Eurovastin

Rosuvastatin

Hypercholesterolaemia: Primary hypercholesterolaemia & mixed dyslipidaemia (including Fredrickson Type IIa & IIb, & heterozygous familial hypercholesterolaemia), & primary dysbetalipoproteinaemia (Fredrickson Type III hyperlipoproteinaemia), as an adjunct to diet when response to diet & exercise is inadequate; reduces elevated LDL-cholesterol, total cholesterol & triglycerides, & increases HDL-cholesterol; lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, LDL-C/HDL-C, total-C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios & increases ApoA-I; homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet & other lipid lowering treatments (eg, LDL apheresis); in childn & adolescents 10-17 yr, as an adjunct to diet to reduce total-C, LDL-C & ApoB levels in adolescent boys & girls (at least 1 yr post-menarche) w/ heterozygous familial hypercholesterolaemia, if after an adequate trial of diet therapy the findings ie, LDL-C >190 mg/dL or >160 mg/dL & there is a positive family history of premature CV disease or ≥2 other CVD risk factors, are present. Primary prevention of CV disease (reduce the risk of stroke, MI, arterial revascularization procedures) in individuals w/o clinically evident CHD but w/ an increased risk of CV disease.

Individualized dosage. Statin-naive patient or those who switched from another HMG-CoA reductase inhibitor Initially 5 or 10 mg once daily. Dose adjustment to the next dose level can be made after 4-6 wk, if necessary. Asian Initially 5 mg once daily. Ped patient w/ heterozygous familial hypercholesterolemia Initially 5 mg once daily. Max: 10 mg daily. Dose adjustment: At ≥4 wk interval. Patient w/ c.521CC or c.421AA genotype Max: 20 mg once daily.

May be taken with or without food.

Hypersensitivity. Active liver disease or unexplained, persistent serum transaminase elevations. Concominant use w/ cyclosporin. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.

Closely supervise therapy when initiated at doses higher than 20 mg; periodically re-evaluate long-term risk/benefit. Increased exposure in Asians. Proteinuria in patients treated w/ higher doses (eg, 40 mg); consider dose reduction in patients w/ unexplained persistent proteinuria during routine urinalysis testing; assess renal function during routine follow-up of patients treated w/ a 40-mg dose. Skeletal muscle effects (eg, myalgia, myopathy & rarely, rhabdomyolysis). Do not measure creatinine kinase following strenuous exercise or in the presence of a plausible alternative cause of CK increase. Do not start treatment if CK levels are significantly elevated at baseline (>10 x ULN). Patients w/ pre-disposing factors for myopathy/rhabdomyolysis eg, renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor, fibrate or niacin, alcohol abuse, age ≥65 yr, situations where an increase in plasma levels may occur, concomitant use of fibrates or niacin. Patients w/ secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome. Malaise- or fever-associated inexplicable muscle pain, weakness or cramps should be reported immediately; discontinue use if CK levels are markedly elevated (>10 x ULN) or if muscular symptoms are severe & cause daily discomfort (even if CK levels ≤10 x ULN). Temporarily withheld in any patient w/ an acute serious condition suggestive of myopathy or predisposing to renal failure development secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders; or uncontrolled seizures). Increases in HbA1c & serum glucose levels may exceed the threshold for DM diagnosis. Discontinue or reduce dose if serum transaminase levels is >3 ULN. Concomitant use w/ PI. Moderate hepatic impairment.

Headache, myalgia, asthenia, constipation, dizziness, nausea, abdominal pain, DM.

May increase plasma conc & may increase risk of myopathy w/ trasporter protein inhibitors including hepatic uptake transporter OATP1B1 & efflux transporter BCRP. Increased steady state AUC_(0-t) by cyclosporin. Exposure may be increased strongly by PI. Increased C_max & AUC_(0-t), increasing risk of myopathy, w/ gemfibrozil & other lipid-lowering products. Decreased plasma conc by Al & Mg hydroxide-containing antacids. Decreased AUC_(0-t) & C_max by erythromycin. Increased INR of warfarin. Increased AUC of OC (eg, ethinyl oestradiol & norgestrel). Caution when used w/ drugs that may decrease levels or activity of endogenous steroid hormones (eg, ketoconazole, spironolactone, cimetidine). Possible muscle related events including rhabdomyolysis w/ fusidic acid.

Dyslipidaemic Agents

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

POM