TRIDEX SYRUP

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

MAH:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN:

DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

units_in_package:

90 ml; 90 ml

manufactured_by:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

PIL

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
____
___________________________________________________________________________________________________________
1
TRIDEX SYRUP
Triprolidine hydrochloride 1.25mg/5ml, Pseudoephedrine hydrochloride
30mg/5ml, Dextromethorphan hydrobromide 15mg/5ml
WHAT IS IN THIS LEAFLET:
1.
What Tridex Syrup is used for
2.
How Tridex Syrup works
3.
Before you use Tridex Syrup
4.
How to use Tridex Syrup
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Tridex Syrup
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT TRIDEX SYRUP IS USED FOR
It
is
indicated
to
relieve
dry
irritating
coughs, which are often associated with
common
cold,
upper
respiratory
tract
infections, allergic rhinitis (seasonal and
perennial) and hay fever. It helps to dry
up
running
nose
and
opens
congested
bronchi to aid clear breathing.
HOW TRIDEX SYRUP WORKS
Triprolidine
Hydrochloride
helps
to
reduce secretion in the nose by blocking a
certain natural substance (histamine) that
your
body
makes
during
an
allergic
reaction.
Dextromethorphan acts as a potent cough
suppressant.
Pseudoephedrine’s effect is best seen in
relieving nasal congestion.
BEFORE YOU USE TRIDEX SYRUP
-
_When you must not use it _

If
you
are
allergic
(hypersensitive)
to
Triprolidine
hydrochloride,
Pseudoephedrine
hydrochloride,
Dextromethorphan hydrobromide
or
other
ingredients
in
this
product.

If you are receiving monoamine
oxidase inhibitors.

If
you
have
liver
disease
or
asthmatic.

If you have severe hypertension
or severe coronary artery disease.

If you have persistent or chronic
cough
or
when
coughing
is
accompanied
by
excessive
secretions unless directed by
a
physician.
-
_Before you start to use it _
You must tell your doctor if:

you
have
allergies
to
any
medicine which you have taken
previously to treat your current
condition.

you
are
pregnant,
trying
to
become
pregnant
or
breast-
feeding.
_Pregnancy and breastfeeding _
Safety
of
its
use
duri

SPC

7217-00
TRIDEX SYRUP
An orange color syrup with tutti-frutti flavour.
PHARMACOLOGY:
Triprolidine, a histamine H
1
-receptor antagonists, competitively inhibit most of the pharmacologic
actions of histamine.
It effectively antagonizes the action of histamine that results in
increased capillary permeability and the formation of
edema. This H
1
-receptor antagonist also suppresses flare and pruritis which
accompany the endogenous release of
histamine.
Dextromethorphan retains only the antitussive activity of other
morphinan derivatives. It is about equal to codeine in
depressing the cough reflex and has no expectorant action. In
therapeutic dosage, dextromethorphan does not inhibit
ciliary activity.
Pseudoephedrine acts directly on the alpha-adrenergic receptors in the
mucosa of the respiratory tract producing
vasoconstriction which results in shrinkage of swollen nasal mucous
membranes, reduction of tissue hyperemia, edema
and nasal congestion, and an increase in nasal airway patency.
PHARMACOKINETICS:
Triprolidine is readily absorbed from the gastrointestinal tract after
oral administration. It is mostly metabolised in the
liver and excreted mainly as inactive metabolites in the urine. It has
a rapid onset and long duration of action.
Following oral administration of antihistamines, symptomatic relief of
allergic reactions usually begins within 15-30
minutes and usually the maximum effect occurs within 1 hour.
Dextromethorphan is rapidly absorbed from the GI tract and exerts its
effect in 15-30 minutes after oral administration.
The duration of action is approximately 3 to 6 hours with conventional
dosage forms.
Pseudoephedrine is rapidly absorbed from the GI tract and exerts its
effect within 30 minutes after oral administration
of 60mg of pseudoephedrine hydrochloride and persists for 4-6 hours.
Pseudoephedrine is incompletely metabolized in
the liver to an inactive metabolite. 55-75% of the drug is excreted
unchanged in urine, together with its metabolites.
The rate of urinary excretion of pseudoephedrine is ac