ALTVEN

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 製品の特徴 (SPC)
25-11-2015
ダウンロード 公開評価報告書 (PAR)
15-11-2017

有効成分:

venlafaxine hydrochloride

から入手可能:

Pfizer Australia Pty Ltd

INN(国際名):

Venlafaxine hydrochloride

認証ステータス:

Registered

情報リーフレット

                                ALTVEN
®
_Venlafaxine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Altven.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Altven against
the benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ALTVEN IS USED
FOR
_WHAT IT DOES_
Altven is used in the treatment and
prevention of relapse of depression.
It is also used in the treatment of
panic attacks and anxiety, including
avoidance or fear of social situations.
Depression can affect your whole
body and may cause emotional and
physical symptoms such as feeling
low in spirit, being unable to enjoy
life, poor appetite or overeating,
disturbed sleep, loss of sex drive,
lack of energy and feeling guilty over
nothing.
Excessive anxiety is a condition in
which you feel constantly and
uncontrollably worried and
distressed. It may also make you feel
irritable, and cause difficulty in
thinking and sleeping. Other
common symptoms associated with
anxiety may include a dry mouth, a
lump in the throat, cold clammy
hands, diarrhoea and nausea.
Depression and anxiety are treatable
illnesses. Anxiety or tension
associated with the normal stress of
everyday life usually does not require
treatment with medicines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
_HOW IT WORKS_
Altven contains the active ingredient
called venlafaxine hydrochloride. It
belongs to a class of medications for
depression and anxiety, called
Serotonin-Noradrenaline Reuptake
Inhibitors (SNRIs).
Serotonin and noradrenaline are
chemical messengers that allow
certain nerves in the brain to work.
Altven capsules increase the level of
these tw
                                
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製品の特徴

                                Version: pfpaltvc11115
Supersedes: pfpaltvc10214
Page 1 of 33
PRODUCT INFORMATION
ALTVEN

VENLAFAXINE (AS HYDROCHLORIDE)
NAME OF THE MEDICINE
ALTVEN Venlafaxine (as hydrochloride) 37.5 mg, 75 mg and 150 mg
modified release
capsules.
ALTVEN contains the active ingredient venlafaxine (as hydrochloride).
The structural formula is shown below:
Chemical name:
(R/S)-1-[(2-dimethylamino)-1-(4-methoxyphenyl)ethyl]
cyclohexanol hydrochloride
Molecular formula:
C
17
H
27
NO
2
.HCl
Molecular weight:
313.87
CAS Registry Number:
99300-78-4
DESCRIPTION
ALTVEN capsules are an extended-release formulation, which release the
active constituent,
venlafaxine hydrochloride, from spheroids within the capsule. Drug
release is controlled by
diffusion through the coating membrane on the spheroids and is not pH
dependent. Three
strengths of ALTVEN capsules are available containing either 37.5 mg,
75 mg or 150 mg of
venlafaxine (as hydrochloride).
Venlafaxine hydrochloride is a white to off-white crystalline solid
with a solubility of
572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium
chloride).
Other
ingredients
are
cellulose-microcrystalline,
ethylcellulose
and
hypromellose.
The
capsule shells contain gelatin, red iron oxide CI 77491, yellow iron
oxide CI 77492, titanium
dioxide and talc purified. In addition to these, the 37.5 mg capsule
shells also contain black
iron oxide CI 77499. The 37.5 mg and 75 mg capsule shells are branded
with Opacode S-1-
15094/S-1-15095 red ink. The 150 mg capsule shells are branded with
TekPrint SB-0007P
white ink.
Version: pfpaltvc11115
Supersedes: pfpaltvc10214
Page 2 of 33
PHARMACOLOGY
ACTIONS
Venlafaxine is a structurally novel antidepressant for oral
administration; it is chemically
unrelated to tricyclic, tetracyclic, or other available antidepressant
agents.
PHARMACODYNAMICS
The antidepressant action of venlafaxine in humans is believed to be
associated with its
potentiation of neurotransmitter activity in the central nervous
system (CNS). Preclinical
studies
have
shown
that
venl
                                
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