DESMOPRESSIN Nasal spray, solution Ref.[2729] Active ingredients: Desmopressin

For nasal use.

Before application blow the nose. Place nozzle inside the nostril and press once. One actuation delivers a dose of 10 micrograms desmopressin acetate trihydrate. If higher doses are prescribed it is recommended that one-half of the dose be administered per nostril. While spraying breathe in slightly.

Treatment of vasopressin-sensitive central diabetes insipidus

5 micrograms cannot be administered with Desmopressin Spray, another medicinal product containing desmopressin should be used.

The daily dose should be divided into 1 – 2 doses (in the morning and if required at bedtime).

In case of insufficient efficacy the dose can be increased on a case by case basis up to 40 µg in adults divided into 2 doses of 20 µg (2 sprays in the morning and at bedtime) and to 20 µg in children and adolescents (< 18 years) divided into 2 doses of 10 µg (1 spray in the morning and at bedtime).

The optimal dosage of Desmopressin Spray must be established individually and should be based on measurements of urine volume and osmolality. The treatment should aim at two goals: a normal water balance and an adequate duration of sleep (as a result of the improvement in the nocturia and nocturnal enuresis often observed in central diabetes insipidus). The goal of 6 to 7 dry nights/week should be achieved.

Diagnostic test of renal concentrating capacity

The test serves both to distinguish diabetes insipidus from polyurias of other aetiology and to determine reduced renal concentrating capacity due to urinary tract infections as well as for early diagnosis of tubulo-interstitial damage e.g. due to lithium, analgesics, chemotherapeutics or immunosuppressants.

The desmopressin test is carried out preferably in the morning. Fluid intake should be restricted from 1 hour before to 8 hours after administration of the medicinal product (see Section 4.4). Children under 5 years old and patients with cardiovascular diseases or hypertension should reduce their fluid intake to 50%. It is recommended that the bladder should be emptied at the time of the administration.

Urine osmolality should be determined before and twice after administration of desmopressin. Urine collected within the first hour should be discarded. Urine osmolality is determined in the two subsequent urine samples, preferentially taken two and four hours after administration of desmopressin. In order to determine the renal concentrating capacity, the higher value is compared to the baseline value or to an age-specific reference value.

A substantial rise in urine osmolality along with a significant decrease in urine volume is indicative of central diabetes insipidus. Low values, absence of a rise or only a slight rise in urinary osmolality indicate reduced renal concentrating capacity.

The safety and efficacy of desmopressin in specific patient populations (with renal or hepatic impairments or other concomitant diseases) has not been investigated.

Method of administration

Remove protective cap, keep bottle upright. Prime pump 3 times before the first application only until a uniform mist is achieved.

When spraying always hold the bottle in such a way that the dip tube points down and is immersed in the solution. Ensure that the pump is pressed down quickly and that even pressure is applied. Insert the nozzle into one of the nostrils and spray once. When a higher dose is needed, spray alternately into each nostril.

After use, replace the protective cap and store the bottle upright.

An overdose prolongs the antidiuretic effect and subsequently increases the risk of hyperhydration. Therefore, symptoms such as increase in body weight, headache, nausea, gastrointestinal cramps and in severe cases cerebral oedema, generalized convulsions and coma may be expected.

There is no antidote for desmopressin. Treatment of overdose consists of discontinuation of Desmopressin Spray and restriction of fluid intake until serum sodium is normalised. In cases of extensive overdose with the risk of water intoxication administration of a diuretic such as furosemide with concomitant monitoring of serum electrolytes should be considered. All cases of suspected cerebral oedema require immediate admission for intensive care measures.

Shelf life: 18 months.

Shelf life after first opening: 4 weeks.

Store in the original package.

Do not store above 25°C.

Store in upright position.

Type I amber glass bottle fitted with a metering pump composed of polypropylene, polyethylene and thermoplastic components secured with a snap on system.

Pack sizes: 6 ml.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.