CARDIO ASPIRIN

País: Indonèsia

Idioma: indonesi

Font: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

ingredients actius:

ACETYLSALICYLIC ACID

Disponible des:

BAYER INDONESIA - Indonesia

Designació comuna internacional (DCI):

ACETYLSALICYLIC ACID

Dosis:

100 MG

formulario farmacéutico:

TABLET SALUT ENTERIK

Unidades en paquete:

DUS, 3 BLISTER @ 10 TABLET SALUT ENTERIK

Fabricat per:

BAYER CONSUMER CARE AG - Switzerland

Data d'autorització:

2018-06-29

Fitxa tècnica

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