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RHINOCORT(R)
1
RHINOCORT(R)
_Budesonide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Rhinocort.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Rhinocort
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING RHINOCORT, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
RHINOCORT.
You may need to read it again.
WHAT RHINOCORT IS
USED FOR
ALLERGIC RHINITIS (HAYFEVER)
Rhinocort is sprayed into the nose to
help prevent and treat allergic rhinitis
(hayfever). Hayfever is an
inflammation or swelling of the nose
lining (which may cause blockage,
runny nose, itching and/or sneezing).
This is often, but not always, due to
an allergy to something in the air (eg
pollen, dust mites).
You may have symptoms only
during spring or summer. This type
of allergy is generally due to various
pollens. Some people may
experience symptoms all year round.
This is usually caused by house dust
mites, pets or moulds.
NASAL POLYPS
Rhinocort is also used to treat nasal
polyps, which are small masses of
tissue that grow from the nose lining.
Rhinocort contains budesonide.
This belongs to a family of
medicines called corticosteroids,
which are used to help reduce
inflammation.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY RHINOCORT HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Rhinocort is not addictive.
Rhinocort is available only with a
doctor's prescription.
BEFORE YOU USE
RHINOCORT
_WHEN YOU MUST NOT USE IT_
DO NOT USE RHINOCORT IF:
1. YOU HAVE AN ALLERGY TO:
*
any medicines containing
budesonide
*
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an
aller
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Rhinocort
®
Product Information
1 (8)
RHINOCORT
®
PRODUCT INFORMATION
(budesonide for nasal inhalation)
NAME OF THE DRUG
The active ingredient, budesonide, is a non-halogenated glucocorticoid
structurally
related to 16a hydroxyprednisolone. The chemical name is 16
α, 17α - 22 R,
S-propylmethylenedioxypregna - 1, 4 - diene - 11ß, 21-diol-3,
20-dione; MW 430.5.
O
H
3
C
HO
H
3
C
C
CH
2
OH
O
O
C
O
H
CH
2
CH
2
CH
3
CAS Number: 51333-22-3
DESCRIPTION
Budesonide is a white to off-white powder, freely soluble in
chloroform, sparingly
soluble in ethanol and practically insoluble in water and heptane.
Budesonide melts
between 224°C and 231.5°C with decomposition.
RHINOCORT is available as a 64
μg per dose aqueous nasal suspension containing
budesonide as the active ingredient with disodium edetate, potassium
sorbate,
glucose anhydrous, dispersible cellulose, polysorbate 80 and
purified water. The pH
of the solution may have been adjusted by hydrochloric acid, if
required.
_ _
PHARMACOLOGY
Studies in animals and humans have shown an advantageous ratio between
topical
anti-inflammatory activity and systemic glucocorticoid effect over a
wide dose range.
Budesonide is approximately twice as potent as beclomethasone
dipropionate as
shown in the skin blanching test for anti-inflammatory activity of
topical steroids in
humans. Budesonide has, however, less systemic effect than
beclomethasone
dipropionate, as measured by depression of morning plasma cortisol
and effect on
differential WBC count. The improved ratio of topical
anti-inflammatory activity to
systemic effect of budesonide is due to high glucocorticoid receptor
affinity combined
with a high first pass metabolism and a short half-life.
apprhi6410509
Rhinocort
®
Product Information
2 (8)
Pre-treatment for one week with intranasal budesonide 400
μg daily in asymptomatic
patients with seasonal rhinitis, significantly inhibited the immediate
reaction
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