Rosucol

Rosuvastatin Ca

Adjunct to diet to reduce elevated total-C, LDL-C, apo B, non-HDL-C & TG levels & to increase HDL-C in patients w/ primary hypercholesterolemia (excluding heterozygous familial & non-familial hypercholesterolemia) & mixed dyslipidemia (Fredrickson type IIa & IIb). Adjunct to diet for patients w/ elevated serum TG levels (Fredrickson type IV). Reduces LDL-C, total-C & apo B in patients w/ HoFH as adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable.

Hypercholesterolemia (excluding heterozygous familial & non-familial) & mixed dyslipidemia (Fredrickson type IIa & IIb) Individualized dosage. Initially 10 mg once daily. Dose range: 5-20 mg once daily. Patient requiring less aggressive LDL-C reductions or who has predisposing factors for myopathy May consider initial dose of 5 mg once daily. Patient w/ marked hypercholesterolemia (LDL-C >190 mg/dL) & aggressive lipid target May consider starting dose of 20 mg. Patient who has not achieved goal LDL-C at 20 mg 40 mg. HoFH Initially 20 mg once daily. Max daily dose: 40 mg. Patient taking cyclosporine 5 mg once daily. Concomitant lipid-lowering therapy eg, gemfibrozil 10 mg once daily. Severe renal impairment (CrCl <30 mL/min/1.73 m²) not on hemodialysis Initially 5 mg once daily. Max: Not to exceed 10 mg once daily.

May be taken with or without food.

Hypersensitivity. Patients w/ active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy & lactation.

Discontinue therapy if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Rare cases of rhabdomyolysis w/ acute renal failure secondary to myoglobinuria. Patients w/ predisposing factors for myopathy eg, renal impairment, advanced age & hypothyroidism. Temporarily w/held therapy in patient w/ acute, serious condition suggestive of myopathy or predisposing to development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, or uncontrolled seizures). Patients who consume substantial quantities of alcohol &/or have history of liver disease. Dipstick +ve proteinuria & microscopic hematuria. Consider dose reduction for patients w/ unexplained persistent proteinuria during routine urinalysis testing. Perform LFTs prior to & at 12 wk following both initiation of therapy & any dose elevation, & periodically (eg, semi-annually) thereafter. Avoid combination therapy w/ gemfibrozil. Concomitant use w/ other lipid-lowering therapies or cyclosporine; fibrates or niacin. Renal impairment. Childn. Elderly 65 yr.

Myalgia, constipation, asthenia, abdominal pain & nausea.

Increased C_max & AUC w/ cyclosporine; gemfibrozil. Rises in INR w/ warfarin. Decreased plasma conc w/ antacid (Al & Mg hydroxide combination). Increased plasma conc of ethinyl estradiol & norgestrel. Concomitant use w/ drugs that may decrease levels or activity of endogenous steroid hormones eg, ketoconazole, spironolactone & cimetidine.

Dyslipidaemic Agents

C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

Rx