TELFAST-D TABLET

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

PSEUDOEPHEDRINE HYDROCHLORIDE; FEXOFENADINE HCL

Sẵn có từ:

DKSH MALAYSIA SDN BHD

INN (Tên quốc tế):

PSEUDOEPHEDRINE HYDROCHLORIDE; FEXOFENADINE HCL

Các đơn vị trong gói:

50 Tablet Tablets; 10 Tablet Tablets; 100 Tablet Tablets; 20 Tablet Tablets; 30 Tablet Tablets

Sản xuất bởi:

Opella Healthcare International SAS

Đặc tính sản phẩm

SA/551685
--,--,--
Effects on Steady-State Fexofenadine
Pharmacokinetics
After 7 Days of Co-Administration with
Fexofenadine
Hydrochloride 120 mg Every 12 Hours
(Two times the recommended twice daily dose)
in Healthy Volunteers (n=24)
Concomitant
Drug
Erythromycin
(500 mg
every 8 hrs)
Ketoconazole
(400 mg once
daily)
C
max. SS
(Peak plasma
concentration)
+ 82%
+ 135%
AUC
ss
(0-12h)
(Extent of
systemicexposure)
+ 109%
+ 164%
DESCRIPTION
TELFAST-D
(fexofenadine
hydrochloride
and
pseudoephedrine
hydrochloride)
Extended-Release
Tablets
for
oral
administration
contain
60
mg
fexofenadine
hydrochloride for immediate release and 120
mg
pseudoephedrine
hydrochloride
for
extended
release.
Tablets
also
contain
as
excipients:
microcrystalline
cellulose,
pregelatinized starch, croscarmellose sodium,
magnesium stearate, carnauba wax, stearic acid,
silicon dioxide, hydropropylmethyl cellulose and
polyethylene glycol.
Fexofenadine hydrochloride, one of the active
ingredients
of
TELFAST-D,
is
a
histamine
H1-receptor antagonist with the chemical name
(±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1
-piperidinyl]-butyl]-α, α-dimethyl benzeneacetic
acid hydrochloride and the following chemical
structure:
The
molecular
weight
is
538.13
and
the
empirical
formula
is
C
32
H
39
NO
4
•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 hydrochloride is a racemate and
exists
as
a
zwitterion
in
aqueous
media
at
physiological pH.
Pseudoephedrine
hydrochloride,
the
other
active ingredient of TELFAST-D, is an adrenergic
(vasoconstrictor) agent with the chemical name
[S-(R*,R*)]-α-[1-(methylamino)ethyl]-benzeneme
thanol
hydrochloride
and
the
following
chemical structure:
The molecular weight is 201.70. The molecular
formula
is
C
10
H
15
NO•HCl.
Pseudoephedrine
hydrochloride occurs as fine, white to off-white
crystals or powder, having a faint characteristic
odor. It is very soluble in water