AXCEL OXYMETAZOLINE 0.025% NASAL DROPS

国家: 马来西亚

语言: 英文

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

有效成分:

OXYMETAZOLINE HYDROCHLORIDE

可用日期:

KOTRA PHARMA (M) SDN. BHD.

INN（国际名称）:

OXYMETAZOLINE HYDROCHLORIDE

每包单位数:

10ml mL

厂商:

KOTRA PHARMA (M) SDN. BHD.

资料单张

AXCEL OXYMETAZOLINE 0.025% NASAL DROPS
Oxymetazoline HCl (0.025% w/v)
1
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1.
What
Axcel
Oxymetazoline
0.025% Nasal Drops
is used for.
2.
How
Axcel
Oxymetazoline
0.025% Nasal Drops works.
3.
Before
you
use
Axcel
Oxymetazoline
0.025%
Nasal
Drops.
4.
How
to
take
Axcel
Oxymetazoline
0.025%
Nasal
Drops.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Oxymetazoline
0.025%
Nasal
Drops.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT
AXCEL
OXYMETAZOLINE
0.025% NASAL DROPS IS USED FOR
Axcel Oxymetazoline 0.025% Nasal
Drops
is
used
for
relief
of
nasal
congestion in acute colds, paranasal
sinusitis (inflammation of the sinuses
at the air spaces within the bones of
the
face)
and
otitis
media
(inflammation of the middle ear).
HOW AXCEL OXYMETAZOLINE 0.025%
NASAL DROPS WORKS
Oxymetazoline is a direct – acting
sympathomimetic agent which has a
vasoconstrictor
effect
on
mucosal
blood
vessels.
Sympathomimetic
agent
is
widely
used
as
nasal
decongestants
to
provide
symptomatic
relief.
They
act
by
vasoconstriction
and
redistributing
local blood flow to reduce oedema of
the
nasal
mucosa
(swelling
of
the
mucous membrane) thus improving
ventilation,
drainage
and
nasal
stuffiness.
BEFORE
YOU
USE
AXCEL
OXYMETAZOLINE
0.025%
NASAL
DROPS
_-When you must not use it _
Do
not
use
Axcel
Oxymetazoline
0.025% Nasal Drops if:

If
you
are
allergic
or
hypersensitive to Oxymetazoline
and Benzalkonium Chloride.

If you have inflammation of the
skin and rhinitis sicca (chronic
form of dryness of the mucous
membranes).

Do not use Axcel Oxymetazoline
0.025% Nasal Drops if you are
pregnant, trying to get pregnant
or think you may be pregnant.

Do not use Axcel Oxymetazoline
0.025% Nasal Drops if you are
breast-feeding. Ask your doctor
or pharmacist for advice before
taking any medicine.
_-Before you start to use it _
Tell your doctor if:

If
you
are
receiving
treatment
with
monoamine-ox

产品特点

MAL20040821AZ
COMPOSITION:
Contains Oxymetazoline HCl 0.025% w/v
(Benzalkonium Cl 0.01% w/v as preservative)
PRESENTATION:
Clear, colourless liquid.
INDICATIONS:
Relief of nasal congestion in acute colds, paranasal sinusitis and
otitis media.
PHARMACOLOGY:
_Mechanism of Action:_
Oxymetazoline is a direct-acting sympathomimetic agent which has a
vasoconstrictor
effect
on
mucosal
blood
vessels.
Sympathomimetic agent mimic the actions produced by stimulation
of
postganglionic
sympathetic
or
adrenergic
nerves,
including
vasoconstriction
of
blood
vessels
supplying
skin
and
mucous
membranes.
Topical
use
of
Oxymetazoline
has
the
advantage of selective of site of action and more rapid action than do
oral agents. It acts within a few minutes and the effects last for up
to
12 hours. Nasal congestion is frequently a symptom of conditions
such as rhinitis. Sympathomimetic agents are widely employed as
nasal decongestants to provide symptomatic relief. They act by
vasoconstriction and redistributing local blood flow to reduce oedema
of the nasal mucosa thus improving ventilation, drainage and nasal
stuffiness.
_Pharmacokinetics:_
Most sympathomimetic agents undergo enzymatic degradation in the
gut and first-pass metabolism of the liver. They are inactivated by
the
enzymes
catechol-O-methyltransferase
(COMT)
and
monoamine
oxidase (MAO). The metabolites are excreted in the urine mainly as
their glucuronide and ethereal sulphate conjugates. Oxymetazoline,
however, is an imidazoline derivative and is more resistant to the
inactivating enzymes of liver and other tissues. It is thus longer
action
and metabolised at a slower rate than the catecholamines such as
ephedrine or phenylephrine. When used in the form of nasal drops it
acts with a few minutes and the effects lasts for several hours.
DIRECTION FOR USE:
For nasal use.
In cases of rhinitis and sinusitis small children receive 1 – 2
drops of
the Axcel Oxymetazoline 0.025% Nasal Drops, instilled into each
nostril, 2 – 3 times daily.
Axcel Oxymetazoline 0.025% Nasal Drops sho