Ferriprox 1000mg Film-Coated Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

DEFERIPRONE

Boleh didapati daripada:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

DEFERIPRONE

Unit dalam pakej:

50tablet Tablets

Dikeluarkan oleh:

APOTEX INC. - ETOBICOKE SITE

Risalah maklumat

FERRIPROX
® 1000MG FILM-COATED TABLET
Deferiprone (1000mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Ferriprox is used for
2.
How Ferriprox works
3.
Before you use Ferriprox
4.
How to use Ferriprox
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Ferriprox
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT FERRIPROX IS USED FOR
Ferriprox is used to treat iron overload in
patients with thalassemia (a type of
blood disorder) major when
deferoxamine therapy is contraindicated
or inadequate.
HOW FERRIPROX WORKS
Ferriprox contains the active substance
deferiprone. Ferriprox removes excess
iron from the body that accumulates
from frequent blood tranfusions.
BEFORE YOU USE FERRIPROX
-
_When you must not use it _
Do not use this product if you are
allergic to_ _deferiprone or any of the
other ingredients of Ferriprox.
Do not use this product if you have a
history of repeated episodes of
neutropenia (low white blood cell
(neutrophil) count), or if you have a
history of agranulocytosis (very low
white blood cell count)._ _
_ _
_Pregnancy and lactation _
Do not take Ferriprox if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take Ferriprox if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
_ _
-
_Before you start to use it _
Before you start to use this product, let
your doctor know if you have any
other known medical condition, or if
you have undergo any type of surgery,
both major or minor. _ _
_ _
_ _
-
_Taking other medicines _
Do not take aluminium-based antacids
while taking Ferriprox. It is also
advised to consult your doctor or
pharmacist before taking Vitamin C
with Ferriprox.
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
HOW TO USE FERRIPROX
-
_How much to use _
The amount of Ferriprox that you take
will depend on your weig

Ciri produk

FERRIPROX® 1000 MG FILM-COATED TABLETS
DEFERIPRONE
IRON CHELATING AGENT
ORAL USE
PHARMACOLOGY
Deferiprone is a bidentate ligand, which binds to iron in a 3:1 molar
ratio and removes iron
from the body. Clinical studies have demonstrated that deferiprone is
effective in
promoting iron excretion and can lower serum ferritin levels and
tissue iron stores in
patients with transfusion-dependent thalassemia. The precise mechanism
by which
deferiprone is effective in promoting iron excretion and preventing
the progress of iron
accumulation is unknown.
PHARMACOKINETICS
Deferiprone is rapidly absorbed from the upper part of the
gastro-intestinal tract. Peak
serum concentration is reported to occur 45 to 60 minutes following a
single dose in fasted
patients. This may be extended to 2 hours in fed patients. Following a
dose of
25 mg/kg, lower peak serum concentrations have been detected in
patients in the
fed state (85 μmol/l) than in the fasting state (126 μmol/l),
although there was no
decrease in the amount of deferiprone absorbed when given with food.
Deferiprone is metabolised predominantly to a glucuronide conjugate.
This
metabolite lacks iron-binding capability because of inactivation of
the 3-hydroxy
group of deferiprone. Peak concentrations of the glucuronide occur 2
to
3 hours
af
ter administration of deferiprone.
In humans, deferiprone is eliminated mainly via the kidneys; 75% to
90% of the
ingested dose is reported as being recovered in the urine in the first
24 hours, in
the form of free deferiprone, the glucuronide metabolite and the
iron-deferiprone
complex. A variable amount of elimination into the feces has been
reported. The
elimination half-life in most patients is 2 to 3 hours.
INDICATION
Ferriprox is indicated for the treatment of iron overload in patients
with
thalassemia major when deferoxamine therapy is contra-indicated or
inadequate.
ADVERSE REACTIONS
The following side effects were reported in patients taking Ferriprox
in clinical
trials:
Very Common (≥1/10): Nausea, vomiting, abdominal pain.