Losartan K Film Coated Tablet 50mg

Šalis: Malaizija

kalba: anglų

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

Veiklioji medžiaga:

LOSARTAN POTASSIUM

Prieinama:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (Tarptautinis Pavadinimas):

LOSARTAN POTASSIUM

Vienetai pakuotėje:

30tablet Tablets

Pagaminta:

PT NOVELL PHARMACEUTICAL LABORATORIES.

Prekės savybės

Attachment 3
LOSARTAN K FILM COATED TABLET
LOSARTAN POTASSIUM 50MG
PRODUCT DESCRIPTION
White, film coated tablet, round, convex, side I labeled LST 50, side
II labeled NPL,
odorless, tasteless
COMPOSITION
Each film coated tablet contains 50 mg of Losartan Potassium
PHARMACODYNAMICS
Angiotensin
II
[formed
from
angiotensin
I
in
a
reaction
catalyzed
by
angiotensin
converting
enzyme
(ACE,
kininase
II)],
is
a
potent
vasoconstrictor,
the
primary
vasoactive hormone of the renin-angiotensin system and an important
component in the
pathophysiology of hypertension. It also stimulates aldosterone
secretion by the adrenal
cortex.
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). There is also an AT2 receptor found in many tissues
but it is not known to
be associated with cardiovascular homeostatis. Both losartan and its
principal active
metabolite do not exhibit any partial agonist activity at the AT1
receptor and have much
greater affinity (about 1000-fold) for the AT1 receptor than for the
AT2 receptor. In vitro
binding studies indicate that losartan is a reversible, competitive
inhibitor of the AT1
receptor. 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.
PHARMACOKINETICS
GENERAL
Losartan is an orally active agent that undergoes substantial
first-pass metabolism by
cytochrome
P450
enzymes.
It
is
converted,
in
part,
to
an
active
carboxylic
acid
metabolite that is responsible for most of the angiotensin II receptor
antagonism that
follo