Skilax Drops 7.5mgml

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SODIUM PICOSULFATE

Boleh didapati daripada:

MILRIN PHARMACEUTICAL CO. (M) SDN BHD

INN (Nama Antarabangsa):

SODIUM PICOSULFATE

Unit dalam pakej:

15 ml

Dikeluarkan oleh:

TERAPUTICS SDN BHD

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
SKILAX DROPS 7.5MG/ML
Sodium Picosulfate 7.5mg
_ _
WHAT IS IN THIS LEAFLET
1.
What Skilax is used for
2.
How Skilax works
3.
Before you use Skilax
4.
How to use Skilax
5.
While you are using Skilax
6.
Side effects
7.
Storage and disposal of Skilax
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT SKILAX IS USED FOR
Skilax
is
used
for
the
relief
of
constipation. It does not assist with
weight loss.
HOW SKILAX WORKS
Skilax
belongs
to
a
group
of
medicines
called
laxative.
It
stimulates the muscle and movement
of
bowel
as
well
as
softening
the
stools
by
promoting
the
accumulation
of
water
in
the
intestines.
These
bring
overnight
relief from constipation.
BEFORE YOU USE SKILAX
_When you must not use it _
Do not take Skilax if:
-
You
suffer
from
any
of
the
following
intestinal
problems;
blockage
of
intestine
(ileus
or
intestinal
obstruction),
serious
abdominal
conditions
(appendicitis,
severe
abdominal
pain
with
nausea
and
vomiting
and/ or fever) or inflammation of
the bowel.
-
You
are
suffering
from
severe
dehydration.
-
You
are
allergic
to
Sodium
Picosulfate
or
any
of
the
other
ingredients in Skilax.
_Before you start to use it _
Tell your doctor if:
-
You
are
pregnant,
planning
to
become pregnant or you are breast
feeding.
-
You are currently taking any other
medications.
_Taking other medicines _
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines, including
those obtained without a prescription
because
they
may
interact
with
Skilax, such as:
-
Diuretics
(medicine
that
reduces
blood pressure)
-
Steroid
-
Antibiotics
HOW TO USE SKILAX
_How much to use _
-
Adults
and
children
over
10
years old: 5 – 10mg (14 to 27
drops per day).
-
Children under 10 years old: Not
to
be
taken
without
doctor’s
recommendation.
-
Children 4 to 10 years old: 2.5 –
5mg (7 to 14 drops per day).
-
Children under 4 years old: The
recommended dosage is 0.25mg
per kilogram body weight per
day (1m

Ciri produk

SKILAX DROPS 7.5MG/ML
Sodium Picosulfate
COMPOSITION PER ML:
Sodium Picosulfate 7.5 mg
(each ml is approx. equiv. to 20 drops)
PHARMACEUTICAL FORM AND CONTENT:
Solution for oral use in drops. Bottle of 15 ml.
PRODUCT DESCRIPTION:
Clear, colourless to slightly yellowish odourless liquid.
PHARMACODYNAMICS:
Sodium Picosulfate has a local laxative effect, which will stimulate
the mucosa of both the
large intestine and the rectum after bacterial cleavage in the colon.
This results in colonic
peristalsis by promoting accumulation of water and electrolytes in the
colonic lumen. This
stimulation and osmotic effect cause defecation, reduction of transit
time and softening of the
stool. Stimulation of the rectum causes increased motility and a
feeling of rectal fullness.
Sodium Picosulfate has no effect on alteration of digestion or
absorption of calories and
essential nutrients in the small intestine.
PHARMACOKINETICS:
Absorption and Distribution
After oral absorption, Sodium Picosulfate reaches the colon with no
significant absorption
and systemic effect.
Biotransformation
Sodium
Picosulfate
is
converted
into
the
active
form,
bis-(p-hydroxyphenyl)-pyridyl-2-
methane (BHPM), via bacterial cleavage in the distal segment of the
intestine. The onset of
action of the preparation is usually between 6 - 12 hours. The
laxative effect is independent
of the plasma levels of the active moiety.
Elimination
Only small amounts of the active form are absorbed and almost
completely conjugated in the
intestinal wall and liver to form the inactive BHPM glucuronide. After
oral administration of
10mg Sodium Picosulfate 10.4% of the total dose was excreted as BHPM
glucuronide in
urine
after
48
hours.
In
general,
urinary
excretion
is
inversely
proportional
to
the
concentration of Sodium Picosulfate administered.
INDICATION:
For the management and short term relief of constipation of any
aetiology.
RECOMMENDED DOSE:
Adults and children over 10 years old: 5 - 10mg (14 to 27 drops per
day).
Children under 10 years old: Not to be taken by childre