PLETAAL

Šalis: Indonezija

kalba: indoneziečių

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

Prekės savybės Prekės savybės (SPC)
26-05-2021

Veiklioji medžiaga:

CILOSTAZOL

Prieinama:

OTSUKA INDONESIA - Indonesia

INN (Tarptautinis Pavadinimas):

CILOSTAZOL

Dozė:

100 MG

Vaisto forma:

TABLET

Vienetai pakuotėje:

DUS, 3 BLISTER @ 10 TABLET

Pagaminta:

OTSUKA INDONESIA - Indonesia

Leidimo data:

2021-05-26

Prekės savybės

                                COMPOSITION AND DESCRIPTION
COMPOSITION
Each
tablet
of
PLETAAL

Tablets
50
contains
50
mg
of
cilostazol. Each tablet of PLETAAL

Tablets 100 contains 100
mg of cilostazol.
Each capsule of PLETAAL

SR Capsules 100 mg contains 100
mg of cilostazol
PRODUCT DESCRIPTION
BRAND
NAME
DESCRIP
TION
APPEARANCE
DIAM
ETER
(MM)
THICKNE
SS (MM)
WEIGHT
(MG)
CODE
PLETAAL

TABLETS 50
White
compres
sed
Tablets
7
2.5
Ca 115
OG31
PLETAAL

TABLETS
100
White
compres
sed
Tablets
8
3.0
Ca 170
OG30
PLETAAL

SR
CAPSULES
100 mg
White
capsules
filled with
white
granules,
imprinted
“OG29” in
black ink.
Approx
.
18
Approx.
6
Approx.
206.8
OG29
INDICATIONS
•
Treatment
of
ischemic
symptoms,
including
ulceration,
pain, and coldness of the extremities, in chronic arterial
occlusion
•
Prevention of recurrence of cerebral infarction (excluding
cardiogenic cerebral embolism)
CONTRAINDICATIONS (CILOSTAZOL IS CONTRAINDICATED IN
THE FOLLOWING PATIENTS.)
1.
Patients
with
hemorrhage
(e.g.,hemophilia,
increased
capillary fragility, intracranial hemorrhage, hemorrhage in
the
digestive
tract,
hemorrhage
in
the
urinary
tract,
hemoptysis, and hemorrhage in the vitreous body)
(Bleeding tendency may be increased.)
2.
Patients with congestive heart failure (Condition may be
worsened.)
(See
item
(5)
under
2.
IMPORTANT
PRECAUTIONS.).
3.
Patients with a history of hypersensitivity to any ingredient
of the drug.
4. Women who are pregnant or may possibly become pregnant (See
4. USE DURING PREGNANCY, DELIVERY, OR LACTATION.)
DOSAGE AND ADMINISTRATION
PLETAAL
 TABLET
The usual adult dose of PLETAAL Tablets is 100 mg of
Cilostazol, twice daily by the oral route. The dosage may be
adjusted according to the age of the patients and the severity of
symptoms.
PLETAAL
 SR CAPSULES 100 MG
The usual adult dose of PLETAAL SR Capsules 100 mg is 200
mg of cilostazol, once daily, by the oral route. This drug is
taken on an empty stomach without food.
PHARMACOLOGY
1.
ANTIPLATELET ACTION
(1) _In vitro_ studies
•
Cilostazol inhibited platelet aggregati
                                
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