MINIRIN ORAL LYOPHILISATE 60 MCG [SIN14260P]

Product Info

MINIRIN ORAL LYOPHILISATE 60 MCG

[SIN14260P]

Therapeutic indications
MINIRIN® oral lyophilisate is indicated for the treatment of central diabetes insipidus.
MINIRIN® oral lyophilisate is indicated for the treatment of primary nocturnal enuresis in patients (from 5 years of age) with normal ability to concentrate urine.

Posology and method of administration
General
Method of administration: MINIRIN® oral lyophilisate is placed under the tongue where it dissolves without the need for water.
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:
Dosage is individual in diabetes insipidus but the total daily sublingual dose normally lies in the range of 120 mcg to 720 mcg. A suitable starting dose in adults and children is 60 mcg three times daily, administered sublingually. This dosage regimen should then be adjusted in accordance with the patient’s response. For the majority of patients, the maintenance dose is 60 mcg to 120 mcg sublingually three times daily.

Primary nocturnal enuresis:
The recommended initial dose is 120 mcg at bedtime, administered sublingually.
If this dose is not sufficiently effective, the dose may be increased up to 240 mcg sublingually. Fluid restriction should be observed. MINIRIN® oral lyophilisate is intended for treatment periods of up to 3 months. The need for continued treatment should be reassessed by means of a period of at least one week without MINIRIN® oral lyophilisate.

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® oral lyophilisate 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® oral lyophilisate is 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 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 substances or to any of the excipients.