Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
100 Tablets; 30 Tablets; 10 Tablets
TORRENT PHARMACEUTICALS LTD.
TOZAAR PLUS LS _ _ Losartan Potassium / Hydrochlorothiazide (50mg / 12.5mg) _ _ _ _ 1 _ _ _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is Tozaar Plus LS used for. 2. How Tozaar Plus LS works. 3. Before you use Tozaar Plus LS. 4. How to use Tozaar Plus LS. 5. While you are using it. 6. Side effects. 7. Storage and Disposal of Tozaar Plus LS. 8. Product Description. 9. Manufacturer and Product Registration Holder. 10. Date of revision. 11. Serial number. WHAT TOZAAR PLUS LS IS USED FOR It is used for: • Treatment of hypertension, for patients in whom combination therapy is appropriate. • Reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy (thickening of the ventricular walls (lower chambers) in the heart). HOW TOZAAR PLUS LS WORKS Losartan is in a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is the hormone that binds to the receptor in blood vessels, which results in narrowing of blood vessels and subsequently raises blood pressure. Losartan inhibits the binding of angiotensin-II to these receptors. Hydrochlorothiazide is a thiazide diuretic that acts directly on the kidney to increase water excretion and thus decrease blood volume and pressure of the blood vessels. BEFORE YOU USE TOZAAR PLUS LS - _When you must not use it _ Do not take Losartan-HCTZ if you: • Are allergic (hypersensitive) to Losartan Potassium, Hydrochlorothiazide or any other ingredients in this medicine. • Experienced absence of urine (anuria). • If you are pregnant, trying to get pregnant or think you may be pregnant. • If you are breast-feeding. _Pregnancy and lactation_ You must tell your doctor if you think you are (or might become) pregnant. Tozaar Plus LS is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage. Do not take Tozaar Plus LS if you are breast-feeding. Ask your doctor or pharmacist for advice before t Baca dokumen lengkap
xxxxxxxx-5253 COMPOSITION: TOZAAR PLUS LS 50/12.5 MG TABLET Each film coated tablet contains: Losartan Potassium Ph. Eur. 50 mg Hydrochlorothiazide Ph. Eur. 12.5 mg DESCRIPTION: Losartan potassium is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-yl phenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22 H 22 ClKN 6 O, and its structural formula is: Losartan potassium is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5- hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1- dioxide. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 and its structural formula is: Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. PHARMACOLOGICAL ACTION: Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)], is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g., vascular smooth muscle, adrenal gland). There is also an AT2 receptor found in many tissues but it is not known to be associated with cardiovascular homeostasis. Both losartan and its principal active metabolite do not exhibit Baca dokumen lengkap