Voriconazole APOTEX voriconazole 50mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
voriconazole
Available from:
Apotex Pty Ltd
INN (International Name):
Voriconazole
Authorization status:
Registered
Patient Information leaflet
VORICONAZOLE APOTEX
TABLETS
_Contains the active ingredient voriconazole_
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 voriconazole. 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
this 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.
You can also download the most up
to date leaflet from
www.apotex.com.au.
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 your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Voriconazole APOTEX tablets. It
contains the active ingredient
voriconazole.
It is used to treat fungal and yeast
infections such as:
•
invasive aspergillosis (as-pur-
jilosis), a fungal infection caused
by a fungus called Aspergillus
(as-pur-jilus), which usually
begins in the respiratory tract (in
the nose, sinuses or lungs).
Aspergillus is harmless in most
healthy people; however, in
people with poor immune
systems (such as people who have
had organ transplants and people
with cancer or HIV/AIDS)
invasive aspergillosis can be
serious and spread to other tissues
and organs.
•
serious Candida (can-did-da)
infections, including Candida
infections of the oesophagus
(food pipe or gullet) and those
that have spread into the blood
stream or to other parts of the
body.
•
serious fungal infections caused
by Scedosporium (ski-doe-s
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Summary of Product characteristics
Product Information – Australia
Voriconazole APOTEX Tablets
Page 1
VORICONAZOLE APOTEX TABLETS
NAME OF THE MEDICINE
Voriconazole
Chemical Name:
(2_R_, 3_S_)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1_H_
-1,2,4-triazol-
1-yl)butan-2-ol
Structural Formula:
Molecular Formula:
C
16
H
14
F
3
N
5
O
Molecular Weight:
349.3
CAS Registry Number:
137234-62-9
DESCRIPTION
Voriconazole, a broad-spectrum, triazole antifungal agent intended for
oral administration.
Voriconazole is a white or almost white powder. It is very slightly
soluble in water, freely soluble in
acetone and in methylene chloride.
Voriconazole Tablets contain 50 mg or 200 mg of voriconazole as the
active ingredient. In addition,
each tablet contains the following inactive ingredients: lactose,
croscarmellose sodium, magnesium
stearate and a coating containing polyvinyl alcohol, macrogol 8000,
purified talc and titanium dioxide.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Mechanism of Action
Voriconazole is a triazole antifungal agent. Voriconazole’s primary
mode of action is the inhibition of
fungal
cytochrome
P450-mediated
14α-sterol
demethylation,
an
essential
step
in
ergosterol
biosynthesis. Voriconazole is more selective than some other azole
drugs for fungal as opposed to
various mammalian cytochrome P450 enzyme systems. The subsequent loss
of normal sterols
correlates with the accumulation of 14α-methyl sterols in fungi and
may be responsible for its
fungistatic/fungicidal activity.
_In vitro_, voriconazole displays broad-spectrum antifungal activity
with high antifungal potency against
_Candida_ species (including fluconazole resistant _C. krusei_ and
resistant strains of _C. glabrata_ and _C. _
_albicans_) and fungicidal activity against all _Aspergillus_ species
tested. In addition, voriconazole shows
_in vitro_ activity against emerging fungal pathogens, such as
_Scedosporium_ or _Fusarium_, some isolates
of which have limited susceptibility to existing antifungal agents. In
addition, voriconazole exhibits _in _
_vitro_ fungicidal activ
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