Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
DESMOPRESSIN ACETATE
Ferring SPA Via Senigallia 18/2, Milan, Italy
H01BA02
DESMOPRESSIN ACETATE 0.2 mg
TABLET
DESMOPRESSIN ACETATE 0.2 mg
POM
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
Withdrawn
2006-08-09
MINIRIN ® Tablets 0,1 and 0,2 mg DECLARATION Tablets 0,1 mg.Each tablet contains desmopressin acetate 0,1 mg and excipients lactose monohydrate,potato starch, povidone and magnesium stearate q.s. Tablets 0,2 mg.Each tablet contains desmopressin acetate 0,2 mg and excipients lactose monohydrate,potato starch, povidone and magnesium stearate q.s. PROPERTIES MINIRIN contains desmopressin, a structural analogue of the natural hormone arginine vasopressin. Two chemical changes have been made to the natural hormone, namely desamination of 1-cysteine and substitution of 8-L-arginine by 8-D-arginine. These structural changes result in a compound with significantly increased antidiuretic potency, very little activity on smooth muscle, hence the avoidance of undesirable pressor side effects. Oral administration of 0,1-0,2 mg desmopressin provides an antidiuretic effect lasting in most patients for 8-12 hours. Relative to intranasal administration the bioavailability is about 5 per cent. 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 urination at night especially when excessive. – Primary involuntary discharge of urine at night in children aged 5 years or more. CONTRAINDICATIONS MINIRIN must NOT be used in cases of: – habitual and psychogenic polydipsia – cardiac insufficiency and other conditions requiring treatment with diuretic agents SPECIAL PRECAUTIONS FOR USE Precautions to prevent fluid overload must be taken in: – the very young and elderly patients – conditions characterized by fluid and/or electrolyte imbalance – patients at risk for increased intracranial pressure – caution in case of severe bladder dysfunc Olvassa el a teljes dokumentumot
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT MINIRIN ® 0.1 & 0.2 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Minirin ® 0.1 mg: Each tablet contains desmopressin acetate 0.1 mg equivalent to desmopressin 0.089 mg. Minirin ® 0.2 mg: Each tablet contains desmopressin acetate 0.2 mg equivalent to desmopressin 0.178 mg. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Tablet Minirin ® 0.1 mg: White, oval and convex tablets with a single score and marked “0.1” on one side or white, round and flat tablets with a single score and marked “0.1” on one side. Minirin ® 0.2 mg: White, round and convex tablets with a single score and marked “0.2” on one side or white, round and flat tablets with a single score and marked “0.2” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MINIRIN ® tablets are indicated for the treatment of central diabetes insipidus and of primary nocturnal enuresis in patients (from 5 years of age) with normal ability to concentrate urine. MINIRIN ® tablets are indicated for the symptomatic treatment of nocturia in adults, associated with nocturnal polyuria, i.e. nocturnal urine production exceeding bladder capacity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Central diabetes insipidus: Page 2 of 8 Dosage is individual in diabetes insipidus but clinical experience has shown that the total daily dose normally lies in the range of 0.2 to 1.2 mg. A suitable starting dose in adults and children is 0.1 mg three times daily. This dosage regimen should then be adjusted in accordance with the patient’s response. For the majority of patients, the maintenance dose is 0.1 mg to 0.2 mg three times daily. In the event of signs of water retention/hyponatraemia treatment should be interrupted and the dose should be adjusted. Olvassa el a teljes dokumentumot