OCTIM Nasal spray Ref.[27954] Active ingredients: Desmopressin

Precautions to prevent fluid overload must be taken in:

• conditions characterised by fluid and/or electrolyte imbalance
• patients at risk for increased intracranial pressure.

Care should be taken with patients who have reduced renal function and or cardiovascular disease or cystic fibrosis.

When repeated doses are used to control bleeding in haemophilia or von Willebrand’s disease, care should be taken to prevent fluid overload. Patients should only take as much fluid as they require to satisfy thirst. Intravenous infusions should not be left up as a routine after surgery. Fluid accumulation can be readily monitored by weighing the patient or by determining plasma sodium or osmolality.

Measures to prevent fluid overload must be taken in patients with conditions requiring treatment with diuretic agents.

Special attention must be paid to the risk of water retention. The fluid intake should be restricted to the least possible and the body weight should be checked regularly.

If there is a gradual increase of the body weight, decrease of serum sodium to 130mmol/l or plasma osmolality to below 270mOsm/kg, the fluid intake must be reduced drastically and the administration of OCTIM Nasal Spray interrupted.

OCTIM Nasal Spray does not reduce prolonged bleeding time in thrombocytopenia.

Indomethacin may augment the magnitude but not the duration of response to desmopressin.

Substances which are known to release antidiuretic hormone e.g. tricyclic antidepressants, chlorpromazine and carbamazepine, may cause an additive antidiuretic effect and increase the risk of water retention.

Pregnancy

OCTIM Nasal Spray should be given with caution to pregnant patients, although the oxytocic effect of desmopressin is very low.

Reproduction studies performed in rats and rabbits with doses of more than 100 times the human dose have revealed no evidence of a harmful action of desmopressin on the fetus. There have been rare reports of malformations in children born to mothers treated for diabetes insipidus during pregnancy. However, a review of available data suggests no increase in the rate of malformations in children exposed to desmopressin throughout pregnancy.

Lactation

Results from analyses of milk from nursing mothers receiving 300 micrograms desmopressin intranasally indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis or haemostasis.

None.

Side-effects include headache, stomach pain, nausea, nasal congestion, rhinitis and epistaxis. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported. Very rare cases of emotional disorders including aggression in children have been reported. Treatment with desmopressin without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with accompanying symptoms of headache, nausea, vomiting, weight gain, decreased serum sodium and in serious cases, convulsions.

Not applicable.