Country: Canada
Language: English
Source: Health Canada
ACETYLSALICYLIC ACID
PENDOPHARM DIVISION OF PHARMASCIENCE INC
N02BA01
ACETYLSALICYLIC ACID
650MG
TABLET (ENTERIC-COATED)
ACETYLSALICYLIC ACID 650MG
ORAL
50/100/115/1000
OTC
SALICYLATES
Active ingredient group (AIG) number: 0101169002; AHFS:
APPROVED
2002-03-11
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 Read the complete document