Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EZETIMIBE; ATORVASTATIN CALCIUM TRIHYDRATE
ORGANON MALAYSIA SDN. BHD.
EZETIMIBE; ATORVASTATIN CALCIUM TRIHYDRATE
30tablet Tablets; 10tablet Tablets
MSD International GmbH (Puerto Rico Branch) LLC
_Consumer Medication Information Leaflet (RiMUP) _ ATOZET ® FILM-COATED TABLETS Ezetimibe/atorvastatin 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg 1 Copyright 2023 Organon group of companies. All rights reserved. WHAT IS IN THIS LEAFLET 1. What ATOZET tablet is used for 2. How ATOZET tablet works 3. Before you take ATOZET tablet 4. How to use ATOZET tablet 5. While you are taking ATOZET tablet 6. Side effects 7. Storage and Disposal of ATOZET tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT ATOZET TABLET IS USED FOR Your doctor has prescribed ATOZET tablet 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 protects against heart disease. Triglycerides are another form of fat in your blood that may increase your risk for heart disease. If you have heart disease, ATOZET reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalization for chest pain. HOW ATOZET TABLET WORKS High cholesterol can be treated in two main ways: LIFESTYLE CHANGES – including a cholesterol-lowering diet, increased physical activity, and weight management. MEDICATION – Cholesterol-lowering medicines are used together with lifestyle changes to help lower cholesterol. Your doctor has prescribed ATOZET to help lower your cholesterol. BEFORE YOU TAKE ATOZET TABLET _WHEN YOU MUST NOT TAKE IT _ DO NOT Baca dokumen lengkap
1 1. NAME OF THE DRUG 2. PHARMACEUTICAL FORM 3. PHARMACEUTICAL PARTICULARS ATOZET ® (EZETIMIBE/ATORVASTATIN) LPC-OG0653C-T-052023 [TABLET] ATOZET ® 10MG/10MG FILM-COATED TABLETS (EZETIMIBE 10 MG/ATORVASTATIN 10 MG) ATOZET ® 10MG/20MG FILM-COATED TABLETS (EZETIMIBE 10 MG/ATORVASTATIN 20 MG) ATOZET ® 10MG/40MG FILM-COATED TABLETS (EZETIMIBE 10 MG/ATORVASTATIN 40 MG) ATOZET ® 10MG/80MG FILM-COATED TABLETS (EZETIMIBE 10 MG/ATORVASTATIN 80 MG) Film-coated tablets 3.1 CHEMISTRY ATOZET contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and atorvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor. _EZETIMIBE _ The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]- 4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C 24 H 21 F 2 NO 3 . Its molecular weight is 409.4. Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is: 2 O H F F _ATORVASTATIN _ _ _ Atorvastatin is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ ,-dihydroxy-5-(1-methylethyl)-3-phenyl-4- [(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Atorvastatin calcium is a white or almost white powder that is soluble in dimethyl sulfoxide. The degree of solubility in water, ethanol, and methylene chloride is very slightly soluble to practically insoluble. The molecular formula of atorvastatin calcium is C 66 H 68 CaF 2 N 4 O 10 .3H 2 O. The molecular weight of atorvastatin calcium is 1209.36. Its structural formula is: 3.2 COMPOSITION ACTIVE INGREDIENTS ATOZET is available for oral use as tablets containing 10 mg of ezetimibe and: 10.9 mg of atorvastatin calcium (crystalline trihydrate), equivalent to 10 mg of atorvastatin (ATOZET 10 mg/10 mg); 21.7 mg of atorvastatin calcium (crystalline trihydrate), equivalent to 20 mg of atorvastatin (ATOZET 10 mg/20 mg); 43.4 mg of atorvastatin calcium ( Baca dokumen lengkap