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Presentation

Nasal spray solution containing desmopressin acetate hydrate.

Drugs List

  • desmopressin 10microgram nasal spray
  • Therapeutic Indications

    Uses

    Diabetes insipidus
    Nocturia associated with multiple sclerosis (after other therapy failed)
    Renal function testing

    Dosage

    Diagnosis of cranial diabetes insipidus
    When used for diagnostic purposes, fluid intake must be limited, not exceeding 500ml from 1 hour before administration and for 8 hours after.

    Failure to elaborate a concentrated urine after water deprivation, followed by the ability to do so after the administration of desmopressin, confirms the diagnosis of cranial diabetes insipidus.
    Failure to concentrate urine after the administration suggests nephrogenic diabetes insipidus.

    Renal function testing
    Adults and children over 1 year with normal renal function are expected to achieve urine concentrations above 700 mOsm/kg 5 to 9 hours following the administration.

    Adults

    Diagnosis of cranial diabetes insipidus
    2 sprays (20 micrograms).

    Treatment of cranial diabetes insipidus
    Dosage is individual but average maintenance dose is 1 to 2 sprays intranasally (10 to 20 micrograms) once to twice daily. If a dose of 2 sprays is required, this should be as 1 spray into each nostril.

    Nocturia associated with multiple sclerosis
    In patients with normal renal function the dose is 1 to 2 sprays intranasally (10 to 20 micrograms) at bedtime. Not more than 1 dose should be used in any 24 hour period. If a dose of 2 sprays is required, this should be as 1 spray into each nostril.

    Renal function testing
    2 sprays into each nostril (a total of 40 micrograms).
    The bladder must be empty at time of administration and fluid intake must be limited, not exceeding 500ml from 1 hour before administration and for 8 hours after.

    Children

    Diagnosis of cranial diabetes insipidus
    2 sprays (20 micrograms).

    The following alternative dosing schedule may be suitable:
    Children aged 12 to 18 years: 2 sprays (20 micrograms) as a single dose.
    Children aged 2 to 12 years: 1 to 2 sprays (10 to 20 micrograms) as a single dose.
    Children aged 1 month to 2 years: 5 to 10 micrograms as a single dose (not usually recommended).

    Treatment of cranial diabetes insipidus
    Dosage is individual but average maintenance dose is 1 to 2 sprays intranasally (10 to 20 micrograms) once to twice daily. If a dose of 2 sprays is required, this should be as 1 spray into each nostril.

    The following alternative dosing schedule via the intranasal route may be suitable:
    Children aged 12 to 18 years: Initially 10 to 20 micrograms once to twice daily, adjusted according to response.
    Children aged 2 to 12 years: Initially 5 to 20 micrograms once to twice daily, adjusted according to response.
    Children aged 1 month to 2 years: Initially 2.5 to 5 micrograms once to twice daily, adjusted according to response.

    Renal function testing
    Child 15 to 18 years: 2 sprays into each nostril (a total of 40 micrograms).

    Child 1 to 15 years1 spray into each nostril (a total of 20 micrograms).

    Infants to 1 year:1 spray (10 micrograms).
    Infants with normal renal function can be expected to achieve a urine concentration of 600 mOsm/kg in the 5 hour period following the administration. Restrict fluid intake to 50% of normal intake at the two feeds/meals following administration to avoid water overload.



    Contraindications

    Alcoholism
    Cardiac impairment
    Hyponatraemia
    Management of nocturia in Multiple Sclerosis in patients over 65 years
    Psychogenic polydipsia
    Renal impairment - creatinine clearance below 50ml/minute
    Treatment of nocturia in Multiple Sclerosis with cardiovascular disorder

    Precautions and Warnings

    Disorders aggravated by fluid retention
    Elderly
    Cardiovascular disorder
    Cystic fibrosis
    Hypertension
    Pregnancy
    Raised intracranial pressure

    Absorption may be irregular in patients with abnormal nasal mucosa
    Not for treatment of von Willebrand's disease type 2B
    Limit fluid intake from 1 hour before to 8 hours after treatment
    Not suitable for delivering doses less than 10 micrograms
    Diagnostic testing: prevent fluid overload
    Monitor fluid and electrolyte status
    Monitor weight and blood pressure
    Renal function testing for infants under 1 should be supervised in hospital
    Suspend dose if vomiting/diarrhoea occurs until fluid/electrolytes normal
    Advise patient not to take NSAIDs unless advised by clinician
    Advise patients to avoid excessive fluid intake

    Hyponatraemic convulsions
    The CSM has advised that patients being treated for primary nocturnal enuresis should be warned to avoid fluid overload (including during swimming) and to stop taking desmopressin during an episode of vomiting and diarrhoea (until fluid balance normal).
    The risk of hyponatraemic convulsions can also be minimised by keeping to the recommended starting doses and by avoiding concomitant use of drugs which increase secretion of vasopressin (e.g. tricyclic antidepressants).

    (The nasal spray is not indicated for this use as an increased incidence of adverse events has been reported)

    Pregnancy and Lactation

    Pregnancy

    Desmopressin should be given with caution during pregnancy, although the oxytocic effect of desmopressin is very low.

    Data from a limited number of pregnant women being treated with desmopressin for diabetes insipidus, indicate rare cases of malformation in children treated during pregnancy. No other epidemiological data is available. Blood pressure monitoring is recommended due to the increased risk of pre-eclampsia.

    Animal studies have not shown any direct or indirect effects relating to pregnancy, embryonic/foetal development, delivery or postnatal development.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 micrograms intranasally) indicated that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Counselling

    Advise patients receiving desmopressin treatment to avoid fluid overload (including during swimming) and to stop taking desmopressin during an episode of vomiting and diarrhoea (until fluid balance normal).

    Advise patients on the need to restrict fluid intake 1 hour before and for 8 hours after administration for diagnostic tests and nocturnal enuresis in multiple sclerosis.

    Ensure that patients are aware of the correct use of the product, and, in particular, that they should discharge the spray to waste until a consistent spray is seen (about 5 sprays on first use of a new spray).

    Advise patient to avoid taking NSAIDs concurrently with this medication as these may induce water retention and/ or hyponatraemia.

    Side Effects

    Aggression in children
    Allergic reaction
    Allergic skin reactions
    Behavioural disturbances (children)
    Epistaxis
    Fluid retention
    Headache
    Hyponatraemia
    Hyponatraemic convulsions
    Nasal congestion
    Nausea
    Rhinitis
    Stomach pain
    Vomiting
    Weight gain

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: April 2013

    Reference Sources

    Summary of Product Characteristics: Desmopressin nasal spray 10mcg/dose. Actavis UK Ltd. Revised July 2015.

    Summary of Product Characteristics: Desmospray, Desmopressin Nasal Spray. Ferring Pharmaceuticals Ltd. Revised June 2011.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 August 2017

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