Fexofenadine (Douglas)
देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
उत्पाद विशेषताएं
(SPC)
08-08-2012
अनुरोध भेजा।
सक्रिय संघटक:
Fexofenadine hydrochloride 180mg; Fexofenadine hydrochloride 180mg
थमां उपलब्ध:
Douglas Pharmaceuticals Limited
INN (इंटरनेशनल नाम):
Fexofenadine hydrochloride 180 mg
डोज़:
180 mg
फार्मास्यूटिकल फॉर्म:
Film coated tablet
रचना:
Active: Fexofenadine hydrochloride 180mg 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 180mg 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
पैकेज में यूनिट:
Blister pack, PVC/PVDC/Al foil, 10 tablets
वर्ग:
Pharmacy only
प्रिस्क्रिप्शन प्रकार:
Pharmacy only
द्वारा बनाया गया:
Sun Pharmaceutical Industries Ltd
उत्पाद समीक्षा:
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
प्राधिकरण की तारीख:
2004-06-23
उत्पाद विशेषताएं
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
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