CARVEDILOL AN 25mg carvedilol 25mg tablets blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

carvedilol

Disponibil de la:

Amneal Pharma Australia Pty Ltd

INN (nume internaţional):

Carvedilol

Statutul autorizaţiei:

Registered

Caracteristicilor produsului

_Carvedilol AN tablets Product Information _
_ _
_ Scentia Pharmaceuticals Pty Ltd _
Doc ID: 47.AN.P.1.0
Page 1 of 23
O
CARVEDILOL AN
_ _
_(CARVEDILOL TABLETS) _
_ _
PRODUCT INFORMATION
_ _
NAME OF THE MEDICINE
The name of the medicine is carvedilol.
H
OH
H
N
O
OCH
3
HN
CHEMICAL NAME
:
(2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-
2-ol
MOLECULAR FORMULA: C
24
H
26
N
2
O
4
MOLECULAR WEIGHT: 406.5
CAS REGISTRY NUMBER: _[72956–09–3]_
DESCRIPTION
Carvedilol is a white or almost white, crystalline powder. It is
slightly soluble in alcohol,
practically insoluble in water and dilute acids.
CARVEDILOL AN is available as tablets containing 3.125, 6.25, 12.5 &
25 mg of carvedilol.
_CARVEDILOL AN 3.125_
White to off-white, oval shaped, film-coated tablets debossed with
‘E’ on one side and ‘01’ on the
other side.
_CARVEDILOL AN 6.25_
White to off-white, oval shaped, film-coated tablets debossed with
‘F 57’ on one side and deep
break line on the other side.
_CARVEDILOL AN 12.5_
White to off-white, oval shaped, film-coated tablets debossed with
‘F 58’ on one side and deep
break line on the other side.
_CARVEDILOL AN 25_
White to off-white, oval shaped, film-coated tablets debossed with
‘F 59’ on one side and deep
break line on the other side.
_Carvedilol AN tablets Product Information _
_ _
_ Scentia Pharmaceuticals Pty Ltd _
Doc ID: 47.AN.P.1.0
Page 2 of 23
CARVEDILOL
AN_ _
tablets
contain
the
following
inactive
ingredients:
Lactose,
colloidal
anhydrous silica, crospovidone (Type A & Type B), povidone, sucrose,
magnesium stearate,
macrogol 400, polysorbate 80, titanium dioxide & hypromellose.
PHARMACOLOGY
PHARMACODYNAMICS
Carvedilol is a dual action cardiovascular agent; a vasodilating,
non-selective beta-blocking agent
with antioxidant properties. Vasodilation has been shown to be
mediated primarily by selective
blockade of alpha
1
-adrenoreceptors.
Carvedilol is a racemic mixture. In animal models, both enantiomers
have alpha-adrenergic
receptor blocking properties. The be