MINIRIN Oral Lyophilisate 120 mcg

FERRING PHARMACEUTICALS PRIVATE LIMITED

FERRING PHARMACEUTICALS PRIVATE LIMITED

Therapeutic

Prescription Only

TABLET, ORALLY DISINTEGRATING

**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.