Minirin Melt

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

Desmopressin

Доступна з:

Ferring Pharmaceuticals Pty Ltd

Клас:

Medicine Registered

інформаційний буклет

MINIRIN
®
 MELT

_Desmopressin_
SUBLINGUAL (UNDER THE TONGUE) WAFERS
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minirin Melt.
It does not contain all the available
information. It does not replace
talking to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Minirin Melt
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS MINIRIN MELT
USED FOR
The active ingredient, desmopressin
in Minirin Melt is a synthetic version
of a naturally occurring substance
produced in the brain called
vasopressin.
It has a number of different actions
on the body including an action on
the kidney to reduce the amount of
urine produced. This means that
Minirin Melt can be used for several
different conditions including:
•
primary nocturnal enuresis
(bedwetting) in patients over 6
years of age who have a normal
ability to concentrate urine and
who have not responded to
treatment with an enuresis alarm
or in whom an enuresis alarm is
contraindicated or inappropriate
•
cranial diabetes insipidus (large
amounts of urine being produced
day and night and constant thirst).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU TAKE
MINIRIN MELT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE MINIRIN MELT IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
desmopressin or any of the
ingredients listed at the end of
this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips,

Характеристики продукта

#16892-v8A 

MINIRIN
_®_
_ _MELT_ _
Desmopressin  

Synonyms of desmopressin: 
DDAVP 
1-desamino-8-D-Arginine vasopressin. 
Desamino-cys-1-D-Arginine-8 vasopressin. 

 SCH
2
CH
2
CO-Tyr-Phe-Gln-Asn-Cys-Pro-D-Arg-Gly-NH
2

CAS Nos.: 
Desmopressin base      16679-58-6 
[http://csi.micromedex.com/Tomes.asp?UserInput=16679-58-6&SearchValueType=CAS]
Desmopressin acetate   62288-83-9 
[http://csi.micromedex.com/Tomes.asp?UserInput=62288-83-9&SearchValueType=CAS]

Molecular weights: 
Desmopressin base      1069.22 
Desmopressin acetate   1183.34 

Physical and chemical characteristics: 
A white, fluffy powder, soluble in water, in alcohol and in
glacial acetic acid. 

DESCRIPTION 

MINIRIN Melt, a sublingual wafer, contains the active substance, desmopressin, (present as the hydrated 
acetate),  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. MINIRIN Melt 
also contains gelatin, mannitol and citric acid, anhydrous. 

PHARMACOLOGY 

Pharmacotherapeutic group: vasopressin and analogues. 

Compared to vasopressin, desmopressin has a considerably longer duration of action and a complete 
lack of pressor effect in the dosages clinically used. 

PHARMACOKINETICS 

The overall mean systemic bioavailability of desmopressin administered sublingually  as  MINIRIN

Melt 
at doses of 200, 400 and 800 

g is 0.25%. The C
max
 was 14, 30 and 65 pg/mL after administration of 
200, 400 and 800 

g, respectively. t
max
 was observed at 0.5 
– 2.0 hours after dosing.  The geometric 
mean terminal half-life is 2.8 (CV = 24%) hours. 

The distribution volume of desmopressin after
intravenous administration is 33 L (0.41 L/kg).