Zyrova

Primary hypercholesterolemia (type IIa), mixed dyslipidemia (type IIb), or HoFH in patients who have not responded adequately to diet & other appropriate measures. Adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients. 5 mg: Reduces LDL-C, Apo B, & triglycerides & increases HDL-C in hyperlipidemia including primary hypercholesterolemia (type IIa), mixed dyslipidemia (type IIb), & hypertriglyceridemia (type IV), & in patients w/ HoFH. Adjunctive therapy to lipid-lowering treatments or alone if such treatments are unavailable to reduce LDL-C, Total-C, & Apo-B in adult patients w/ homozygous familial hyperlipidemia. 40 mg: Reduces elevated Total-C, LDL-C, Apo B, non-HDL-C & triglycerides & increases HDL-C in adult patients w/ primary hyperlipidemia or mixed dyslipidemia. Adjunct to diet to reduce total-C, LDL-C & Apo B levels in adolescent boys & girls 10-17 yr w/ heterozygous familial hypercholesterolemia who are at least 1 yr postmenarche. Hypertriglyceridemia; primary dysbetalipoproteinemia (type III hyperlipoproteinemia). Adjunctive therapy to lipid-lowering treatments or alone if such treatments are unavailable to reduce LDL-C, Total-C, & Apo-B in adult patients w/ HoFH. Prevention of CV disease to reduce the risk of stroke, MI, arterial revascularization procedures.

Maintenance dose range: 5-40 mg once daily. Patient requiring less aggressive LDL-C reductions/predisposed to myopathy Initially 5 mg once daily. Marked hypercholesterolemia (LDL-C >190 mg/dL) Initially 20 mg. Patient who have not achieved goal LDL-C at 20 mg 40 mg. Severe renal impairment (CrCl <30 mL/min/m²) not on hemodialysis Initially 5 mg once daily. Max dose: 10 mg once daily. 40 mg Initially 10-20 mg once daily. HoFH Initially 20 mg once daily. Ped patient 10-17 yr w/ heterozygous familial hypercholesterolemia Usual dose range: 5-20 mg daily. Max: 20 mg daily. May adjust dose at ≥4-wk intervals. Asian patient Initially 5 mg once daily. Patient taking cyclosporine Max: 5 mg once daily. Patient taking gemfibrozil 5 mg once daily. Max: 10 mg once daily. Patient taking lopinavir & ritonavir or atazanavir & ritonavir Initially 5 mg once daily. Max: 10 mg once daily.

May be taken with or without food.

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

Perform LFTs prior to & 12 wk following both the initiation & any elevation of dose & periodically thereafter. Patients who consume substantial quantities of alcohol &/or have a history of chronic liver disease; diffuse myalgias, muscle tenderness/weakness. Discontinue therapy if CPK levels >5x the ULN occur. Acute, serious condition suggestive of myopathy or risk factor to renal failure secondary to rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic endocrine & electrolyte disorders, uncontrolled seizures). Patients w/ predisposing factors for myopathy eg, age ≥65 yr, inadequately treated hypothyroidism, renal impairment. Women of childbearing potential should use appropriate contraceptive measures. Elderly. 40 mg: Myopathy & rhabdomyolysis w/ acute renal failure secondary to myoglobinuria. Discontinue therapy if markedly elevated creatinine kinase levels occur or myopathy is diagnosed or suspected. Immune-mediated necrotizing myopathy. Promptly interrupt therapy if serious liver injury w/ clinical symptoms &/or hyperbilirubinemia or jaundice occur. Proteinuria & hematuria. Increased in Hb1Ac & fasting glucose levels. Concomitant use w/ drugs that may decrease the levels or activity of endogenous steroid hormones (eg, ketoconazole, spironolactone, & cimetidine).

Myalgia, abdominal pain & nausea, headache, asthenia. 10 mg/20 mg: Constipation. 5 mg/10 mg: Rhabdomyolysis w/ myoglobinuria & acute renal failure & myopathy, liver enzyme abnormalities.

Increased exposure w/ cyclosporine, gemfibrozil, lopinavir/ritonavir or atazanavir/ritonavir combination. Increased INR w/ coumarin anticoagulants (eg, warfarin). Enhanced risk of skeletal muscle effects w/ niacin. Increased in risk of myopathy w/ fenofibrates. Itraconazole, antacids containing Al & Mg hydroxide, erythromycin, OC. Colchicine.

Dyslipidaemic Agents

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

Rx