- Approval Id
- 9ee63e67bc0487a8
- Drug Name
- NOCDURNA ORAL LYOPHILISATE 50MCG
- Product Name
- NOCDURNA ORAL LYOPHILISATE 50MCG
- Approval Number
- SIN15462P
- Approval Date
- 2018-04-03
- Registrant
- FERRING PHARMACEUTICALS PRIVATE LIMITED
- Licence Holder
- FERRING PHARMACEUTICALS PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, ORALLY DISINTEGRATING
- Dosage
- **POSOLOGY AND METHOD OF ADMINISTRATION**
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.
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 section Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
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 section Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 section Contraindications).
_Hepatic impairment_
No dose adjustment is needed for patients with hepatic impairment (see section Pharmacokinetic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
_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 section Pharmacokinetic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Route Of Administration
- SUBLINGUAL
- Indication Info
- **THERAPEUTIC INDICATIONS**
NOCDURNA® is indicated for symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults (see section Pharmacodynamic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Contraindications
- **CONTRAINDICATIONS**
- Hypersensitivity to the active substances or to any of the excipients
- Habitual or psychogenic polydipsia (resulting in a urine production exceeding 40 ml/kg/24 hours)
- Known or suspected cardiac insufficiency or other conditions associated with fluid overload, sufficient to require treatment with diuretics, including a history of such conditions
- Moderate and severe renal insufficiency (creatinine clearance below 50 ml/min)
- Known history of hyponatremia
- Syndrome of inappropriate ADH secretion (SIADH)
- Atc Code
- H01BA02
- Atc Item Name
- desmopressin
- Pharma Manufacturer Name
- FERRING PHARMACEUTICALS PRIVATE LIMITED
- Company Detail Path
- /organization/ferring-pharmaceuticals-private-limited
