Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
Ezetimibe
Merck Sharp & Dohme Australia Pty Ltd
Medicine Registered
EZETROL ® (PRONOUNCED EZ-EH-TROL) _Ezetimibe_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about EZETROL. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking EZETROL against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT EZETROL IS USED FOR EZETROL helps to lower cholesterol levels. It is used in people whose cholesterol levels are too high and when diet alone cannot lower these levels adequately. EZETROL may be taken alone or with other cholesterol-lowering medicines known as HMG-CoA reductase inhibitors (or statins), in addition to diet. In people who have high levels of plant sterols in their blood (which doctors call sitosterolaemia), EZETROL helps to lower these levels. _CHOLESTEROL_ 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 protects against heart disease. _TRIGLYCERIDES_ Triglycerides are another form of fat in your blood that may increase your risk for heart disease. _HOW EZETROL WORKS_ EZETROL reduces elevated total- cholesterol, LDL (bad) cholesterol and triglycerides and increases HDL (good) cholesterol. EZETROL works by decreasing the absorption of cholesterol Aqra d-dokument sħiħ
EZETROL PI A20120726 v2 1 of 21 WPC-MK0653-T-112011 PRODUCT INFORMATION EZETROL Ò [/au_hum_1410_SPC.html#1] (EZETIMIBE) NAME OF THE MEDICINE EZETROL, ezetimibe is described chemically as 1-(4-fluorophenyl)-3(R)-[3-(4- fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The CAS registry number is 163222-33-1. The empirical formula is C 24 H 21 F 2 NO 3 . Its molecular weight is 409.4 and its structural formula is: DESCRIPTION Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Each tablet of EZETROL for oral administration contains 10 mg ezetimibe. Each 10 mg tablet contains croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. PHARMACOLOGY MECHANISM OF ACTION: EZETROL (ezetimibe) is in a class of lipid-modifying compounds that inhibit the intestinal absorption of cholesterol and related plant sterols. Ezetimibe has a mechanism of action that differs from other classes of cholesterol reducing compounds (eg statins, bile acid sequestrants [resins], fibric acid derivatives, and plant sterols.) N O H F F S S R O O H EZETROL PI A20120726 v2 2 of 21 WPC-MK0653-T-112011 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 therefore inhibits the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the liver. This causes a reduction of Aqra d-dokument sħiħ