KESTINE FILM-COATED TABLET 20MG

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

Micronised Ebastine

Tilgængelig fra:

EURODRUG LABORATORIES SINGAPORE PTE. LTD.

ATC-kode:

R06AX22

Lægemiddelform:

TABLET, FILM COATED

Sammensætning:

Micronised Ebastine 20.0mg

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

Industrias Farmaceuticas Almirall. S.A. (IFA)

Autorisation status:

ACTIVE

Autorisation dato:

2019-03-12

Produktets egenskaber

EBASTINE
KESTINE
®
20 MG FILM-COATED TABLET
ANTIHISTAMINE
FORMULATION:
Each Ebastine (Kestine®) Film-coated tablet contains:
Ebastine ……………………………….......….. 20mg
Excipients: microcrystalline cellulose, pregelatinised maize starch,
lactose monohydrate,
croscarmellose sodium, magnesium stearate, hypromellose, macrogol and
titanium dioxide.
PHARMACEUTICAL FORM AND CONTENT OF PACKAGE:
Round, white film-coated tablets with one side marked E20. Boxes
containing 10 (1x10), 20
(2x10) 30 (3x10), 50 (5x10) and 100 (10x10) tablets in PVC/Aluminium
blisters.
Not all the presentations are available in all markets.
INDICATION:
EBASTINE (Kestine®) is indicated in the treatment of allergic
rhinitis (seasonal and perennial)
with or without allergic conjunctivitis.
MECHANISM OF ACTION:
EBASTINE (Kestine®) produces rapid and prolonged inhibition of the
effects induced by
histamines, showing a strong afinity for binding to H1 receptors.
After oral administration,
neither
EBASTINE
(Kestine®)
nor
it’s
metabolites
cross
the
blood-brain
barrier.
This
characteristic is consistent with the low sedation observed in the
results of experiments in which
the effects of EBASTINE (Kestine®) on the central nervous system were
studied.
The in vitro and in vivo data demonstrate that EBASTINE (Kestine®) is
a powerful antagonist
with a prolonged effect and highly selective of the histamine H1
receptors, free of CNS side
effects and anticholinergic effects.
PHARMACOKINETIC PROPERTIES:
Absorption
- Ebastine is rapidly absorbed and undergoes extensive hepatic and
intestinal first pass
metabolism after oral administration.
- Ebastine is almost totally converted into the pharmacologically
active metabolite, carebastine.
- Administration of ebastine with food increases the plasma levels of
carebastine 1.5 to 2.0 fold.
- After a single 10 mg oral dose, peak plasma level of the metabolite
(Cmax) occurs at 2 to 4
hours and achieves a mean value of 80 to 100 ng/mL.
- The half-life of carebastine is between 15 and 19 hours wit