Minirin Dosage/Direction for Use

Tablet: General: Optimal dose of MINIRIN tablets is individually adjusted.
Effect of food: Food intake may reduce the intensity and duration of the antidiuretic effect at low doses of desmopressin (see Interactions).
In the event of signs or symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions) treatment should be interrupted until the patient has fully recovered. When restarting treatment strict fluid restriction should be enforced (see Precautions).
If adequate clinical effect is not achieved within 4 weeks following appropriate dose titration the medication should be discontinued.
Indication Specific: Central diabetes insipidus: A suitable initial dose for children and adults is 0.1 mg three times daily. The dose is then adjusted according to the response of the patient. According to clinical experience gained so far, the daily dose lies in the range of 0.2 mg and 1.2 mg. For most patients, 0.1-0.2 mg three times daily is the optimal dose regimen.
In the event of signs of water retention/hyponatremia treatment should be 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. The need for continued treatment should be reassessed after 3 months by means of a period of at least 1 week without MINIRIN treatment. Fluid restriction should be observed.
Tablet & Oral lyophilisate: Special Populations: Elderly: The initiation of treatment in patients >65 years is not recommended. Should physicians decide to initiate desmopressin treatment in these patients then serum sodium should be measured before beginning the treatment and 3 days after initiation or increase in dosage and at other times during treatment as deemed necessary by the treating physician.
Paediatric Population: MINIRIN 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.
Tablet, Oral lyophilisate & Nasal spray: Renal Impairment: see Contraindications.
Hepatic Impairment: see Interactions.
Nasal spray: 1 dose of the spray provides 0.1 ml, which corresponds to 10 μg desmopressin acetate.
MINIRIN nasal formulations should be used only when treatment with oral formulations is inappropriate and always start at the lowest dose (see Precautions).
Fluid restriction should be observed (see Indication Specific instructions in Precautions).
If signs of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain and in serious cases convulsions) develop, treatment should be discontinued until the patient has recovered completely. Fluid intake should be strictly limited when treatment is reinstated (see Precautions).
Elderly: See Precautions.
Paediatric Population: MINIRIN is indicated in children with central diabetes insipidus and for testing of renal concentration capacity, see Precautions & Adverse Reactions.
Central diabetes insipidus: Oral lyophilisate: Dosage is individual in diabetes insipidus but the total daily sublingual dose normally lies in the range of 120-720 mcg.
Adults and Children: Starting dose: 60 mcg 3 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 60-120 mcg 3 times daily.
Injection: The injection may be used when the intranasal or oral administration is considered unsuitable. Individual dosage is determined after testing of the effect on urine osmolality and diuresis at different dose levels. In the event of signs of water retention/hyponatraemia 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 (0.1-0.25 ml) 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.
Nasal spray: Dosage is individual but clinical experience has shown that the normal daily dose for adults is 10-20 μg 1-2 times daily and for children 5-10 μg, 1-2 times daily.
Primary Nocturnal Enuresis: Oral lyophilisate: Recommended Initial Dose: 120 mcg at bedtime, administered sublingually.
If this dose is not sufficiently effective, the dose may be increased up to 240 mcg sublingually. Fluid restriction should be observed. Minirin oral lyophilisate is intended for treatment periods of up to 3 months. The need for continued treatment should be reassessed by means of a period at least 1 week without Minirin oral lyophilisate.
Renal concentrating capacity test: Injection: Normal adult dose by intramuscular or subcutaneous injection is 4 μg (1 ml).
For children above the age of 1 year the dose is 1 to 2 μg (0.25 to 0.5 ml).
For children below the age of 1 year is 0.4 μg (0.1 ml).
For children it is recommended to use primarily the intranasal presentation.
After administration of MINIRIN injection, any urine collected within 1 hour is discarded. During the next 8 hours 2 portions of urine are collected for measurement of osmolality. Fluid restriction should be observed, see 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.
Nasal spray: Normal Dose: Adults: 40 μg. Children >12 months: 20 μg; <12 months: 10 μg. After administration of Minirin dDAVP, possible urine within 1 hour is discarded. During the next 8 hours, 2 portions of urine are collected for urine osmolality testing. Fluid restriction should be observed, (see 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 similar 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: Injection: 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.
Injection: Posology for special populations: Renal impairment: MINIRIN injection should be used with caution in patients with moderate and severe renal insufficiency (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No studies have been performed in this population.
It is unlikely that desmopressin will interact with drugs affecting hepatic metabolism, since desmopressin has been shown not to undergo significant liver metabolism in in vitro studies with human microsomes.
Method of administration: Oral lyophilisate: Minirin oral lyophilisate is placed under the tongue where it dissolves without the need for water.
In the event of signs or symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain and in severe cases, convulsions) treatment should be interrupted until the patient has fully recovered. When restarting treatment strict fluid restriction should be enforced (see Precautions).
If adequate clinical effect is not achieved within 4 weeks following appropriate dose titration the medication should be discontinued.
Injection: The injection is normally administered intravenously but may, if needed, also be given intramuscularly or subcutaneously, depending on the indications.