Betacor 2.5 Tablet

Valsts: Bangladeša

Valoda: angļu

Klimata pārmaiņas: DGDA (Directorate General of Drug Administration)

Lietošanas instrukcija Lietošanas instrukcija (PIL)
01-05-2024

Aktīvā sastāvdaļa:

Bisoprolol Hemifumarate

Pieejams no:

Popular Pharmaceuticals Ltd.

SNN (starptautisko nepatentēto nosaukumu):

Bisoprolol Hemifumarate

Deva:

2.5 mg

Zāļu forma:

Tablet

Lietošanas instrukcija

                                Bisoprolol Fumarate 2.5 mg & 5 mg Tablet
Beta
COR
Manufactured by:
_POPULAR PHARMACEUTICALS LTD._
164, TONGI INDUSTRIAL AREA, GAZIPUR, BANGLADESH
PRESENTATIONS
_Betacor 2.5 Tablet:_ Each film coated tablet contains 2.5 mg
Bisoprolol Fumarate USP.
_Betacor 5 Tablet:_ Each film coated tablet contains 5 mg Bisoprolol
Fumarate USP.
PHARMACOLOGY
_Pharmacodynamic properties: _ Bisoprolol is a potent highly beta
1
-selective-adrenoceptor blocking agent, lacking intrinsic stimulating
and without relevant
membrane stabilising activity. It only shows low affinity to the beta
2
-receptor of the smooth muscles of bronchi and vessels as well as to
the beta
2
-receptors
concerned with metabolic regulation. Therefore, Bisoprolol is
generally not to be expected to influence the airway resistance and
beta
2
-mediated metabolic
effects. Its beta1-selectivity extends beyond the therapeutic dose
range.
_Pharmacokinetic properties:_ 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
bioavailability is not affected by food intake. Bisoprolol shows
linear kinetics and the plasma
concentrations are proportional to the administered dose over the dose
range 5 to 20 mg. Peak plasma concentrations occur within 2-3
hours.The plasma protein
binding of Bisoprolol is about 30%. The distribution volume is 3.5
l/kg. The total clearance is approximately 15 l/h. The plasma
elimination half-life (10-12 hours)
provides 24 hours efficacy following a once daily dosage. Bisoprolol
is metabolised via oxidative pathways with no subsequent conjugation.
All metabolites, being
very polar, are renally eliminated. The major metabolites in human
plasma and urine were found to be without pharmacological activity. In
vitro data from studies
in human liver microsomes show that Bisoprolol is primarily
metabolised via CYP3A4 (~95%) with CYP2D6 having only a minor role.
Bisoprolol is excreted from
the body by two routes,
                                
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