Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EZETIMIBE; SIMVASTATIN
ORGANON MALAYSIA SDN. BHD.
EZETIMIBE; SIMVASTATIN
10Tablet Tablets; 30Tablet Tablets
MSD International GmbH (Singapore Branch)
_Consumer Medication Information Leaflet (RiMUP) _ VYTORIN ® Ezetimibe/Simvastatin (10mg/10mg, 10mg/20mg, 10mg/40mg) 1 Copyright 2023 Organon group of companies. All rights reserved. WHAT IS IN THIS LEAFLET 1. What VYTORIN is used for 2. How VYTORIN works 3. Before you use VYTORIN 4. How to use VYTORIN 5. While you are using it 6. Side effects 7. Storage and disposal of VYTORIN 8. Product description 9. Manufacturer and product registration holder 10. Date of revision 11. Serial number WHAT VYTORIN IS USED FOR VYTORIN (ezetimibe/simvastatin) is a tablet that is available in four strengths: − VYTORIN 10/10 (ezetimibe 10 mg/simvastatin 10 mg) − VYTORIN 10/20 (ezetimibe 10 mg/simvastatin 20 mg) − VYTORIN 10/40 (ezetimibe 10 mg/simvastatin 40 mg) VYTORIN is a medicine used to lower levels of total cholesterol, LDL (bad) cholesterol, and fatty substances called triglycerides in the blood. In addition, VYTORIN raises levels of HDL (good) cholesterol. VYTORIN is for patients who cannot control their cholesterol levels by diet alone. You should stay on a cholesterol- lowering diet while taking this medicine. If you have heart disease, VYTORIN reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalization for chest pain. WHY HAS MY DOCTOR PRESCRIBED VYTORIN? Your doctor has prescribed VYTORIN to reduce the amount of cholesterol and triglycerides in your blood. Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol. LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke. HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and p Прочетете целия документ
1 I. THERAPEUTIC CLASS II. COMPOSITION III. CLINICAL PHARMACOLOGY _IIIA. MECHANISM OF ACTION_ _ _ LPC-OG0653A-T-052023-Malaysia LOCAL PRODUCT CIRCULAR TABLETS VYTORIN ® 10/10 (EZETIMIBE 10 MG/SIMVASTATIN 10 MG) VYTORIN ® 10/20 (EZETIMIBE 10 MG/SIMVASTATIN 20 MG) VYTORIN ® 10/40 (EZETIMIBE 10 MG/SIMVASTATIN 40 MG) VYTORIN (ezetimibe/simvastatin) is a lipid-lowering product that selectively inhibits the intestinal absorption of cholesterol and related plant sterols and inhibits the endogenous synthesis of cholesterol. VYTORIN is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (VYTORIN 10/10), 20 mg of simvastatin (VYTORIN 10/20) or 40 mg of simvastatin (VYTORIN 10/40). _VYTORIN _ Plasma cholesterol is derived from intestinal absorption and endogenous synthesis. VYTORIN contains ezetimibe and simvastatin, two lipid-lowering compounds with complementary mechanisms of action. VYTORIN reduces elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and increases HDL-C through dual inhibition of cholesterol absorption and synthesis. _ _ _EZETIMIBE _ Ezetimibe inhibits the intestinal absorption of cholesterol. Ezetimibe is orally active and has a mechanism of action that differs from other classes of cholesterol-reducing compounds (e.g., statins, bile acid sequestrants [resins], fibric acid derivatives, and plant stanols). The molecular target of ezetimibe is the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is responsible for the intestinal uptake of cholesterol and phytosterols. Ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the liver; statins reduce cholesterol synthesis in the liver and together these distinct mechanisms provide complementary cholesterol reduction. In a 2-week clinical study in 18 hypercholesterolemic patients, ezetimibe inhibited intestinal cholesterol absorption by 54%, compared with placebo. 2 _IIIB. PHARMACOKINETICS_ _ _ Прочетете целия документ