Vasoten F.C. Tablets 5mg

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

BISOPROLOL FUMARATE

Available from:

APEX PHARMACY MARKETING SDN. BHD.

INN (International Name):

BISOPROLOL FUMARATE

Units in package:

100Tablet Tablets

Manufactured by:

SYNMOSA BIOPHARMA CORPORATION

Summary of Product characteristics

VASOTEN F.C. TABLETS 5MG
(Bisoprolol Fumarate)
17/08/2010
1 of 8
COMPOSITION:
Each tablet contains: Bisoprolol Fumarate 5mg
PRODUCT DESCRIPTION:
Yellow to light-yellow, heart-shaped, biconvex film coated tablets,
and vertically scored in half on both sides.
CLINICAL PHARMACOLOGY:
-
PHARMACODYNAMICS:
Bisoprolol is a beta1-selective adrenergic blocking agent. The drug
does not exhibit the intrinsic sympathomimetic activity seen with
pindolol or the membrane-stabilizing activity possessed by propranolol
or pindolol. At low dosages, bisoprolol selectively inhibits
response
to
adrenergic
stimuli
by
competitively
blocking
cardiac
beta1-adrenergic
receptors,
while
having
little
effect
on
the
beta2-adrenergic receptors of bronchial and vascular smooth muscle. At
high doses (e.g., 20mg or higher), the selectivity of bisoprolol on
beta1- and beta2-adrenergic receptors usually diminishes, and the drug
will competitively inhibit and adrenergic receptors.
-
PHARMACOKINETICS:
Bisoprolol is absorbed almost completely from the gastrointestinal
tract. Together with the very small first pass effect in the liver,
this
results in a high bioavailability of approximately 90%. The drug is
cleared equally by the liver and kidneys.
The long plasma half-life (9-12 hours) provides 24-hour efficacy
following a once daily dosage. About 95% of the drug substance is
excreted through the kidneys, 50% of a dose as unchanged bisoprolol.
There are no active metabolites in man.
There are limited data in children and an appropriate dosing regimen
has not been established. Therefore, bisoprolol fumarate cannot be
recommended for use in children.
The pharmacokinetics of bisoprolol fumarate in the pediatric
population were examined in three independent studies and showed that
the
half-life of bisoprolol fumarate ranged from 3.6 hours to 14 hours and
the clearance ranged from 0.12 L/hr/kg to 0.44 L/hr/kg. In adults,
the half-life of bisoprolol fumarate ranged from 9 hours to 12 hours
and the clearance ranged from 0.14 L/hr/kg to 0.15 L/hr/kg.
INDICATION