Minirin Dosage/Direction for Use

General: The dose of MINIRIN Oral Lyophilisate is individually adapted. MINIRIN Oral Lyophilisate 60 mcg is calculated to correspond to MINIRIN tablet 0.1 mg, and 120 mcg corresponds to 0.2 mg (see 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.
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. In the event of signs or symptoms of water retention and/or hyponatraemia the treatment should be interrupted until the patient has completely recovered. When the treatment is resumed strict fluid restriction is necessary, see Precautions. 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. In the event of signs or symptoms of water retention and/or hyponatraemia the treatment should be interrupted until the patient has completely recovered. When the treatment is resumed strict fluid restriction is necessary, see Precautions.
If adequate clinical effect is not achieved within 4 weeks following appropriate dose titration the treatment should be discontinued.
Special Populations: Paediatric Population: MINIRIN Oral Lyophilisate is indicated in Central Diabetes Insipidus and Primary Nocturnal Enuresis (see Pharmacology: Pharmacodynamics under Actions and indication specific information as previously mentioned). Dose recommendations are the same as in adults.
Elderly: Treatment of nocturia should not be initiated in patients >65 years (see dosage as previously mentioned).
Renal Impairment: see Contraindications.
Hepatic Impairment: see Interactions.
Administration: MINIRIN Oral Lyophilisate is placed under the tongue where it is dissolved without water.