SINTROM TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ACENOCOUMAROL

Available from:

PALADIN LABS INC.

ATC code:

B01AA07

INN (International Name):

ACENOCOUMAROL

Dosage:

1MG

Pharmaceutical form:

TABLET

Composition:

ACENOCOUMAROL 1MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

COUMARIN DERIVATIVES

Product summary:

Active ingredient group (AIG) number: 0104595001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-09-02

Summary of Product characteristics

PRESCRIBING INFORMATION
SINTROM
1 mg and 4 mg tablets
Oral Anticoagulant
Paladin Labs Inc.
Date of Preparation:
6111 Royalmount Avenue, Suite 102
May 22, 2009
Montreal, Quebec
H4P 2T4
Control No.: 130073
2
NAME OF DRUG
SINTROM
1 MG AND 4 MG TABLETS
THERAPEUTIC CLASSIFICATION
ORAL ANTICOAGULANT
ACTIONS
Sintrom
(acenocoumarol)
a
4-hydroxycoumarin
derivative,
reduces
the
concentration
of
prothrombin
in
blood
and
increases
the
prothrombin
time
by
inhibiting
the
formation
of
prothrombin (coagulation factor II) in the liver. The drug also
interferes with the production of
coagulation factors VII, IX, X, as well as protein C, so their
concentration in the blood is lowered
during therapy.
Coumarin derivatives are vitamin K antagonists. They inhibit the
g-carboxylation of certain
glutamic acid molecules which are located at several sites near the
amino terminal end of vitamin
K-dependent coagulation factors. g-carboxylation has a significant
bearing on the interaction of
the coagulation factors with calcium. Without this reaction, blood
clotting cannot be initiated.
Precisely how coumarin derivatives prevent vitamin K from bringing
about g-carboxylation of the
glutamic acid molecules in the coagulation factors has not yet been
determined.
Depending on the size of the initial dose, maximal effect on
prothrombin time is usually achieved
within 36 to 48 hours. Following a single therapeutic dose or
cessation of therapy, the prothrombin
time usually returns to normal within 48 hours.
Sintrom is rapidly absorbed by the oral route. At least 60% of the
dose is systemically available.
Peak plasma concentrations are generally attained within 1 to 3 hours
of oral administration, with
levels
of
0.3
±
0.05
mg/ml
observed
following
a
single
10
mg
dose.
The
peak
plasma
3
concentrations and the areas under the blood concentration-time curve
(AUC) are proportional to
the size of the dose over a range of 8 to 16 mg.
No correlation can be established between the plasma concentrations of
Sintrom and the apparent
prothrombin level due to va