SW-Dexasone Tablet 0.5mg

Country: Malaysia

Language: English

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

Active ingredient:

DEXAMETHASONE

Available from:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (International Name):

DEXAMETHASONE

Units in package:

1000 Tablets; 500 Tablet Tablets; 100 Tablet Tablets; 1000 Tablet Tablets

Manufactured by:

SUNWARD PHARMACEUTICAL SDN. BHD.

Patient Information leaflet

SW-DEXASONE TABLET
Dexamethasone (0.5mg)
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What SW-Dexasone Tablet is used for
2. How SW-Dexasone Tablet works
3. Before you use SW-Dexasone Tablet
4. How to use SW-Dexasone Tablet
5. While you are using it
6. Side effects
7. Storage and disposal of SW-Dexasone
Tablet
8. Product description
9. Manufacturer and Product Registration
Holder
10. Date of revision
WHAT SW-DEXASONE TABLET IS USED FOR
It is used for primary or secondary
adrenocortical insufficiency (lack of cortisol
hormone),
rheumatic
disorders
(affecting
muscles,
tendons,
joints,
bones),
collagen
diseases (systemic lupus erythematosus), skin
diseases (pemphigus, severe psoriasis, severe
seborrheic dermatitis), bronchial asthma, eye
diseases
(eye
inflammation,
herpes
zoster
ophthalmicus, allergic conjunctivitis), blood
disorders,
cancer
diseases
(leukemias),
swelling states and gastrointestinal diseases
(ulcerative colitis).
HOW SW-DEXASONE TABLET WORKS
The active ingredient in the medicine
is Dexamethasone. It has the capacity to pre-
vent or suppress the development of the local
heat,
redness,
swelling
and
tenderness
by
which
inflammation
is
recognized
at
the
gross level of observation. At the microscopic
level, they inhibit not only the early phenom-
ena of the inflammatory process but also the
later manifestations.
Naturally
occurring
glucocorticoids
which
also have salt- retaining properties are used as
replacement therapy in adrenocortical (hor-
mone) deficiency states. Their synthetic ana-
logs including dexamethasone are primarily
used for their potent anti-inflammatory ef-
fects in disorders of many
organ systems.
Glucocorticoids can cause various metabolic
effects.
It
can
change
a
person’s
body
immune response.
BEFORE YOU USE SW-DEXASONE TABLET
_- When you must not use it _
Do not use SW-Dexasone Tablet if:-

you have systemic fungal infections.

you
have
hypersensitivity
to
dexame-
thasone or any ingredients listed at the end
of this leaflet.

You
have
in

Summary of Product characteristics

SW-DEXASONE TABLET
AMENDED FOR LEAFLET
Each tablet contains:-
Dexamethasone 0.5 mg
PHARMACOLOGY:
Dexamethasone has the capacity to prevent or suppress the development
of the local heat, redness, swelling and
tenderness by which inflammation is recognized at the gross level of
observation. At the microscopic level, they
inhibit not only the early phenomena of the inflammatory process
(edema, fibrin deposition, capillary dilatation,
migration of phagocytes into the inflamed area, and phagocytic
activity) but also the later manifestations (capillary
proliferation, fibroblast proliferation, deposition of collagen and
still later cicatrization). Naturally occurring
glucocorticoids which also have salt-retaining properties, are used as
replacement therapy in adrenocortical
deficiency
states.
Their
synthetic
analogs
including
dexamethasone
are
primarily
used
for
their
potent
anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic
effects. In addition, they modify the body ' s immune responses to
diverse stimuli. At equipotent anti-inflammatory
doses, dexamethasone almost completely lacks the sodium-retaining
property of hydrocortisone. It is among the
most potent glucocorticoids, having about 25-30 times the
anti-inflammatory activity of hydrocortisone. In contrast, its
effect on electrolytes is slight. Dexamethasone is effective when
given by mouth and is absorbed from the
gastrointestinal tract.The steroid exist in plasma in two forms: a
protein bound form and a free form. The binding is
accounted for by two protein fractions. One, ' corticosteroid-binding
globulin ' is a glyco-protein and the other is
plasma albumin. The globulin has high affinity but low total binding
capacity; the albumin has low affinity but
relatively large binding capacity. Consequently, at low or normal
concentration of corticosteroids most of the
hormone is bound to globulin. When the amount of corticosteroid is
increased, concentration of both free and
albumin-bound steroid increase wi