CARVEDILOL AN 3.125mg carvedilol 3.125mg tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

carvedilol, Quantity: 3.125 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Carvedilol

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hypromellose; macrogol 400; crospovidone; povidone; lactose monohydrate; magnesium stearate; titanium dioxide; colloidal anhydrous silica; polysorbate 80; sucrose

Administration route:

Oral

Units in package:

60, 1000, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Carvedilol is indicated for the treatment of hypertension. Data have not been provided to support the use of this drug in renovascular disease.,Carvedilol is indicated for the treatment of patients with symptomatic mild to severe (NYHA Class II - IV) congestive heart failure (CHF) as an adjunct to conventional treatments (e.g. diuretics, digoxin, ACE inhibitors and vasodilators).

Product summary:

Visual Identification: White to off-white, oval shaped, film-coated tablets debossed with 'E' on one side and '01' on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2011-11-11

Summary of Product characteristics

_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