DDAVP/Desmopressin Intranasal Solution Nasal Drops Soln 0.1mg/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DESMOPRESSIN ACETATE

Available from:

Ferring Pharmaceuticals Limited

ATC code:

H01BA02

INN (International Name):

DESMOPRESSIN ACETATE

Pharmaceutical form:

NASAL DROPS, SOLUTION

Composition:

DESMOPRESSIN ACETATE 100 µg/ml

Prescription type:

POM

Therapeutic area:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Authorization status:

Authorised

Patient Information leaflet

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DDAVP / Desmopressin
®
Intranasal Solution
desmopressin acetate
PATIENT INFORMATION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE.
• Keep this leaflet, you may need to read it again
• If you have further questions, please ask your doctor
or pharmacist
• This medicine has been prescribed for you personally
and you should not pass it on to others. It may harm
them even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
IMPORTANT THINGS THAT YOU NEED TO KNOW:
• DDAVP/Desmopressin Intranasal Solution is used
- to treat patients with multiple sclerosis suffering
from nocturia (the need to get up at night to pass
urine), when other treatments have failed
- to diagnose and treat cranial diabetes insipidus
(a condition that causes extreme thirst and the
continuous production of large volumes of dilute
urine, when other treatments have failed)
- as a test to check if the kidneys are functioning
properly (renal function test)
• You should avoid drinking large amounts of fluid while
you are being treated with DDAVP/Desmopressin
Intranasal Solution, as this could lead to a build up of
water which dilutes the salt in the body. This is a
serious problem and may lead to convulsions.
• If you experience unusually bad or prolonged headache,
confusion, unexplained weight gain, ankle swelling,
nausea or vomiting STOP USING DDAVP/DESMOPRESSIN
INTRANASAL SOLUTION. You should tell your doctor
immediately or go to the casualty department at
your nearest hospital.
Now read the rest of this leaflet. It includes other important
information on the safe and effective use of this medicine
that might be especially important for you. This leaflet was
last updated on 29/11/08
In this leaflet:
1. What DDAVP/Desmopressin Intranasal Solution is and
what it is used for
2. Before you use DDAVP/Desmopressin Intranasal
Solution
3. How t

Summary of Product characteristics

Page 1 of 6
1.
NAME OF THE MEDICINAL PRODUCT
DDAVP
®
/Desmopressin Intranasal Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Desmopressin acetate 0.01% w/v
3.
PHARMACEUTICAL FORM
Aqueous solution for intranasal administration
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DDAVP
®
/Desmopressin Intranasal Solution is indicated for:
1)
The diagnosis and treatment of vasopressin-sensitive cranial diabetes
insipidus.
2)
The treatment of nocturia associated with multiple sclerosis where
other treatments have
failed.
3)
Establishing renal concentration capacity.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
TREATMENT OF DIABETES INSIPIDUS:
Dosage is individual but clinical experience has shown that the
average maintenance doses
are as follows:
_Adults_: 10 to 20 micrograms once or twice daily.
_Elderly_: 10 to 20 micrograms once or twice daily.
_Children_: 5 to 20 micrograms daily, (a lower dose may be required
for infants).
DIAGNOSIS OF DIABETES INSIPIDUS:
The
diagnostic
dose
in adults and children is 20 micrograms. Failure to elaborate a
concentrated urine after water deprivation, followed by the ability to
do so after the
administration of Desmopressin confirms the diagnosis of cranial
diabetes insipidus. Failure
to concentrate after the administration suggests nephrogenic diabetes
insipidus.
TREATMENT OF NOCTURIA:
Page 2 of 6
For multiple sclerosis patients up to 65 years of age with normal
renal function suffering
from nocturia the dose is 10 to 20 micrograms at bed time. Not more
than one dose should
be used in any 24 hour period.
RENAL FUNCTION TESTING:
To establish renal concentration capacity, the following single doses
are recommended:
Adults: 40 micrograms
Elderly: 40 micrograms
Children (1 - 15 years): 20 micrograms
Infants (to 1 year): 10 micrograms
Adults and children with normal renal function can be expected to
achieve concentrations
above
700mOsm/kg
in
the
period
of
5-9
hours
following
administration
of
DDAVP
®
/Desmopressin Intranasal Solution. It is recommended that the bladder
should be
em