ROSART TABLETS 50 mg

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

LOSARTAN POTASSIUM

متاح من:

RANBAXY (MALAYSIA) SDN. BHD.

INN (الاسم الدولي):

LOSARTAN POTASSIUM

الوحدات في الحزمة:

100Tablet Tablets; 100 Tablet Tablets; 30 Tablet Tablets

المصنعة من قبل:

RANBAXY (MALAYSIA) SDN. BHD.

نشرة المعلومات

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
ROSART TABLETS
Losartan Potassium (50mg/100mg)
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What
ROSART
TABLETS
is
used for
2.
How
ROSART TABLETS
works
3.
Before
you
use
ROSART
TABLETS
4.
How to use
ROSART TABLETS
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
ROSART
TABLETS
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ROSART TABLETS IS USED
FOR
ROSART TABLETS
is used to treat
high blood pressure. If you have high
blood pressure and a thickening of the
left ventricle, the heart’s main pumping
chamber, your doctor has
prescribed
ROSART TABLETS
to
help lower
the risk of cardiovascular events, such
as stroke.
ROSART
TABLETS
also
provide
kidney
protection
by
delaying
the
worsening of kidney disease in type 2
diabetic patients with protein in their
urine (proteinuria). Kidney disease can
be measured by testing the urine for
protein.
HOW ROSART TABLETS WORKS
ROSART
TABLETS
contain
an
active substance called losartan which
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. Losartan prevents the binding
of
angiotensin-II
to
these
receptors,
causing
the
blood
vessels
to
relax
which
in
turn
lowers
the
blood
pressure. Losartan slows the decrease
of kidney function in patients with high
blood pressure and type 2 diabetes.
Your
doctor
however,
may
have
prescribed
this
medicine
for
another
purpose. Ask your doctor if you have
any
questions
why
it
has
been
prescribed for you.
This medicine is available only with a
doctor’s prescription.
BEFORE YOU USE ROSART TABLETS
_ _
-
_When you must not use it _
DO NOT TAKE ROSART TABLETS IF:

you have an allergy to losartan or
any
of
the
ingredients
of
ROSART
TABLETS
(see
PRODUCT
DESCRIPTION
)
(An
allergic reaction may include skin
rash, itching or hives, swelling of
the face, l

خصائص المنتج

_For the use only of a Registered Medical Practitioner _
_ _
PRESCRIBING INFORMATION
ROSART TABLETS
(LOSARTAN POTASSIUM TABLETS 50 / 100 MG)
COMPOSITION
ROSART TABLETS 50 MG
Each Film coated Tablet contains
Losartan Potassium…………….50 mg
ROSART TABLETS 100 MG
Each Film coated Tablet contains
Losartan Potassium…………….100 mg
PRODUCT DESCRIPTION
ROSART TABLETS 50 MG
White to off white, circular, biconvex, film-coated tablets with score
line on one side and plain on the other
side. Diameter 7.6 mm
ROSART TABLETS 100 MG
White to off white, circular, biconvex, film-coated tablets with score
line on one side and plain on the other
side. Diameter 9.6 mm
DESCRIPTION
ROSART (Losartan potassium) is an angiotensin II receptor (type AT
1
) antagonist. Losartan potassium, a
non-peptide
molecule,
is
chemically
described
as
2-butyl-4-chloro-1-[p-(o-1_H_-tetrazol-5-
ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical
formula is C
22
H
22
ClKN
6
O and
molecular weight is 461.01. The structural formula is as below:
LOSARTAN POTASSIUM
Oxidation of the 5-hydroxymethyl group on the imidazole ring results
in the active metabolite of losartan.
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES
_THERAPEUTIC CLASS _
Losartan potassium, the first of a new class of agents for the
treatment of hypertension, is an angiotensin II
receptor (type AT1) antagonist. Losartan also provides a reduction in
the combined risk of cardiovascular
death, stroke, and myocardial infarction in hypertensive patients with
left ventricular hypertrophy and
provides renal protection for type 2 diabetic patients with
proteinuria.
_ _
_MECHANISM OF ACTION_
Angiotensin II, a potent vasoconstrictor, is the primary active
hormone of the renin-angiotensin system, and
a major determinant of the pathophysiology of hypertension.
Angiotensin II binds to the AT
1
receptor found
in many tissues (e.g., vascular smooth muscle, adrenal gland, kidneys,
and the heart) and elicits several
important biological actions, including vasoconstriction and t