Source: European Medicines Agency (EU) Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Pharmacotherapeutic group: Antithrombotic
ATC-Code: B01AB06
Nadroparin 19,000 I.U. is the calcium salt of nadroparin, a low-molecular weight heparin with a mean molecular weight of about 4,500 Daltons. It is made by depolymerisation of standard heparin. Structurally it is referred to as a glycosaminoglycan. Nadroparin inhibits Factor Xa in particular and thrombin to a lesser extent. Inhibition is partially mediated via the plasma protease inhibitor antithrombin III.
Nadroparin has less effect on platelet function and aggregation and only has a minor effect on primary haemostasis compared to heparin. The biological activity of different low-molecular weight heparins cannot be expressed in a single test that allows simple dose comparison between different preparations.
The pharmacokinetic properties have been determined by measuring the anti-Xa activity in plasma.
Following subcutaneous injection, the maximum anti-Xa activity (Cmax) was reached after approximately 4 to 6 hours (tmax). Following intravenous injection, the maximum anti-Xa concentration in plasma is reached within less than 10 minutes, the half-life is about 2 hours. The bioavailability in terms of anti-Xa activity is nearly complete (about 98%).
The elimination half-life following subcutaneous injection is about 8 to 10 hours.
In a clinical study on the pharmacokinetics of intravenously administered nadroparin in patients with varying degrees of renal impairment, a correlation was found between nadroparin clearance and creatinine clearance. In patients with moderate renal impairment (creatinine clearance 36–43 ml/min), the mean AUC as well as the elimination half-life were increased by 52 and 39% respectively, compared to healthy study participants. In these patients, the mean plasma clearance of nadroparin was decreased to 63% of the normal value. In the study, wide inter-individual variability was observed. In patients with severe renal impairment (creatinine clearance 10–20 ml/min), the mean AUC and the elimination half-life were increased by 95% and 112% respectively, compared to healthy study participants. The plasma clearance of patients with severe renal impairment was reduced by 50%, compared to patients with normal kidney function. In patients with severe renal impairment (creatinine clearance 10–20 ml/min), the mean AUC and the elimination half-life were increased by 62% and 65% respectively, compared to healthy study participants. The plasma clearance of haemodialysis patients with severe renal impairment was reduced by 67%, compared to patients with normal kidney function (see sections 4.2 and 4.4).
Not relevant.
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