COZAAR 50MG TABLET

Country: Malaysia

Language: English

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

Active ingredient:

LOSARTAN POTASSIUM

Available from:

ORGANON MALAYSIA SDN. BHD.

INN (International Name):

LOSARTAN POTASSIUM

Units in package:

15 Tablet Tablets; 30Tablet Tablets

Manufactured by:

Organon Pharma (UK) Limited

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
COZAAR
® TABLET
Losartan potassium (50 mg, 100 mg)
Copyright 2022 Organon group of companies. All rights reserved.
1
WHAT IS IN THIS LEAFLET
1.
What COZAAR is used for
2.
How COZAAR works
3.
Before you take COZAAR
4.
How to take COZAAR
5.
While you are taking COZAAR
6.
Side effects
7.
Storage and Disposal
of COZAAR
8.
Product description
9.
Product Manufacturer and
Product Registration
Holder
10.
Date of Revision
WHAT COZAAR IS USED FOR
COZAAR is an angiotensin II
receptor antagonist which lowers
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 COZAAR to help
lower the risk of cardiovascular
events, such as stroke.
COZAAR also provides 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.
WHY HAS MY DOCTOR
PRESCRIBED COZAAR?
Your doctor has prescribed
COZAAR because you have a
condition known as hypertension
(high blood pressure). In patients
with high blood pressure and a
thickening of the left ventricle,
COZAAR has been shown to
decrease the risk of stroke and
heart attack and to help patients live
longer (see
_“_WHILE YOU ARE USING
IT”- _USE IN BLACK PATIENTS WITH _
_HIGH BLOOD PRESSURE AND A _
_THICKENING OF THE LEFT VENTRICLE)_
.
Your doctor may also have
prescribed COZAAR
because you have type 2 diabetes
with protein in the urine. In type 2
diabetic patients with protein in the
urine, COZAAR has been shown to
slow the worsening of kidney
disease.
HOW COZAAR WORKS
COZAAR works by widening your
blood vessels to make it easier for
the heart to pump blood to all parts
of your body. This helps to reduce
high blood pressure. COZAAR also
helps to lower the risk of
cardiovascular events, such as
stroke, in patients with high blood
pressure and a thickening of the left
ventricle of the heart. In addition to
these blood

Summary of Product characteristics

I. THERAPEUTIC CLASS
II. CLINICAL PHARMACOLOGY
LOCAL PRODUCT CIRCULAR
LPC-OG0954-T-102021-MALAYSIA
TABLETS
COZAAR
®
(losartan potassium)
COZAAR
(losartan
potassium),
the
first
of
a
new
class
of
agents
for
the
treatment
of
hypertension, is an angiotensin II receptor (type AT
1
) antagonist. COZAAR also provides a
reduction in the combined risk of cardiovascular death, stroke, and
myocardial infarction in
hypertensive patients with left ventricular hypertrophy and 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 the
release of aldosterone. Angiotensin II also stimulates smooth muscle
cell proliferation. A second
angiotensin II receptor has been identified as the AT
2
receptor subtype, but it plays no known
role in cardiovascular homeostasis.
Losartan is a potent, synthetic, orally active compound. Based on
binding and pharmacological
bioassays, it binds selectively to the AT
1
receptor.
_In vitro _
and
_in vivo_
, both losartan and its
pharmacologically active carboxylic acid metabolite (E-3174) block all
physiologically relevant
actions of angiotensin II, regardless of the source or route of
synthesis. In contrast to some
peptide antagonists of angiotensin II, losartan has no agonist
effects.
1
Losartan binds selectively to the AT
1
receptor and does not bind to or block other hormone
receptors or ion channels important in cardiovascular regulation.
Furthermore, losartan does not
inhibit ACE (kininase II), the enzyme that degrades bradykinin.
Consequently, effects
not
directly related to blocking the AT
1
receptor, such as the potentiation of bradykinin-mediated
effects or the generation of edema (losa