The oral bioavailability of pentosan polysulphate sodium in healthy volunteers

Faaij, Richard A.; Srivastava, N.; Griensven, J. M. T. Van; Schoemaker, Rik C.; Kluft, C.; Burggraaf, J.; Cohen, Adam F.

doi:10.1007/s002280050577

Cited by 14 publications

(9 citation statements)

References 24 publications

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“…Taken together, these results indicate that oral PPS does not have anticoagulant activity following oral administration, nor does it affect warfarin pharmacokinetics. Previous studies have shown that PPS has a low oral bioavailability and that anticoagulant activity is notable only following injection 9 . Thus, it is not surprising that the pharmacodynamics of warfarin are not affected upon coadministration of oral warfarin and pentosan polysulfate sodium.…”

Section: Discussionmentioning

confidence: 99%

“…Faaij and colleagues 9 evaluated the oral availability of oral pentosan polysulfate sodium in 18 healthy male subjects with normal coagulation. In their study, subjects received 1500 mg of oral pentosan polysulfate sodium or 50 mg IV.…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies have shown that PPS has a low oral bioavailability and that anticoagulant activity is notable only following injection. 9 Thus, it is not surprising that the pharmacodynamics of warfarin are not affected upon coadministration of oral warfarin and pentosan polysulfate sodium.…”

Section: Modi Et Almentioning

confidence: 99%

“…Faaij et al 9 studied the pharmacodynamic effect of PPS following IV (50 mg) and oral (1500 mg) administration. Intravenous PPS significantly increased activated partial thromboplastin time (aPTT) and antiactivated factor X (anti‐Xa) activity compared with placebo.…”

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confidence: 99%

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Pharmacokinetics and Pharmacodynamics of Warfarin When Coadministered With Pentosan Polysulfate Sodium

Modi¹,

Kell²,

Simon³

et al. 2005

The Journal of Clinical Pharma

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The effect of pentosan polysulfate sodium on warfarin pharmacokinetics and pharmacodynamics was investigated in healthy subjects. Warfarin was titrated to an international normalized ratio between 1.4 and 1.8. Subjects continued their titrated dose of warfarin and received pentosan polysulfate sodium 100 mg or placebo every 8 hours for 7 days. The Cmax of R- and S-warfarin was approximately 840 to 890 ng/mL and 680 to 730 ng/mL, respectively, and was similar in the absence and presence of pentosan polysulfate sodium. The half-life for R- and S-warfarin was 52 to 56 hours and 36 to 40 hours, respectively. Prothrombin time, partial thromboplastin time, and the international normalized ratio for warfarin + placebo and warfarin + pentosan polysulfate sodium were comparable. The AUC(INR) indicated no treatment effect (P = .772); however, there was a period effect. Analysis of variance for the treatments by period indicated no treatment effect (P > .1). Adverse events were mild and included headache, epistaxis, and rash. Most adverse events were unrelated to treatment and were seen during warfarin titration. Pentosan polysulfate sodium did not affect warfarin pharmacokinetics or pharmacodynamics.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Modi Et Almentioning

confidence: 99%

mentioning

confidence: 99%

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Pharmacokinetics and Pharmacodynamics of Warfarin When Coadministered With Pentosan Polysulfate Sodium

Modi¹,

Kell²,

Simon³

et al. 2005

The Journal of Clinical Pharma

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“…1 A study of oral pentosan polysulfate administered to 18 healthy volunteers reported negligible bioavailability after a single dose of 1500 mg failed to alter coagulation parameters. 5 Furthermore, trials using oral pentosan polysulfate sodium doses greater than 900 mg/d reported no significant coagulopathies 6,7 and no significant adverse anticoagulation effects were demonstrated in longterm studies (90-119 months) of oral pentosan polysulfate use in interstitial cystitis. 8,9 Despite its limited bioavailability, coagulation monitoring with oral pentosan polysulfate has been suggested.…”

Section: Commentmentioning

confidence: 99%

Massive Bleeding on a Bladder Protectant

Gill¹,

Naiman²,

Jamal³

et al. 2002

Arch Intern Med

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Pentosan polysulfate sodium (Elmiron; Alza Pharmaceuticals, Mountain View, Calif) is an oral preparation of pentosan polysulfate used in the symptomatic management of interstitial cystitis. While pentosan polysulfate has a known heparin-like effect in its parenteral form, there have been no previous reports of coagulopathy with oral use. We present an interesting case of inadvertent systemic anticoagulation resulting in serious bleeding complications in a young woman taking oral pentosan polysulfate for interstitial cystitis.

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Venous Thromboembolism

2006

Wiley Handbook of Current and Emerging Drug Therapies

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The oral bioavailability of pentosan polysulphate sodium in healthy volunteers

Abstract: The oral bioavailability of PPS is negligible in young healthy males.

Cited by 14 publications

References 24 publications

Pharmacokinetics and Pharmacodynamics of Warfarin When Coadministered With Pentosan Polysulfate Sodium

Pharmacokinetics and Pharmacodynamics of Warfarin When Coadministered With Pentosan Polysulfate Sodium

Massive Bleeding on a Bladder Protectant

Venous Thromboembolism

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