SARANTO 100 mg (Losartan Potassium Tablets 100 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LOSARTAN POTASSIUM

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

LOSARTAN POTASSIUM

Unit dalam pakej:

30 Tablets; 100 Tablets; 30 Tablets; 100 Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

SARANTO
_Consumer Medication Information Leaflet (RiMUP)_
Losartan Potassium Tablet (50 mg, 100 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Saranto is used for
2.
How Saranto works
3.
Before you use Saranto
4.
How to use Saranto
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Saranto
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS SARANTO USED FOR

Hypertension
(High
Blood
Pressure)

Hypertensive Patients with Left
Ventricular
Hypertrophy
(Enlargement of Left Ventricle of
the Heart).
Losartan
Potassium
is
indicated
to
reduce the risk of stroke in patients
with hypertension and left ventricular
hypertrophy.

Nephropathy
(Appearance
of
Low
but
abnormal
levels
of
albumin in the urine) in Type 2
Diabetic Patients
Losartan Potassium may also be used
to treat other conditions, for
example,
heart
failure
and
kidney
disease in diabetic patients with high
blood pressure.
HOW SARANTO WORKS
Saranto
belongs
to
a
group
of
medicines
known
as
angiotensin-II
receptor antagonists. Angiotensin- II
is a substance produced in the body
which
binds
to
receptors
in
blood
vessels, causing them to tighten. This
results
in
an
increase
in
blood
pressure. Saranto prevents the binding
of angiotensin-II to these receptors,
causing
the
blood
vessels
to
relax
which
in
turn
lowers
the
blood
pressure. Saranto slows the decrease
of kidney function in patients with
high
blood
pressure
and
type
2
diabetes.
BEFORE YOU USE SARANTO
_-When you must not use it _

You are allergic (hypersensitive)
to losartan or any of its other
ingredients,

You
are
more
than
3
months
pregnant.
(It
is
also
better
to
avoid
Saranto
in
early
pregnancy)
_-Before you start to use it _
It
is
important
to
tell
your
doctor
before taking Saranto if :-

You
have
a
history
of
angioedema (swelling of the face,
lips, throat, mouth and/or tongue)
as you may be more likely to
develop an allergic reaction.

You
think
you
are
(or
might
become) pregnant. Saranto is not
recommended
in

Ciri produk

SUMMARY OF
PRODUCT
CHARACTERISTICS
_Rx Only_
SARANTO 100
Losartan Potassium
Tablets 100 mg
NAME OF DRUG PRODUCT:
Losartan Potassium Tablets 100 mg
(TRADE) NAME OF
PRODUCT:
SARANTO 100
STRENGTH:
100 mg
PHARMACEUTICAL DOSAGE FORM:
Tablet.
Q U A L I TAT I V E
A N D
Q U A N T I TAT I V E
COMPOSITIONS:
_Losartan Potassium Tablets 100 mg_
Each film-coated tablet contains Losartan Potassium
Ph.Eur. 100 mg.
PHARMACEUTICAL FORM:
_Losartan Potassium Tablets 100 mg: _White to off-
white, oval shaped, biconvex film-coated tablets
debossed with 'E' on one side and '47' on the other
side.
CLINICAL PARTICULARS:
PHARMACODYNAMICS/PHARMACOKINETICS
PHARMACODYNAMICS:
Losartan
inhibits
systolic
and
diastolic
pressor
responses to angiotensin II infusions. At peak, 100
mg of losartan potassium inhibits these responses
by approximately 85%; 24 hours after single and
multiple – dose administration, inhibition is about 26-
39%.
During
losartan
administration,
removal
of
angiotensin
II
negative
feedback
on
rennin
secretion leads to increased plasma rennin activity.
Increases in plasma rennin activity lead to increases
in angiotensin II in plasma. During chronic (6 weeks)
treatment of hypertensive patients with 100 mg/day
losartan,
approximately
2-3
fold
increases
of
plasma angiotensin II were observed at time of peak
plasma
drug
concentrations.
In
some
patients,
greater increases were observed particularly during
short
term
(2
weeks)
treatment.
However,
antihypertensive activity and suppression of plasma
aldosterone concentration were apparent at 2 and 6
weeks, indicating effective angiotensin II receptor
blockade. After discontinuation of losartan, plasma
renin activity and angiotension II levels declined to
untreated levels within 3 days. Since losartan is a
specific antagonist of the angiotensin II receptor
type AT1, it does not inhibit ACE (kininase II), the
enzyme
that
degrades
bradykinin.
Plasma
concentrations of losartan and its active metabolite
and the antihypertensive effect of losartan increase
with increasing dose. Since losa