Nocdurna Dosage/Direction for Use

Posology: Women: 25 mcg daily, one hour before bedtime, administered sublingually without water.
Men: 50 mcg daily, one hour before bedtime, administered sublingually without water.
A dose increase with this product is not recommended in elderly patients ≥65 years.
If higher doses are considered for patients under the age of 65 years in case of an insufficient response to NOCDURNA, other desmopressin oral lyophilisate products should be used (see Precautions, Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
In the event of signs or symptoms of water retention and/or hyponatremia (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions) treatment should be interrupted and reassessed. When restarting treatment strict fluid restriction should be enforced and serum sodium levels monitored (see Precautions).
NOCDURNA should be discontinued if the serum sodium level falls below the lower limit of normal range (i.e. 135 mmol/L).
Special Populations: Elderly patients (65 years of age and older): Elderly patients are at increased risk of developing hyponatraemia with desmopressin treatment and may also have impaired renal function. Caution should therefore be exercised in this age group and daily doses above 25 mcg for females and 50 mcg for males should not be used. In elderly patients serum sodium must be within the normal range, before initiating treatment, in the first week (4-8 days after initiation) and again at one month. NOCDURNA should be discontinued if the serum sodium level falls below the lower limit of normal range (see Precautions). Continued therapy must be carefully reconsidered in elderly patients who show no evidence of therapeutic benefit beyond 3 months.
Renal impairment: NOCDURNA is contraindicated in patients with moderate and severe renal insufficiency (see Contraindications).
Hepatic impairment: No dose adjustment is needed for patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: There is no relevant use of NOCDURNA in the paediatric population for the indication of symptomatic treatment of nocturia due to idiopathic nocturnal polyuria.
Method of administration: NOCDURNA is placed under the tongue where it dissolves without the need for water.
Food intake may reduce the intensity and duration of the antidiuretic effect at low doses of desmopressin (see Pharmacology: Pharmacokinetics under Actions).