PMS-ASA EC TABLET (DELAYED-RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ACETYLSALICYLIC ACID

Boleh didapati daripada:

PHARMASCIENCE INC

Kod ATC:

N02BA01

INN (Nama Antarabangsa):

ACETYLSALICYLIC ACID

Dos:

325MG

Borang farmaseutikal:

TABLET (DELAYED-RELEASE)

Komposisi:

ACETYLSALICYLIC ACID 325MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

1000

Jenis preskripsi:

OTC

Kawasan terapeutik:

SALICYLATES

Ringkasan produk:

Active ingredient group (AIG) number: 0101169001; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2018-05-07

Ciri produk

1
PRODUCT MONOGRAPH
pms-ASA EC
(Acetylsalicylic Acid Delayed Release Tablets USP)
325 mg and 650 mg
Nonsteroidal Anti-inflammatory, Analgesic Agent
Platelet Aggregation Inhibitor
Pharmascience Inc.
Date of Preparation:
6111 Royalmount Ave. # 100
August 10, 2006
Montreal, Quebec
H4P 2T4
Control No.: 107504
2
PRODUCT MONOGRAPH
pms-ASA EC
Nonsteroidal Anti-inflammatory Analgesic Agent Platelet Aggregation
Inhibitor
ACTION AND CLINICAL PHARMACOLOGY
pms-ASA EC (acetylsalicylic acid) has analgesic, antipyretic and
anti-inflammatory properties.
In rheumatic diseases, although the analgesic and antipyretic effects
are useful, the major purpose
for which ASA is used is to reduce the intensity of the inflammatory
process. Inhibition of
prostaglandin synthesis may be involved in the anti-inflammatory
action of ASA.
ASA also alters platelet aggregation and release reaction by
inhibiting prostagiandin synthesis.
Thromboxane A2 is an essential step in platelet aggregation. ASA
prevents Thromboxane A2
formation by acetylation of platelet cyclooxygenase. This inhibition
of prostaglandin synthesis is
irreversible and affects platelet function for the life of the
platelet.
The enteric coating substantially resists disintegration in aqueous
fluids having a pH lower than 3.5
for a period of at least 2 hours and is capable of disintegrating in
aqueous fluids having a pH of at
least 5.5 in from 10 to 30 minutes. Thus, enteric coating effectively
inhibits the release of ASA in
the stomach, while allowing the tablet to dissolve in the upper
portion of the small intestine for
absorption from the duodenal area.
Clinical experience has shown that enteric-coated acetylsalicylic acid
diminishes or eliminates
gastric distress during long-term treatment with high doses of ASA.
3
Pharmacokinetic Information
Since pms-ASA EC are enteric-coated, the pharmacological effects are
not immediate. Peak serum
salicylate concentrations are reached 6 to 8 hours after single oral
administration. This means that
pms-ASA EC tablets are more useful for chroni