Fexofenadine (Douglas)

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Fexofenadine hydrochloride 120mg; Fexofenadine hydrochloride 120mg

متاح من:

Douglas Pharmaceuticals Limited

INN (الاسم الدولي):

Fexofenadine hydrochloride 120 mg

جرعة:

120 mg

الشكل الصيدلاني:

Film coated tablet

تركيب:

Active: Fexofenadine hydrochloride 120mg Excipient: Croscarmellose sodium Hyprolose Hypromellose Iron oxide red Iron oxide yellow Macrogol 400 Magnesium stearate Microcrystalline cellulose Opacode black S-1-8152HV Povidone Purified talc Purified water Titanium dioxide Active: Fexofenadine hydrochloride 120mg Excipient: Croscarmellose sodium Hyprolose Hypromellose Iron oxide red Iron oxide yellow Macrogol 400 Magnesium stearate Microcrystalline cellulose Opacode black S-1-27794 Povidone Purified talc Purified water Titanium dioxide

الوحدات في الحزمة:

Blister pack, PVC/PVDC/Al foil, 10 tablets

الفئة:

Pharmacy only

نوع الوصفة الطبية :

Pharmacy only

المصنعة من قبل:

Sun Pharmaceutical Industries Ltd

ملخص المنتج:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al foil - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al foil - 30 tablets - 36 months from date of manufacture stored at or below 25°C

تاريخ الترخيص:

2004-06-23

خصائص المنتج

 
DATA SHEET 

FEXOFENADINE 
Fexofenadine Tablets 

PRESENTATION 
Fexofenadine 120 mg Tablets are pink coloured, capsule- shaped
film coated tablets 
imprinted with "F1" in black ink on one side and plain on the other
side containing 
120 mg fexofenadine hydrochloride.

Fexofenadine 180 mg Tablets are pink coloured, capsule- shaped
film coated tablets 
imprinted with "F2" in black ink on one side and plain on the other
side containing 
180 mg fexofenadine hydrochloride.

USES  
Fexofenadine hydrochloride is the synthetic hydrochloride salt of
fexofenadine, the 
carboxylic acid metabolite of terfenadine (Teldane). It is an orally
active non-sedating 
H
1
-receptor antagonist and is effective for the relief of symptoms
associated with 
seasonal allergic rhinitis (sneezing, rhinorrhea, pruritus and
lacrimation).  
ACTIONS  
Fexofenadine is the major metabolite of terfenadine in man and
is largely responsible 
for the antihistaminic effect following the administration of
terfenadine. 

The antihistaminic effects of fexofenadine have been demonstrated in
animal systems 
_in vitro _and _in vivo_. Oral administration of fexofenadine to
guinea pigs indicated that 
fexofenadine antagonised histamine-induced skin wheals in a
dose-dependent manner. 
The antihistaminic effects of fexofenadine and terfenadine were
also assessed in the 
isolated guinea pig ileum _in vitro_. Both drugs antagonised the
contractile effects of 
histamine, however, fexofenadine was found to be a more selective
histamine 
antagonist than terfenadine.  

Fexofenadine inhibited antigen induced bronchospasm in sensitised
guinea pigs and at 
high doses inhibited histamine release from peritoneal mast cells of
the rat. 

In laboratory animals, no anticholinergic or
alpha-1-adrenergic receptor blocking 
effects were observed. Radiolabelled tissue distribution studies in
rat indicated that 
fexofenadine did not cross the blood brain barrier. 

Fexofenadine is not associate