Dyna Ticlopidine Tablet 250mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Ticlopidine Hydrochloride

Boleh didapati daripada:

DYNAPHARM (M) SDN BHD

INN (Nama Antarabangsa):

Ticlopidine Hydrochloride

Unit dalam pakej:

40 Tablets; 100 Tablets; 30 Tablets

Dikeluarkan oleh:

DYNAPHARM (M) SDN BHD

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
DYNA TICLOPIDINE TABLET 250MG
Ticlopidine Hydrochloride (250 mg)
1
What is in this leaflet
1.
What Ticlopidine Tablet is used for
2.
How Ticlopidine Tablet works
3.
Before you used Ticlopidine Tablet
4.
How to use Ticlopidine Tablet
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Ticlopidine
Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
What Ticlopidine Tablet is used for
Ticlopidine Tablet is indicated for:
1.
Maintenance of openness of
coronary artery bypass implant.
2.
Maintenance of openness of access
sites in patients on chronic kidney
dialysis.
3.
Reducing risk of stroke due to blood
clot (fatal or nonfatal) in individuals
who experienced stroke precursor or
had a completed stroke.
4.
Prevention of blockage following
coronary STENT(s) implantation.
5.
Prevent stroke.
How Ticlopidine Tablet works
Ticlopidine Tablet prevents blood
clotting and as well as prolong of
bleeding time.
Before you use Ticlopidine Tablet
-
When you must not use it
Do not use Ticlopidine Tablet in
individuals with:
1.
Abnormal bleeding
2.
Lesions which are likely to bleed;
active gastroduodenal ulcer or
bleeding stroke in the critical phase.
3.
Blood disease involving prolonged
bleeding time.
4.
History of allergy to Ticlopidine
5.
History of low number of white
blood cells, low platelet count and
acute disease with lowered white
blood cells count.
Pregnancy and lactation
Do not take Ticlopidine Tablet if you
are pregnant, trying to get pregnant or
think you may be pregnant. Do not take
Ticlopidine Tablet if you are breast-
feeding.
Ask your doctor or pharmacists for
advice before taking Ticlopidine Tablet
-
Before you start to use it
Tell your doctor or pharmacist if you
have:
1.
Impaired liver function
2.
Low number of neutrophils in blood
and low platelet count
-
Taking other medicines
Tell your doctor if you are taking
heparins, oral anticoagulants,
antiplatelet drugs, theophylline,
phenytoin, phosphenytoin, cy

Ciri produk

DYNA TICLOPIDINE TABLET 250MG
MAL08111762AZ
EACH TABLET CONTAINS:
Ticlopidine Hydrochloride ................................. 250 mg
DESCRIPTION:
TABLET
Colour
:
Pink
Shape
:
Round and Biconvex
Coating
:
Film-coated
PHARMACODYNAMICS:
Ticlopidine is an inhibitor of platelet aggregation. It causes
dose-dependent inhibition of platelet aggregation and release of
platelet factors, as
well as a prolongation of bleeding time. The drug has no significant
in vitro activity, but only in vivo activity; however, there is no
evidence for a
circulating active metabolite.
PHARMACOKINETICS:
After oral administration of a single standard dose of Ticlopidine, a
rapid absorption occurs, with peak plasma levels occurring
approximately 2
hours after dosing.
Absorption is practically complete. Administration of Ticlopidine
after meals improves bioavailability.
Steady-state plasma levels are obtained after 7-10 days of dosing at
250 mg twice daily. The average terminal elimination half-life of
Ticlopidine
at steady state is approximately 30-50 hours. However, the inhibition
of platelet aggregation does not correlate with plasma drug levels.
Ticlopidine is extensively metabolized by the liver. Following an oral
dose of radiolabeled product, 50-60% are recovered in the urine and
20-30%
in faeces.
INDICATION:
Maintenance of patency of coronary artery by-pass graft.
Maintenance of patency of access sites in patients on chronic
haemodialysis.
Reducing risk of thrombotic stroke (fatal or nonfatal) in patients who
have experienced stroke precursors and in patients who have had a
completed stroke.
Prevention of subacute occlusions following coronary STENT(s)
implantation.
Because Ticlopidine hydrochloride is associated with a risk of
neutropenia/granulocytosis, which may be life-threatening (see Adverse
Reactions),
Ticlopidine hydrochloride should be reserved for patients who are
intolerant to aspirin therapy where indicated to prevent stroke.
RECOMMENDED DOSE:
The tablets should be taken with meals.
Adults: Usual Dosage: 2 tablets daily, wit