Generic Name
Composition
Therapeutic Category
Division
Rosuvastatin
Rosuvastatin Calcium 5 mg Tablet
Rosuvastatin Calcium 10 mg Tablet
Rosuvastatin Calcium 20 mg Tablet
Hypolipidemic
GENESIS
CARPRO 5 Each film coated tablet contains : Rosuvastatin Calcium IP 5mg
CARPRO 10 Each film coated tablet contains : Rosuvastatin Calcium IP 10 mg
CARPRO 20 Each film coated tablet contains : Rosuvastatin Calcium IP 20mg
PHARMACOLOGY
Pharmacotherapeutic Group: Lipid lowering agents
Pharmacodynamic Properties
Rosuvastatin is a member of the drug class known as statins, used for lowering blood cholesterol. It competitively inhibits HMG-CoA Reductase , the enzyme that catalyzes the conversion of HMG-CoA to Mevalonic acid. This results in the induction of the LDL receptors, leading to lowered LDL-cholesterol concentration. In in vivo and in vitro studies, Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell-surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.
Pharmacokinetic Properties
Absorption: In clinical pharmacology studies in man, peak plasma concentrations of Rosuvastatin were reached 3 to 5 hours following oral dosing. The absolute bioavailability of Rosuvastatin is approximately 20%. Administration of Rosuvastatin with food did not affect the AUC of Rosuvastatin.
Distribution: Mean volume of distribution at steady-state of Rosuvastatin is approximately 134 liters. Rosuvastatin is 88% bound to plasma proteins, mostly albumin.
Metabolism: Rosuvastatin is not extensively metabolized; approximately 10% of a radiolabeled dose is recovered as metabolite. The major metabolite is N-desmethyl Rosuvastatin.
Excretion: Following oral administration, Rosuvastatin and its metabolites are primarily excreted in the feces (90%). The elimination half-life (t1/2) of Rosuvastatin is approximately 19 hours.
INDICATIONS
DOSE: Once daily, can be taken with or without food.
Pregnancy Category: X
Storage: Store below 25 °C
Missed dose: Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
CONTRAINDICATIONS
SPECIAL PRECAUTIONS
PRESENTATION