MINIRIN TABLET 0.1 MG (OVAL) [SIN11656P]

Product Info

MINIRIN TABLET 0.1 MG (OVAL)

[SIN11656P]

THERAPEUTIC INDICATIONS
MINIRIN® tablets are indicated for the treatment of 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.

MINIRIN® tablets are indicated for the treatment of primary nocturnal enuresis in children aged 5 years or more.

POSOLOGY AND METHOD OF ADMINISTRATION
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 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).

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 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 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.

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.

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® Tablet is indicated in Central Diabetes Insipidus and Primary Nocturnal Enuresis (see section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information and indication specific information in Posology and method of administration above). Dose recommendations are the same as in adults.

CONTRAINDICATIONS
MINIRIN® tablets are contraindicated in cases of:

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

• A history of known or suspected cardiac insufficiency and other conditions that requiring treatment with diuretics;

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

• Known hyponatraemia;

• Syndrome of inappropriate ADH secretion (SIADH);

• Hypersensitivity to the active substance or to any of the excipients