hovid-Etoricoxib Tablet 120 mg

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

ETORICOXIB

Disponible depuis:

HOVID BERHAD

DCI (Dénomination commune internationale):

ETORICOXIB

Unités en paquet:

10tablet Tablets; 30tablet Tablets; 100tablet Tablets

Fabriqué par:

HOVID BERHAD

Notice patient

NOT APPLICABLE

Résumé des caractéristiques du produit

DESCRIPTION
Round,
10.0mm
in
diameter,
red
film-coated
tablet,
bevel-edged
and
shallow convex faces.
COMPOSITION
Each tablet contains 120 mg of Etoricoxib.
PHARMACODYNAMICS
Etoricoxib
is
a
nonsteroidal
anti-
inflammatory agent (dipyridinyl derivative)
for
oral
administration.
It
is
a
highly
selective
inhibitor of cyclooxygenase-2
(COX-2) that exhibits anti-inflammatory,
analgesic,
and
antipyretic
activities
in
animal models.
Two isoforms of cyclooxygenase have
been
identified:
cyclooxygenase-1
(COX-1) and cyclooxygenase-2 (COX-2).
The COX-1 isoenzyme is constitutively
expressed
in
most
tissues,
and
is
particularly
involved
in
prostaglandin
synthesis
in
kidneys,
platelets,
and
gastric
mucosa;
products
of
COX-1
appear cytoprotective, and inhibition of
this isoform has been associated with
antiplatelet and gastrointestinal toxicity.
The inducible COX-2 isoform is expressed
at sites of inflammation, and its inhibition
is considered responsible for analgesic
and
anti-inflammatory
properties
of
nonsteroidal anti-inflammatory agents.
The COX-1-sparing effects of selective
COX-2 inhibitors suggest they may be as
effective as nonselective inhibitors of both
COX-1
and
COX-2
(ie,
naproxen,
ibuprofen, ketorolac) in treating pain and
inflammation with a reduced propensity for
hematologic and gastrointestinal toxicity.
PHARMACOKINETICS
ABSORPTION
Etoricoxib
is
well
absorbed
from
the
gastrointestinal tract after oral doses.
The
mean
oral
bioavailability
is
approximately 100%.
Peak
plasma
concentrations
occur
in
about 1 hour in fasted adults; food delays
absorption by about 2 hours, although it
has no effect on the extent of absorption.
Antacids (calcium carbonate, aluminum/
magnesium hydroxide) do not significantly
affect the absorption of etoricoxib.
DISTRIBUTION:
Plasma protein binding is about 92%.
Etoricoxib may cross the placenta and
that some is distributed into breast milk.
VOLUME OF DISTRIBUTION
119 L at steady state.
METABOLISM
Etoricoxib is extensively metabolized with
<2% of a dose recovered in urine as the
parent
dr