Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ATORVASTATIN CALCIUM TRIHYDRATE
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
ATORVASTATIN CALCIUM TRIHYDRATE
3x10 Tablets; 10 x 10 Tablets
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
CRYSTORVAS TABLET Atorvastatin (40mg; 20mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Crystorvas is used for 2. How Crystorvas works 3. Before you use Crystorvas 4. How to use Crystorvas 5. While you are using it 6. Side effects 7. Storage and Disposal of Crystorvas 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CRYSTORVAS IS USED FOR Crystorvas belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Crystorvas is used to lower lipids known as cholesterol (total cholesterol, low-density lipoprotein [LDL] cholesterol) and other fats (triglycerides) in the blood when a low fat diet and lifestyle changes on their own have failed. Crystorvas can lower the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as: Age, smoking, high blood pressure, low HDL-C, heart disease in the family. Crystorvas can lower the risk for heart attack or stroke in patients with diabetes and risk factors such as: Eye problems, kidney problems, smoking, or high blood pressure. HOW CRYSTORVAS WORKS Crystorvas works by reducing the amount of cholesterol made by the liver. In terms of good and bad cholesterol, Crystorvas reduces the bad cholesterol and raises the good cholesterol. BEFORE YOU USE CRYSTORVAS - _When you must not use it_ Do not take Crystorvas: • if you are hypersensitive (allergic) to Crystorvas or to any similar medicines used to lower blood lipids or to any of the other ingredients of the medicine; • if you have or have ever had a disease which affects the liver; • if you have had any unexplained abnormal blood tests for liver function; • if you are a woman able to have • children and not using reliable contraception; • if you are pregnant or trying to • become pregnant; • if you are breast-feeding. _Pregnancy and lactation _ Women of childbearing potential Women of child-bearing poten Baca dokumen lengkap
BRAND NAME: CRYSTORVAS PRODUCT NAME CRYSTORVAS TABLET 40MG CRYSTORVAS TABLET 20MG ACTIVE INGREDIENT Crystalline Atorvastatin Calcium PRODUCT DESCRIPTION ATORVASTATIN TABLET 40MG - White to off-white, 10 mm round, biconvex, with “40” marking on one side and plain on the other side, film-coated tablet. ATORVASTATIN TABLET 20MG -White to off-white, 7 mm round, biconvex, with “20” marking on one side and plain on the other side, film-coated tablet. PHARMACODYNAMICS Pharmacotherapeutic group: Lipid modifying agents, HMG-CoA-reductase inhibitors, ATC code: C10AA05 Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme responsible for the conversion of 3-hydroxy-3-methyl-glutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Triglycerides and cholesterol in the liver are incorporated into very low-density lipoproteins (VLDL) and released into the plasma for delivery to peripheral tissues. Low-density lipoprotein (LDL) is formed from VLDL and is catabolised primarily through the receptor with high affinity to LDL (LDL receptor). Atorvastatin lowers plasma cholesterol and lipoprotein serum concentrations by inhibiting HMG-CoA reductase and subsequently cholesterol biosynthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL. Atorvastatin reduces LDL production and the number of LDL particles. Atorvastatin produces a profound and sustained increase in LDL receptor activity coupled with a beneficial change in the quality of circulating LDL particles. Atorvastatin is effective in reducing LDL-C in patients with homozygous familial hypercholesterolaemia, a population that has not usually responded to lipid-lowering medicinal products. Reductions in total-C, LDL-C, and apolipoprotein B have been proven to reduce risk for cardiovascular events and cardiovascular mortality. PHARMACOKINETIC Absorption Atorvastatin is rapidly absorbed after oral administration; maximum plasma co Baca dokumen lengkap