ANPRODEX TABLETS 2 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DEXCHLORPHENIRAMINE MALEATE

Boleh didapati daripada:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

DEXCHLORPHENIRAMINE MALEATE

Unit dalam pakej:

1000 Tablets

Dikeluarkan oleh:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
ANPRODEX TABLETS
Dexchlorpheniramine maleate (2mg)
WHAT IS IN THIS LEAFLET:
1.
What Anprodex Tablets is used
for
2.
How Anprodex Tablets works
3.
Before you use Anprodex Tablets
4.
How to use Anprodex Tablets
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
of
Anprodex Tablets
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ANPRODEX TABLETS IS USED FOR
Dexchlorpheniramine
Maleate
is
indicated for symptomatic treatment
of

perennial (symptoms are present
throughout the year) and seasonal
allergic rhinitis (inflammation of
nose)

vasomotor (non-allergic) rhinitis.

allergic
conjunctivitis
(inflammation of the membrane
covering the eye)

mild, uncomplicated allergic skin
manifestations
of
urticaria
(a
raised, itchy rash on skin caused
by
an
allergic
reaction)
and
angioedema (swelling under the
skin)

allergic
reactions
to
blood
plasma.

Skin
conditions
e.g.
allergic
eczema (itchy skin condition with
redness, swelling, oozing of fluid,
crusting
which
may
lead
to
scaling), atopic dermatitis (a
type
of
eczema),
contact
dermatitis
(inflammation
caused
by
contact
with
a
foreign
substance),
insect
bites,
dermographism
(a
condition
in
which
lightly
touching
or
scratching the skin causes raised,
reddish
marks)
and
medicine
reactions.
HOW ANPRODEX TABLETS WORKS
It
contains
the
active
ingredient
dexchlorpheniramine
maleate.
Dexchlorpheniramine
maleate
is
an
antihistamine.
Histamine
is
a
chemical
released
into
the
body
during an allergic reaction. It causes
itching and inflammation.
Anprodex Tablets works by blocking
the effects of the naturally occurring
chemical histamine in your body.
BEFORE YOU USE ANPRODEX TABLETS
_-When you must not use it _

If
you
are
allergic
(hypersensitive)
to
Dexchlorpheniramine Maleate or
to an antihistamine or any of the
other
ingredients
of
Anprodex
Tablets.

If you are receiving monoamine
oxidase
inhibitors
(MAOIs)
therapy for depression treatment.

I

Ciri produk

7143-02
NAME AND STRENGTH OF ACTIVE SUBSTANCE:
Each tablet contains :
Dexchlorpheniramine
maleate………………………………………………………..
2mg
PRODUCT DESCRIPTION:
A red, scored, flat of oval tablet (7.7x5.25mm)
PHARMACODYNAMICS:
Dexchlorpheniramine is the dextrorotarory isomer of chlorpheniramine
maleate, which is a racemic
mixture,
and
has
approximately
twice
the
activity
of
chlorpheniramine
on
a
weight
basis.
Dexchlorpheniramine maleate is a histamine H1-receptor antagonist,
used in symptomatic relief
of
hypersensitivity reactions and in pruritic skin disorders. The
antihistaminic activity appears to compete
with histamine for cell receptor sites on effector cells.
PHARMACOKINETICS:
Chlorpheniramine maleate appears to be well absorbed following oral
administration. However, the drug
undergoes substantial metabolism in the GI mucosa during absorption
and on first pass through the liver.
Limited data indicate that about 25-45% of a single oral dose of
chlorpheniramine as conventional tablets,
reaches the systemic circulation as unchanged drug. Following oral
administration, chlorpheniramine
appears in plasma within 30-60 minutes and the peak plasma
concentration of the drug occurs within 2-6
hours.
Distribution of chlorpheniramine into human body tissues and fluids
has not been fully characterized.
Following IV administration in rabbits, highest concentration of the
drug are attained in lungs, heart,
kidneys, brain, small intestine, and spleen, with lower concentrations
in the large intestine, muscle,
stomach, adrenals, fat, liver and mesentery. Following IV
adminstration in humans, chlorpheniramine
undergoes rapid and extensive distribution with an average apparent
steady-state volume of 2.5-3.2L/kg in
adults and 3.8L/kg in children. Chlorpheniramine is distributed into
saliva and the drug/or its metabolite
appear to be distributed in small amounts in bile. Invitro,
chlorpheniramine is approximately 69-72% bound
to plasma protein.
Chlorpheniramine is rapidly and extensively metabolized,