Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LOSARTAN POTASSIUM
RANBAXY (MALAYSIA) SDN. BHD.
LOSARTAN POTASSIUM
100Tablet Tablets; 100 Tablet Tablets; 30 Tablet Tablets
RANBAXY (MALAYSIA) SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 ROSART TABLETS Losartan Potassium (50mg/100mg) _ _ _ _ WHAT IS IN THIS LEAFLET 1. What ROSART TABLETS is used for 2. How ROSART TABLETS works 3. Before you use ROSART TABLETS 4. How to use ROSART TABLETS 5. While you are using it 6. Side effects 7. Storage and Disposal of ROSART TABLETS 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ROSART TABLETS IS USED FOR ROSART TABLETS is used to treat high blood pressure. If you have high blood pressure and a thickening of the left ventricle, the heart’s main pumping chamber, your doctor has prescribed ROSART TABLETS to help lower the risk of cardiovascular events, such as stroke. ROSART TABLETS also provide kidney protection by delaying the worsening of kidney disease in type 2 diabetic patients with protein in their urine (proteinuria). Kidney disease can be measured by testing the urine for protein. HOW ROSART TABLETS WORKS ROSART TABLETS contain an active substance called losartan which belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Your doctor however, may have prescribed this medicine for another purpose. Ask your doctor if you have any questions why it has been prescribed for you. This medicine is available only with a doctor’s prescription. BEFORE YOU USE ROSART TABLETS _ _ - _When you must not use it _ DO NOT TAKE ROSART TABLETS IF: you have an allergy to losartan or any of the ingredients of ROSART TABLETS (see PRODUCT DESCRIPTION ) (An allergic reaction may include skin rash, itching or hives, swelling of the face, l Прочетете целия документ
_For the use only of a Registered Medical Practitioner _ _ _ PRESCRIBING INFORMATION ROSART TABLETS (LOSARTAN POTASSIUM TABLETS 50 / 100 MG) COMPOSITION ROSART TABLETS 50 MG Each Film coated Tablet contains Losartan Potassium…………….50 mg ROSART TABLETS 100 MG Each Film coated Tablet contains Losartan Potassium…………….100 mg PRODUCT DESCRIPTION ROSART TABLETS 50 MG White to off white, circular, biconvex, film-coated tablets with score line on one side and plain on the other side. Diameter 7.6 mm ROSART TABLETS 100 MG White to off white, circular, biconvex, film-coated tablets with score line on one side and plain on the other side. Diameter 9.6 mm DESCRIPTION ROSART (Losartan potassium) is an angiotensin II receptor (type AT 1 ) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1_H_-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22 H 22 ClKN 6 O and molecular weight is 461.01. The structural formula is as below: LOSARTAN POTASSIUM Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES _THERAPEUTIC CLASS _ Losartan potassium, the first of a new class of agents for the treatment of hypertension, is an angiotensin II receptor (type AT1) antagonist. Losartan also provides a reduction in the combined risk of cardiovascular death, stroke, and myocardial infarction in hypertensive patients with left ventricular hypertrophy and provides renal protection for type 2 diabetic patients with proteinuria. _ _ _MECHANISM OF ACTION_ Angiotensin II, a potent vasoconstrictor, is the primary active hormone of the renin-angiotensin system, and a major determinant of the pathophysiology of hypertension. Angiotensin II binds to the AT 1 receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland, kidneys, and the heart) and elicits several important biological actions, including vasoconstriction and t Прочетете целия документ