Xylocon 0.025% Nasal Drops

Country: Malaysia

Language: English

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

Active ingredient:

OXYMETAZOLINE HYDROCHLORIDE

Available from:

MEDISPEC (M) SDN.BHD

INN (International Name):

OXYMETAZOLINE HYDROCHLORIDE

Units in package:

6 x 10ml mL

Manufactured by:

SQUARE PHARMACEUTICALS LTD

Patient Information leaflet

XYLOCON NASAL DROPS
®
Oxymetazoline Hydrochloride USP (0.05%, 0.025%)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET?
1.
What
_Xylocon _
is used for
2.
How
_Xylocon_
works
3.
Before you use
_Xylocon_
4.
How to use
_Xylocon_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Xylocon_
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT _XYLOCON_
IS USED FOR
To
relieve
nasal
congestion
due
to
rhinitis
acuta
(acute
cold),
sinusitis
(inflammation
of
the
sinuses),
eustachitis
(inflammation
of
the
mucous
membrane
of
the
eustachian
tube), and otitis media (inflammation of
the media ear)
HOW _XYLOCON_ WORKS
The
active
ingredient
of
Xylocon,
Oxymetazoline
hydrochloride
has
a
decongestant
effect
on
the
mucous
membrane. The application of this nasal
drops
into
the
nostrils
leads
to
decongestion
of
the
inflamed
nasal
mucosa and thus to normalization of
nasal breathing.
BEFORE YOU USE _Xylocon_
-
_When you must not use it _
Do not use Xylocon nasal drops if:
•
You are hypersensitivity to the
active ingredient or to any of
the excipients
•
You
are
children
under
12
years of age.
•
If you have inflammation of
the
skin
and
rhinitis
sicca
(chronic form of dryness of the
mucous
membranes
in
the
nose)
•
You
have
narrow-angle
glaucoma
•
You have hypertension, heart
diseases or asthma
•
You
have
any
metabolic
disorders
(eg:
hyperthyroidism, diabetes)
•
You have
Phaeochromocytoma (small
vascular tumor of the adrenal
medulla)
_Pregnancy and lactation _
_ _
Xylocon
nasal
drops
should
only
be
used
after
the
consultation
with
a
physician
during
pregnancy
and
lactation.
The
recommended
dosage
must not be exceeded.
_ _
_ _
-
_Before you start to use it _
Tell your doctor if:
•
If you are receiving treatment
with
monoamine-oxidase
inhibitors (MAOI’s)
•
If
you
are
having
heart
disease,
high
blood pressure,
thyroid
disease,
diabetes
or
difficulty in urination.
•
If you are on pregnancy and
breastfeeding.
-
_Taking other medicines

Summary of Product characteristics

NAME OF PRODUCT
Xylocon 0.05% Nasal Drops
Xylocon 0.025% Nasal Drops
NAME AND STRENGTH OF ACTIVE INGREDIENT(S)
Xylocon 0.05% Nasal Drops: Each ml contains Oxymetazoline
Hydrochloride
USP 0.50 mg.
Xylocon 0.025% Nasal Drops: Each ml contains Oxymetazoline
Hydrochloride
USP 0.25 mg.
PRODUCT DESCRIPTION
A clear colorless solution having rose-like odor, filled and sealed in
plastic
container.
PHARMACODYNAMICS
Oxymetazoline is a direct-acting sympathomimetic amine. It acts on
alpha-adren-
ergic receptors in the vessels of the nasal mucosa producing
vasoconstriction and
decongestion. Onset of action is within minutes and lasts 6-8 hours.
PHARMACOKINETICS
Oxymetazoline enters tissues rapidly and local vasoconstriction is
normally
achieved within 5-10 minutes of intranasal administration. The full
effect lasts for
5-6 hours and then gradually subsides over the next 6 hours. Plasma
half-life is
5-8 days with 30% of any absorbed drug being excreted in the urine
unchanged
and 10% being excreted in the faeces.
INDICATION
Rhinitis acuta , sinusitis, eustachitis and otitis media.
RECOMMENDED DOSAGE
_Xylocon 0.025% Nasal Drops_
Unless otherwise prescribed, instill 1 - 2 drops of the Xylocon 0.025%
into each
nostril, 2 - 3 times per day. Xylocon 0.025% should not be used by
children
younger than 1 year. Unless specifically specified by the doctor,
Xylocon 0.025%
should only be used for short periods of time.
_Xylocon 0.05% Nasal Drops_
Unless otherwise prescribed, instill 1 - 2 drops of the Xylocon 0.05%
into each
nostril, 2 - 3 times per day. Xylocon 0.05% should only be used by
adults and
children of school age. Unless specifically specified by the doctor,
Xylocon 0.05%
should only be used for short periods of time.
Permanent use of decongestant rhinological agents may attenuate their
effect.
The abuse of local rhinological agents may cause mucosal atrophy and
reactive
hperaemia with rhinitis medicamentosa. Longer use of oxymetazoline may
cause
damage to the mucosal epithelium with inhibition of ciliary activity.
This may
poss