ENTROPHEN ECT 975MG TABLET (ENTERIC-COATED)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ACETYLSALICYLIC ACID

Dostopno od:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Koda artikla:

N02BA01

INN (mednarodno ime):

ACETYLSALICYLIC ACID

Odmerek:

975MG

Farmacevtska oblika:

TABLET (ENTERIC-COATED)

Sestava:

ACETYLSALICYLIC ACID 975MG

Pot uporabe:

ORAL

Enote v paketu:

50/100/500

Tip zastaranja:

OTC

Terapevtsko območje:

SALICYLATES

Povzetek izdelek:

Active ingredient group (AIG) number: 0101169004; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2002-03-11

Lastnosti izdelka

1
PRODUCT MONOGRAPH
ENTROPHEN
(ACETYLSALICYLIC ACID DELAYED RELEASE TABLETS/CAPLETS USP)
325, 500, 650 & 975mg
NONSTEROIDAL ANTI-INFLAMMATORY, ANALGESIC AGENT
PLATELET AGGREGATION INHIBITOR
PENDOPHARM, DIVISION OF/DE PHARMASCIENCE INC. DATE OF PREPARATION:
8580 ESPLANADE JUNE 28, 2006
MONTREAL (QUEBEC) CANADA
H2P 2R8
DATE DE REVISION:
APRIL 18, 2007
CONTROL NO.: 105396
2
PRODUCT MONOGRAPH
ENTROPHEN TABLETS
NONSTEROIDAL ANTI-INFLAMMATORY ANALGESIC AGENT PLATELET AGGREGATION
INHIBITOR
ACTION AND CLINICAL PHARMACOLOGY
Entrophen (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 ENTROPHEN
are enteric-coated, the pharmacological effects are not immediate.
Peak serum
salicylate concentrations are reached 6 to 8 hours after single oral
adminis