DDAVP MELT Oral lyophilisate Ref.[7949] Active ingredients: Desmopressin

The overall mean systemic bioavailability of desmopressin administered sublingually as Melts at doses of 200, 400 and 800 micrograms is 0.25% with a 95% confidence interval of 0.21%-0.31%. The C_max was 14, 30 and 65pg/ml after administration of 200, 400 and 800 micrograms respectively. T_max was observed at 0.5–2.0 hours after dosing. The geometric mean terminal half-life is 2.8 (CV=24%) hours.

Correlation table between desmopressin in Tablet and Melt forms:

⁺ calculated for comparative purposes

The distribution volume of desmopressin after intravenous administration is 33 L (0.41 L/kg). Desmopressin does not cross the blood-brain barrier. Desmopressin exhibits a moderate to high variability in bioavailability, both within and between subjects. Concomitant use of food decreases the rate and extent of absorption by 40%.

In vitro, in human liver microsome preparations, it has been shown that no significant amount of desmopressin is metabolised in the liver and thus human liver metabolism in vivo is not likely to occur.

It is unlikely that desmopressin will interact with drugs affecting hepatic metabolism, since desmopressin has been shown not to undergo significant liver metabolism in in vitro studies with human microsomes. However, formal in vivo interaction studies have not been performed.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.