Land: Indonesien
Sprache: Indonesisch
Quelle: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ACETYLSALICYLIC ACID
BAYER INDONESIA - Indonesia
ACETYLSALICYLIC ACID
100 MG
TABLET SALUT ENTERIK
DUS, 3 BLISTER @ 10 TABLET SALUT ENTERIK
BAYER CONSUMER CARE AG - Switzerland
2018-06-29
Under evaluation at BPOM No. Aju : EREG10036612000113 (CCDS 07 – BEC 16098 (BLUE) & CCDS 08 – BEC 16665 (PURPLE)) & Proposal : CCDS 9 – BEC 17992 (RED) 1 CARDIO A SPIRIN ® Acetylsalicylic Acid 100mg ENTERIC COATED TABLET COMPOSITION: Each enteric-coated tablet Cardio Aspirin contains acetyl salicylic acid 100 mg. PHARMACODYNAMIC PROPERTIES : The biochemical mode of action of acetylsalicylic acid on the inhibition of platelet aggregation is therefore based on: 1. An irreversible inhibition of cyclo-oxygenase in the platelets, and 2. A reversible inhibition of cyclo-oxygenase in the vessel wall. PHARMACOKINETIC PROPERTIES ABSORPTION Following oral administration, acetylsalicylic acid is absorbed rapidly and completely from the gastro-intestinal tract. During and after absorption acetylsalicylic acid is converted into its main metabolite, salicylic acid. Due to the principle of the acid-resistant formulation of Cardio Aspirin ® 100/300 mg enteric – coated tablets, acetylsalicylic acid is not released in the stomach but in the alkaline milieu of the intestine. Therefore, C max of acetylsalicylic acid is reached 2-7 hours after administration of the enteric – coated tablets, i.e., delayed in comparison to immediate-release tablets Simultaneous ingestion of food leads to a delayed but complete absorption of acetylsalicylic acid, implying that its rate of absorption, but not the extent of absorption, is altered by food. Due to the mechanistic relationship between the total plasma exposure of acetylsalicylic acid and its inhibitory effect on platelet aggregation, the delay of absorption for Cardio Aspirin ® enteric – coated tablets is not considered relevant for the chronic therapy with low dose Aspirin ® in order to accomplish adequate inhibition of platelet aggregation. Nevertheless, in order to assure the beneficial gastro-resistance of the formulation, Cardio Aspirin ® enteric – coated tablets should be taken preferably (30 minutes or more) before meals, with plenty of liquid _(see section “ Admi Lesen Sie das vollständige Dokument