Each tablet contains 5mg/10mg/20mg/40mg of Rosuvastatin.
As an adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia and to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.
Rosuvastatin is an inhibitor of HMG-CoA reductase, an enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.
Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal
with 20 mg.
Hypersensitivity to the active substance(s) or to any of the excipients. Active liver disease, which may include unexplained persistent elevations in hepatictransaminase levels, pregnant and nursing women.
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis). Monitor liver enzymes before and during treatment. Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Rosuvastatin, Immune-Mediated Necrotizing Myopathy
Pregnancy Category X. Rosuvastatin is contraindicated in women who are or may become pregnant. Lactating women should be advised not to nurse their infants. Should be avoided in children below 6 years.
Following drug interact with Rosuvastatin caution to be taken with
Cyclosporine, Gemfibrozil, Lopinavir/Ritonavir or atazanavir/ritonavir, Coumarin anticoagulants and fibrates. Aspirin administered with anticoagulant and anti-platelets causes
increased risk of bleeding.
The most commonly reported adverse events are headache, myalgia, abdominal pain, asthenia, and nausea.