SHINADEX EYE DROPS

Country: Malaysia

Language: English

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

Active ingredient:

CHLORAMPHENICOL; DEXAMETHASONE SODIUM PHOSPHATE

Available from:

Y.S.P. INDUSTRIES (M) SDN BHD

INN (International Name):

CHLORAMPHENICOL; DEXAMETHASONE SODIUM PHOSPHATE

Units in package:

5.0ml mL

Manufactured by:

Y.S.P. INDUSTRIES (M) SDN BHD

Summary of Product characteristics

ATTACHMENT
1
L
260mm
±
2mm
SHINADEX®
EYE
DROPS
INGREDIENT(S):
Each
ml
contains:
Chloramphenicol
5mg
Dexamethasone
Sodium
Phosphate
1mg
Phenylmercuric
Nitrate
(as
preservative)
0.02mg
PHARMACOLOGY
(SUMMARY
OF
PHARMACODYNAMIC
AND
PHARMACOKINETIC):
PHARMACODYNAMIC
:
The
anti-inflammatory
effect
of
dexamethasone
is
approximately
25
times
stronger
than
that
of
hydrocortisone.
As
an
anti-inflammatory
glucocorticoid,
one
of
the
actions
of
dexamethasone
is
to
inhibit
the
phospholipase
A2,
the
first
step
in
prostaglandin
synthesis.
Also,
dexamethasone
inhibits
the
chemotactic
infiltration
of
neutrophils
into
the
site
of
inflammation.
Chloramphenicol
is
a
low-molecular
weight,
predominantly
lipophilic,
antibiotic,
and
is
effective
against
gram-positive
and
gram
negative
bacteria,
and
also
against
spirochete,
salmonella,
rickettsiae
and
chlamydiae
(trachoma).
The
mechanism
of
action
has
been
shown
to
be
by
selective
inhibition
of
bacterial
protein
synthesis.
PHARMACOKINETIC
:
Dexamethasone
Sodium
Phosphate:
Its
biological
half
life
in
plasma
is
about
190
minutes.
Binding
of
dexamethasone
to
plasma
proteins
is
less
than
for
most
other
corticosteroids.
Corticosteroids
in
the
circulation
are
extensively
bound
to
plasma
proteins,
mainly
to
globulin
and
less
so
to
albumin.
The
corticosteroid-binding
globulin
has
high
affinity
but
low
binding
capacity,
while
the
albumin
has
low
affinity
but
large
binding
capacity.
Only
unbound
corticosteroid
has
pharmacological
effects
or
is
metabolized.
The
synthetic
corticosteroids
are
less
extensively
protein
bound
than
hydrocortisone
(cortisol).
They
also
tend
to
have
longer
half
lives.
Corticosteroids
are
metabolized
mainly
in
the
liver
but
also
in
the
kidney,
and
are
excreted
in
the
urine.
Urinary
excretion
of
1
7-hydroxy-corticoids
is
used
as
an
index
of
adrenal
function.
The
slower
metabolism
of
the
synthetic
corticosteroids
with
their
lower
protein-binding
affinity
may
account
for
their
increased
potency
compared
with
the
natural
corticosteroids.
Chloramphenicol:
Protein
binding
At
pea