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DDAVP DESMOPRESSIN Solution for injection (2011)

Active ingredients: Desmopressin

Contraindications

DDAVP/Desmopressin Injection is contraindicated in cases of:

GENERAL:

  • habitual and psychogenic polydipsia

RENAL FUNCTION TESTING, TREATMENT OF LUMBAR PUNCTURE HEADACHE OR FIBRINOLYTIC RESPONSE TESTING:

  • should not be carried out in patients with hypertension, heart disease, cardiac insufficiency and other conditions requiring treatment with diuretic agents

FOR HAEMOSTATIC USE:

  • unstable angina pectoris
  • decompensated cardiac insufficiency
  • von Willebrand’s Disease Type IIB where the administration of Desmopressin may result in pseudothrombocytopenia due to the release of clotting factors which cause platelet aggregation.

Special warnings and precautions for use

GENERAL

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.

When DDAVP/Desmopressin Injection is used for diagnostic purposes, fluid intake must be limited and not exceed 0.5 litres from 1 hour before until 8 hours after administration.

Renal concentration capacity testing in children below the age of 1 year should only be performed under carefully supervised conditions in hospital.

FOR HAEMOSTATIC USE

When repeated doses are used to control bleeding in haemophilia or von Willebrand’s disease, 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. 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 below 130mmol/l or plasma osmolality to below 270mOsm/kg, the fluid intake must be reduced drastically and the administration of DDAVP/Desmopressin Injection interrupted.

During infusion of DDAVP/Desmopressin Injection for haemostatic use, it is recommended that the patient’s blood pressure is monitored continuously.

DDAVP/Desmopressin Injection does not reduce prolonged bleeding time in thrombocytopenia.

Interaction with other medicinal products and other forms of interaction

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 water retention and/or hyponatraemia.

NSAIDs may induce water retention and/or hyponatraemia.

Pregnancy and lactation

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/fetal 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.

Lactation

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 or haemostasis.

Effects on ability to drive and use machines

None.

Undesirable effects

Side-effects include headache, stomach pain and nausea. 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.

Incompatibilities

None known.