MINIRIN NASAL SPRAY 10 MCG/DOSE [SIN03760P]

Product Info

MINIRIN NASAL SPRAY 10 MCG/DOSE

[SIN03760P]

THERAPEUTIC INDICATIONS
Central diabetes insipidus
The use of MINIRIN® in patients with an established diagnosis will result in a reduction in urinary output with concomitant increase in urine osmolality and decrease in plasma osmolality. This will result in decreased urinary frequency and decreased nocturia.

Renal concentrating capacity test
MINIRIN® can be used to test the capacity of the kidneys to concentrate urine; as a diagnostic aid in the examination of the kidney function. This is especially useful in the differential diagnosis between level of urinary tract infections. Cystitis will opposite to pyelonephritis not cause a subnormal ability to concentrate urine.

POSOLOGY AND METHOD OF ADMINISTRATION
General
1 dose of the spray provides 0.1 ml, which corresponds to 10 mcg desmopressin acetate.

MINIRIN® nasal formulations should be used only when treatment with oral formulations is inappropriate and always start at the lowest dose (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).

Fluid restriction should be observed (see indication specific instructions in section Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 section Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Indication specific
Central diabetes insipidus:
Dosage is individual but clinical experience has shown that the normal daily dose for adults is 10–20 mcg 1–2 times daily and for children 5–10 mcg 1–2 times daily.

Renal concentrating capacity test:
Normal adult dose is 40 mcg. For children over 12 months the dose is 20 mcg. For children under 12 months the dose is 10 mcg. After administration of MINIRIN® any urine collected within 1 hour is discarded. During the next 8 hours 2 portions of urine are collected for osmolality testing. Fluid restriction should be observed, see also under Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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.

Special populations
Elderly: 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.
Renal Impairment: see section Contraindications.
Hepatic Impairment: see section Interaction with other medicinal products and other forms of interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Paediatric Population: MINIRIN® is indicated in children with central diabetes insipidus and for testing of renal concentration capacity, see section Special warnings and precautions for use and Undesirable effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

CONTRAINDICATIONS
MINIRIN® must NOT be used in:

• habitual or psychogenic polydipsia (resulting in a urine production exceeding 40ml/kg/24 hours)

• syndrome of inappropriate ADH secretion (SIADH)

• known hyponatraemia

• known or suspected cardiac insufficiency and other conditions requiring treatment with diuretics

• moderate and severe renal insufficiency (creatinine clearance below 50ml/min)

• hypersensitivity to the active substances or to any of the excipients