NTP-5-AMINOSALICYLIC ACID TABLET (ENTERIC-COATED)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MESALAZINE

Available from:

TEVA CANADA LIMITED

ATC code:

A07EC02

INN (International Name):

MESALAZINE

Dosage:

400MG

Pharmaceutical form:

TABLET (ENTERIC-COATED)

Composition:

MESALAZINE 400MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0116808001; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2015-08-06

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
NTP-5-AMINOSALICYLIC ACID
(5-aminosalicylic acid)
400 mg Enteric Coated Tablets
Lower Gastrointestinal, Anti-inflammatory
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 165695
Date of Preparation:
June 21, 2013
2
PRODUCT MONOGRAPH
PR
NTP-5-AMINOSALICYLIC ACID
(5-aminosalicylic acid)
400 mg Enteric Coated Tablets
THERAPEUTIC CLASSIFICATION
Lower Gastrointestinal, Anti-inflammatory
ACTION AND CLINICAL PHARMACOLOGY
NTP-5-AMINOSALICYLIC ACID (5-aminosalicylic acid) is thought to be the
major active
component of sulphasalazine for the treatment of inflammatory bowel
disease. Its mechanism of
action is not fully elucidated, however, evidence suggests that it has
a topical anti-inflammatory
effect on the colon, where it may inhibit prostaglandin and
leukotriene synthesis.
NTP-5-AMINOSALICYLIC ACID tablets have an acrylic based resin coating,
which does not
allow the drug to be released below pH 5.5. Thus the coating delays
release of the 5-
aminosalicylic acid until it reaches the terminal ileum and colon.
Once released in the colon, 5-
aminosalicylic acid is minimally absorbed and plasma levels are
similar to those found following
rectal administration. The absorbed drug is rapidly acetylated through
the gut mucosal wall and
by the liver. The drug is excreted mainly by the kidney as
N-acetyl-5-aminosalicylic acid.
A randomized, double-blind, parallel, multi-center clinical study was
conducted in 201 patients
diagnosed with ulcerative colitis of mild to moderate intensity to
compare the efficacy and safety
of two oral formulations of 5-aminosalicylic 400 mg enteric coated
tablet products. The study
demonstrated therapeutic equivalence of NTP-5-AMINOSALICYLIC ACID 400
mg tablets and
ASACOL
®
400 mg tablets when administered at a daily dose of 3.2 gm for up to 8
weeks. Both
treatments were well tolerated and there was no evidence of a
difference between the two
treatments for intercurrent events in nature, severity, or frequency.
INDICATIONS
NTP-5-AMINO