Lostad HCT 50/12.5mg film-coated tablets

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE

Dostopno od:

STADPHARM SDN. BHD.

INN (mednarodno ime):

LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE

Enote v paketu:

30tablet Tablets

Izdeluje:

STELLAPHARM J.V. Co., LTD. - BRANCH 1

Navodilo za uporabo

_Consumer Medication Information Leaflet (RiMUP) _
LOSTAD HCT FILM COATED TABLETS
One tablet of Lostad HCT 50/12.5mg contains 50mg of Losartan potassium
and 12.5mg of Hydrochlorothiazide
One tablet of Lostad HCT 100/25mg contains 100mg of Losartan potassium
and 25mg of Hydrochlorothiazide
1
WHAT IS IN THIS LEAFLET
1.
What Lostad HCT is used for
2.
How Lostad HCT works
3.
Before you use Lostad HCT
4.
How to use Lostad HCT
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Lostad HCT
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT LOSTAD HCT IS USED FOR
Lostad HCT is used for the treatment of
high blood pressure. This drug is not used
for initial therapy of high blood pressure,
except when it is severe enough that the
value of a achieving prompt blood pressure
control exceeds the risk of initiating
therapy in these patients.
Lostad HCT is used to reduce the risk of
stroke (a sudden attack of weakness
affecting one side of the body) in patients
with high blood pressure and left
ventricular hypertrophy (the thickening of
the muscle of the left ventricle of the
heart), but there is evidence that this
benefit does not apply to Black patients.
HOW LOSTAD HCT WORKS
Lostad HCT is a combination of Losartan
potassium and Hydrochlorothiazide.
Losartan is an angiotensin II receptor
antagonists. Losartan keeps blood vessels
from narrowing, which lowers blood
pressure and improves blood flow.
Hydrochlorothiazide is a thiazide diuretic
(water pill) that helps prevent your body
from absorbing too much salt, which can
cause fluid retention.
BEFORE YOU USE LOSTAD HCT
_-When you must not use it _
-
If you are allergic (hypersensitive) to
any component of this product.
-
If you are allergic to other
sulfonamide-derived drugs.
-
If you are unable to urinate.
-
If you are pregnant.
_-Before you start to use it _
_If any of the situations mentioned below _
_apply to you, you should tell your doctor _
_before taking this drug: _
-
If you have renal artery stenosis
(narrow

Lastnosti izdelka

LOSTAD HCT 50/12.5
COMPOSITION
One Lostad HCT 50/12.5 film-coated tablet contains 50 mg of
losartan potassium and 12.5 mg of hydrochlorothiazide.
DESCRIPTION
White, round-shaped, film-coated tablet, biconvex, plain on both
sides.
PHARMACODYNAMICS
Losartan
and
its
principal
active
metabolite
block
the
vasoconstrictor and aldosterone-secreting effects of angiotensin
II by selectively blocking the binding of angiotensin II to the AT1
receptor found in many tissues, (e.g., vascular smooth muscle,
adrenal gland). The active metabolite is 10 to 40 times more
potent by weight than losartan and appears to be a reversible,
non-competitive inhibitor of the AT1 receptor. Neither losartan nor
its active metabolite inhibits ACE (kininase II, the enzyme that
converts angiotensin I to angiotensin II and degrades bradykinin);
nor do they bind to or block other hormone receptors or ion
channels known to be important in cardiovascular regulation.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the
renal tubular mechanisms
of
electrolyte reabsorption,
directly
increasing excretion of sodium and chloride in approximately
equivalent
amounts.
Indirectly,
the
diuretic
action
of
hydrochlorothiazide reduces plasma volume, with aldosterone
secretion, increases in urinary potassium. The renin - aldosterone
link
is
mediated
by
angiotesin
II,
so
coadministration
of
an
angiotensin II receptor antagonist tends to reverse the potassium
loss
associated
with
these
diuretics.
The
mechanism
of
the
antihypertensive effect of thiazides is unknown.
Non-melanoma
skin
cancer:
Based
on
available
data
from
epidemiological studies, cumulative dose-dependent association
between
HCTZ
and
NMSC
has
been
observed.
One
study
included a population comprised of 71,533 cases of BCC and of
8,629
cases
of
SCC
matched
to
1,430,833
and
172,462
population controls, respectively. High HCTZ use (≥ 50,000 mg
cumulative) was associated with an adjusted OR of 1.29 (95% CI:
1.23-1.35) for BCC and 3.98 (95% Cl: 3.68-4.31) for SCC. A clear
cumulative dose respons