Rovapro

Rosuvastatin

Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet & exercise is inadequate. To reduce elevated LDL-C, total cholesterol, triglycerides, & ApoB, & to increase HDL-C. Patients w/ HoFH as an adjunct to diet & other lipid lowering treatment, eg, LDL apheresis.

Initially 5 or 10 mg once daily. If needed, dose adjustment can be made after 4 wk. Severe hypercholesterolemia w/ high CV risk or w/ familial hypercholesterolemia Max: 40 mg. Patients w/ predisposing factors to myopathy Initially 5 mg once daily. Patients w/ severe kidney impairment (CrCl <30 mL/min/1.73 m²) w/o hemodialysis Initially 5 mg daily. Max: 10 mg once daily. Patients w/ Child-Pugh 8 & 9 Max: 20 mg once daily. Elderly Initially 5 mg once daily.

May be taken with or without food.

Hypersensitivity. Active liver disease including persistent & unexplained elevation of serum transaminase. Patients w/ myopathy. Patients receiving concomitant therapy w/ cyclosporins. Women of childbearing potential who are not using appropriate contraceptive measures. Pregnancy, lactation.

Proteinuria; myalgia, myopathy, rhabdomyolysis. Patients w/ predisposing factors for myopathy/rhabdomyolysis ie, 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, situations where an increase in plasma levels may occur, concomitant use of fibrates. Patients who consume excessive alcohol &/or have a history of liver disease. Perform LFT prior to treatment until 3 mth after treatment. Patients w/ secondary hypercholesterolemia due to hypothyroidism or nephrotic syndrome should be treated prior to rosuvastatin therapy. Patients at high risk for developing DM. Asian patients. Pregnancy & lactation. Childn. Elderly >70 yr.

Hypersensitivity reactions including angioedema; DM; headache, dizziness; constipation, nausea, abdominal pain, pancreatitis; pruritus, rash, urticaria; myalgia, myopathy (including myositis) & rhabdomyolysis; asthenia; proteinuria; increased transaminase & creatine kinase, increased HbA1C.

Concomitant use w/ cyclosporin, ritonavir, gemfibrozil, fenofibrate, other fibrates, niacin (nicotinic acid), antacids, erythromycin, vit K antagonists (including warfarin, coumarin), OC or HRT.

Dyslipidaemic Agents

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

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