MINIRIN desmopressin acetate 100 microgram tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

desmopressin acetate, Quantity: 0.1 mg (Equivalent: desmopressin, Qty 89 microgram)

Available from:

Ferring Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; lactose monohydrate; potato starch; povidone

Administration route:

Oral

Units in package:

30 tablets, 7 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Minirin tablets are indicated for the treatment of: cranial diabetes insipidus; primary nocturnal enuresis, in patients from 6 years of age with normal ability to concentrate urine, who are refractory to an enuresis alarm, or in whom an enuresis alarm is contraindicated or inappropriate.

Product summary:

Visual Identification: White, oval, convex tablet with a single score, engraved 0.1; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2003-04-02

Summary of Product characteristics

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#1735-v23
AUSTRALIAN PI - MINIRIN
® (DESMOPRESSIN ACETATE) TABLETS
1. NAME OF THE MEDICINE
Desmopressin Acetate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Minirin Tablets contain desmopressin, (present as the hydrated acetate
with variable amounts of
acetic acid and water), a synthetic 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.
Desmopressin free base represents 89% of the desmopressin acetate
content. This is due to the
difference in molecular weight as well as the presence of acetic
acid/acetate, water and impurities.
Desmopressin acetate is a white, fluffy powder, soluble in water, in
alcohol and in glacial acetic
acid.
Excipient with known effect: lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Minirin Tablets 100 micrograms desmopressin (as desmopressin acetate).
White, oval and convex
tablets with a single score and marked “0.1” on one side.
Minirin Tablets 200 micrograms desmopressin (as desmopressin acetate).
White, round and convex
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
•
cranial diabetes insipidus
•
primary nocturnal enuresis in patients from 6 years of age with normal
ability to concentrate
urine, who are refractory to an enuresis alarm or in whom an enuresis
alarm is contraindicated
or inappropriate.
4.2 DOSE AND METHOD OF ADMINISTRATION
There is no predictable dose equivalence between intranasal and oral
dosing, so individual dose
titration is needed. If adequate clinical effect is not achieved
within 4 weeks following appropriate
dose titration, the medication should be discontinued.
FOR ADH-SENSITIVE CRANIAL DIABETES INSIPIDUS
Dosage is individualised in diabetes insipidus but clinical experience
has shown that the total daily
dose normally lies in the range of