Страна: Сингапур
Език: английски
Източник: HSA (Health Sciences Authority)
Olmesartan medoxomil
PFIZER PRIVATE LIMITED
C09CA08
10mg
TABLET, FILM COATED
ORAL
Prescription Only
DAIICHI SANKYO EUROPE GmbH
2004-07-19
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 Прочетете целия документ