THROMBOREDUCTIN KAPSUL 0,5 MG

Country: Indonesia

Bahasa: Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

ANAGRELIDE

Boleh didapati daripada:

COMBIPHAR - Indonesia

INN (Nama Antarabangsa):

ANAGRELIDE

Dos:

0,5 MG

Borang farmaseutikal:

KAPSUL

Unit dalam pakej:

DUS, BOTOL PLASTIK @ 42 KAPSUL

Dikeluarkan oleh:

AOP PHARMACEUTICALS AG - Austria

Tarikh kebenaran:

2015-03-31

Ciri produk

THROMBOREDUCTIN
®
ANAGRELIDE HCL
0.5 mg Capsule
COMPOSITION
Each one capsule contains:
Anagrelide HCI 0.57 mg equivalent to anagrelide 0.5 mg
MODE OF ACTION
PHARMACODYNAMIC PROPERTIES
In humans Anagrelide causes a dose dependent decrease in platelet
count, the
mechanism of action is unknown and species specific.
There are no data a platelet count reducing effect in any experimental
animal
model. It is therefore hypothesized that Anagrelide acts via a
metabolite that is
generated in man.
Anagrelide exerts its action via reducing the size and ploidy of
megakaryocytes in
the post mitotic phase of maturation.
Anagrelide does not cause significant changes in white blood cells and
coagulation
parameters, minor changes in red blood cells were observed.
When administered in high, non-therapeutic doses Anagrelide inhibits
the c-AMP
phosphodiesterase and ADP and collagen induced thrombocyte
aggregation.
PHARMACOKINETIC PROPERTIES
The bioavailability of Anagrelide after oral administration is 70%
according to data
from a mass balanced study.
In healthy volunteers the time to maximal plasma level (t max) was
about 1 to 2
hours, the elimination half life is short (1 to 2 hours).
Anagrelide has a high volume of distribution (120 L/kg), the
distribution in different
compartment is unknown, as is plasma protein binding.
Anagrelide
is
intensively
metabolised,
at
least
4
metabolites
emerge. After
administration of C
14
labeled Anagrelide 75% of radioactivity are excreted within 6
days via urine, 10% via faeces.
The clinical experience in fasted or non-fasted patients shows that
there is no effect
of food on the efficacy of Anagrelide.
Accumulation
of Anagrelide
should
not
occur
upon
long-term
administration
because of the short half-life.
This assumption is supported by clinical experience: upon stopping
treatment
platelet counts recover to pre treatment levels within 4 to 8 days.
No data are available for elderly patients and patients with renal or
liver
insufficiency. When using Anagrelide in these patients careful
monitoring e