TELFAST

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

FEXOFENADINE HYDROCHLORIDE

Tersedia dari:

AVENTIS PHARMA - Indonesia

INN (Nama Internasional):

FEXOFENADINE HYDROCHLORIDE

Dosis:

60 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 1 BLISTER @ 10 TABLET SALUT SELAPUT

Diproduksi oleh:

AVENTIS PHARMA - Indonesia

Tanggal Otorisasi:

2021-10-21

Karakteristik produk

FEXOFENADINE HCL
®
60
mg
DESCRIPTION
Fexofenadine
hydrochloride,
the
active
ingredient of TELFAST 60 mg, is a histamine
H1-receptor
antagonist
with
the
chemical
name
(+)-4-[1-hydroxy-4-[4-(hydroxydiphe-
n y l - m e t h y l ) - 1 - p i p e r i d i n y l ] - b u t y l ] -
a,a-dimethyl benzeneacetic acid hydrochlo-
ride, it has the following chemical structure:
The
molecular
weight
is
538.13
and
the
empirical
formula
is
C32H39NO4.HCl.
Fexofenadine
hydrochloride
is
a
white
to
off-white
crystalline
powder.
It
is
freely
soluble
in
methanol
and
ethanol,
slightly
soluble
in
chloroform
and
water,
and
insoluble in hexane. Fexofenadine hydrochlo-
ride is a racemate and exists as a zwitterion in
aqueous media at physiological pH.
TELFAST 60 mg is formulated as tablet for oral
administration.
Each
film
coated
tablet
contains 60 mg Fexofenadine Hydrochloride
and the following excipients: croscarmellose
sodium,
pregelatinized
maize
starch,
microcrystalline
cellulose,
magnesium
stearate, and purified water. The coated tablet
shell is made from hydroxypropyl methylcel-
lulose
E-15,
hydroxypropyl
methylcellulose
E-5,
povidone,
titanium
dioxide
(E171),
colloidal anhydrous silica, macrogol 400, pink
iron oxide blend, yellow iron oxide blend and
purified water.
CLINICAL PHARMACOLOGY
Mechanism of action
Fexofenadine, a metabolite of terfenadine, is
an
antihistamine
with
selective
peripheral
H1-receptor antagonist activity. Fexofenadine
inhibited antigen-induced bronchospasm in
sensitized guinea pigs and histamine release
from
peritoneal
mast
cells
in
rats.
In
laboratory
animals,
no
anticholinergic
or
alpha1-adrenergic receptor blocking effects
were observed.
Moreover,
no
sedative
or
other
central
nervous
system
effects
were
observed.
Radiolabeled
tissue
distribution
studies
in
rats
indicated
that
fexofenadine
does
not
cross the blood-brain barrier.
Pharmacokinetics
Fexofenadine
Hydrochloride
was
rapidly
absorbed following oral administration of a
single dose of two 60 mg tablet to healthy
male
volunteers
with
a
mean
time
to
maximum p