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  • 1
    Digitale Medien
    Digitale Medien
    Comparative bioavailability of 5-aminosalicylic acid from a controlled release preparation and an azo-bond preparation (1994)
    Oxford, UK : Blackwell Publishing Ltd
    Alimentary pharmacology & therapeutics 8 (1994), S. 0 
    Details
    ISSN: 1365-2036
    Quelle: Blackwell Publishing Journal Backfiles 1879-2005
    Thema: Medizin
    Notizen: Background: Knowledge of the bioavailability of 5-aminosalicylic acid (5-ASA, mesalazine) from the different 5-ASA-containing drugs is important for rational therapy of inflammatory bowel diseases. Methods: The local and systemic bioavailability of 5-ASA from a controlled release 5-ASA preparation (Pentasa—2, 4 or 6 g/day) was investigated and compared with the azo-bond 5-ASA preparation olsalazine (Dipenturn—2 g/day) in 13 healthy volunteers during steady state conditions. Results: The therapeutically relevant parameter of 5-ASA at the rectal level, expressed as the mean concentration in faecal water, showed a significant trend towards higher concentrations with increasing Pentasa dose: 9.2 mmol/L, 19.0 mmol/L and 24.4 mmol/L, respectively. The concentration of olsalazine 2 g/day was 16.0 mmol/L. The concentration of the metabolite N-acetyl-5-aminosalicylic acid (Ac-5-ASA) did not rise with increasing Pentasa dose, indicating saturable presystemic acetylating capacity of 5-ASA. Total urinary excretion of 5-ASA and Ac-5-ASA, as a percentage of the daily ingested 5-ASA dose, remained constant on the three Pentasa doses, but there was a significant increase in the 5-ASA fraction. Mean steady state plasma concentrations of 5-ASA and Ac-5-ASA were significantly higher on Pentasa 4 g/day and 6 g/day than on 2 g/day. Values on Pentasa 2 g/day were comparable with those on olsalazine 2 g/day. Conclusions: The study confirmed that 5-ASA is released from Pentasa in a predictable manner, the amount released increasing with dose. Olsalazine is an excellent generator of 5-ASA in the colon.
    Materialart: Digitale Medien
    URL: http://dx.doi.org/10.1111/j.1365-2036.1994.tb00290.x
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  • 2
    Digitale Medien
    Digitale Medien
    The risk of congenital abnormalities in children fathered by men treated with azathioprine or mercaptopurine before conception (2004)
    Oxford, UK : Blackwell Science Ltd
    Alimentary pharmacology & therapeutics 19 (2004), S. 0 
    Details
    ISSN: 1365-2036
    Quelle: Blackwell Publishing Journal Backfiles 1879-2005
    Thema: Medizin
    Notizen: Background : Immunosuppressive therapy with azathioprine and mercaptopurine is commonly used in patients with various chronic diseases. The few existing data on the reproductive safety of these drugs after paternal use before conception are inconclusive.Aim : To examine the risk of congenital abnormalities in children fathered by men exposed to azathioprine or mercaptopurine before conception.Methods : This was a Danish population-based cohort study, based on data from the Prescription Database, the Medical Birth Registry and the Hospital Discharge Registry of North Jutland County, Denmark. Fifty-four exposed pregnancies, in which the father filed a prescription for azathioprine or mercaptopurine (between 1 January 1991 and 31 December 2001) before conception, were included. The controls comprised 57 195 pregnancies with no paternal azathioprine or mercaptopurine use.Results : Four children with congenital abnormalities (underlying paternal diseases: glomerulonephritis and severe skin disease) were found in 54 exposed pregnancies (7.4%), compared with 2334 (4.1%) in controls. The adjusted odds ratio for congenital abnormalities in children fathered by men treated with azathioprine or mercaptopurine was 1.8 (95% confidence interval, 0.7–5.0).Conclusions : Our data may indicate that paternal use of azathioprine or mercaptopurine before conception is associated with an increased risk of congenital abnormalities. However, more data are needed to determine whether the association is causal.
    Materialart: Digitale Medien
    URL: http://dx.doi.org/10.1111/j.1365-2036.2004.01889.x
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  • 3
    Digitale Medien
    Digitale Medien
    Influence of renal function on the elimination of morphine and morphine glucuronides (1988)
    Springer
    European journal of clinical pharmacology 34 (1988), S. 353-357 
    Details
    ISSN: 1432-1041
    Schlagwort(e): morphine ; morphine glucuronides ; renal function ; pharmacokinetics ; radioimmunoassay
    Quelle: Springer Online Journal Archives 1860-2000
    Thema: Chemie und Pharmazie , Medizin
    Notizen: Summary The influence of renal function, measured by 51Cr-EDTA clearance, on morphine and morphine glucuronide kinetics has been studied in 13 patients after a single i.v. injection of morphine. Unconjugated morphine and morphine glucuronides were measured by a sensitive, specific RIA after extraction from plasma. No significant correlation was found between total body clearance of unconjugated morphine and 51Cr-EDTA clearance. However, patients with renal insufficiency had impaired elimination of morphine glucuronides, and the apparent clearance was significantly correlated with the 51Cr-EDTA clearance (r=0.94, p〈0.001). A relatively long terminal elimination half-life of morphine was found in all patients (mean±SD: 9.2±2.5 h), irrespective of glomerular function.
    Materialart: Digitale Medien
    URL: http://dx.doi.org/10.1007/BF00542435
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  • 4
    Digitale Medien
    Digitale Medien
    5-Aminosalicylic acid in patients with an ileo-rectal anastomosis (1986)
    Springer
    European journal of clinical pharmacology 31 (1986), S. 23-26 
    Details
    ISSN: 1432-1041
    Schlagwort(e): sulphasalazine ; Pentasa ; slow release preparation ; 5-aminosalicylic acid ; ileo-rectal anastomosis ; ulcerative colitis ; pharmacokinetics
    Quelle: Springer Online Journal Archives 1860-2000
    Thema: Chemie und Pharmazie , Medizin
    Notizen: Summary The pharmacokinetics of 5-aminosalicylic acid (5-ASA) from sulphasalazine (SASP) and the slow-release 5-ASA preparation Pentasa was investigated in a cross-over study in 9 otherwise healthy patients with an ileo-rectal anastomosis. The 24-hour recoveries of the drugs were 90.5% and 84.7%, respectively. The median release of 5-ASA from SASP was 50% and from Pentasa 75%. Equal amounts of 5-ASA (18.0% vs 17.9%) were found in the faeces, and a significantly larger amount (4.4% vs 28.9%) of the metaboliteN-acetyl-5-aminosalicylic acid (ac-5-ASA) was found in faeces following Pentasa. A larger amount of 5-ASA was absorbed and subsequently excreted in the urine, mainly as the metabolite (2.5% vs 20.5%) from Pentasa. This confirms previous results in ileostomized patients treated with Pentasa. The present findings also demonstrate that bacterial azo-reduction of SASP in patients with ileorectal anastomosis may be an adequate way to deliver 5-ASA in this type of patient. Both treatments may be used in these patients during a flare up of ulcerative colitis, but randomized studies are needed.
    Materialart: Digitale Medien
    URL: http://dx.doi.org/10.1007/BF00870980
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  • 5
    Digitale Medien
    Digitale Medien
    Dicloxacillin and flucloxacillin: Pharmacokinetics, protein binding and serum bactericidal titers in healthy subjects after oral administration (1995)
    Springer
    Infection 23 (1995), S. 107-112 
    Details
    ISSN: 1439-0973
    Quelle: Springer Online Journal Archives 1860-2000
    Thema: Medizin
    Beschreibung / Inhaltsverzeichnis: Zusammenfassung Bei 12 gesunden freiwilligen Probanden wurde die Pharmakokinetik von Dicloxacillin und Flucloxacillin nach oraler Gabe untersucht. Die Probanden erhielten eine Einzeldosis Dicloxacillin (0,5 g, 0,75 g oder 1,0 g) oder Flucloxacillin (0,75 g) im Überkreuz-Verfahren. Die Antibiotikakonzentrationen wurden im Serum und Urin über einen Zeitraum von 8 und 24 Stunden verfolgt und mittels Bioassay bestimmt. Die drei Dosierungen von Dicloxacillin ließen keine signifikanten Unterschiede in den Serum-Eliminations-Halbwertzeiten (t1/2β; median 72 min) erkennen. Der Vergleich der 0,75 g Dosis von Flucloxacillin mit derselben Dosis von Dicloxacillin zeigte keine signifikanten Unterschiede für die Werte Cmax, t1/2β und AUC. Die Eiweißbindung wurde durch Ultrafiltration in gepoolten Seren mit 94,7–96,2% für Flucloxacillin und von 96,4–97,2% für Dicloxacillin ermittelt. Beide Medikamente zeigten ähnliche Serumbakterizidietiter. Dicloxacillin wies folglich nach Gabe von 0,75 g bei Probanden ähnliche pharmakokinetische Eigenschaften auf wie Flucloxacillin.
    Notizen: Summary The pharmacokinetics of dicloxacillin and flucloxacillin were studied in 12 healthy volunteers after oral administration. The participants received a single dose of either dicloxacillin (0.5 g, 0.75 g or 1.0 g) or flucloxacillin (0.75 g) in a cross-over fashion. Antibiotic concentrations were determined in serum and urine by bioassay and followed for 8 and 24 h, respectively. The three dicloxacillin dosages showed no significant differences for the serum elimination half-lives (t1/2β, median: 72 min). Comparing 0.75 g flucloxacillin with the same dose of dicloxacillin, no significant differences between the values of Cmax, t1/2β and AUC were found. Protein binding as determined by ultrafiltration in pooled serum was 94.7–96.2% for flucloxacillin and 96.4–97.2% for dicloxacillin. The serum bactericidal titers were similar for the two drugs. In conclusion, dicloxacillin and flucloxacillin showed similar pharmacokinetic behavior after 0.75 g doses in human volunteers.
    Materialart: Digitale Medien
    URL: http://dx.doi.org/10.1007/BF01833876
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  • 6
    Digitale Medien
    Digitale Medien
    Pharmacokinetics of 5-aminosalicylic acid in man following administration of intravenous bolus andper os slow-release formulation (1991)
    Springer
    Digestive diseases and sciences 36 (1991), S. 1735-1740 
    Details
    ISSN: 1573-2568
    Schlagwort(e): 5-aminosalicylic acid ; pharmacokinetics ; ulcerative colitis
    Quelle: Springer Online Journal Archives 1860-2000
    Thema: Medizin
    Notizen: Abstract The fate of 5-aminosalicylic acid (5-ASA), which is used in the treatment of chronic inflammatory bowel diseases, was studied in six healthy volunteers receiving doses of 100 mg and 250 mg intravenous bolus as well as 250 mgper os (slow release). Following intravenous administration, the drug was rapidly eliminated with a plasma half-life of about 40 min, mainly due to rapid metabolism. No parent drug was recovered in feces, and the total recovery following oral administration (30%) was significantly lower than following the intravenous doses (77% and 72%). Nonlinear pharmacokinetics were suggested as the 2.5-fold increase in intravenous dose was followed by a significant relative increase (〉2.5) in the renal elimination of 5-ASA, as well as a significant decrease (〈2.5) in the elimination of the metaboliteN-acetyl-5-ASA. There was also a trend towards a decreasing total body clearance and metabolic ratio. The present study confirms earlier findings on the pharmacokinetics of 5-ASA and suggests a possible saturation of theN-acetylating system in the dose range studied. This may be of interest in the design of controlled-release formulations and dosage regimes for the treatment of diseases of the small-bowel, where 5-ASA is easily absorbed. Further, for the first time, a marked difference in the intestinal fate compared to the systemic fate of the drug is demonstrated, suggesting alternative presystemic metabolism of 5-ASA, which may bear relevance to its mode of action. Further studies on the pharmacokinetics of 5-ASA, preferably in patients, are warranted.
    Materialart: Digitale Medien
    URL: http://dx.doi.org/10.1007/BF01296618
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