PROPYL TABLET 50MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PROPYLTHIOURACIL

Boleh didapati daripada:

IMEKS PHARMA SDN. BHD.

INN (Nama Antarabangsa):

PROPYLTHIOURACIL

Unit dalam pakej:

500 Tablets

Dikeluarkan oleh:

Sriprasit Pharma Co. Ltd.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PROPYL TABLET 50MG
Propylthiouracil (50mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What PROPYL is used for
2.
How PROPYL works
3.
Before you use PROPYL
4.
How to use PROPYL
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of PROPYL
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT PROPYL IS USED FOR
PROPYL is used to treat hyperthyroidism or
overactive thyroid gland (a condition where
the thyroid gland produces too much thyroid
hormone).
It
may
also
be
used
to
treat
symptoms of hyperthyroidism before surgery
or radioactive iodine therapy.
HOW PROPYL WORKS
PROPYL
contains
the
active
ingredient
Propylthiouracil which belongs to a group of
medicines called antithyroid drugs. It works
by reducing the amount of thyroid hormones
made in your thyroid gland.
BEFORE YOU USE PROPYL_ _
-
_When you must not use it_
Do not take PROPYL if you:
• are allergic to propylthiouracil or related
thioamide derivatives or any ingredients in
the formulation.
_If you are not sure whether you should start _
_taking this medicine, talk to your doctor. _
-
_Before you start to use it _
Tell your doctor if you:
• have allergies to any other medicines, food,
preservatives or dyes.
• are prone to getting infections.
• have ever had any problems with your liver
or kidneys.
• have or have had asthma.
• are pregnant, may become pregnant or are
breastfeeding.
Tell your doctor or pharmacist immediately
if during treatment you suffer from:
• sore throat, fever, mouth ulcers or other
symptoms
of
infection
because
PROPYL
may affect your body’s ability to fight an
infection.
• liver problems or the side effects of liver
problems such as anorexia, itching or pain in
the upper part of stomach on the right side.
• kidney problems.
Your doctor will arrange for you to have
regular
blood
tests
to
make
sure
that
the
medicine is working properly.
Check
with
your
doctor
if
any
of
the
following applies to you:
•
Some
cases
of
severe
li

Ciri produk

DESCRIPTION
White round biconvex tablet with a bisect and embossed with
“PROPYL”, “SPS” on
one side, plain on the other.
Each PROPYL tablet contains 50mg Propylthiouracil USP.
PHARMACODYNAMICS
Within the thyroid gland, PROPYL depresses the formation of
iodotyrosines by inhibiting
the iodination of thyroglobulin, and reduction of the synthesis of
triiodothyronine and
thyroxine by inhibiting the coupling reaction between iodotyrosines.
In addition, PROPYL
blocks the peripheral deiodination of thyroxine (T
4
) to the more potent triiodothyronine
(T
3
). PROPYl does not interfere with the action and release of thyroid
hormones already
formed. Therefore, patients may only respond to PROPYl after depletion
of circulating
and colloid-stored thyroid hormones. The rapid fall in serum
triiodothyronine (T
3
)
concentration, before serum thyroxine (T
4
) levels fall, parallels a clinical improvement
in the thyrotoxic patient, and is generally seen after the first
week. The patient may
become euthyroid after 4-6 weeks. Hence, a decreased rate of
conversion of circulating
thyroxine (T
4
) to triiodothyronine (T
3
) may be clinically beneficial in patients with
thyrotoxic crisis, since metabolic activity of triiodothyronine (T
3
) is 3 to 5 times that
of thyroxine (T
4
).
PHARMACOKINETICS
Absorption: Propylthiouracil is rapidly absorbed from the
gastrointestinal tract and
has a bioavailability of 50-75%.
Distribution: Propylthiouracil appears to be concentrated in the
thyroid gland. It readily
crosses the placenta and is distributed into breast milk. About 80% of
propylthiouracil
is protein bound.
Metabolism: Propylthiouracil undergoes rapid first-pass metabolism in
the liver where
it is metabolised to its glucuronic acid conjugate.
Excretion: The elimination half-life of propylthiouracil is estimated
to be 1-2 hours.
Propylthiouracil is mainly excreted in the urine as the glucuronic
acid conjugate.
Very little unchanged drug is excreted in the urine and negligible
amounts are excreted
in the faeces.
INDICATION
PROPY