Olmetec Tablet 20mg

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

Olmesartan medoxomil

Fáanlegur frá:

PFIZER PRIVATE LIMITED

ATC númer:

C09CA08

Skammtar:

20mg

Lyfjaform:

TABLET, FILM COATED

Samsetning:

Olmesartan medoxomil 20mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

Prescription Only

Framleitt af:

DAIICHI SANKYO EUROPE GmbH

Leyfisstaða:

ACTIVE

Leyfisdagur:

2004-07-17

Upplýsingar fylgiseðill

Page 1 of 12 
OLMETEC® FILM-COATED TABLETS 

(Olmesartan 
medoxomil) 

USE IN PREGNANCY 

WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS,
DRUGS THAT ACT DIRECTLY ON THE 
RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND EVEN DEATH
TO THE DEVELOPING FETUS. When pregnancy 
is detected, Olmesartan medoxomil should be discontinued as soon
as possible. See WARNINGS, 
FETAL/NEONATAL MORBIDITY AND MORTALITY. 

DESCRIPTION 

Olmesartan medoxomil is a prodrug, which
is hydrolysed to the active metabolite olmesartan during 
absorption from the gastrointestinal tract. Olmesartan is a
selective AT
1
 subtype angiotensin II receptor 
antagonist.  

Olmesartan medoxomil is described
chemically as (5-methyl-2-oxo-1,3-dioxolen-4-yl)methyl 4-(1-
hydroxy-1-methylethyl)-2-propyl-1[[2’-1H-tetrazol-5-yl]-1,1’biphenyl-4-yl]methyl]1H-imidazol-5-
carboxylate. Alternatively, it can be described as
“2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-
methylethyl)-2-propyl-1-[_p_-(_o_-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate,
cyclic 2,3-
carbonate”.  

Its empirical formula is C
29
H
30
N
6
O
6
 and its structural formula is: 
Olmesartan medoxomil is
a white to light yellowish-white powder or crystalline powder with
a 
molecular weight of 558.59. It is practically insoluble in
water and sparingly soluble in methanol. 
Olmetec® is available for oral use as film-coated tablets
containing 10 mg, 20 mg, or 40 mg of 
olmesartan medoxomil and the following inactive ingredients:
hydroxypropylcellulose, lactose, 
low-substituted hydroxypropylcellulose, magnesium
stearate, microcrystalline cellulose, talc and 
titanium dioxide.  

Page 2 of 12 
CLINICAL PHARMACOLOGY 

MECHANISM OF ACTION 
Angiotensin II is formed from angiotensin I in a reaction catalyzed
by angiotensin converting enzyme 
(ACE, kininase II). Angiotensin II is the principal pressor agent
of the�

Vara einkenni

OLMETEC
® FILM-COATED TABLETS
(Olmesartan medoxomil)
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, DRUGS
THAT ACT DIRECTLY
ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND EVEN DEATH TO THE
DEVELOPING FETUS.
When pregnancy is detected, Olmesartan medoxomil should be
discontinued as soon as
possible.
See
Sections
WARNINGS,
FETAL/NEONATAL
MORBIDITY
AND
MORTALITY
and
PRECAUTIONS, PREGNANCY
.
DESCRIPTION
Olmesartan medoxomil is a prodrug, which is hydrolyzed to the active
metabolite olmesartan
during absorption from the gastrointestinal tract. Olmesartan is a
selective AT
1
subtype
angiotensin II receptor antagonist.
Olmesartan medoxomil is described chemically as
(5-methyl-2-oxo-1,3-dioxolen-4-yl)methyl
4-(1-hydroxy-1-methylethyl)-2-propyl-1[[2’-1H-tetrazol-5-yl]-1,1’biphenyl-4-yl]methyl]1H-
imidazol-5-carboxylate. Alternatively, it can be described as
“2,3-dihydroxy-2-butenyl 4-(1-
hydroxy-1-methylethyl)-2-propyl-1-[
_p_
-(
_o_
-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-
carboxylate, cyclic 2,3-carbonate”.
Its empirical formula is C
29
H
30
N
6
O
6
and its structural formula is:
Olmesartan medoxomil is a white to light yellowish-white powder or
crystalline powder with
a molecular weight of 558.59. It is practically insoluble in water and
sparingly soluble in
methanol. Olmetec is available for oral use as film-coated tablets
containing 10 mg, 20 mg, or
40
mg
of
olmesartan
medoxomil
and
the
following
inactive
ingredients:
hydroxypropylcellulose, lactose, low substituted
hydroxypropylcellulose, magnesium stearate,
microcrystalline cellulose, talc and titanium dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Angiotensin II is formed from angiotensin I in a reaction catalyzed by
angiotensin converting
enzyme
(ACE,
kininase
II).
Angiotensin
II
is
the
principal
pressor
agent
of
the
renin-angiotensin system (RAS), with effects that include
vasoconstriction, stimulation of
synthesis and release of aldosterone, cardiac stimulation and renal
reabsorption of sodium.
Olmesartan b