CANDESARTAN GH candesartan cilexetil 4 mg tablet blister pack

Summary of Product characteristics

                                Candesartan GH PI v5.0
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PRODUCT INFORMATION
CANDESARTAN GH
_Candesartan cilexetil 4mg, 8mg, 16mg & 32mg tablets _
NAME OF THE MEDICINE
Candesartan
cilexetil.
The
chemical
name
for
candesartan
cilexetil
is
(1_RS_)-1-
[[(Cyclohexyloxy)carbonyl]oxy]ethyl
2-ethoxy-1-[[2′-(1_H_-tetrazol-5-yl)biphenyl-4-yl]methyl]-1_H_-
benzimidazole-7-carboxylate. Its structural formula is:
C
33
H
34
N
6
O
6
Molecular weight: 611
CAS No.: 145040-37-5
DESCRIPTION
Candesartan cilexetil is a white or almost white powder and is
practically insoluble in water, freely
soluble in methylene chloride and slightly soluble in anhydrous
ethanol. Three polymorphic forms
have been identified; crystal form I, crystal form II and an amorphous
form. Crystalline form I is
used in CANDESARTAN GH.
CANDESARTAN GH tablets come in four strengths and contain 4 mg, 8 mg,
16 mg or 32 mg of
candesartan cilexetil. The tablets also contain lactose monohydrate,
carmellose calcium, maize
starch, macrogol 8000, hyprolose, magnesium stearate and Pigment Blend
PB-24880 Pink (ARTG
108327) which contains iron oxide red and lactose. The tablets are
gluten free.
PHARMACOLOGY
PHARMACODYNAMICS
Angiotensin II is the primary vasoactive hormone of the
renin-angiotensin-aldosterone system and
plays
a
significant
role
in
the
pathophysiology
of
hypertension,
heart
failure
and
other
cardiovascular
disorders.
It
also
has
an
important
role
in
the
pathogenesis
of
end
organ
Candesartan GH PI v5.0
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hypertrophy
and
damage.
The
major
physiological
effects
of
angiotensin
II,
such
as
vasoconstriction, aldosterone stimulation, regulation of salt and
water homeostasis and stimulation
of cell growth, are mediated via the type 1 (AT
1
) receptor.
Candesartan cilexetil is a prodrug suitable for oral use. It is
rapidly converted to the active drug,
candesartan, by ester hydrolysis during absorption from the
gastrointestinal tract. Candesartan is
an angiotensin II receptor antagonist, selective for AT
1
receptors, with tight binding to and slow
dissociation from the rece
                                
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