Adverse events should be reported. Reporting forms and information can be found at: yellowcard.mhra.gov.uk. Adverse events should also be reported to Aspire Pharma Ltd on +44 (0)1730 231148.
Desmopressin Spray 10 micrograms/dose Nasal Spray solution Prescribing Information
(please refer to the full SmPC before prescribing)
Indications: Treatment of vasopressin-sensitive central diabetes insipidus. Diagnostic test of the renal concentrating capacity. Dosage and method of administration: 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. Vasopressin-sensitive central diabetes insipidus: Adults daily dose: 10–20 micrograms (1 – 2 sprays). Children and Adolescents <18 years: 5–10 micrograms (1 spray). 5 micrograms cannot be administered with desmopressin spray; another medicinal desmopressin product should be used. The daily dose should be divided into 1 – 2 doses (in the morning and if required at bedtime). Dose can be increased 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). Optimal dosage must be established individually based on measurements of urine volume and osmolality. Treatment aims for a normal water balance and an adequate duration of sleep. Diagnostic test of renal concentrating capacity: <10 kg: 10 micrograms. 10-30 kg: 20 micrograms. 30-50 kg: 30 micrograms. >50 kg: 40 micrograms. Preferably carry the test out in the morning. Restrict fluid intake from 1 hour before to 8 hours after administration of the medicinal product. Children <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 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. Renal concentrating capacity is determined by comparing the higher value to baseline 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. Contraindications: Hypersensitivity to desmopressin or any of the excipients. Primary polydipsia and polydipsia due to alcohol abuse. Hyponatraemia or risk of developing hyponatraemia. Cardiac insufficiency and other conditions requiring treatment with diuretic agents. Syndrome of inappropriate secretion of antidiuretic hormone, because this syndrome is associated with dilutional hyponatraemia. Polyuria without objective diagnostic of central diabetes insipidus. Von Willebrand disease Type IIb. Thrombotic thrombocytopenic purpura (TTP). Special warnings and precautions for use: Use with caution in patients with coronary heart disease, hypertension and severe hypertension or fluid and electrolyte imbalance (such as patients with renal impairment or cystic fibrosis patients). Use in patients with renal impairments may theoretically increase risk of water retention and hyponatraemia. Desmopressin therapy without concomitant adjustment of fluid intake may lead to fluid retention and hyponatraemia, accompanied by symptoms such as weight gain, headache, nausea and oedema. In severe cases cerebral oedema, convulsions and coma may occur. Infants and elderly patients are at increased risk of water and electrolyte imbalance. As a precaution to prevent hyperhydration and hypo-natremia, fluid intake should be reduced in conditions characterised by fluid and electrolyte imbalance or by increased intracranial pressure. There is evidence for the occurrence of severe hyponatraemia in association with the nasal spray formulation of desmopressin, when it is used in the treatment of cranial diabetes insipidus. Risk of water intoxication and hyponatraemia can be minimised by keeping to the recommended starting doses and by avoiding concomitant use of medicinal products which may increase the antidiuretic effect of desmopressin. Monitor body weight and blood pressure during therapy. Increase in body weight may be due to overdosage or due to increased fluid intake. In case of weight increase or plasma sodium level <130mmol/L or plasma osmolality < 270mOsm/kg: the fluid intake should be limited and discontinue administration of desmopressin. 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; fluid intake should be limited to 500 ml from 1 hour before to 8 hours after administration. Renal concentration capacity testing in infants < 1 year should only be performed under carefully supervised conditions in hospital. Absorption may be irregular in patients with oedema, scarring or other abnormal conditions of the nasal mucosa. Interactions: Clofibrate, chlorpromazine, carbamazepine, tricyclic antidepressants, serotonin reuptake inhibitors and non-steroidal anti-inflammatory medicinal products (NSAIDs) may enhance the antidiuretic effect of desmopressin thus increasing the risk of water intoxication and hyponatraemia. Glibenclamide and lithium may attenuate the antidiuretic effect of desmopressin. May enhance the effect of antihypotensive and attenuate the effect of antihypertensive medicinal products. Pregnancy and lactation: Data on a limited number (n = 53) of exposed pregnancies in women with diabetes insipidus indicate rare cases of malformations in children treated during pregnancy. Exercise caution when prescribing to pregnant women. Blood pressure monitoring is recommended due to the increased risk of pre-eclampsia. Breast-feeding: Results from analyses of milk from nursing mothers receiving high dose Desmopressin indicate that the amounts of Desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis. Effects on ability to drive and use machines: No studies on the effect of Desmopressin Spray on the ability to drive and use machines have been performed. Desmopressin has no known effect on the ability to drive and use machines. Side effects: For full list of side effects consult SmPC. ‘Common’ and ‘serious side effects included in this prescribing information. Common (>1/100 < 1/100): Conjunctivitis, asthenia. Rare serious (> 1/ 10,000 < 1/1,000): Cerebral oedema, hyponatraemia. Very rare serious (< 1/10,000, including isolated reports): allergic and hypersensitivity reactions (e.g. bronchospasms, anaphylaxis). Due to increased water reabsorption blood pressure may rise and in some cases hypertension may develop. In patients with coronary heart disease angina pectoris may occur. Overdose: An overdose prolongs the antidiuretic effect and subsequently increases the risk of hyperhydration. 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. MA number: PL 35533/0145. Cost: £35.25 (60 dose). MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG. Legal category: POM. Version number: MAT-UK-DES-0001-1 | March 2026.
MAT-UK-COR-0087-1 | March 2026
