To print: Select File and then Print from your browser's menu
---------------------------------------------------------------------------------------
Title: Intranasal Desmopressin Loses Indication for Primary Nocturnal Enuresis in Canada
URL: http://www.pslgroup.com/dg/226002.htm
Doctor's Guide
July 18, 2008

OTTAWA, Ontario -- July 18, 2008 -- Health Canada is informing healthcare professionals that all intranasal formulations of desmopressin (DDAVP), including DDAVP Spray and DDAVP Rhinyle Nasal Solution, are no longer indicated for the treatment of primary nocturnal enuresis (PNE) due to an increased risk of hyponatremia with the intranasal formulations.

· All intranasal formulations of desmopressin are now contraindicated for the treatment of PNE.

· All patients using intranasal formulations of desmopressin for treatment of PNE should be reassessed to determine their need for continued treatment and to discuss other options.

· If ongoing treatment is considered necessary, patients should be switched to the lowest starting dose of an oral formulation, with the dose increased only if necessary to control symptoms.

· New patients treated for PNE with desmopressin should only be prescribed an oral formulation.

· Fluid intake and desmopressin dosage should be adjusted carefully in order to reduce the possibility of water retention and hyponatremia, especially in very young and elderly patients or when significant daily variables occur such as hot climate conditions, intense exercise, or other situations where increased water intake can be expected.

· Prodromal symptoms such as headache, nausea, or vomiting may herald impending hyponatremia. A patient treated with desmopressin for PNE and/or their guardian should be advised that if such symptoms occur, desmopressin should be discontinued and medical attention sought immediately.

Worldwide postmarketing data indicate a higher incidence of hyponatremia in patients being treated with the desmopressin intranasal formulations compared with the oral formulations.

Hyponatremia has been reported at a rate of approximately 5 cases per 10 million doses for nasal formulations and about 1 case per 10 million doses for oral formulations.

When desmopressin treatment is needed, physicians should discuss with the patient and/or guardian the importance of limiting the amount of fluid intake 1 hour before taking the medication and during the 8 hours postdose.

SOURCE: Health Canada

---------------------------------------------------------------------------------------------
Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content.
---------------------------------------------------------------------------------------------
This news story was printed from *Doctor's Guide to the Internet*
located at http://www.docguide.com
---------------------------------------------------------------------------------------

Return to News Story Page

This site is maintained by webmaster@pslgroup.com
Please contact us with any comments, problems or bugs.
All contents Copyright (c) 1998 P\S\L Consulting Group Inc.
All rights reserved.