Apo-Azathioprine 50mg Tablets

Страна: Малайзия

Език: английски

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

Активна съставка:

AZATHIOPRINE

Предлага се от:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Международно Name):

AZATHIOPRINE

Броя в опаковка:

100Tablet Tablets

Произведено от:

RPG LIFE SCIENCES LTD

Листовка

APO-AZATHIOPRINE TABLET
Azathioprine (50mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Apo-Azathioprine is used for
2.
How Apo-Azathioprine works
3.
Before you use Apo-Azathioprine
4.
How to use Apo-Azathioprine
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Apo-
Azathioprine
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT APO-AZATHIOPRINE IS USED FOR
Azathioprine is used to prevent your
body from rejecting a transplanted organ,
like kidney and liver. It is also used to
treat symptoms where control of the
immunity system is required.
Apo-Azathioprine is usually taken in
combination with other medicines such
as corticosteroids or other
immunosuppressive medicines
HOW APO-AZATHIOPRINE WORKS
Apo-Azathioprine contains azathioprine,
which is a type of immunosuppressant. It
works by lowering your body's immune
system.
The immune system helps your body
fight infections; however, the immune
system can also fight or "reject" a
transplanted organ such as a liver or
kidney. This is because the immune
system treats the new organ as an
invader. Azathioprine is used to prevent
your body from rejecting a transplanted
kidney. It also works in particular cases
where the immune system requires
adjustment.
BEFORE YOU USE APO-AZATHIOPRINE
-
_When you must not use it _
Do not take this medication if you are
allergic to azathioprine or any other
ingredients in this medication.
_ _
_Pregnancy and lactation _
Do not take Apo-Azathioprine if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Apo-Azathioprine if you
are breast-feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
-
_Before you start to use it _
Before you start using this medication,
you need to inform your doctor if:
•
you are planning to undergo any form
of surgery during, and after the
period of taking Apo-Azathioprine.
•
you have a condition where your
body produces too little of a natural
chemical

Данни за продукта

APO‐AZATHIOPRINE
AZATHIOPRINE TABLETS USP 50 MG
IMMUNOSUPPRESSIVE AGENT
PRODUCT DESCRIPTION
Pale yellow, flat‐faced, peanut‐shaped, beveled‐edge tablets,
scored and engraved “AZ 50” on one side, “APO” on the other.
Apo‐Azathioprine
50mg is packed in HDPE bottles of 100 tablets.
PHARMACOKINETICS
Azathioprine is well absorbed following oral
administration. After oral administration of [35S]‐azathioprine, the
maximum plasma radioactivity
occurs at 1‐2 hours and decays with a half‐life of 4‐6 hours.
This is not an estimate of the half‐life of azathioprine itself, but
reflects the
elimination from plasma of azathioprine and the [35S]‐containing
metabolites of the drug. Studies in which the plasma concentration of
azathioprine and 6‐MP have been determined following intravenous
administration of azathioprine have estimated the mean plasma T1/2 for
azathioprine to be in the range of 6‐28 minutes and the mean plasma
T1/2 for 6‐MP to be in the range 38‐114 minutes after i.v.
administration
of the drug.
Azathioprine is principally excreted as 6‐thiouric uric acid in the
urine. 1‐methyl‐4‐nitro‐5‐thioimidazole has also been
detected in urine as a
minor excretory product. A small proportion of the drug may be cleaved
between the sulphur‐atom and the purine ring. Only a small amount of
the dose of azathioprine administered is excreted unmetabolised in the
urine.
PHARMACODYNAMICS
Azathioprine is an imidazole derivative of 6‐mercaptopurine
(6‐MP). It is rapidly broken down _in vivo _into 6‐MP and a
methylnitroimidazole
moiety. The 6‐MP readily crosses cell membranes and is converted
intracellularly into a number of purine thioanalogues, which include
the
main active nucleotide, thioinosinic acid. The rate of conversion
varies from one person to another. Nucleotides do not traverse cell
membranes and therefore do not circulate in body fluids. Irrespective
of whether it is given directly or is derived _in vivo _from
azathioprine, 6‐
MP is eliminated mainly as the inact