Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LOSARTAN POTASSIUM
HEALOL PHARMACEUTICALS SDN. BHD.
LOSARTAN POTASSIUM
30 Tablets; 100 Tablets; 30 Tablets; 100 Tablets
Aurobindo Pharma Limited (Unit III),
SARANTO _Consumer Medication Information Leaflet (RiMUP)_ Losartan Potassium Tablet (50 mg, 100 mg) 1 WHAT IS IN THIS LEAFLET 1. What Saranto is used for 2. How Saranto works 3. Before you use Saranto 4. How to use Saranto 5. While you are using it 6. Side effects 7. Storage and Disposal of Saranto 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS SARANTO USED FOR Hypertension (High Blood Pressure) Hypertensive Patients with Left Ventricular Hypertrophy (Enlargement of Left Ventricle of the Heart). Losartan Potassium is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy. Nephropathy (Appearance of Low but abnormal levels of albumin in the urine) in Type 2 Diabetic Patients Losartan Potassium may also be used to treat other conditions, for example, heart failure and kidney disease in diabetic patients with high blood pressure. HOW SARANTO WORKS Saranto 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. Saranto prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Saranto slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. BEFORE YOU USE SARANTO _-When you must not use it _ You are allergic (hypersensitive) to losartan or any of its other ingredients, You are more than 3 months pregnant. (It is also better to avoid Saranto in early pregnancy) _-Before you start to use it _ It is important to tell your doctor before taking Saranto if :- You have a history of angioedema (swelling of the face, lips, throat, mouth and/or tongue) as you may be more likely to develop an allergic reaction. You think you are (or might become) pregnant. Saranto is not recommended in Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS _Rx Only_ SARANTO 100 Losartan Potassium Tablets 100 mg NAME OF DRUG PRODUCT: Losartan Potassium Tablets 100 mg (TRADE) NAME OF PRODUCT: SARANTO 100 STRENGTH: 100 mg PHARMACEUTICAL DOSAGE FORM: Tablet. Q U A L I TAT I V E A N D Q U A N T I TAT I V E COMPOSITIONS: _Losartan Potassium Tablets 100 mg_ Each film-coated tablet contains Losartan Potassium Ph.Eur. 100 mg. PHARMACEUTICAL FORM: _Losartan Potassium Tablets 100 mg: _White to off- white, oval shaped, biconvex film-coated tablets debossed with 'E' on one side and '47' on the other side. CLINICAL PARTICULARS: PHARMACODYNAMICS/PHARMACOKINETICS PHARMACODYNAMICS: Losartan inhibits systolic and diastolic pressor responses to angiotensin II infusions. At peak, 100 mg of losartan potassium inhibits these responses by approximately 85%; 24 hours after single and multiple – dose administration, inhibition is about 26- 39%. During losartan administration, removal of angiotensin II negative feedback on rennin secretion leads to increased plasma rennin activity. Increases in plasma rennin activity lead to increases in angiotensin II in plasma. During chronic (6 weeks) treatment of hypertensive patients with 100 mg/day losartan, approximately 2-3 fold increases of plasma angiotensin II were observed at time of peak plasma drug concentrations. In some patients, greater increases were observed particularly during short term (2 weeks) treatment. However, antihypertensive activity and suppression of plasma aldosterone concentration were apparent at 2 and 6 weeks, indicating effective angiotensin II receptor blockade. After discontinuation of losartan, plasma renin activity and angiotension II levels declined to untreated levels within 3 days. Since losartan is a specific antagonist of the angiotensin II receptor type AT1, it does not inhibit ACE (kininase II), the enzyme that degrades bradykinin. Plasma concentrations of losartan and its active metabolite and the antihypertensive effect of losartan increase with increasing dose. Since losa Διαβάστε το πλήρες έγγραφο