Desmotabs Melt

Company: Ferring Ireland Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Desmopressin (free base) 240mcg (as desmopressin acetate).
Description: White, round, oral lyophilisate marked with three drop shaped figures on one side.
Presentation: 30, €78.24.
Indications: Diagnosis and treatment of cranial diabetes insipidus including post-hypophysectomy polyuria/polydipsia and treatment of primary nocturnal enuresis in patients (from 5 to 65 years of age) with normal ability to concentrate urine. Symptomatic treatment of nocturia in adults up to 65 years only, associated with nocturnal polyuria, i.e. nocturnal urine production exceeding bladder capacity.

Pharmacology: Desmotabs Melt contains desmopressin, a structural analogue of the natural pituitary hormone arginine vasopressin.
Dosage: Adult: Diabetes insipidus: Dose range, 120-720mcg daily. Initially, 60mcg sublingually three times daily. Usual maintenance dose, 60-120mcg sublingually three times daily. Primary nocturnal enuresis: Initially, 120mcg sublingually at bedtime; may be increased up to 240mcg. Duration up to 3 months. Restrict fluid intake. Reassess need for continued treatment by suspending for one week. Nocturia: Initially 60mcg sublingually at bedtime; may be increased up to 120mcg and subsequently 240mcg by weekly dose escalations. Use frequency/volume chart to diagnose nocturnal polyuria for at least 2 days before starting treatment. Restrict fluid intake. Discontinue if no effect within 4 weeks. Elderly: Over 65 years, contraindicated. Children: Diabetes insipidus and primary nocturnal enuresis: Over 5 years, as per adults.
Contraindications: Hypersensitivity to desmopressin or to any of the excipients. Habitual or psychogenic polydipsia, cardiac insufficiency and other conditions requiring treatment with diuretics, moderate and severe renal insufficiency, hyponatraemia, syndrome of inappropriate ADH secretion, patients > 65 years for treatment of primary nocturnal enuresis or nocturia.
Special precautions: Reduced renal function, cardiovascular disease, cystic fibrosis, severe bladder dysfunction, outlet obstruction. Nocturnal enuresis or nocturia: Limit fluid intake to a minimum from 1 hour before until 8 hours after administration; treatment without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with/without symptoms (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions); interrupt until patient fully recovers. Systemic infections, fever, gastroenteritis, vomiting/diarrhoea (interrupt treatment). Pregnancy.
Drug interactions: Caution: Drugs known to induce SIADH (e.g. TCAs, SSRIs, chlorpromazine, carbamazepine), NSAIDs, loperamide.
Adverse drug reactions: All conditions: Headache, nausea, abdominal pain. Nocturia: Hyponatraemia, dizziness, dry mouth, peripheral oedema, micturition frequency, weight gain.
Full prescribing information and references available from Ferring Ireland Ltd. Telephone: (01) 4637355. E-mail: enquiries.ireland@ferring.com