OMNARIS NASAL SPRAY 50MCG(60 PUFFS & 120 PUFFS)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CICLESONIDE

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

CICLESONIDE

Unit dalam pakej:

60Units Units; 120Units Units

Dikeluarkan oleh:

CONTRACT PHARMACEUTICALS LIMITED

Risalah maklumat

CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
OMNARIS
(CICLESONIDE) NASAL SPRAY, 50MCG
60 PUFFS AND 120 PUFFS
Page 1
WHAT IS IN THIS LEAFLET
1.
What Omnaris is used for
2.
How Omnaris works
3.
Before you use Omnaris
4.
How to use Omnaris
5.
While you are using Omnaris
6.
Side Effects
7.
Storage and Disposal of Omnaris
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT OMNARIS IS USED FOR
This medicine is used to treat nasal
symptoms (i.e., runny nose, itchy
nose, sneezing, and nasal congestion)
that happen with:
•
Seasonal nasal allergy in adults
and adolescents 12 years of age
and older.
•
Year-round
nasal
allergy
symptoms in adults and
adolescents 12 years of age
HOW OMNARIS WORKS
Omnaris
Nasal
Spray
contains
a
medicine called ciclesonide,
which is
a synthetic corticosteroid (a substance
that reduces inflammation).
BEFORE YOU USE OMNARIS
_-_
_ _
_Before you start to use it _
Before you take Omnaris, tell your
doctor if you
:
•
are pregnant or plan to
become pregnant.
•
are breastfeeding or plan to
breastfeed. It is not known if
Omnaris
passes
into
your
breast
milk.
You
and
your
doctor should decide if you
will
take
Omnaris
or
breastfeed.
You
should
not
do both without first talking
with your doctor.
_-_
_ _
_Taking other medicines _
TELL YOUR DOCTOR OR PHARMACIST IF
YOU ARE TAKING, HAVE RECENTLY TAKEN
OR MIGHT TAKE ANY OTHER MEDICINES
,
including
prescription
and
non-
prescription medicines, vitamins, and
herbal supplements.
In
particular,
tell
your
doctor
or
pharmacist
about
the
following
medicines:
•
Medicines to treat fungal
infections,
such
as
ketoconazole
and
itraconazole
•
medicines for HIV such as
ritonavir,
nelfinavir
or
cobicistat-containing
products
These medicines may affect or may be
affected
by
the
treatment
with
Omnaris. They may also increase the
effects of Omnaris and your doctor
may wish to monitor you carefully if
you are taking them.
Ask your doctor if you are not sure if
you
are
taking
a
medicine
listed
above.
Know the medicines you

Ciri produk

AG16853_GA_30003_C_V02_Omnaris_Outsert_Template - TOP FRONT
Width: 312 mm, Length: 480 mm
Fold Size: 63 mm x 80 mm
DESCRIPTION
The active component of OMNARIS
®
Nasal Spray is ciclesonide, a non-halogenated
glucocorticoid. Ciclesonide is delivered as the R-epimer. The
empirical formula is
C
32
H
44
O
7
and its molecular weight is 540.7.
OMNARIS
®
Nasal Spray is a metered-dose, manual-pump spray formulation
containing a hypotonic aqueous suspension of ciclesonide. OMNARIS
®
Nasal
Spray also contains microcrystalline cellulose, carboxymethylcellulose
sodium,
hypromellose, potassium sorbate and edetate disodium; and hydrochloric
acid to
adjust the pH to 4.5. The contents of one 7.1 g bottle provide 60
actuations and
12.5 g bottle provide 120 actuations, after initial priming.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Ciclesonide is a pro-drug that is enzymatically hydrolyzed to a
pharmacologically
active metabolite, C21-desisobutyryl-ciclesonide (desciclesonide or
RM1) following
intranasal application.
The precise mechanism through which ciclesonide affects allergic
rhinitis symptoms
is not known. Corticosteroids have been shown to have a wide range of
effects
on multiple cell types (e.g., mast cells, eosinophils, neutrophils,
macrophages,
and lymphocytes) and mediators (e.g., histamine, eicosanoids,
leukotrienes, and
cytokines) involved in allergic inflammation.
PHARMACODYNAMICS
In a 12-week study in children 6-11 years of age with perennial
allergic rhinitis,
daily doses of 200 mcg, 100 mcg, and 25 mcg of OMNARIS
®
Nasal Spray were
compared to placebo nasal spray. Adrenal function was assessed by
measurement
of 24-hour urinary free cortisol (in 32 to 44 patients per group) and
morning plasma
cortisol levels (in 45 to 61 patients per group) before and after 12
consecutive
weeks of treatment.
The ciclesonide-treated groups had a numerically greater decline in
24-hour
urinary free cortisol compared to the placebo treated group. The
differences
(and 95% confidence intervals) from placebo in the mean change from
ba