SALAZOPYRIN EN-TABLET 500 mg

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

有効成分:

SULPHASALAZINE

から入手可能:

PFIZER PRIVATE LIMITED

ATCコード:

A07EC01

投薬量:

500 mg

医薬品形態:

ENTERIC COATED TABLET

構図:

SULPHASALAZINE 500 mg

投与経路:

ORAL

処方タイプ:

Prescription Only

製:

Recipharm Uppsala AB

認証ステータス:

ACTIVE

承認日:

1988-06-01

情報リーフレット

1 

1.  NAME OF THE MEDICINAL PRODUCT 
SALAZOPYRIN EN-TABLET 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION  
Each coated gastro-resistant tablet for oral administration
contains 500 mg of sulfasalazine. 

3. PHARMACEUTICAL 
FORM 
ORAL: gastro-resistant tablets. 

4. CLINICAL 
PARTICULARS 

DESCRIPTION  
Salazopyrin is used for the treatment
of inflammatory bowel diseases and rheumatoid arthritis. The 
use
of enteric coated tablets will reduce the incidence of gastrointestinal side effects. For rheumatoid 
arthritis only Salazopyrin EN-tabs should be used. In the colon
sulfasalazine is split by intestinal 
bacteria into sulfapyridine and 5-aminosalicylic acid.
Sulfasalazine and its metabolites have 
antiflammatory, immunosuppressive and antibacterial effects. 

4.1 THERAPEUTIC INDICATIONS  
TABLETS AND ENTERIC COATED TABLETS 
_Ulcerative colitis_ 
In the treatment of mild to moderate ulcerative
colitis and as adjunctive therapy in severe ulcerative 
colitis. For maintenance of remission in ulcerative colitis.  
_ _
_Crohn’s disease_ 
In the treatment
of active Crohn’s disease, especially in patients with colonic involvement.  

ENTERIC COATED TABLETS 
_Ulcerative colitis and Crohn’s disease._ 
_Rheumatoid Arthritis._ 

SUPPOSITORIES 
_Ulcerative proctitis _ 
4.2  POSOLOGY AND METHOD OF ADMINISTRATION  
TABLETS AND ENTERIC COATED TABLETS 
The dosage should be adjusted according
to the patient’s response to treatment and tolerance to the 
drug. The tablets should be taken at regular intervals during the
day, preferably in connection with 
meals. Patients not
previously treated with Salazopyrin/Salazopyrin EN-tabs are
recommended to 
increase the dose gradually during the first few weeks. The use
of enteric coated tablets will reduce 
the incidence of gastrointestinal side effects. The
enteric coated ta

製品の特徴

1.
NAME OF THE MEDICINAL PRODUCT
Salazopyrin EN-Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated gastro-resistant tablet for oral administration contains
500 mg of
sulfasalazine.
3.
PHARMACEUTICAL FORM
ORAL: gastro-resistant tablets.
4.
CLINICAL PARTICULARS
DESCRIPTION
Salazopyrin
is
used
for
the
treatment
of
inflammatory
bowel
diseases
and
rheumatoid arthritis. The use of enteric coated tablets will reduce
the incidence of
gastrointestinal side effects. For rheumatoid arthritis only
Salazopyrin EN-tabs
should be used. In the colon, sulfasalazine is split by intestinal
bacteria into
sulfapyridine and 5-aminosalicylic acid. Sulfasalazine and its
metabolites have
anti-inflammatory, immunosuppressive and antibacterial effects.
4.1 THERAPEUTIC INDICATIONS
TABLETS AND ENTERIC COATED TABLETS
_Ulcerative colitis_
In the treatment of mild to moderate ulcerative colitis and as
adjunctive therapy in
severe ulcerative colitis. For maintenance of remission in ulcerative
colitis.
_ _
_Crohn’s disease_
In the treatment of active Crohn’s disease, especially in patients
with colonic
involvement.
ENTERIC COATED TABLETS
_Ulcerative colitis and Crohn’s disease._
_Rheumatoid Arthritis._
SUPPOSITORIES
_Ulcerative proctitis_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
TABLETS AND ENTERIC COATED TABLETS
The dosage should be adjusted according to the patient’s response to
treatment
and tolerance to the drug. The tablets should be taken at regular
intervals during
the day, preferably in connection with meals. Patients not previously
treated with
Salazopyrin/Salazopyrin
EN-tabs
are
recommended
to
increase
the
dose
gradually during the first few weeks. The use of enteric coated
tablets will reduce
the incidence of gastrointestinal side effects. The enteric coated
tablets must be
swallowed intact, preferably after meals, and should not be crushed or
broken.
_Inflammatory bowel diseases _
Acute attacks:
_ADULTS _
Severe attacks: 2-4 tablets 3-4 times a day may be given in
conjunction with
steroids as part of an intensive