability. As an adjunct to psychotherapy, this study supports the inclusion of Acamprosate in a strategy for treating alcoholism.

Acamprosate↗
PubMed1995

[Drug monitoring].

Explore the source record for details and available documents.

Adverse Drug Reaction Reporting Systems↗
PubMed1993

Influence of food intake on the pharmacokinetics of a sustained release formulation of sodium valproate.

The effect of food intake on the pharmacokinetics of DEPAKINE CHRONO 500 mg (Sanofi, France), a sustained release formulation containing 333 mg sodium valproate and 145 mg valproic acid, was studied in 12 young healthy female volunteers. Relative to fasting conditions (F), when the tablet was given at the midpoint of the breakfast (NF), the maximum concentration (F: 34.6 +/- 8.9 micrograms ml-1 and NF: 40.9 +/- 7.3 micrograms ml-1; p = 0.014) and the mean cumulative amount absorbed up to time 6 h (F: 76.3 +/- 11.8% and NF: 90 +/- 10.4%; p = 0.0099) were significantly increased. Nevertheless, the extent of absorption (F: 46.7 +/- 9.9 mg l-1; NF: 48.7 +/- 7 mg l-1) was not significantly affected. There was no change in the area under the curve (1129 micrograms.h ml-1), in the mean residence time (28 h), or in the elimination half-life (16 h). On the basis of this study, the question as to whether DEPAKINE CHRONO should be administered to subjects in the fasting or non-fasting state would not appear to be a major consideration when deciding on the regimen.

Adult↗
PubMed1992

Determination of zopiclone in plasma using column liquid chromatography with ultraviolet detection.

A reversed-phase liquid chromatographic method with ultraviolet detection for the determination of zopiclone in plasma is described. It is rapid, sensitive, reproducible and linear over a wide range. The method was used to study plasma zopiclone concentrations in a case of acute intoxication after oral ingestion of 300 mg of the drug. The plasma level was 1600 ng/ml 4.5 h after the dose and the elimination half-life was 3.5 h.

Adult↗
PubMed1992

Automated determination of disopyramide and N-monodealkyldisopyramide in plasma by reversed-phase liquid chromatography with a column switching system.

A rapid and simple column liquid chromatographic method involving a column switching system for the determination of disopyramide and its N-monodealkyl metabolite (NMD) in plasma is described. The deproteinized plasma is applied to an automated system. Purification and concentration were performed using a precolumn connected to a six-position valve; analytical separation was done on-line using a cyano reversed-phase column with a mobile phase consisting of 10 mmol/l trimethylamine (pH 2.5, adjusted with phosphoric acid)-acetonitrile-tetrahydrofuran (78:20:2, v/v/v). Absorbance was measured at 265 nm, with a minimum detectable amount of disopyramide and NMD of 0.1 micrograms/ml. The method can be applied to drug monitoring and pharmacokinetic studies.

Chromatography, High Pressure Liquid↗
PubMed1992

Plasma thiamine concentrations after intramuscular and oral multiple dosage regimens in healthy men.

A novel liquid chromatographic method for the determination of thiamine in plasma has been developed and has been used to study plasma thiamine concentrations after multiple dosage regimens for 11 days. The method involves purification, concentration and analytical separation of thiochrome on-line, using a switching column system. Ten healthy men were given 500 mg thiamine i.m. once a day (Group 1) and ten were given 250 mg p.o. every 12 h (Group 2). The times to reach steady state (7 and 5.6 days for Groups 1 and 2, respectively) were not different (P greater than 0.05). The mean elimination half-life was 1.8 days. The mean minimum steady-state concentration after the oral regimen (23 micrograms.l-1) was 78% of that after the intramuscular regime (29 micrograms.l-1).

Administration, Oral↗
PubMed1992

Plasma and cerebrospinal fluid concentrations of paracetamol after a single intravenous dose of propacetamol.

Since the antipyretic and probably the analgesic effects of paracetamol are, at least in part, centrally mediated, its plasma and cerebrospinal fluid (CSF) concentrations were measured in 43 patients with nerve-root compression pain. Each subject was given a short i.v. infusion of 2 g propacetamol, a prodrug which is hydrolysed to paracetamol within 7 min. Single blood and CSF samples were drawn concomitantly in each patient at intervals between 20 min and 12 h. Maximum CSF drug concentrations were observed at the 4th hour, subsequent concentrations exceeding those in plasma. The elimination half-life of paracetamol calculated from pooled data was shorter in plasma (2.4 h) than in CSF (3.2 h). The time-course of paracetamol in CSF may parallel that of analgesic effect.

Acetaminophen↗
PubMed1991

Effect of plasma exchange on flumequine pharmacokinetics: comparison with control kinetics.

The effect of plasma exchange (PE) on the pharmacokinetics of flumequine (Apurone) was studied in eight patients receiving a single oral dose of 800 mg. The maximum concentration (38 micrograms/ml) and time to maximum concentration (2.6 h) values were not significantly altered by PE beginning 3 h after administration of flumequine. There was no change in the terminal elimination half-lives (6.6 h), in the steady-state volume of distribution (29 L), or in the apparent plasma clearance (2.5 L/h). By contrast, PE decreased the mean residence time by 30% (14.3 +/- 4.1 h without PE; 9.88 +/- 1.36 h with PE; p less than 0.05). The amount of flumequine extracted by PE (72 mg) was proportional to the plasma concentration at the beginning of the exchange. The elimination half-life during PE (3.15 +/- 1.23 h) decreased by 40%. Renal clearance (0.3 L/h) was not affected. PE only partially modifies the pharmacokinetics of flumequine administered in a single oral dose before PE.

Administration, Oral↗
PubMed1990

Pharmacovigilance. The French system.

The French system of drug surveillance (pharmacovigilance) is a combination of mandatory reporting and intensive hospital surveillance. The Regional Centres are decentralised but coordinated through a national network. An algorithm index is used to assess the relationship between drugs and adverse effects. The adverse reactions alert system is produced by the compilation and analysis of the cases entered in a data bank (8062 in 1988) and by the analysis of queries from general practitioners (20,000 in 1988). The duties of the centres are also to provide information, analyse data and to improve the safe use of drugs.

Communication↗
PubMed1990

Differences in sodium salicylate protein binding in serum and synovial fluid from patients with a knee effusion.

Protein binding of sodium salicylate in synovial fluid and in serum from 23 inpatients with rheumatic diseases were studied, ex vivo, by equilibrium dialysis. Scatchard model with two classes of sites was used as a mathematical tool. At therapeutic concentrations, protein binding of sodium salicylate was significantly higher in serum than in synovial fluid. The ratio of areas under the curves for bound concentrations for synovial fluid to that for serum was 0.867. This difference was attributed to the hypoalbuminemia observed in the synovial fluid; for a given molar ratio of drug to albumin, or in other words, for the same amount of available drug per mole of albumin. The number of sites occupied was the same in the two biological media.

Adolescent↗
PubMed1989

Identification and simultaneous determination of non-steroidal anti-inflammatory drugs using high-performance liquid chromatography.

An isocratic high-performance liquid chromatographic procedure is presented for the screening of plasma samples for the presence of sixteen non-steroidal anti-inflammatory drugs. Detection was achieved simultaneously at two wavelengths (254 and 370 nm) and the purity of the eluted peaks was tested using absorbance ratios at the two wavelengths; identification could thus be effective without interferences from substances of other pharmacological classes. The drugs were extracted simultaneously with diethyl ether after acidification and separated from each other on an octadecyl reversed-phase column using only one eluent, acetonitrile-0.3% acetic acid-tetrahydrofuran (36:63.1:0.9, v/v). The recovery, precision and reproducibility of the method were satisfactory as it allowed the determination of the drugs from infra- to supratherapeutic concentrations.

Anti-Inflammatory Agents, Non-Steroidal↗