DESMOPRESSIN Nasal spray, solution Ref.[2729] Active ingredients: Desmopressin

Desmopressin should be used 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). The use of desmopressin in patients with renal impairments may theoretically increase the risk of water retention and hyponatraemia.

Desmopressin should be used with caution in pregnant women.

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.

In particular, infants and elderly patients (depending on their general health) are at increased risk of water and electrolyte imbalance.

As a precautionary measure 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 some evidence from post-marketing data 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.

The risk of water intoxication and hyponatraemia can also 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 (see Section 4.5).

It is important to monitor body weight and blood pressure during therapy with Desmopressin Spray. An increase in body weight may be due to overdosage or, more often, 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 as much as possible and the administration of desmopressin should be discontinued.

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.

When Desmopressin Spray is used for diagnostic testing purposes fluid intake should be limited to 500 ml from 1 hour before to 8 hours after administration.

Renal concentration capacity testing in infants below the age of 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.

Clofibrate, chlorpromazine, carbamazepine, tricyclic anti-depressants, serotonin reuptake inhibitors and non steroidal antiinflammatory 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.

Desmopressin may enhance the effect of antihypotensive and attenuate the effect of antihypertensive medicinal products.

Pregnancy

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. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.

Caution should be exercised 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 (300 micrograms intranasally) indicate that the amounts of Desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis.

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.

The following undesirable effects of desmopressin were recorded from clinical studies and postmarketing experience. Adverse reactions are listed according to the following categories:

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, including isolated reports

Nervous system disorder

Uncommon: headache

Rare: cerebral oedema

Very rare: emotional disturbance in case of nocturnal enuresis

Eye disorders

Common: conjunctivitis

Respiratory, thoracic and mediastinal disorders

Uncommon: nasal congestion, epistaxis, rhinitis

Gastrointestinal disorders

Uncommon: nausea, abdominal cramps, vomiting

General disorders and administration site conditions

Common: asthenia

Very rare: allergic and hypersensitivity reactions (e.g. pruritus, exanthema, fever, bronchospasms, anaphylaxis).

Metabolism disorders

Rare: hyponatraemia

Cardiovascular/Vascular disorders

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.

These adverse effects, except for allergic reactions, may be prevented or disappear if the desmopressin dose is reduced.

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. Healthcare professionals are asked to report any suspected adverse reactions via the YellowCard Scheme (website: www.mhra.gov.uk/yellowcard).

Not applicable.