APO-DESMOPRESSIN
ATC Code
H01BA02
Warning
Association of increased risk of hyponatremia/water intoxication with all intra-nasal spray formulations of the antidiuretic drug desmopressin (including Apo-Desmopressin Spray).
Apotex Inc., in collaboration with Health Canada, wishes to advise you that all intranasal formulations of the antidiuretic drug desmopressin, including Apo-Desmopressin Spray, are now contraindicated for the treatment of Primary Nocturnal Enuresis, as international post-market data has indicated intranasal formulations of desmopressin are associated with greater risk of hyponatremia than oral formulations. Hyponatremia is a serious, potentially fatal, adverse reaction caused by water retention resulting from the potent antidiuretic effect of desmopressin. If unrecognized, hyponatremia can lead to seizures and death.
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