Țară: Singapore
Limbă: engleză
Sursă: HSA (Health Sciences Authority)
Hydrochlorothiazide; Olmesartan medoxomil
PFIZER PRIVATE LIMITED
25.00mg
TABLET, FILM COATED
Hydrochlorothiazide 25.00mg; Olmesartan medoxomil 40.00mg
ORAL
Prescription Only
Daiichi Sankyo Europe GmbH
ACTIVE
2007-05-22
Page 1 of 18 OLMETEC PLUS TM (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) 1. TRADENAME OF THE MEDICINAL PRODUCT Olmetec Plus TM 20/12.5 mg Olmetec Plus TM 40/12.5 mg Olmetec Plus TM 40/25 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Olmetec Plus TM 20/12.5 mg tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. Olmetec Plus TM 40/12.5 mg tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. Olmetec Plus TM 40/25 mg tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Olmetec Plus TM 20 mg/12.5 mg: reddish-yellow, circular, film-coated tablets, approximately 8.5 mm in diameter, with "C22" debossed on one side. Olmetec Plus TM 40 mg/12.5 mg: reddish-yellow, oval, film-coated tablets, approximately 15 x 7 mm, with "C23" debossed on one side. Olmetec Plus TM 40 mg/25 mg: pink, oval, film-coated tablets, approximately 15 x 7 mm, with "C25" debossed on one side. 4. CLINICAL PARTICULARS Olmetec Plus TM (olmesartan medoxomil-hydrochlorothiazide) is a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[_p_-(o- 1_H _tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. 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 Citiți documentul complet
OLMETEC PLUS TM (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) 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 and hydrochlorothiazide should be discontinued as soon as possible (see WARNINGS, FETAL/NEONATAL MORBIDITY AND MORTALITY). 1. TRADE NAME OF THE MEDICINAL PRODUCT Olmetec Plus TM 20/12.5 mg Olmetec Plus TM 40/12.5 mg Olmetec Plus TM 40/25 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Olmetec Plus TM 20/12.5 mg tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. Olmetec Plus TM 40/12.5 mg tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. Olmetec Plus TM 40/25 mg tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Olmetec Plus TM 20 mg/12.5 mg: reddish-yellow, circular, film-coated tablets, approximately 8.5 mm in diameter, with "C22" debossed on one side. Olmetec Plus TM 40 mg/12.5 mg: reddish-yellow, oval, film-coated tablets, approximately 15 x 7 mm, with "C23" debossed on one side. Olmetec Plus TM 40 mg/25 mg: pink, oval, film-coated tablets, approximately 15 x 7 mm, with "C25" debossed on one side. 4. CLINICAL PARTICULARS Olmetec Plus TM (olmesartan medoxomil-hydrochlorothiazide) is a combination of an angiotensin II receptor antagonist (AT 1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2- propyl-1-[_p_-(o-1_H _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 crystall Citiți documentul complet