Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2011 Publisher: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom
DDAVP Melt is indicated for the treatment of vasopressin-sensitive cranial diabetes insipidus or in the treatment of post-hypophysectomy polyuria/polydipsia.
DDAVP Melt is for sublingual use.
Dosage is individual in diabetes insipidus but the total daily sublingual dose normally lies in the range of 120 micrograms to 720 micrograms. A suitable starting dose in adults and children is 60 micrograms three times daily, administered sublingually. This dosage regimen should then be adjusted in accordance with the patient’s response. For the majority of patients, the maintenance dose is 60 micrograms to 120 micrograms sublingually three times daily.
The dose of DDAVP Melt should be controlled by measurement of urine osmolality.
An overdose of DDAVP Melt leads to a prolonged duration of action with an increased risk of water retention and/or hyponatraemia.
Although the treatment of hyponatraemia should be individualised, the following general recommendations can be given. Hyponatraemia is treated by discontinuing the desmopressin treatment, fluid restriction and symptomatic treatment if needed.
48 months.
Store in the original package in order to protect from moisture and light.
PVC/Polyamide/Aluminium/Polyamide/PVC blisters. Top foil consists of Paper/Polyester teraphthalate/Aluminium/heat seal lacquer. Strips of 10 oral lyophilisates in packs of 100 oral lyophilisates.
None.
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