POSACONAZOLE ARX posaconazole 100 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

posaconazole, Quantity: 100 mg

Available from:

Dr Reddys Laboratories Australia Pty Ltd

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: hyprolose; triacetin; titanium dioxide; microcrystalline cellulose; hypromellose acetate succinate; macrogol 400; croscarmellose sodium; purified talc; iron oxide red; magnesium stearate; silicon dioxide; hypromellose

Administration route:

Oral

Units in package:

96, 24

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

POSACONAZOLE ARX (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older: ,? Invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. ,? Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. ,POSACONAZOLE ARX is also indicated for the: ,? Prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (HSCT) recipients.

Product summary:

Visual Identification: Brown, capsule-shaped, bevelled edge, film-coated tablet, debossed with '470' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-07-24

Patient Information leaflet

POSACONAZOLE ARX
1
POSACONAZOLE ARX
MODIFIED
RELEASE TABLETS
_Posaconazole_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about POSACONAZOLE
ARX. 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
POSACONAZOLE ARX against the
benefits this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING POSACONAZOLE ARX,
ASK YOUR DOCTOR OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
TAKING POSACONAZOLE ARX.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
POSACONAZOLE
ARX IS USED FOR
POSACONAZOLE ARX contains
the active ingredient, posaconazole.
Posaconazole is a medicine that
belongs to the triazole group of
antifungal medicines.
POSACONAZOLE ARX works by
killing or stopping the growth of the
fungi causing these infections.
POSACONAZOLE ARX Modified
Release Tablets are used for:
•
The treatment of invasive
aspergillosis, a fungal infection
caused by a fungus called
aspergillus
•
The treatment of other serious
fungal infections called
fusariosis, zygomycosis,
chromoblastomycosis and
mycetoma.
These types of fungal infections
usually occur in some patients who
may have lowered resistance to
infection due to poor immunity.
Treatment of these serious fungal
infections with POSACONAZOLE
ARX is usually reserved for patients
who do not respond to or cannot
tolerate other medicines used to treat
these types of fungal infections.
POSACONAZOLE
ARX
is
also
used
to
treat
coccidioidomycosis, a rare and
serious fungal infection.
POSACONAZOLE ARX is also
used to prevent fungal infections,
such as yeasts and moulds, from
occurring in patients who are at
high-risk of developing these
infections.
Your doctor may have prescribed
POSACONAZOLE ARX for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
POSACONAZOLE
ARX
HAS
BEEN PRESCRIBED FOR YOU.
This medicine is avail

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – POSACONAZOLE ARX
(POSACONAZOLE) MODIFIED RELEASE TABLETS
1
NAME OF THE MEDICINE
Posaconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release tablet contains 100 mg of posaconzole.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
POSACONAZOLE ARX MODIFIED RELEASE TABLET is a
brown, capsule shaped, bevelled edge,
film coated tablet, debossed with ‘470’ on one side and plain on
other side
.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
POSACONAZOLE ARX (posaconazole) is indicated for use in the treatment
of the following
invasive fungal infections in patients 13 years of age or older:
•
Invasive aspergillosis in patients intolerant of, or with disease that
is refractory to,
alternative therapy.
•
Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and
mycetoma in
patients intolerant of, or with disease that is refractory to,
alternative therapy.
POSACONAZOLE ARX is also indicated for the
prophylaxis of invasive fungal infections among patients 13 years of
age and older, who are at
high risk of developing these infections, such as patients with
prolonged neutropenia or
haematopoietic stem cell transplant (HSCT) recipients.
4.2
D
OSE AND METHOD OF ADMINISTRATION
POSACONAZOLE ARX Modified Release Tablets should be swallowed whole,
and not be divided,
crushed, or chewed. POSACONAZOLE ARX Modified Release Tablets may be
taken without
regard
to food intake.
Coadministration of drugs that can decrease the plasma concentrations
of posaconazole should
generally be avoided unless the benefit outweighs the risk. If such
drugs are necessary, patients
should be monitored closely for breakthrough fungal infections (see
4.5 INTERACTIONS WITH
OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS).
1
ADMINISTRATION INSTRUCTIONS FOR POSACONAZOLE ARX MODIFIED RELEASE
TABLETS
REFRACTORY INVASIVE FUNGAL INFECTIONS (IFI) / INTOLERANT PATIENTS WITH
IFI: Loading dose of
300 mg (three 100 mg modified release tablets) twice a d