DESMOPRESSIN

Posology Treatment of diabetes insipidus:

Dosage is individual in diabetes insipidus but the total daily sublingual dose normally lies in the range of 120 micrograms to 720 micrograms. A suitable starting dose in adults and children is 60 micrograms three times daily, administered sublingually.

This dosage regimen should then be adjusted in accordance with the patient's response. For the majority of patients, the maintenance dose is 60 micrograms to 120 micrograms sublingually three times daily.

Post-hypophysectomy polyuria/polydipsia:

The dose of desmopressin sublingual tablets should be controlled by measurement of urine osmolality. 4). 3). 2). 2 above). Dose recommendations are the same as in adults. Method of administration Sublingual use, place the tablet under the tongue where it dissolves without the need for water.

5).

The most serious adverse reaction with desmopressin is hyponatraemia, which is associated with headache, nausea, vomiting, decreased serum sodium, weight increase, malaise, abdominal pain, muscle cramps, dizziness, confusion, decreased consciousness and in severe cases convulsions and coma.

The cause of the potential hyponatraemia is the anticipated antidiuretic effect. The hyponatraemia is reversible and in children, it is often seen to occur in relation to changes in daily routines affecting fluid intake and/or perspiration.

4. Tabulated summary of adverse reactions The table below is based on the frequency of adverse drug reactions reported in clinical trials with oral desmopressin conducted in children and adolescents for the treatment of Primary Nocturnal Enuresis (PNE) (N = 1923).

9). 4). Anaphylactic reactions, Psychomotor hyperactivity and some Psychiatric reactions such as abnormal behaviour, emotional disorder, depression, hallucination & insomnia, have not been seen in clinical trials but spontaneous reports have been received.

In children, psychiatric disorders including affect lability, aggression, anxiety, mood swings & nightmare are generally reversed upon treatment discontinuation. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported.

4). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Special warnings:

Care should be taken with patients who have reduced renal function and/or cardiovascular disease or cystic fibrosis. In chronic renal disease, the antidiuretic effect of desmopressin sublingual lyophilisate would be less than normal.

Precautions Desmopressin should be used with caution in patients with conditions characterised by fluid and/or electrolyte imbalance. Precautions must be taken in patients at risk for increased intracranial pressure.

Information related to excipients:

This medicine contains less than 1 mmol sodium (23 mg) per sublingual lyophilisate, that is to say essentially ‘sodium-free’.

1 Known or suspected cardiac insufficiency and other conditions requiring treatment with diuretic agents. Desmopressin sublingual tablets should only be used in patients with normal blood pressure. Before prescribing Desmopressin, the diagnoses of habitual or psychogenic polydipsia (resulting in a urine production exceeding 40 ml/kg/24 hours) and alcohol abuse should be excluded.

Desmopressin should not be prescribed to patients over the age of 65 Moderate and severe renal insufficiency (creatinine clearance below 50ml/min) Known hyponatremia Syndrome of inappropriate ADH secretion (SIADH)