DESMOPRESSIN NASAL

Each spray contains 10 micrograms desmopressin acetate.

Dosage and administration Treatment of nocturia:

For multiple sclerosis patients up to 65 years of age (with normal renal function) suffering from nocturia the dose is one or two sprays intranasally (10 to 20 micrograms) at bedtime. Not more than one dose should be used in any 24 hour period.

If a dose of two sprays is required this should be as one spray in each nostril. During the treatment of nocturia the fluid intake should be limited to a minimum and only to satisfy thirst for 8 hours following administration.

Treatment of diabetes insipidus:

Dosage is individual but clinical experience has shown that the average maintenance dose in adults and children is one or two sprays (10 to 20 micrograms) once or twice daily. If a dose of two sprays is required, this should be as one spray into each nostril.

Diagnosis of diabetes insipidus:

The diagnostic test in adults and children is two sprays (20 micrograms). Failure to elaborate a concentrated urine after water deprivation, followed by the ability to do so after the administration of Desmopressin Nasal Spray 10 micrograms/dose confirms the diagnosis of cranial diabetes insipidus.

Failure to concentrate after the administration suggests nephrogenic diabetes insipidus. 5 litres from 1 hour before until 8 hours after administration.

Renal function testing:

Recommended doses for the renal concentration capacity test: Adults: Two sprays into each nostril (a total of 40 micrograms).

Children (1-15 years):

One spray into each nostril (a total of 20 micrograms).

Infants (to 1 year):

One spray (10 micrograms). Adults and children with normal renal function can be expected to achieve concentrations above 700 mOsm/kg in the period 5 to 9 hours following administration of Desmopressin Nasal Spray 10 micrograms/dose.

It is recommended that the bladder should be emptied at the time of administration. 5 litres from 1 hour before until 8 hours after administration. In normal infants a urine concentration of 600 mOsm/kg should be achieved in the 5 hour period following administration of Desmopressin Nasal Spray 10 micrograms/dose.

Side-effects include headache, stomach pain, nausea, nasal congestion, rhinitis and epistaxis. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported. Very rare cases of emotional disorders including aggression in children have been reported.

Treatment with desmopressin without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with or without accompanying warning signs and symptoms (headache, nausea/vomiting, weight gain, decreased serum sodium and in severe cases, cerebral oedema and convulsions).

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

Desmopressin Nasal Spray should only be used in patients where orally administered formulations are not suitable. When Desmopressin Nasal Spray is prescribed, it is recommended: - to start at the lowest dose - to ensure compliance with fluid restriction instructions - to increase dosage progressively, with caution - to ensure that in children, administration is under adult supervision in order to control the dose intake.

Care should be taken with patients who have reduced renal function and/or cardiovascular disease or cystic fibrosis. Severe bladder dysfunction and outlet obstruction should be considered before starting treatment. When Desmopressin Nasal Spray 10 micrograms/dose is used in the treatment of nocturia, associated with multiple sclerosis, periodic assessments should be made of blood pressure and weight to monitor the possibility of fluid overload.

Treatment with desmopressin should be interrupted during acute intercurrent illness characterised by fluid and/or electrolyte imbalance (such as vomiting, diarrhoea, systemic infections, fever, gastroenteritis). In the event of signs or symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain and in severe cases, convulsions) treatment should be interrupted until the patient has fully recovered.

When restarting treatment, strict fluid restriction should be enforced. Elderly patients and patients with low serum sodium levels may have an increased risk of hyponatraemia. g. tricyclic antidepressants, selective serotonin reuptake inhibitors, chlorpromazine, carbamazepine and NSAIDs.

5 litres from 1 hour before until 8 hours after administration. Following diagnostic testing for diabetes insipidus or renal concentration, care should be taken to prevent fluid overload. Fluid should not be forced, orally or parenterally, and patients should only take as much fluid as they require to satisfy thirst.

Desmopressin Nasal Spray 10 micrograms/dose is contra-indicated in cases of:

Cardiac insufficiency and other conditions requiring treatment with diuretic agents. Hypersensitivity to the active substance or to any of the excipients, including hypersensitivity to the preservative. Moderate and severe renal insufficiency (creatinine clearance below 50ml/min).

Known hyponatraemia. Syndrome of inappropriate ADH secretion (SIADH). Before prescribing Desmopressin Nasal Spray 10 micrograms/dose the diagnosis of habitual or psychogenic polydipsia (resulting in urine production exceeding 40mg/kg/24hours) and alcohol abuse should be excluded.

When used to control nocturia in patients with multiple sclerosis, Desmopressin Nasal Spray 10 micrograms/dose should not be used in patients with hypertension or cardiovascular disease. Desmopressin Nasal Spray10 micrograms/dose should not be prescribed to patients over the age of 65 for the treatment of nocturia associated with multiple sclerosis.