SALAZINE Enteric Coated Tablet 500mg

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

SULPHASALAZINE

Mevcut itibaren:

IMEKS PHARMA SDN. BHD.

INN (International Adı):

SULPHASALAZINE

Paketteki üniteler:

50 Tablets; 100 Tablets; 500 Tablets

Tarafından üretildi:

Sriprasit Pharma Co. Ltd.

Bilgilendirme broşürü

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SALAZINE ENTERIC COATED TABLET
Sulfasalazine (500 mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What SALAZINE is used for
2.
How SALAZINE works
3.
Before you use SALAZINE
4.
How to use SALAZINE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of SALAZINE
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT SALAZINE IS USED FOR
SALAZINE
is
used
to
treat
and
manage
ulcerative colitis and Crohn's disease which
are inflammatory bowel diseases.
SALAZINE is also used to treat rheumatoid
arthritis, which is a painful joint disease.
HOW SALAZINE WORKS
SALAZINE
contains
the
active
ingredient
sulfasalazine. It is an anti-inflammatory drug
and belongs to a group of medicines called
aminosalicylates.
Ulcerative
colitis
and
Crohn's disease cause inflammation of the
intestine,
leading
to
such
problems
as
abdominal pain and diarrhoea. SALAZINE
can be used to control these symptoms and
help prevent the disease from flaring up. It
also can help prevent damage to joints and
reduce swelling and stiffness in joints.
BEFORE YOU USE SALAZINE_ _
-
_When you must not use it_
Do not take
SALAZINE if you:
• are allergic (hypersensitive) to sulfasalazine
or any ingredients in the formulation.
• are allergic (hypersensitive)
to salicylates
(e.g.
aspirin)
or
sulfonamide
(e.g.
certain
type of antibiotic).
•
have
any
form
of
intestinal
or
urinary
obstruction.
• have a rare blood pigments disorder known
as porphyria.
Do not give SALAZINE to children under 2
years of age.
_If you are not sure whether you should start _
_taking this medicine, consult your doctor. _
_ _
_ _
_ _
_ _
-
_Before you start to use it _
Tell your doctor if you have allergies to any
other
medicines,
foods,
preservatives
or
dyes.
Tell your doctor if you:
•
are
pregnant,
think
you
may
become
pregnant or are trying to become pregnant.
• are breastfeeding or planning to breastfeed.
• have severe allergy or bronchial asthma
(wheezing or shortness of breath).
•

Ürün özellikleri

_ _
SALAZINE ENTERIC COATED TABLET 500MG
FRONT SIDE
80X180 MM
1 COLOR
JOB NAME
เภสัชกรรมศรีประสิทธิ์
ธานินท
ยศ
12/09/2566
(PIS0019) SALAZINE LEAFLET (MALAYSIA) (REV:1)
CONTENT
Each enteric-coated tablet contains Sulfasalazine 500 mg.
DESCRIPTION
Yellow oval biconvex enteric film coated tablet embossed with "S21"
on one side and "SPS" on the other side.
PHARMACODYNAMICS
Sulfasalazine is metabolized by bacteria in the colon into its active
metabolites, sulfapyridine and 5-aminosalicylic acid (mesalazine),
the rest remains as unchanged sulfasalazine. The three compounds
are having active pharmacological effects, principally
immunomodulatory,
antibacterial and alteration of the arachidonic acid cascade and the
activity of certain enzymes. The net result clinically is a reduction
in
the activity of the inflammatory diseases namely ulcerative colitis,
Crohn’s disease and rheumatoid arthritis. A disease modifying effect
is evident in rheumatoid arthritis in one to three months, but
mesalazine
is not believed to be responsible for this effect. There are
improvements
in CRP and other indicators of inflammation together with significant
reduction in progression (Larsen or Sharp Index) in early patients
compared with placebo or hydroxychloroquine treatment over two
years. The benefit appears to be maintained even when the drug
is stopped.
PHARMACOKINETICS
Absorption: 15% of the dose is absorbed from small intestine;
the rest reaches the colon where the azo bond is cleaved by the
intestinal flora, producing sulfapyridine and 5-aminosalicylic acid
(mesalazine). About 60% of the sulfapyridine and 10-30% of the
mesalazine is absorbed from the colon.
Distribution: Sulfasalazine is extensively protein bound (> 99.3%),
while sulfapyridine is only about 70% protein bound and distributed
to most body tissues. Acetylsulfapyridine (AcSP), the principle
metabolite of sulfapyridine, is approximately 90% bound to plasma
proteins. Sulfapyridine crosses the placenta and found i