Nocdurna Special Precautions

Patients, in particular the elderly, should undergo clinical examination and questioning before commencing treatment with NOCDURNA, given that nocturnal polyuria can be a symptom of cardiovascular or other medical conditions associated with fluid overload. If there is any suspicion of such coexistent conditions, treatment with desmopressin is not recommended (see Contraindications).
Fluid intake must be limited to a minimum from 1 hour before until 8 hours after administration. Treatment without concomitant reduction of fluid intake may lead to prolonged fluid retention and/or hyponatremia with or without accompanying warning signs and symptoms (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions).
Elderly patients with serum sodium levels in the lower range of normal may have an increased risk of hyponatremia. Patients 65 years and older should have their serum sodium monitored before initiating the treatment, in the first week of treatment (4-8 days) and again at one month after treatment initiation (see Dosage & Administration).
At a 50 mcg dose level females may have an increased risk of hyponatraemia compared with males (see Pharmacology: Pharmacodynamics under Actions). It is therefore important that the gender-specific recommendations for dose are adhered to.
NOCDURNA should be discontinued if the serum sodium level falls below the lower limit of normal range.
Desmopressin should be used with caution in patients with conditions characterized by fluid and/or electrolyte imbalance.
Treatment with desmopressin should be interrupted and reassessed during acute intercurrent illnesses characterised by fluid and/or electrolyte imbalance (such as systemic infections, fever, and gastroenteritis).
Precautions to avoid hyponatremia including careful attention to fluid restriction and more frequent monitoring of serum sodium must be taken in case of concomitant treatment with drugs, which are known to induce SIADH, e.g. tricyclic antidepressants, selective serotonin reuptake inhibitors, chlorpromazine, diuretics and carbamazepine, and some antidiabetics of the sulfonylurea group, particularly chlorpropamide, and in case of concomitant treatment with non-steroidal anti-inflammatory drugs (NSAIDs).
Special caution should be exercised in patients taking thiazide or loop diuretics for hypertension or other medical conditions not associated with fluid overload. Sodium monitoring in these patients is warranted.
Severe bladder dysfunction and outlet obstruction should be considered before starting treatment.
Caution is required in cases of cystic fibrosis, coronary heart disease, hypertensions, chronic renal disease and pre-eclampsia.
A diagnosis of nephrogenic diabetes insipidus should be considered if there is no reduction in night‑time urine output after commencement of desmopressin.
Special caution should be exercised in patients taking lithium in case of masking of early‑stage lithium-induced nephrogenic diabetes insipidus by administration of desmopressin for a nocturia indication. Desmopressin is not recommended in patients suspected of having lithium-induced nephrogenic diabetes insipidus.
Effects on ability to drive and use machines: NOCDURNA has no or negligible influence on the ability to drive and use machines.