Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ATORVASTATIN CALCIUM
PHARMAFORTE (MALAYSIA) SDN. BHD.
ATORVASTATIN CALCIUM
60tablet Tablets; 30tablet Tablets
APOTEX INC
NOT APPLICABLE 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