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DDAVP DESMOPRESSIN Solution for injection (2011)

Active ingredients: Desmopressin

Therapeutic indications

DDAVP/Desmopressin Injection is indicated as follows :

  1. Diagnosis and treatment of cranial diabetes insipidus.
  2. To increase Factor VIII:C and Factor VIII:Ag in patients with mild to moderate haemophilia or von Willebrand’s disease undergoing surgery or following trauma.
  3. To establish renal concentration capacity.
  4. To treat headache resulting from a lumbar puncture.
  5. To test for fibrinolytic response.

Posology and method of administration

Treatment of Cranial Diabetes Insipidus

By subcutaneous, intramuscular or intravenous injection.

Adults: The usual dose is 1 to 4 micrograms given once daily.

Children and infants: Doses from 0.4 micrograms (0.1ml) may be used.

Diagnosis of Cranial Diabetes Insipidus

The diagnostic dose in adults and children is 2 micrograms given by subcutaneous or intramuscular injection. Failure to elaborate a concentrated urine after water deprivation, followed by the ability to do so after the administration of Desmopressin confirms a diagnosis of cranial diabetes insipidus. Failure to concentrate after the administration suggests nephrogenic diabetes insipidus.

Mild to moderate haemophilia and von Willebrand’s disease

By intravenous administration.

The dose for adults, children and infants is 0.4 micrograms per kilogram body weight administered by intravenous infusion. Further doses may be administered at 12 hourly intervals so long as cover is required. As some patients have shown a diminishing response to successive doses, it is recommended that monitoring of Factor VIII levels should continue. The dose should be diluted in 50ml of 0.9% sodium chloride for injection and given over 20 minutes. This dose should be given immediately prior to surgery or following trauma. During administration of intravenous Desmopressin, vasodilation may occur resulting in decreased blood pressure and tachycardia with facial flushing in some patients.

Increase of Factor VIII levels are dependent on basal levels and are normally between 2 and 5 times the pre-treatment levels. If results from a previous administration of Desmopressin are not available then blood should be taken pre-dose and 20 minutes post-dose for assay of Factor VIII levels in order to monitor response.

Unless contraindicated, when surgery is undertaken, tranexamic acid may be given orally at the recommended dose from 24 hours beforehand until healing is complete.

Renal Function Testing

By subcutaneous or intramuscular injection.

Adults and children can be expected to achieve urine concentrations above 700mOsm/kg in the period of 5 to 9 hours following a dose of 2 micrograms DDAVP/Desmopressin Injection. It is recommended that the bladder should be emptied at the time of administration.

In normal infants, a urine concentration of 600mOsm/kg should be achieved in the five hour period following a dose of 0.4 micrograms DDAVP/Desmopressin Injection. The fluid intake at the two meals following the administration should be restricted to 50% of the ordinary intake to avoid water overload.

Post Lumbar Puncture Headache

By subcutaneous or intramuscular injection.

Where a headache is thought to be due to a lumbar puncture, an adult patient can be given a dose of 4 micrograms DDAVP/Desmopressin Injection which may be repeated 24 hours later if necessary. Alternatively, a prophylactic dose of 4 micrograms can be given immediately prior to the lumbar puncture and repeated 24 hours later.

Fibrinolytic Response Testing

By intravenous administration.

The dose for adults and children is 0.4 micrograms per kilogram body weight administered by intravenous infusion. The dose should be diluted in 50ml of 0.9% sodium chloride for injection and given over 20 minutes.

A sample of venous blood should be taken 20 minutes after the infusion. In patients with a normal response the sample should show fibrinolytic activity of euglobulin clot precipitate on fibrin plates of at least 240mm².

Overdose

An overdose of DDAVP/Desmopressin injection leads to a prolonged duration of action with an increased risk of water retention and/or hyponatraemia.

Treatment

Although the treatment of hyponatraemia should be individualised, the following general recommendations can be given. Hyponatraemia is treated by discontinuing the desmopressin treatment, fluid restriction and symptomatic treatment if needed.

Shelf life

Shelf life of unopened ampoule: 48 months.

Special precautions for storage

To be stored in a refrigerator at 2°C to 8°C.

Nature and contents of container

Carton containing 10 × 1ml clear Type I glass ampoules. Each ampoule contains 1ml of a sterile, clear, colourless solution for injection.

Special precautions for disposal and other handling

As indicated under the posology and method of administration section.