PMS-SULFASALAZINE-E.C. TAB 500MG TABLET (ENTERIC-COATED)

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

SULFASALAZINE

Доступна з:

PHARMASCIENCE INC

Код атс:

A07EC01

ІПН (Міжнародна Ім'я):

SULFASALAZINE

Дозування:

500MG

Фармацевтична форма:

TABLET (ENTERIC-COATED)

Склад:

SULFASALAZINE 500MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100/500

Тип рецепту:

Prescription

Терапевтична области:

SULFONAMIDES

Огляд продуктів:

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

Статус Авторизація:

MARKETED

Дата Авторизація:

1984-12-31

Характеристики продукта

PRODUCT MONOGRAPH
PR
PMS-SULFASALAZINE
Sulfasalazine Tablets USP
500 mg
PR
PMS-SULFASALAZINE-E.C.
Sulfasalazine Delayed-Release Tablets USP
500 mg
ANTI-INFLAMMATORY
Treatment of Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's
Disease (all dosage forms)
Rheumatoid Arthritis (
pms-SULFASALAZINE-E.C.
Tablets only)
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Avenue, Suite 100
April 30, 2020
Montréal, Canada
H4P 2T4
www.pharmascience.com
Submission Control No.: 237428
_pms-SULFASALAZINE & pms-SULFASALAZINE-E.C. Product Monograph _
_Page 2 of 30_
PR
PMS-SULFASALAZINE
(Sulfasalazine Tablets USP)
PR
PMS-SULFASALAZINE-E.C.
(Sulfasalazine Delayed-Release Tablets USP)
PART I: HEALTH PROFESSIONAL INFORMATION
THERAPEUTIC CLASSIFICATION
Anti-inflammatory drug
ACTION AND CLINICAL PHARMACOLOGY
About 20% of 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 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 concentration
after 12 hours. Sulfapyridine has a tend