Adin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Desmopressin acetate trihydrate 0.1mg Equivalent to 0.089 mg free base

Available from:

Pharmaco (NZ) Ltd

INN (International Name):

Desmopressin acetate trihydrate 0.1 mg (Equivalent to 0.089 mg free base)

Dosage:

0.1 mg

Pharmaceutical form:

Tablet

Composition:

Active: Desmopressin acetate trihydrate 0.1mg Equivalent to 0.089 mg free base Excipient: Lactose monohydrate Magnesium stearate Potato starch Povidone

Units in package:

Bottle, plastic, 30mL HDPE bottle, PP cap - 30 tablets, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

PolyPeptide Laboratories AB

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, 30mL HDPE bottle, PP cap - 30 tablets - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, 30mL HDPE bottle, PP cap - 100 tablets - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2005-08-23

Summary of Product characteristics

NEW ZEALAND DATA SHEET
ADIN® TABLETS – ADINTAB002
20 September 2011
ADIN
®
TABLETS
Desmopressin acetate
PRESENTATION
ADIN
®
0.1mg: Each tablet contains desmopressin acetate 0.1mg equivalent to desmopressin
(free base) 0.089mg. White, oval and convex tablets with a single score and marked “0.1” on one
side.
ADIN
®
0.2mg: Each tablet contains desmopressin acetate 0.2mg equivalent to desmopressin
(free base) 0.178mg. White, round and convex tablets with a single score and marked “0.2” on
one side.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal
doses.
For a full list of excipients see PHARMACEUTICAL PRECAUTIONS.
USES
ACTIONS
ADIN
®
tablets contain desmopressin, a structural analogue of the natural pituitary hormone
arginine vasopressin. The difference lies in the desamination of cysteine and substitution of L-
arginine by D-arginine. This results in a considerably longer duration of action and a complete
lack of pressor effect in the dosages clinically used. Desmopressin is a potent compound with an
EC
50
value of 1.6pg/mL, for the antidiuretic effect. After oral administration, an effect lasting from
6 to 14 hours or more can be expected.
Clinical trials with desmopressin tablets in the treatment of nocturia showed the following:
 A reduction of at least 50% in the mean number of nocturnal voids was obtained in 39% of
patients with desmopressin compared to 5% of patients with placebo (p<0.0001).
 The mean number of voids per night decreased by 44% with desmopressin compared to 15%
with placebo (p<0.0001).
 The median duration of first undisturbed sleep period increased by 64% with desmopressin
compared to 20% with placebo (p<0.0001).
 The mean duration of first undisturbed sleep period increased by 2�