Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2011 Publisher: Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom
In its main biological effects, desmopressin does not differ qualitatively from vasopressin. However, desmopressin is characterised by a high antidiuretic activity whereas the uterotonic and vasopressor actions are extremely low.
In a modelling study in which intravenous desmopressin was infused over two hours in healthy adult male subjects, the EC50 value was calculated as 1.7pg/ml based on urinary osmolality and 2.4pg/ml based on urinary volume.
The absolute bioavailability of orally administered desmopressin varies between 0.08% and 0.16%. Mean maximum plasma concentration is reached within 2 hours. The distribution volume is 0.2–0.32 l/kg. Desmopressin does not cross the blood-brain barrier. The oral terminal half-life varies between 2.0 and 3.11 hours.
After oral administration of a single dose of 2 × 200 micrograms desmopressin tablets to healthy subjects, 25% of the subjects had plasma concentrations of desmopressin above 1pg/ml up to at least 14 hours post dosing.
In in vitro studies in human liver microsome preparations, it has been shown that no significant amount of desmopressin is metabolised, and thus human liver metabolism in vivo is not likely to occur. Consequently it is also unlikely that desmopressin will interact with drugs affecting hepatic metabolism. However, formal in vivo interaction studies have not been performed.
About 65% of the amount of desmopressin absorbed after oral administration could be recovered in the urine within 24 hours.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
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