Rosalta

10 mg: As an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, non-HDL-C & TG levels & to increase HDL-C in patients w/ primary hypercholesterolemia (heterozygous familial & nonfamilial) & mixed dyslipidemia (Fredrickson type IIa & IIb), elevated serum TG levels (Fredrickson type IV). To reduce LDL-C total-C & ApoB in patients w/ HoFH as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable. 20 mg: As an adjunct to diet when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate in adults, adolescents & childn ≥6 yr w/ primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb). HoFH as an adjunct to diet & other lipid lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate. Prevention of major CV events in patients who are estimated to have a high risk for a 1st CV event, as an adjunct to correction of other risk factors.

10 mg Initially 5-10 mg once daily. Maintenance: 5-40 mg once daily. Patient w/ high CV risk who do not achieve their target cholesterol level 40 mg dose. Elderly, Asian & patient at risk of myopathy 5 mg once daily, may be increased at intervals of 4 wk. Max: 20 mg once daily. Severe hypercholesterolemia 40 mg once daily. Patient w/ marked hypercholesterolemia eg, those w/ HoFH Initially 20 mg once daily, adjust dose after 2-4 wk, to a max of 20 mg once daily; a dose of 40 mg once daily may be necessary in some patients. Patient receiving cyclosporine Max of 5 mg once daily. Patient receiving gemfibrozil or ritonavir boosted lopinavir Max of 10 mg once daily. 20 mg Hypercholesterolaemia Statin naïve & patient 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 wk, if necessary. Patient w/ severe hypercholesterolemia at high CV risk (particularly those w/ familial hypercholesterolaemia) Max final titration: 40 mg (if 20 mg treatment goal is not achieved). Prevention of CV events 20 mg daily. Patient w/ genetic polymorphisms Lower daily dose. Patient w/ predisposing factors to myopathy Initially 5 mg. Heterozygous familial hypercholesterolaemia Childn & adolescent 6-17 yr (Tanner stage <II-V) Initially 5 mg daily. Dose range: Childn 10-17 yr 5-20 mg orally once daily; 6-9 yr 5-10 mg orally once daily. Elderly >70 yr Initially 5 mg. Moderate renal impairment (CrCl <60 mL/min) Initially 5 mg. Asian ancestry Initially 5 mg.

May be taken with or without food.

Hypersensitivity. 10 mg: Active liver disease or w/ unexplained persistent elevations of serum transaminases. 20 mg: Active liver disease including unexplained, persistent elevations of serum transaminases & exceeding 3x ULN. Myopathy. Concomitant use w/ ciclosporin. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation. Dose of 40 mg in patients w/ predisposing factors for myopathy/rhabdomyolysis including those w/ moderate renal impairment (CrCl <60 mL/min), hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, increase in plasma levels, Asians, & concomitant use w/ fibrates.

10 mg: Discontinue immediately if the patient become pregnant while on therapy. Pregnancy & lactation. 20 mg: Proteinuria w/ higher doses, particularly w/ 40 mg; consider renal function assessment during patient's routine follow-up. Skeletal muscle effects eg, myalgia, myopathy, & rhabdomyolysis (rarely). Do not measure creatinine kinase (CK) following strenuous exercise or in the presence of a plausible alternative cause of CK increase which may confound the result interpretation. Discontinue therapy if CK levels are markedly elevated (>5x ULN) or if muscular symptoms are severe & cause daily discomfort (even if CK levels are ≤5x ULN). Concomitant use w/ fibric acid derivatives including gemfibrozil, ciclosporin, nicotinic acid, azole antifungals, PIs & macrolides. Do not co-administer w/ systemic fusidic acid or w/in 7 days of stopping treatment. Not to be used in patient w/ acute, serious conditions suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders; or uncontrolled seizures). Consumption of excessive quantities of alcohol &/or has history of liver disease. Perform LFTs prior to, & 3 mth following the initiation of treatment. Secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome should be treated prior to initiating therapy. HIV patients receiving PIs & when initiating & up-titrating doses in patients treated w/ PIs. Discontinue therapy if patient has developed ILD. Monitor blood glucose levels. Not recommended in childn <6 yr.

Constipation, nausea, abdominal pain; myalgia; asthenia. 20 mg: DM; headache, dizziness.

10 mg: Alcohol, antacids, birth control pills, cyclosporine, itraconazole, drugs that lower cholesterol or triglycerides (eg, fenofibrate, gemfibrozil, niacin), red yeast rice, & warfarin. Caffeine, smoking, or illegal drugs. 20 mg: Increased plasma conc & risk of myopathy w/ transporter protein inhibitors. Higher AUC values w/ ciclosporin. Increased exposure w/ PIs. Increased C_max & AUC w/ gemfibrozil. Increased AUC w/ ezetimibe in hypercholesterolaemic patients. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Decreased C_max & AUC w/ erythromycin. Increase INR w/ vit K antagonists (eg, warfarin or another coumarin anticoagulant). Increased ethinyl estradiol & norgestrel AUC. Increased risk of myopathy including rhabdomyolysis w/ systemic fusidic acid.

Dyslipidaemic Agents

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

Rx