Apo-Mometasone Furoate Aqueous Nasal Spray 50mcgmetered spray

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MOMETASONE FUROATE

Boleh didapati daripada:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

MOMETASONE FUROATE

Unit dalam pakej:

140units Units

Dikeluarkan oleh:

Apotex Inc.-Richmond Hill Site

Risalah maklumat

APO-MOMETASONE FUROATE AQUEOUS
NASAL SPRAY 50MCG/METERED SPRAY
Mometasone Furoate (50 µg/spray)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Apo-Mometasone is used for
2.
How Apo-Mometasone works
3.
Before you use Apo-Mometasone
4.
How to use Apo-Mometasone
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Apo-
Mometasone
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT APO-MOMETASONE
IS USED FOR
Apo Mometasone is used for the
following condition:
•
Treatment of symptoms of seasonal
or perennial (all year long) rhinitis
(inflammation of the lining inside the
nose)
•
Treatment of nasal polyps (soft and
painless growths on the lining of your
nasal passages)
•
Treatment of symptoms of acute
rhinosinusitis (inflammation of nasal
passage)
•
Prevention of seasonal allergic
rhinitis (inflammation of the lining
inside the nose due to allergy)
symptoms
HOW APO-MOMETASONE WORKS
Apo-Mometasone belongs in the
corticosteroid group. It works by
reducing inflammation at the affected
area, relieving symptoms of the
condition mentioned above.
BEFORE YOU USE APO-MOMETASONE
-
_When you must not use it _
Do not use this product if you are:
_ _
_ _
•
allergic to
_ _
mometasone furoate, or
any other ingredients in this
medicine.(Please refer to
PRODUCT
DESCRIPTION
)
_ _
•
if you have an infection in the nose
that is not being treated
_ _
•
if your nose is recently operated or
injured
_ _
•
if you have been diagnosed with
tuberculosis
_ _
•
if you have any known infection,
such as untreated fungal, bacterial,
systemic viral infections, or herpes
simplex.
_ _
_Pregnancy and lactation _
Do not take Apo-Mometasone if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Apo-Mometasone if you
are breast-feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
_ _
-
_Before you start to use it _
_ _
Before you start to use Apo-
Mometasone, your doctor needs to
know if

Ciri produk

APO-MOMETASONE
MOMETASONE
FUROATE
AQUEOUS
NASAL
SPRAY
50 MCG/METERED SPRAY
CORTICOSTEROID
APO-MOMETASONE
FUROATE
AQUEOUS
NASAL
SPRAY
50MCG/METERED
SPRAY
is a white suspension that contains 50mcg of
Mometasone furoate in each metered spray.
PHARMACODYNAMICS:
Mometasone furoate is a topical glucocorticosteroid with local
anti-inflammatory
properties at doses that are not systemically active. It is likely
that much of the
mechanism for the anti-allergic and anti-inflammatory effects of
mometasone furoate
lies in its ability to inhibit the release of mediators of allergic
reactions. Mometasone
furoate significantly inhibits the release of leukotrienes from
leucocytes of allergic
patients. In cell culture, mometasone furoate demonstrated high
potency in inhibition
of synthesis and release of IL-1, IL-5, IL-6 and TNFα; it is also a
potent inhibitor of
leukotriene
production.
In
addition,
it
is
an
extremely
potent
inhibitor
of
the
production of the Th2 cytokines, IL-4 and IL-5, from human CD4+
T-cells.
PHARMACOKINETICS:
ABSORPTION: Mometasone furoate, administered as a nasal spray, has a
systemic
bioavailability of <1% in plasma, using a sensitive assay with a lower
quantitation
limit of 0.25 pg/mL.
DISTRIBUTION: Not applicable as mometasone is poorly absorbed via the
nasal route.
BIOTRANSFORMATION:
The
small
amount that may
be
swallowed
and
absorbed
undergoes extensive first-pass hepatic metabolism.
ELIMINATION: Absorbed mometasone furoate is extensively metabolized
and the
metabolites are excreted in urine and bile.
INDICATIONS AND CLINICAL USE:
APO-MOMETASONE Aqueous Nasal
Spray is indicated for use in adults, adolescents and children between
the
ages of 3 and 11 years to treat the symptoms of seasonal or perennial
rhinitis.
In patients who have a history of moderate to severe symptoms of
seasonal
allergic
rhinitis,
prophylactic
treatment
with
APO-MOMETASONE
is
recommended two to four weeks prior to the anticipated start of the
pollen
season.
APO-MOMETASONE Nasal Spray is also indicated for the treatment of
nasal
po