Minirin

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

DESMOPRESSIN ACETATE

Предлага се от:

Ferring SPA Via Senigallia 18/2, Milan, Italy

АТС код:

H01BA02

INN (Международно Name):

DESMOPRESSIN ACETATE 0.2 mg

Лекарствена форма:

TABLET

Композиция:

DESMOPRESSIN ACETATE 0.2 mg

Вид предписание :

POM

Терапевтична област:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Статус Оторизация:

Withdrawn

Дата Оторизация:

2006-08-09

Листовка

 
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

Данни за продукта

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.