国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROSUVASTATIN CALCIUM
PHARMAFORTE (MALAYSIA) SDN. BHD.
ROSUVASTATIN CALCIUM
30tablet Tablets
APOTEX INC
APO-ROSUVASTATIN TABLETS Rosuvastatin Calcium (10mg, 20mg) 1 _Consumer Medication Information Leaflet (RiMUP)_ WHAT IS IN THIS LEAFLET 1. What Apo-Rosuvastatin is used for 2. How Apo-Rosuvastatin works 3. Before you use Apo-Rosuvastatin 4. How to use Apo-Rosuvastatin 5. While you are using it 6. Side effects 7. Storage and Disposal of Apo- Rosuvastatin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT APO-ROSUVASTATIN IS USED FOR Apo-Rosuvastatin is indicated as an adjunct treatment in the treatment of hyperlipidemic or dyslipidemic (high level of fat and fatty substance) cases, where diet and exercise is not sufficient in bringing down your cholesterol level. HOW APO-ROSUVASTATIN WORKS Apo-Rosuvastatin is a prescription medication containing the active ingredient, rosuvastatin calcium. Apo- Rosuvastatin is a form of HMG-COA reductase inhibitor. It works by blocking an enzyme that is needed by the body to make cholesterol, so this reduces the amount of cholesterol in the blood. BEFORE YOU USE APO-ROSUVASTATIN - _When you must not use it_ _ _ Do not use this product if you are allergic to _ _ Rosuvastatin Calcium or any other ingredients in this medication. (Please refer to PRODUCT INFORMATION ) _ _ _ _ You cannot use this medication if you have certain medical condition, such as: - active liver disease - kidney impairments - myopathy (muscle tissue disorder) _ _ _Pregnancy and lactation _ Do not take Apo-Rosuvastatin if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Apo-Rosuvastatin if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. _ _ - _Before you start to use it_ _ _ Before taking Apo-Rosuvastatin your doctor needs to know if you have any other medical condition that you may have, including low blood pressure, kidney, liver disease, and/or any that involve your muscle tissues. - _Taking other medicines _ Tell your doctor if you are taking any other medicines, including any that you b 完全なドキュメントを読む
APO‐ROSUVASTATIN TABLETS ROSUVASTATIN 10MG & 20MG (AS ROSUVASTATIN CALCIUM) PRODUCT DESCRIPTION 10 mg: Pink, round, biconvex, film‐coated tablet. Engraved “APO” on one side, “ROS” over “10” on the other side 20 mg: Pink, round, biconvex, film‐coated tablet. Engraved “APO” on one side, “ROS” over “20” on the other side. MECHANISM OF ACTION Rosuvastatin is a selective and competitive inhibitor of HMG‐CoA reductase, the rate‐limiting enzyme that converts 3‐hydroxy‐3‐ methylglutaryl coenzyme A to mevalonate, a precursor for cholesterol. The primary site of action of rosuvastatin is the liver, the target organ for cholesterol lowering. Rosuvastatin increases the number of hepatic LDL receptors on the cell‐surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles. PHARMACODYNAMICS Rosuvastatin reduces elevated LDL‐cholesterol, total cholesterol and triglycerides and increases HDL‐cholesterol. It also lowers ApoB, nonHDL‐C, VLDL‐C, VLDL‐TG and increases ApoA‐I. Rosuvastatin also lowers the LDL‐C/HDL‐C, total C/HDL‐C and nonHDL‐C/HDL‐C and the ApoB/ApoA‐I ratios. Rosuvastatin is effective in adults with hypercholesterolaemia, with and without hypertriglyceridaemia, regardless of race, sex, or age and in special populations such as diabetics, or patients with familial hypercholesterolaemia. PHARMACOKINETICS Absorption: Maximum rosuvastatin plasma concentrations are achieved approximately 5 hours after oral administration. The absolute bioavailability is approximately 20%. Distribution: Rosuvastatin is taken up extensively by the liver which is the primary site of cholesterol synthesis and LDL‐C clearance. The volume of distribution of rosuvastatin is approximately 134 L. Approximately 90% of rosuvastatin is bound to plasma proteins, mainly to albumin. Metabolism: Rosuvastatin undergoes limited metabolism (approximately 10%). _In _ _vitro_ metabolism studies us 完全なドキュメントを読む