Silatio 20mg tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SILDENAFIL CITRATE

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

SILDENAFIL CITRATE

Unit dalam pakej:

10 x 10 Tablets

Dikeluarkan oleh:

UNISON LABORATORIES CO.LTD

Risalah maklumat

SILATIO 20MG TABLET
Sildenafil citrate eq. to Sildenafil (20mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Silatio_
_ _
is used for
2.
How
_Silatio_
_ _
works
3.
Before you use
_Silatio_
4.
How to use
_Silatio_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Silatio_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT SILATIO IS USED FOR
Silatio is indicated to treat adults with
high blood pressure in the blood
vessels in the lungs (pulmonary arterial
hypertension), to improve exercise
capacity.
HOW SILATIO WORKS
Silatio belongs to a group of medicines
called phosphodiesterase type 5 (PDE5)
inhibitors.
Silatio brings down blood pressure in
the lungs by widening the blood
vessels in the lungs.
BEFORE YOU USE SILATIO
_- When you must not use it _
•
if you are allergic (hypersensitive)
to sildenafil or any of the other
ingredients of this medicine.
•
if you are taking medicines
containing nitrates or nitric oxide
donors.
•
Silatio can cause a serious increase
in the low blood pressure effects
of these medicines. Tell your
doctor if you are taking any of
these medicines. If you are not
certain, ask your doctor or
pharmacist.
•
if you have pulmonary
hypertension due to abnormality
of red blood cells (sickle cell
anaemia).
•
if you are taking PDE5 inhibitors,
including guanylate cyclase
stimulators, such as riociguat.
•
if you have recently had a stroke, a
heart attack or if you have severe
liver disease or very low blood
pressure (<90/50 mmHg).
•
if you are taking a medicine to
treat fungal infections such as
ketoconazole or itraconazole or
medicines containing ritonavir (for
HIV).
•
if you have ever had loss of vision
because of a problem with blood
flow to the nerve in the eye called
non-arteritic anterior ischaemic
optic neuropathy (NAION).
_Pregnancy and breastfeeding _
If you are pregnant, or breastfeeding,
think you may be pregnant or are
planning to have a baby, ask your

Ciri produk

1 of 3
SILATIO 20 MG TABLET
Each film coated tablet contains:
SILDENAFIL CITRATE EQ. TO
SILDENAFIL 20 MG

PRODUCT DESCRIPTION:
White, round, biconvex, film coated tablet with engraved 20 on one
side and scored on the other side
The tablet is not meant to be split and should be swallowed whole.

MECHANISM OF ACTION:
_PHARMACOLOGY_
Sildenafil is a potent and selective inhibitor of cyclic guanosine
monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5), the
enzyme that is responsible for degradation of cGMP.
Apart from the presence of this enzyme in the corpus cavernosum of the
penis, PDE5 is also present in the pulmonary vasculature
_. _
Sildenafil, therefore, increases cGMP within pulmonary
vascular smooth muscle cells resulting in relaxation. In patients with
pulmonary arterial hypertension this can lead to vasodilation of the
pulmonary vascular bed and, to a lesser degree,
vasodilatation in the systemic circulation.
_ _
_PHARMACOKINETICS _
Absorption
Sildenafil is rapidly absorbed. Maximum observed plasma concentrations
are reached within 30 to 120 minutes (median 60 minutes) of oral
dosing in the fasted state. The mean absolute
oral bioavailability is 41% (range 25-63%). After oral three times a
day dosing of Sildenafil, AUC and C
max
increase in proportion with dose over the dose range of 20-40 mg.
After oral
doses of 80 mg three times a day a more than dose proportional
increase in Sildenafil plasma levels has been observed. In pulmonary
arterial hypertension patients, the oral bioavailability
of Sildenafil after 80 mg three times a day was on average 43% (90%
CI: 27-60%) higher compared to the lower doses.
When Sildenafil is taken with food, the rate of absorption is reduced
with a mean delay in T
max
of 60 minutes and a mean reduction in C
max
of 29% however, the extent of absorption was
not significantly affected (AUC decreased by 11%).
Distribution
The mean steady state volume of distribution (V
SS
) for Sildenafil is 105 L, indicating distribution into the tissues.
After oral doses of 20 mg