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Atorvastatin Calcium Trihydrate
TCL-R is a preparation of atorvastatin which acts as a cholesterol lowering agent. TCL-R inhibits 3- hydroxy-3-methyl glutaryl-coenzyme A (HMG-CoA) reductase, an enzyme that catalyzes the biosynthesis of cholesterol. The enzyme catalyzes the conversion of HMGCoA to mevalonate, an early and rate limiting step in the synthesis of cholesterol.
- Absorption: Atorvastatin is rapidly absorbed after oral administration, maximum plasma levels occur within 1 to 2 hours. Extent of absorption increases in proportion to atorvastatin dose. The absolute bioavailability of atorvastatin (parent drug) is approximately 14% and the systemic availability of HMG-CoA reductase inhibitory activity is apporximately 30%.
- Distribution: Mean volume of distribution of atorvastatin is approximately 381 liters.
- Atorvastatin is >98% bound to plasma proteins. Metabolism: Atorvastatin is extensively metabolized to ortho- and parahydroxylated derivatives and various beta-oxidation product. Atorvastatin is metabolized by cytochrome P450 3A4.
- Excretion: Atorvastatin and its metabolites are eliminated primarily in bile following hepatic metabolism. Mean plasma elimination half-life is approximately 14 hours. Less than 2 % of a dose of atorvastatin is recovered in urine following oral administration.