Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ATORVASTATIN CALCIUM
PHARMAFORTE (MALAYSIA) SDN. BHD.
ATORVASTATIN CALCIUM
30tablet Tablets; 30tablet Tablets
APOTEX INC
APO-ATORVASTATIN TABLET Atorvastatin Calcium (20mg, 40mg, 80mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What APO-ATORVASTATIN is used for 2. How APO-ATORVASTATIN works 3. Before you use APO- ATORVASTATIN 4. How to use APO- ATORVASTATIN 5. While you are using it 6. Side effects 7. Storage and Disposal of APO- ATORVASTATIN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT APO-ATORVASTATIN IS USED FOR Atorvastatin is used to lower the levels of cholesterol (particularly Low Density Lipoprotein (LDL) cholesterol) and other fats in the blood. This may help prevent heart disease is caused by cholesterol clogging the blood vessels or slow the progression of atherosclerosis (hardening of the arteries that nourish your heart), so-called coronary heart disease (CHD). HOW APO-ATORVASTATIN WORKS APO-ATORVASTATIN inhibits an enzyme that is necessary for the body to make cholesterol. In this way, less cholesterol is produced in the liver. BEFORE YOU USE APO- ATORVASTATIN - _When you must not use it _ Tell your physician if • You have previously taken atorvastatin or any other medication in the same class - example, simvastatin, pravastatin or fluvastatin and were allergic, or had reacted badly to it. • You are pregnant or intend to become pregnant. This medicine should not be used during pregnancy. • You are breast-feeding, or intend to breast-feed. • You have other medical conditions, especially liver disease. _ _ _Pregnancy and lactation _ Do not take APO-ATORVASTATIN if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take APO-ATORVASTATIN if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. _ _ _ _ - _Before you start use it _ APO-ATORVASTATIN may not be suitable for you: • If you have kidney problems • If you have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems • If you have had previous muscula Baca dokumen lengkap
APO‐ATORVASTATIN TABLET 20MG, 40MG, 80MG Atorvastatin calcium PRODUCT DESCRIPTION 20 mg: White, oval, biconvex film‐coated tablets. Engraved "APO" on one side, "ATV20" on the other side. 40 mg: White, oval, biconvex film‐coated tablets. Engraved "APO" on one side, "ATV40" on the other side. 80 mg: White, oval, biconvex film‐coated tablets. Engraved "APO" on one side, "ATV80" on the other side. PHARMACODYNAMICS Atorvastatin calcium is a synthetic lipid‐lowering agent, which is an inhibitor of 3‐hydroxy‐3‐methylglutaryl‐coenzyme A (HMG‐ CoA) reductase. This enzyme catalyzes the conversion of HMG‐ CoA to mevalonate, an early and rate‐ limiting step in cholesterol biosynthesis. Atorvastatin is a selective, competitive inhibitor of HMG‐CoA reductase, the rate‐limiting enzyme that converts 3‐hydroxy‐3‐ methylglutaryl‐coenzyme A to mevalonate, a precursor of sterols, including cholesterol. In patients with homozygous and heterozygous familial hypercholesterolemia (FH), nonfamilial forms of hypercholesterolemia, and mixed dyslipidemia, atorvastatin reduces total‐C (total cholesterol), LDL‐C (low‐ density lipoprotein cholesterol), and apo B (apolipoprotein B). Atorvastatin also reduces VLDL‐C (very‐low‐density lipoprotein cholesterol) and TG (triglycerides) and produces variable increases in HDL‐C (high‐density lipoprotein cholesterol). Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG‐CoA reductase and cholesterol synthesis in the liver and by increasing 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 in patients with homozygous familial hypercholesterolemia, a population that has not normally responded to lipid‐lowering Baca dokumen lengkap