TELFAST

देश: इंडोनेशिया

भाषा: इंडोनेशियाई

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

सक्रिय संघटक:

FEXOFENADINE HYDROCHLORIDE

थमां उपलब्ध:

AVENTIS PHARMA - Indonesia

INN (इंटरनेशनल नाम):

FEXOFENADINE HYDROCHLORIDE

डोज़:

120 Mg

फार्मास्यूटिकल फॉर्म:

TABLET SALUT SELAPUT

पैकेज में यूनिट:

DUS, 10 BLISTER @ 10 TABLET SALUT SELAPUT

द्वारा बनाया गया:

AVENTIS PHARMA - Indonesia

प्राधिकरण की तारीख:

2021-05-26

उत्पाद विशेषताएं

TELFAST
120 MG
FEXOFENADINE HCL
COMPOSITION
Each film coated tablet contains 112 mg of
the active ingredient fexofenadine (as 120
mg
of
fexofenadine
hydrochloride).
The
tablets
also
contain
microcrystalline
cellulose,
pregelatinised
maize
starch,
croscarmellose
sodium,
magnesium
stearate, hypromellose, povidone, titanium
dioxide (E171), colloidal anhydrous silica,
macrogol 400 and iron oxide (E172).
PROPERTIES
PHARMACODYNAMIC
Fexofenadine
hydrochloride
is
a
non-
sedating H1 antihistamine. Fexofenadine is a
pharmacologically
active
metabolite
of
terfenadine.
Human histamine wheal and flare studies
following single and twice daily doses of
fexofenadine hydrochloride demonstrate that
the
drug
exhibits
an
antihistaminic
effect
beginning
within
one
hour,
achieving
maximum at 6 hours and lasting 24 hours.
There was no evidence of tolerance to these
effects after 28 days of dosing. A positive
dose
–
response
relationship
between
doses of 10 mg to 130 mg taken orally was
found to exist. In this model of antihistaminic
activity, it was found that doses of at least
130
mg
were
required
to
achieve
a
consistent effect that was maintained over a
24-hour period.
Maximum inhibition in skin wheal and flare
areas
were
greater
than
80%.
Clinical
studies conducted in allergic rhinitis have
shown that a dose of 120 mg is sufficient for
24-hour efficacy. No significant differences in
QTc
intervals
were
observed
in
easonal
allergic rhinitis patients given fexofenadine
hydrochloride up to 240 mg twice daily for 2
weeks when compared to placebo. Also, no
significant
change
in
QTc
intervals
was
observed
in
healthy
subjects
given
fexofenadine
hydrochloride
up
to
60
mg
twice daily for 6 months, 400 mg twice daily
for 6.5 days and 240 mg once daily for 1
year,
when
compared
to
placebo.
Fexofenadine
at
concentrations
32
times
greater than the therapeutic concentration in
man had no effect on the delayed rectifier K+
channel
cloned
from
human
heart.
Fexofenadine hydrochloride (5-10 mg/kg po)
inhibited antigeninduced bronchospasm in
sensitiz