TELFAST PLUS

国: インドネシア

言語: インドネシア語

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

有効成分:

FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

から入手可能:

AVENTIS PHARMA - Indonesia

INN（国際名）:

FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

投薬量:

60.00 MG /120.00 MG

医薬品形態:

TABLET PELEPASAN LAMBAT

パッケージ内のユニット:

DUS, 10 BLISTER @ 10 TABLET PELEPASAN LAMBAT

製:

AVENTIS PHARMA - Indonesia

承認日:

2020-10-29

製品の特徴

absolute
bioavailability
of
fexofenadine
hydrochloride has not been established, it
is
unknown
if
the
fecal
component
is
unabsorbed drug or the result of biliary
excreation.
The
pharmacokinetics
of
fexofenadine
hydrochloride
in
seasonal
allergic
rhinitis
patients
was
similar
to
those
in
healthy
subjects.
Peak
fexofenadine plasma concentrations were
similar between adolescent (12–16 years of
age) and adult patients. Fexofenadine is
60%
to
70%
bound
to
plasma
proteins,
primarily
albumin
and
α
1-acid
glycoprotein.
Pseudoephedrine has been shown to have
a mean elimination half-life of 4–6 hours,
which
is
dependent
on
urine
pH.
The
elimination half-life is decreased at urine
pH lower than 6 and may be increased at
urine pH higher than 8.
The
biovailability
of
fexofenadine
hydrochloride
and
pseudoephedrine
hydrochloride
from
TELFAST-PLUS
Extended-Release Tablets is similar to that
achieved with separate administration of
the
components.
Co-administration
of
fexofenadine and pseudoephedrine does
not significantly affect the biovailability of
either component.
Fexofenadine
hydrochloride
was
rapidly
absorbed
following
single-dose
administration of the 60-mg fexofenadine
hydrocloride/120
mg
pseudoephedrine
hydrochloride tablet with median time to
mean
maximum
fexofenadine
plasma
concentration of 191 ng/mL occurring 2
hours
post-dose.
Pseudoephedrine
hydrochloride
produced
a
mean
single-dose pseudoephedrine peak plasma
concentration
of
206
ng/mL,
which
occurred
6
hours
postdose.
Following
multiple
dosing
to
steady-state,
a
fexofenadine peak concentration of 255
ng/mL was observed 2 hours postdose.
Following multiple dosing to steady-state, a
pseudoephedrine peak concentration of
411 ng/mL was observed 5 hours postdose.
Co-administration of TELFAST-PLUS with a
high
fat
meal
decreased
fexofenadine
plasma
concentrations
C
max
(-46%)
and
AUC
(-42%).
Time
to
maximum
concen-tration (T
max
) was delayed by 50%.
The
rate
or
extent
of
pseudoephedrine
absorption was not affected by food. It is
recommended that the administration