CHEMMART CARVEDILOL carvedilol 25 mg tablet blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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下载 资料单张 (PIL)
01-12-2017
下载 产品特点 (SPC)
01-12-2017
下载 公众评估报告 (PAR)
30-11-2017

有效成分:

carvedilol

可用日期:

Apotex Pty Ltd

INN(国际名称):

Carvedilol

授权状态:

Registered

资料单张

                                CHEMMART CARVEDILOL
_Contains the active ingredient, carvedilol_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about carvedilol. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
the medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with the medicine.
You may need to read it again
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart Carvedilol. It contains the
active ingredient, carvedilol.
It is used to treat high blood pressure
and, together with other medicines,
to help treat congestive heart failure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Carvedilol belongs to a group of
medicines called beta-blockers.
These medicines work by relaxing
tightened blood vessels and slowing
the heart rate. Carvedilol has the
additional effect of being an
antioxidant.
Heart failure occurs when the heart
can no longer pump blood strongly
enough for the body's needs. Often
the heart grows in size to try to
improve the blood flow but this can
make the heart failure worse.
Symptoms of heart failure include
shortness of breath and swelling of
the feet or legs due to
                                
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产品特点

                                Product Information – Australia
Chemmart Carvedilol Tablets
Page 1
CHEMMART CARVEDILOL TABLETS
NAME OF THE MEDICINE
CARVEDILOL.
Chemical Name:
(+/-)-1-(9 H-carbazol-4-yloxy) -3-{[2-(2-methoxyphenoxy)
ethyl]amino}propan-2-ol.
Structural Formula:
Molecular Formula:
C
24
H
26
N
2
0
4
Molecular Weight:
406.5
CAS Registry Number: 72956-09-3
DESCRIPTION
Carvedilol is a white crystalline powder and has low solubility in
water (0.01 mg/mL). It is soluble in
ethanol (22.7 mg/mL).
Each tablet contains carvedilol, as the active ingredient. In
addition, each tablet contains the following
inactive ingredients: cellulose microcrystalline, lactose,
crospovidone, povidone, colloidal anhydrous silica,
magnesium stearate, opadry II complete film coating system YS-22-18096
white.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Carvedilol is a dual action cardiovascular agent.
It is 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 beta-adrenergic receptor blocking properties
are non-selective for beta
1
- and
beta
2
-adrenoreceptors and are associated with the laevorotatory enantiomer
of carvedilol. Carvedilol has
no intrinsic sympathomimetic activity and, like propranolol, it has
membrane stabilising properties.
Carvedilol suppresses the renin/angiotensin/aldosterone system through
beta-blockade.
The mechanism for the beneficial effects of carvedilol in congestive
heart failure has not been established.
Possible mechanisms include neurohormonal inhibition, beta-blockade,
balanced vasodilation (reduced
preload and afterload), antioxidant activity, potent anti-ischaemic
activity and inhibition of neutrophil
adhesion. Antioxidant activity and inhibition of neutrophil adhesion
have been demonstrated in _in vitro _and
_in vivo _animal models and in _in vitro _human models.
Carvedilol reduces 
                                
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