Quốc gia: Singapore
Ngôn ngữ: Tiếng Anh
Nguồn: HSA (Health Sciences Authority)
EZETIMIBE; SIMVASTATIN
ORGANON SINGAPORE PTE. LTD.
10 mg
TABLET
EZETIMIBE 10 mg; SIMVASTATIN 20 mg
ORAL
Prescription Only
MSD INTERNATIONAL GMBH (SINGAPORE BRANCH)
ACTIVE
2004-06-18
SG-PPI-OG0653A-T-062023 Patient Product Information (PPI) INFORMATION FOR THE PATIENT ABOUT VYTORIN™ Please read this information carefully before you start to take your medicine, even if you have just refilled your prescription. Some of the information may have changed. You should also read any information provided with other medicines you are currently taking. Remember that your doctor has prescribed this medicine only for you. Never give it to anyone else. What is VYTORIN? 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 10/80 (ezetimibe 10 mg/simvastatin 80 mg) Not all presentations/dosage strengths are available. 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. It is used 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. How does VYTORIN work? VYTORIN works to reduce your cholesterol in two ways. It reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself. VYTORIN does not help you lose weight. 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 th Đọc toàn bộ tài liệu
SG-OG0653A-T-062023 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™ 10/80 (EZETIMIBE 10 MG/SIMVASTATIN 80 MG) I. THERAPEUTIC CLASS 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. II. ACTIVE INGREDIENTS 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), 40 mg of simvastatin (VYTORIN 10/40), or 80 mg of simvastatin (VYTORIN 10/80). III. INDICATIONS Primary Hypercholesterolemia VYTORIN is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high- density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hypercholesterolemia or mixed hyperlipidemia. Homozygous Familial Hypercholesterolemia (HoFH) VYTORIN is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. IV. CLINICAL PHARMACOLOGY IVa. Mechanism of Action 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 o Đọc toàn bộ tài liệu