TELFAST TABLET 180 mg

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

FEXOFENADINE HCl

Tersedia dari:

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

Kode ATC:

R06AX26

Dosis:

180 mg

Bentuk farmasi:

TABLET, FILM COATED

Komposisi:

FEXOFENADINE HCl 180 mg

Rute administrasi :

ORAL

Jenis Resep:

Prescription Only

Diproduksi oleh:

PT. Aventis Pharma

Status otorisasi:

ACTIVE

Tanggal Otorisasi:

2001-10-27

Selebaran informasi

COMPOSITION
TELFAST 30MG: Each tablet contains 30 
mg of the active ingredient fexofenadine 
hydrochloride (as 28 mg of 
fexofenadine). 
TELFAST 120MG: Each tablet contains 120 
mg of the active ingredient fexofenadine 
hydrochloride (as 112mg fexofenadine).
TELFAST 180MG: Each tablet contains 
180mg of the active ingredient 
fexofenadine hydrochloride (as 168mg 
fexofenadine).
Each tablet also contains 
microcrystalline cellulose, pregelatinised 
maize starch, croscarmellose sodium, 
magnesium stearate, hypromellose, 
povidone, titanium dioxide (E 171), 
colloidal anhydrous silica, macrogol 400 
and iron oxide (E172).
PROPERTIES
PHARMACODYNAMIC 
Fexofenadine hydrochloride is a 
non-sedating H1 
antihistamine 
(ATC-code: R06A X26). 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 10mg to 130mg taken orally 
was found to exist. In this model of 
antihistaminic activity, it was found that 
doses of at least 130mg 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 that 80%. 
Clinical studies conducted in allergic 
rhinitis have shown that a dose of 
120mg is sufficient for 24 hours efficacy. 
In children aged 6 to 11 years, the 
suppressive effects of fexofenadine 
hydrochloride on histamine-induced 
wheal and flare to were comparable to 
that in adults at similar exposure.
In an integrated analysis of placebo 
controlled double-blind phase I

Karakteristik produk

TELFAST 180MG
_Fexofenadine HCl _
COMPOSITION
TELFAST 180MG:
Each tablet contains 180mg of
the active ingredient fexofenadine
hydrochloride (as 168mg fexofenadine).
Each tablet also contains
microcrystalline cellulose, pregelatinised
maize starch, croscarmellose sodium,
magnesium stearate, hypromellose,
povidone, titanium dioxide (E 171),
colloidal anhydrous silica, macrogol 400
and iron oxide (E172).
PROPERTIES
PHARMACODYNAMIC
Fexofenadine hydrochloride is a
non-sedating H1 antihistamine
(ATC-code: R06A X26). 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 10mg to 130mg taken orally
was found to exist. In this model of
antihistaminic activity, it was found that
doses of at least 130mg 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 that 80%.
Clinical studies conducted in allergic
rhinitis have shown that a dose of
120mg is sufficient for 24 hours efficacy.
In children aged 6 to 11 years, the
suppressive effects of fexofenadine
hydrochloride on histamine-induced
wheal and flare to were comparable to
that in adults at similar exposure.
In an integrated analysis of placebo
controlled double-blind phase III
studies, involving 1369 children with
seasonal allergic rhinitis aged 6 to 11
years, fexofenadine hydrochloride at
30mg twice daily was significantly better
than placebo in reducing total symptom
score (p=0.0001). All individual
component symptoms including
rhinorrea, sneezing, itchy nose/palate
and throat, and nasal congestion were
significantly (p=0.0334 to p=0.0001)
improved by fexofenadine
hydrochloride.
In a double