Minirin Dosage/Direction for Use

Tablet/Melt oral lyophilisate: General: The dose of MINIRIN is individually adapted. MINIRIN Melt 60 mcg is calculated to correspond to MINIRIN tablet 0.1 mg, and 120 mcg corresponds to 0.2 mg (see also Pharmacology: Pharmacokinetics under Actions).
Desmopressin should always be taken at the same time in relation to food intake, since food intake causes decreased absorption and by that also might influence the effect of desmopressin, see Interactions.
In the event of signs of water retention/hyponatraemia (headache, nausea/vomiting, weight gain, and in serious cases convulsions) the treatment should be temporarily interrupted until the patient has completely recovered. When the treatment is resumed strict fluid restriction is necessary, see Precautions.
Special Populations: Paediatric Population: MINIRIN is indicated in Central Diabetes Insipidus and Primary Nocturnal Enuresis (see indication specific information as follows and Pharmacology: Pharmacodynamics under Actions). Dose recommendations are the same as in adults.
Elderly: Treatment of nocturia should not be initiated in patients >65 years (see as follows).
Renal Impairment: see Contraindications.
Hepatic Impairment: see Interactions.
Tablet: Indication specific: Central diabetes insipidus: A suitable initial dose for children and adults is 0.1 mg 3 times daily. The dosage regimen is then adjusted in accordance with the patient's response. Clinical experience has shown, that the daily dose varies between 0.2 mg and 1.2 mg. For most patients, the maintenance dose is 0.1-0.2 mg 3 times daily. In the event of signs of water retention/hyponatraemia treatment should be temporarily interrupted and the dose should be adjusted.
Primary nocturnal enuresis: A suitable initial dose is 0.2 mg at bedtime. The dose may be increased up to 0.4 mg if the lower dose is not sufficiently effective. Fluid restriction shall be enforced. Evaluation of continued need of treatment should be carried out after three months by means of at least one treatment-free week.
Nocturia: In nocturic patients, a frequency/volume chart should be used to diagnose nocturnal polyuria for at least 2 days and nights before starting treatment. A night-time urine production exceeding the functional bladder capacity or exceeding 1/3 of the 24-hour urine production is regarded as nocturnal polyuria.
The recommended initial dose is 0.1 mg at bedtime. If this dose is not sufficiently effective after one week, the dose may be increased up to 0.2 mg and subsequently 0.4 mg by weekly dose escalations. Fluid restriction should be enforced.
Treatment should not be initiated in the elderly (65 years of age and over). Should treatment of these patients be considered, serum sodium should be measured before beginning of treatment and after 3 days of treatment. The same applies at increase in dosage and other occasions during treatment as deemed necessary by the treating physician, see Precautions.
If adequate clinical effect is not achieved within 4 weeks following appropriate dose titration the treatment should be discontinued.
Melt oral lyophilisate: Indication specific: Central diabetes insipidus: A suitable initial dose for children and adults is 60 mcg 3 times daily, administered sublingually. The dosage regimen is then adjusted in accordance with the patient's response. Clinical experience has shown, that the daily dose varies between 120 mcg and 720 mcg sublingually. For most patients, the maintenance dose is 60 mcg to 120 mcg sublingually 3 times daily. In the event of signs of water retention/hyponatraemia treatment should be temporarily interrupted and the dose should be adjusted.
Primary nocturnal enuresis: A suitable initial dose is 120 mcg at bedtime, administered sublingually. The dose may be increased up to 240 mcg sublingually if the lower dose is not sufficiently effective. Fluid restriction shall be enforced. Evaluation of continued need of treatment should be carried out after three months by means of at least one treatment-free week.
Nocturia: In nocturic patients, a frequency/volume chart should be used to diagnose nocturnal polyuria for at least 2 days and nights before starting treatment. A night-time urine production exceeding the functional bladder capacity or exceeding 1/3 of the 24-hour urine production is regarded as nocturnal polyuria.
The recommended initial dose is 60 mcg at bedtime, administered sublingually. If this dose is not sufficiently effective after one week, the dose may be increased up to 120 mcg sublingually and subsequently 240 mcg sublingually by weekly dose escalations. Fluid restriction should be enforced.
Treatment should not be initiated in the elderly (65 years of age and over). Should treatment of these patients be considered, serum sodium should be measured before beginning of treatment and after 3 days of treatment. The same applies at increase in dosage and other occasions during treatment as deemed necessary by the treating physician, see Precautions.
If adequate clinical effect is not achieved within 4 weeks following appropriate dose titration the treatment should be discontinued.
Administration: MINIRIN Melt is placed under the tongue where it is dissolved without water.
Solution for injection: Central diabetes insipidus: The injection may be used when the intranasal administration is considered unsuitable. Individual dosage is determined after testing of the effect on urine osmolality and diuresis at dose levels. In the event of signs of water retention/hyponatremia treatment should be interrupted and the dose should be adjusted.
Normal dosage, intravenous injection: Adults 1-4 µg (0,25-1 ml) 1-2 times daily. Children above the age of 1 year 0,4-1 µg (0,1-0,25ml) 1-2 times daily. Children below the age of 1 year 0,2-0,4 µg (0,05-0,1 ml) 1-2 times daily.
For patients who have been controlled on intranasal MINIRIN and who must be switched to the injection form, either because of poor intranasal absorption, or because of the need for surgery, the comparable antidiuretic dose of the injection is about 10% of the intranasal dose.
Renal concentrating capacity test: Normal adult dose by intramuscular or subcutaneous injection is 4 µg (1ml). For children over 12 months of age the dose is 1 to 2 µg (0,25 to 0,5ml). For children under 12 months the dose is 0,4 µg (0,1 ml). For children it is recommended to use primarily the intranasal presentation.
After administration of MINIRIN, possible urine within 1 hour is discarded. During the next 8 hours 2 portions of urine are collected for measurement of osmolality. A restricted water intake must be observed, see also under Precautions.
The reference level for normal urine osmolality after MINIRIN administration is 800 mOsm/kg for most patients. With values under this level, the test should be repeated. A repeated low result indicates an impaired ability to concentrate urine and the patient should be referred for further examination into the underlying cause of the malfunction.
Haemophilia A and von Willebrand's Disease: MINIRIN injection is administered as an intravenous infusion at a dose of 0,3 µg/kg bodyweight diluted in sterile physiological saline and infused slowly over 15-30 minutes. In adults and children weighing 10 kg or more, 50 ml of diluent is used; in children weighing 10 kg or less, 10 ml of diluent is used.
If a positive effect is obtained, the initial MINIRIN dose may be repeated 1-2 times with intervals of 6-12 hours. Further repetition of the dose may result in a reduced effect.
In patients with haemophilia the desired increase of VIII:C is appraised by the same criterion as in the treatment with factor VIII-concentrate. The VIII:C-concentration must be followed up regularly since in a few cases the effect has been seen to decrease with repeated doses. If the MINIRIN-infusion does not lead to the desired increase of the VIII:C-concentration in plasma, the treatment may be complemented with a supply of factor VIII-concentrate. The treatment of patients with haemophilia should be conducted in consultation with each patient's coagulation laboratory.
Determination of the coagulation factor and bleeding time before MINIRIN-treatment.
Plasma levels of VIII:C and vWF:Ag increase substantially after desmopressin administration. However, it has not been possible to establish any correlation between the plasma concentration of these factors and the bleeding time, either before or after desmopressin. The effect of desmopressin on the bleeding time should therefore, if possible, be tested in the individual patient.
The bleeding time test should be as standardized as possible, e.g. with the use of Simplate II. Determination of bleeding time and plasma levels of the coagulation factors should be conducted in cooperation or consultation with a coagulation laboratory.