The only licensed desmopressin oral solution
Abridged Prescribing Information
Product name : Demovo 360mcg / ml oral solution
Composition : Each ml of the oral solution contains 360 micrograms of anhydrous and acetic-free desmopressin , equivalent to 400 micrograms of desmopressin acetate . Other excipients ( per ml ): Sodium methyl parahydroxybenzoate ( E-219 ): 2.1 mg / ml . Sodium propyl parahydroxybenzoate ( E-217 ): 0.22 mg / ml .
Therapeutic Indication : Treatment of central diabetes insipidus . Treatment of primary nocturnal enuresis in patients ( over 5 years of age ) with normal ability to concentrate urine .
Posology : Treatment of central diabetes insipidus : A suitable starting dose in adults and children is 90 mcg ( 0.25 ml ) three times daily . The dosage is individually adjusted but clinical experience has demonstrated that the total daily dose normally lies in the range from 180 mcg ( 0.5 ml ) to 1080 mcg ( 3 ml ) of desmopressin . Thereafter , this dosage regimen should then be adjusted in accordance with the patient ’ s response . In most patients , the maintenance dose is 90-180 mcg ( 0.25 – 0.5 ml ) three times daily . If symptoms of fluid retention and / or hyponatremia appear ( headache , nausea , vomiting , weight gain , and , in severe cases , seizures ), the treatment should be discontinued and the dose of desmopressin should be readjusted .
Primary nocturnal enuresis : Adults and Children above the age of 5 . The appropriate starting dose is 180 mcg ( 0.5 ml ) of desmopressin at bedtime . The dose may be increased up to 360 mcg ( 1 ml ) if the lower dose is not effective enough . Desmopressin 360 micrograms / ml oral solution is recommended for treatment periods of 3 months . In connection with long-term treatment , a treatment free period of at least one week should be introduced every three months to assess whether spontaneous healing has occurred . Fluid intake should be controlled . If symptoms or signs of fluid retention and / or hyponatremia appear ( headache , nausea , vomiting , weight gain , and , in severe cases , seizures ), the treatment should be discontinued until the patient has recovered . Once treatment is reinstated , fluid intake should be tightly controlled If the desired clinical effect is not achieved after 4 weeks of dose titration , treatment should be discontinued .
Elderly ( ≥65 years of age ): Treatment should be followed closely due to the increased risk of hyponatremia . Serum sodium should be measured at baseline , three days after onset of treatment or at any dose increase and regularly during prolonged therapy .
Method of Administration : Desmopressin 360 micrograms / ml oral solution is for oral use
Contraindications : Hypersensitivity to the active substance or to any of the excipients . Psychogenic or habitual polydipsia . Known or suspected history of cardiac insufficiency . Hyponatraemia or predisposition to hyponatraemia . Conditions requiring concomitant treatment with diuretic agents . Moderate or severe renal failure ( creatinine clearance < 50 ml / min ). Uncontrolled blood pressure . Syndrome of inadequate ADH Production ( SIADH ).
Special warnings and precautions : Warnings : In the case of primary nocturnal enuresis , fluid intake should be limited from 1 hour before administration until the next morning ( at least 8 hours ). Treatment without concomitant reduction in water intake may result in fluid retention and / or hyponatraemia with or without warning symptoms and signs . It is therefore recommended that this danger be pointed out to patients , in particular elderly patients and the parents of young children . Cerebral oedema has repeatedly been reported in children and young adults treated with desmopressin for nocturnal enuresis .
During treatment with desmopressin , body weight , serum sodium and / or blood pressure may have to be monitored . Care should be taken in patients with reduced renal function and / or cardiovascular disease . In chronic renal disease the antidiuretic effect of Desmopressin 360 micrograms / ml oral solution may be less than usual . Warnings of excipients : Contains sodium methyl ( E-219 ) and sodium propyl ( E-217 ) parahydroxybenzoate which may cause allergic reactions ( possibly delayed ).
Precautions for use : Precautions to prevent hyponatremia should be taken in : conditions characterised by fluid and / or electrolyte imbalance , such as systemic infections , fever , gastroenteritis , and SIADH ( syndrome of inappropriate secretion of ADH ); concomitant treatment with drugs known to induce SIADH , such as tricyclic antidepressants , selective inhibitors of serotonin reuptake , chlorpromazine and carbamazepine ; concomitant treatment with non steroidal anti-inflammatory drugs ( NSAIDs ). Desmopressin should be used with caution , and the dose should be adjusted on the basis of the plasma osmolality , in patients with cystic fibrosis . Serious bladder dysfunction and outlet obstruction should be considered before onset of treatment . In patients with urge incontinence , organic causes of increased frequency of micturition or nocturia ( e . g . benign prostatic hyperplasia ( BPH ), urinary tract infection , bladder stones / tumours , bladder sphincter disorders ), polydipsia and inadequately controlled diabetes mellitus , the specific cause of the problem should primarily be treated or excluded . Older people and patients with low serum sodium may have an increased risk of hyponatraemia .
Interactions : Substances which are known to induce SIADH e . g . tricyclic antidepressants , selective serotonin re-uptake inhibitors , chlorpromazine and carbamazepine , may cause an additive antidiuretic effect leading to an increased risk of fluid retention and / or hyponatraemia . NSAIDs may induce fluid retention and / or hyponatraemia . Concomitant treatment with loperamide may result in a 3-fold increase of desmopressin plasma concentrations , which may lead to an increased risk of water retention and / or hyponatraemia . Concomitant treatment with diuretic agents is contraindicated . Concomitant treatment with dimeticone may reduce the absorption of desmopressin . A standardised 27 % greasy meal decreased the absorption of desmopressin ( rate and extent ) but no significant effect on the pharmacodynamics ( urine production and osmolality ) was observed . There is the potential for this to occur at lower doses . If a diminution of effect is noted , then the effect of food should be considered before increasing the dose .
Pregnancy & Lactation : Pregnancy : There is a limited amount of data from the use of desmopressin in pregnant women . Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity . Reproductive studies performed in animals at doses 100 higher than that recommended in humans did not reveal harmful evidence of desmopressin on foetuses . Data on a limited number of exposed pregnancies in women treated with desmopressin during pregnancy indicate rare cases of malformations in children . Nonetheless , a review of available data did not suggest an increase of malformations in children exposed to desmopressin during pregnancy . To date , no other relevant epidemiological data are available . Caution should be exercised when prescribing to pregnant women . Blood pressure monitoring is recommended due to the increased risk of pre-eclampsia . The physician should weigh the possible therapeutic advantages against the possible risk in each case . Lactation : Results from analyses of milk from nursing mothers receiving high dose desmopressin ( 300 micrograms intranasally ) indicate that the amounts of desmopressin which may be transferred to the infant are considerably lower than the amounts required to influence diuresis . A decision must be made whether to discontinue
breast-feeding or to discontinue / abstain from Desmopressin 360 micrograms / ml oral solution therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman . Fertility : No fertility data available .
Undesirable effects : Treatment without concomitant restriction of fluid intake may result in fluid restriction / hyponatraemia with or without concurrent warning signs or symptoms . The frequency of adverse events listed below is defined using the following convention : very common ( ≥ 1 / 10 ); common ( ≥ 1 / 100 , < 1 / 10 ); uncommon ( ≥ 1 / 1,000 , < 1 / 100 ); rare ( ≥ 1 / 10,000 , < 1 / 1,000 ); very rare (< 1 / 10,000 ); not known ( cannot be estimated from the available data ). Common : Headache , stomach pain and nausea . Very rare : Allergic skin reactions , Emotional disturbances , Hyponatraemia . Not known : Allergic reactions .
NHS price : Amber glass bottle and 1.5ml syringe : 15ml : £ 19.95 Legal classification : POM Marketing Authorisation Holder : ALTURiX Ltd , 287 Upper Fourth Street , Milton Keynes , MK9 1EH MA number : PL 44490 / 0008 Date of revision of the text : March 2023 Job Code : DM005
Reporting adverse effects : Adverse events should be reported . Reporting forms and information can be found at https :// yellowcard . mhra . gov . uk or search for MHRA Yellow Card in the Google Play or Apple App Store . Adverse events should also be reported to Alturix Limited at safety @ alturix . com and + 44 ( 0 ) 1908 038 083