Hovid Febuxostat Film-Coated Tablets 80mg

Land: Maleisië

Taal: Engels

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

Werkstoffen:

Febuxostat

Beschikbaar vanaf:

HOVID BERHAD

INN (Algemene Internationale Benaming):

Febuxostat

Eenheden in pakket:

3x10 Tablets

Geproduceerd door:

RV LIFESCIENCES LIMITED

Bijsluiter

HOVID FEBUXOSTAT FILM-COATED TABLETS
Febuxostat (40mg, 80mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Hovid Febuxostat Film-
Coated Tablets is used for
2.
How Hovid Febuxostat Film-Coated
Tablets works
3.
Before you use Hovid Febuxostat
Film-Coated Tablets
4.
How to use Hovid Febuxostat Film-
Coated Tablets
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Hovid
Febuxostat Film-Coated Tablets
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT HOVID FEBUXOSTAT FILM-COATED
TABLETS IS USED FOR
Hovid
Febuxostat
Film-Coated
Tablets
contain the active substance febuxostat
and
are
used
to
treat
gout,
which
is
associated with an excess of a chemical
called uric acid (urate) in the body. In
some people, the amount of uric acid
builds up in the blood and may become
too high to remain soluble. When this
happens, urate crystals may form in and
around
the
joints
and
kidneys.
These
crystals can cause sudden, severe pain,
redness, warmth and swelling in a joint
(known as a gout attack). Left untreated,
larger deposits called tophi may form in
and around joints. These tophi may cause
joint and bone damage.
Hovid
Febuxostat
Film-Coated
Tablets
works
by
reducing
uric
acid
levels.
Keeping uric acid levels low by taking
Hovid
Febuxostat
Film-Coated
Tablets
once every day stops crystals building
up, and over time it reduces symptoms.
Keeping uric acid levels sufficiently low
for a long enough period can also shrink
tophi.
Hovid Febuxostat Film-Coated Tablets is
for adults.
HOW
HOVID
FEBUXOSTAT
FILM-COATED
TABLETS WORKS
The
active
substance
in
Hovid
Febuxostat
Film-Coated
Tablets,
febuxostat, reduces the formation of uric
acid. It works by blocking an enzyme
called xanthine oxidase, which is needed
to
make
uric
acid
in
the
body.
By
reducing
the
production
of
uric
acid,
Hovid
Febuxostat
Film-Coated
Tablets
can
reduce
levels
of
uric
acid
in
the
blood
and
keep
them
low,
stopping
crystals
from
building
up.
This
can

Productkenmerken

DESCRIPTION
HOVID FEBUXOSTAT FILM-COATED TABLETS 40MG
White coloured, round shaped, biconvex, film coated tablets
plain on both sides.
HOVID FEBUXOSTAT FILM-COATED TABLETS 80MG
White coloured, round shaped, biconvex, film coated tablets
with break line on one side and plain on other side.
The break line only meant for facilitating swallow of whole
tablet in 2 smaller portions. The tablet is not to be broken into
half for divided doses.
COMPOSITION
HOVID FEBUXOSTAT FILM-COATED TABLETS 40MG
Each tablet contains 40mg febuxostat.
HOVID FEBUXOSTAT FILM-COATED TABLETS 80MG
Each tablet contains 80mg febuxostat.
PHARMACODYNAMICS
Pharmacotherapeutic
group:
Antigout
preparation,
preparations
inhibiting
uric
acid
production, ATC
code:
M04AA03
Mechanism of action
Uric acid is the end product of purine metabolism in humans
and is generated in the cascade of hypoxanthine → xanthine
→ uric acid. Both steps in the above transformations are
catalyzed
by
xanthine
oxidase
(XO).
Febuxostat
is
a
2-arylthiazole derivative that achieves its therapeutic effect of
decreasing
serum
uric
acid
by
selectively
inhibiting
XO.
Febuxostat is a potent, non-purine selective inhibitor of XO
(NP-SIXO) with an in vitro inhibition Ki value less than one
nanomolar. Febuxostat has been shown to potently inhibit both
the
oxidized
and
reduced
forms
of
XO. At
therapeutic
concentrations febuxostat does not inhibit other enzymes
involved in purine or pyrimidine metabolism, namely, guanine
deaminase, hypoxanthine guanine phosphoribosyltransferase,
orotate phosphoribosyltransferase, orotidine monophosphate
decarboxylase or purine nucleoside phosphorylase.
PHARMACOKINETICS
In healthy subjects, maximum plasma concentrations (Cmax)
and area under the plasma concentration time curve (AUC) of
febuxostat increased in a dose proportional manner following
single and multiple doses of 10 mg to 120 mg. For doses
between
120
mg
and
300
mg,
a
greater
than
dose
proportional increase in AUC is observed for febuxostat.
There is no appreciable accumulation when doses of 1