Rosetta

Rosuvastatin

Reduce total mortality & risk of major CV events (CV death, stroke, MI, unstable angina, or arterial revascularization) in adults w/ increased risk of atherosclerotic CV disease based on presence of CV disease risk markers eg, elevated high sensitivity C-reactive protein level, age, HTN, low HDL-C, smoking or family history of premature CHD. Adjunct to diet in primary hypercholesterolaemia [type IIa including heterozygous familial hypercholesterolaemia (HeFH)] or mixed dyslipidaemia (type IIb) when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate. HoFH as adjunct to diet & other lipid lowering treatments (eg, LDL apheresis) if such treatments are not appropriate. Slow or delay progression of atherosclerosis. Reduce total cholesterol, LDL-C & Apo B in childn & adolescents 6-17 yr w/ HeFH.

Individualised dose. Statin naïve patient or patient switched from another HMG-CoA reductase inhibitor Recommended starting dose: 5 or 10 mg once daily. Adjust dose to 20 mg after 2-4 wk. Patient w/ severe hypercholesterolaemia at high CV risk (in particular those w/ familial hypercholesterolaemia), who do not achieve treatment goal on 20 mg, & in whom routine follow-up will be performed Consider doubling the dose to 40 mg. HeFH Childn 10-17 yr 5-20 mg once daily, 6-9 yr 5-10 mg once daily.

May be taken with or without food.

Hypersensitivity. Active liver disease including unexplained persistent serum transaminase elevations & any serum transaminase elevation >3x ULN. Concomitant use w/ cyclosporine. Severe renal impairment (CrCl <30 mL/min/1.73 m²). Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation. Asian patients (40 mg-dose).

Discontinue treatment if pain or ache (myalgia) developed on calf, back or body muscles; transaminase level is >3x ULN; creatine kinase (CK) levels are markedly elevated (>5x ULN) or if muscular symptoms are severe & cause daily discomfort (even if CK levels are ≤5x ULN). Interrupt therapy if serious hepatotoxicity w/ clinical symptoms &/or hyperbilirubinemia or jaundice occurs during treatment. Not to be started if repeat test confirms baseline CK >5x ULN. Not to be used 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). Increased risk of rhabdomyolysis in high dosage, elderly, hepatic/renal impairment, chronic alcoholism, hypothyroidism. Increased risk of increased blood sugar levels; serum aminotransferase (ie, AST [SGOT], ALT [SGPT]) conc; HbA1c & fasting serum glucose conc; risk of developing DM. Myopathy & rhabdomyolysis w/ acute renal failure secondary to myoglobinuria; immune-mediated necrotizing myopathy. Transient dipstick +ve proteinuria & microscopic hematuria. Patients w/ predisposing 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 or fibrate, alcohol abuse, age >70 yr, situations where increased plasma levels may occur, concomitant use of fibrates; history of liver disease. Asian patients. Perform LFTs before treatment, & 6 & 12 wk after treatment initiation; every 6 mth in patients regularly receiving treatment. Treat secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome prior to initiating treatment. Consider confirmatory test w/in 5-7 days if CK levels are significantly elevated at baseline (>5x ULN). Consider dose reduction if unexplained proteinuria &/or hematuria persists. Concomitant use w/ digoxin & warfarin; colchicine. Increased risk of myopathy & rhabdomyolysis in concomitant use w/ azole antifungals (eg, ketoconazole, itraconazole), macrolides (eg, erythromycin, clarithromycin), HIV PIs (eg, indinavir, ritonavir, nelfinavir, saquinavir), verapamil, diltiazem, gemfibrozil, nicotinic acid, cyclosporine, amiodarone. May cause fetal harm. Discontinue treatment during pregnancy. Childn & adolescents ≥8 yr w/ homozygous familial hypercholesterolaemia.

Dizziness, headache; new onset DM; constipation, nausea; interstitial cystitis; increased serum ALT (>3x ULN); arthralgia, increased creatine phosphokinase, myalgia, weakness.

Decreased C_max & AUC w/ Al & Mg hydroxide containing antacids; erythromycin. Increased risk of myopathy & increased C_max & AUC w/ cyclosporine; gemfibrozil. Increased risk of myopathy w/ fenofibrate; antilipemic dose (≥1 g daily) of niacin. Increased exposure w/ HIV PIs. Increased AUC of OC containing ethinyl estradiol & norgestrel. Increased INR w/ coumarin anticoagulants eg, warfarin.

Dyslipidaemic Agents

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

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