Desmospray (desmopressin acetate) Prescribing Information
Desmospray (Desmopressin acetate)
Prescribing Information
Composition: Desmospray® contains 10 micrograms of Demopressin acetate per actuation. Therapeutic Indication: Treatment of nocturia associated with multiple sclerosis where other treatments have failed. Diagnosis and treatment of vasopressin-sensitive cranial diabetes insipidus. Establishing renal concentration capacity. Dosage and Method of 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. 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. Diagnosis of Diabetes Insipidus: The diagnostic dose 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 Desmospray® confirms the diagnosis of cranial diabetes insipidus. Failure to concentrate after the administration suggests nephrogenic diabetes insipidus. 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 700mOsm/kg in the period of 5-9 hours following administration of Desmospray®. It is recommended that the bladder should be emptied at the time of administration. In normal infants a urine concentration of 600mOsm/kg should be achieved in the 5 hour period following the administration of Desmospray®. The fluid intake at the two meals following the administration should be restricted to 50% of the ordinary intake in order to avoid water overload. Contraindications: Cardiac insufficiency and other conditions requiring treatment with diuretic agents. Hypersensitivity to the preservative. Psychogenic polydipsia and alcohol abuse. When used to control nocturia in patients with multiple sclerosis, Desmopressin should not be used in patients with hypertension or cardiovascular disease. Desmopressin should not be prescribed to patients over the age of 65 for the treatment of nocturia associated with multiple sclerosis. Special Warnings and Precautions for Use: Desmospray® should only be used in patients where orally administered formulations are not suitable. Care in patients with cystic fibrosis and those with reduced renal function and/or cardiovascular disease. Patients should be warned to discontinue Desmospray® during an episode of vomiting and/or diarrhoea until their fluid balance is once again normal. When Desmospray® is used for the treatment of nocturia associated with multiple sclerosis, fluid intake must be limited from 1 hour before until 8 hours after administration. When Desmospray® is used in the treatment of nocturia, periodic assessments should be made of blood pressure and weight to monitor the possibility of fluid overload. When used for diagnostic purposes, fluid intake must be limited and not exceed 0.5 litres from 1 hour before until 8 hours after administration. Following diagnostic testing for diabetes insipidus or renal concentration capacity, 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. Precautions to prevent fluid overload must be taken in conditions characterised by fluid and/or electrolyte imbalance and patients at risk for increased intracranial pressure Renal concentration capacity testing in children below the age of 1 year should only be performed under carefully supervised conditions in hospital. Pregnancy and Lactation. Give with caution to pregnant patients and monitor blood pressure due to increased risk of pre-eclampsia. Side Effects: Prescribers should consult the summary of product characteristics in relation to other side-effects. Headache, stomach pain and nausea, nasal congestion, rhinitis and epistaxis. Isolated cases of allergic skin reactions and more severe general allergic reactions. Very rare cases of emotional disturbances in children. Treatment with Desmopressin without concomitant reduction of fluid intake may lead to fluid retention, hyponatraemia and in more serious cases, convulsions. Special Precautions for Storage: Store at room temperature (up to 25oC) and protect from light. Nature and Contents of Container: Amber glass vial fitted with a snap-on tamper-proof pre-compression pump spray device, to which a 20mm nasal adaptor is attached. Bottle contains 6ml desmopressin acetate solution which gives 60 sprays. Basic NHS Price: £25.02 for 6ml (60 x 0.1ml sprays). Legal Category: POM. Marketing Authorisation Number: PL 3194/0024. Marketing Authorisation Holder: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS. Date of Revision of prescribing information: May 2011. Desmospray is a registered trade mark.
