DIQUAS-S ophthalmic solution 3%

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Diquafosol Sodium

Boleh didapati daripada:

SANTEN PHARMA MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

Diquafosol Sodium

Unit dalam pakej:

0.4mL X 30 Units

Dikeluarkan oleh:

HUONS CO.,LTD.

Risalah maklumat

DIQUAS
®
-S OPHTHALMIC SOLUTION 3%
Diquafosol sodium (30mg/mL)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What Diquas-S is used for
2.
How Diquas-S works
3.
Before you use Diquas-S
4.
How to use Diquas-S
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Diquas-S
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DIQUAS-S
IS USED FOR
This medicine should be used in patients
diagnosed with dry eye, associated with
keratoconjuctival
epithelium
disorders
that
accompany
lacrimal
fluid
abnormality.
HOW DIQUAS-S WORKS
This
medicine
improves
keratoconjunctival epithelial disorder by
promoting secretion of mucin and water
as
components
of
tears,
thereby
improving the tear film conditions.
BEFORE YOU USE DIQUAS-S
-
_When you must not use it _
Do not use Diquas-S if you are allergic
to any of the ingredients in this product.
_ _
-
_Before you start use it _
Before using this medicine, be sure to
tell your doctor or pharmacist:
•
If
you
have
previously
experienced
any
allergic
reactions (itch, rash, etc.) to any
medicines.
•
If
you
are
pregnant
or
breastfeeding
-
_Taking other medicines _
If you are taking any other medicinal
products, some medicines may interact to
enhance or diminish medicinal effects.
Beware
of
over-the-counter
medicines
and dietary supplements as well as other
prescription medicines.
HOW TO USE DIQUAS-S
-
_How much to use _
In general, instill 1 drop a time, 6 times a
day. Strictly follow the instructions.
-
_When to use it _
6 times a day.
-
_How long to use it _
Do not stop using this medicine unless
your doctor instructs you to do so.
-
_If you forget to use it _
If you miss a dose, instill the missed dose
as soon as possible. If it is almost time
for the next dose, skip the missed dose
and
continue
your
regular
dosing
schedule.
You
should
not
apply
two
doses at one time.
-
_If you use too much (overdose) _
If you accidentally instill more than your
prescribed dose, consult with your doctor
or ph

Ciri produk

1
FOR THE TREATMENT OF DRY EYE
DIQUAS
®
-S OPHTHALMIC SOLUTION 3%
(Diquafosol sodium 3%)
1. PRODUCT DESCRIPTION
DIQUAS-S ophthalmic solution is a clear, colourless, sterile aqueous
ophthalmic solution.
Each mL contains 30 mg of diquafosol sodium. It also contains dibasic
sodium phosphate hydrate, disodium
edetate hydrate, sodium chloride, potassium chloride, hydrochloric
acid and sodium hydroxide as additives.
The product has pH 7.2
−
7.8 and osmolar ratio 1.0 - 1.1.
2. INDICATION
This product should be used in patients diagnosed with dry eye,
associated with keratoconjunctival epithelium
disorders that accompany lacrimal fluid abnormality.
3. RECOMMENDED DOSAGE
Instill 1 drop a time in the affected eye(s) 6 times daily.
4. ROUTE OF ADMINISTRATION
For ophthalmic use only
5. PHARMACOLOGICAL PROPERTIES
5.1. PHARMACODYNAMICS
1) MECHANISM OF ACTION
Diquafosol sodium is a mucin/aqueous secretagogue acting on the P2Y
2
receptors on conjunctival epithelium
and goblet cell membranes. The increased intracellular calcium ions
promote water and mucin secretion.
2) STIMULATORY ACTION ON SECRETION OF TEAR FLUID INCLUDING MUCIN
(1) A single dose administration of diquafosol sodium into the eyes of
normal animals (rabbits and rats)
promoted tear fluid secretion and mucin secretion from the
conjunctival cells.
(2) A single dose administration of diquafosol sodium into the eyes of
dry eye model rats promoted tear
fluid secretion. Repeated dose administration increased mucin contents
in the conjunctival tissues.
3) STIMULATORY ACTION ON MUCIN PRODUCTION IN CORNEAL EPITHELIAL CELLS
Diquafosol sodium stimulated gene expression and protein production of
membrane-associated mucin in
corneal epithelial cells.
4) IMPROVEMENT OF CORNEAL EPITHELIAL DAMAGE
Repeated dose administration of diquafosol sodium 6 times daily for 4
weeks improved corneal epithelial
damage in rat dry eye model in a dose-dependent manner, and exhibited
the maximal effect at the
concentration of 1% or higher. Repeated dose of 1% diquafosol sodium
for 2 weeks exhi