Olmetec Tablet 10mg

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

Olmesartan medoxomil

Beschikbaar vanaf:

PFIZER PRIVATE LIMITED

ATC-code:

C09CA08

Dosering:

10mg

farmaceutische vorm:

TABLET, FILM COATED

Toedieningsweg:

ORAL

Prescription-type:

Prescription Only

Geproduceerd door:

DAIICHI SANKYO EUROPE GmbH

Autorisatie datum:

2004-07-19

Bijsluiter

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�