PMS-SULFASALAZINE 500MG/TAB USP TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

SULFASALAZINE

Sẵn có từ:

PHARMASCIENCE INC

Mã ATC:

A07EC01

INN (Tên quốc tế):

SULFASALAZINE

Liều dùng:

500MG

Dạng dược phẩm:

TABLET

Thành phần:

SULFASALAZINE 500MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100/500

Loại thuốc theo toa:

Prescription

Khu trị liệu:

SULFONAMIDES

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

MARKETED

Ngày ủy quyền:

1984-12-31

Đặc tính sản phẩm

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