Xicard 25mg Tablet

Riik: Filipiinid

keel: inglise

Allikas: FDA (Food And Drug Administration)

Osta kohe

Laadi alla Toote omadused (SPC)
14-06-2024

Toimeaine:

Carvedilol

Saadav alates:

Getz Pharma Phils Inc

INN (Rahvusvaheline Nimetus):

Carvedilol

Annus:

25mg

Ravimvorm:

Tablet

Ühikuid pakis:

Alu/Alu Blister pack x 10's (box of 10 tablets)

Valmistatud:

Getz Pharma Pvt Ltd

Loa andmise kuupäev:

2018-07-09

Toote omadused

                                DESCRIPTION
Carvedilol is a nonselective
β
-adrenergic blocking agent with
α
1
-blocking
activity.
Chemically
it
is
-1 -( 9 H- ca rb a zo l-4 - ylo xy )- 3- [- 2 -( 2-
methoxyphenoxy)ethyl] amino]propan-2-ol. Its molecular formula is
C
24
H
26
N
2
O
4
. It is a racemic mixture with the following structure:
FORMULATION
Carvedilol (Xicard
) is available for oral administration as:
1. Carvedilol (Xicard ) Tablets 6.25mg
Each tablet contains:
Carvedilol…6.25mg
2. Carvedilol (Xicard
) Tablets 12.5mg
Each tablet contains:
Carvedilol…12.5mg
3. Carvedilol (Xicard
) Tablets 25mg
Each tablet contains:
Carvedilol…25mg
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Carvedilol is a vasodilating non-selective beta-blocking agent with
antioxidant
properties. Vasodilation is predominantly mediated through
α
1
receptor
antagonism.
Carvedilol reduces the peripheral vascular resistance through
vasodilation
and suppresses the renin-angiotensin-aldosterone system through beta-
blockade. Carvedilol is a racemate of two stereoisomers. Beta-blockade
is attributed to the S(-) enantiomer; in contrast, both enantiomers
exhibit
the same
α
1
-blocking activity.
Carvedilol is a potent antioxidant, a scavenger of reactive oxygen
radicals
and an anti-proliferative agent.
PHARMACOKINETICS
_Absorption_
Carvedilol is rapidly and extensively absorbed following oral
administration,
with absolute bioavailability of approximately 25% to 35% due to a
significant
degree of first pass metabolism. The rate of absorption is delayed by
taking carvedilol with food with no significant difference in extent
of
bio
availability.
_Distribution_
Carvedilol is more than 98% bound to plasma proteins, primarily with
albumin. The steady-state volume of distribution is approximately
115L,
indicating substantial distribution into extravascular tissues.
_Metabolism_
Carvedilol is extensively metabolised. It is metabolized primarily by
aromatic
ring oxidation and glucuronidation. The oxidative metabolites are
further
metabolized by conjugation via glucuronidation and
                                
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