SALAZOPYRIN EN-TABS 500 MG TABLET (ENTERIC-COATED)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

SULFASALAZINE

Dostępny od:

PFIZER CANADA ULC

Kod ATC:

A07EC01

INN (International Nazwa):

SULFASALAZINE

Dawkowanie:

500MG

Forma farmaceutyczna:

TABLET (ENTERIC-COATED)

Skład:

SULFASALAZINE 500MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/300

Typ recepty:

Prescription

Dziedzina terapeutyczna:

SULFONAMIDES

Podsumowanie produktu:

Active ingredient group (AIG) number: 0106101001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2001-06-07

Charakterystyka produktu

_Salazopyrin_
®
_Product Monograph _
1
PRODUCT MONOGRAPH
PR
SALAZOPYRIN
®
Sulfasalazine tablets USP, 500 mg
PR
SALAZOPYRIN EN-TABS
®
(Sulfasalazine delayed-release tablets USP, 500 mg)
ANTI-INFLAMMATORY
(Treatment of inflammatory bowel disease, ulcerative colitis, Crohn's
disease all dosage forms)
rheumatoid arthritis (Salazopyrin EN-tabs only)
Pfizer Canada ULC
Date of Revision:
17,300 Trans-Canada Highway
October 19, 2020
Kirkland, Quebec H9J 2M5
CONTROL NO. 239257
®
Pfizer Health AB
Pfizer Canada ULC, Licensee

Pfizer Canada ULC 2020
_ _
_Salazopyrin_
®
_Product Monograph _
2
NAME OF DRUG
Pr
SALAZOPYRIN
®
(Sulfasalazine tablets USP, 500 mg),
Pr
SALAZOPYRIN EN-tabs
®
(Sulfasalazine delayed-release tablets USP, 500 mg),
THERAPEUTIC CLASSIFICATION_ _
Anti-inflammatory drug
ACTION AND CLINICAL PHARMACOLOGY
About 20% of SALAZOPYRIN (sulfasalazine) is absorbed in the small
intestine after oral
administration. A small percentage of the absorbed sulfasalazine is
excreted in the urine and the
rest via the bile into the small intestine (enterohepatic
circulation). This portion together with the
unabsorbed sulfasalazine enters the colon where it is split by
bacteria into two main metabolites,
sulfapyridine and 5-amino-salicylic acid (5-ASA). The peak serum
concentration is reached after
3-5 hours. The mean serum half-life after a single dose is about 6
hours; after repeated doses it is
about 8 hours. After intake of SALAZOPYRIN EN-tabs (sulfasalazine
delayed-release tablets),
sulfasalazine has been detected in serum somewhat later than after
intake of plain tablets, as
expected, the peak serum concentration being observed between 3 and 12
hours.
Sulfapyridine is absorbed, partially acetylated and/or hydroxylated in
the liver and/or conjugated
with glucuronic acid. In patients who are slow acetylators, the serum
concentration of free
sulfapyridine is higher than that in fast acetylators. The major part
is excreted in the urine.
Non-acetylated sulfapyridine is bound to serum proteins and reaches a
maximum serum
c