Roswin

Decreases elevated total cholesterol (total-C), LDL-C & triglycerides (TG) & increases HDL-C in adults w/ primary hypercholesterolemia (heterozygous familial & non-familial) or mixed dyslipidemia (Fredrickson types IIa & IIb). Decreases Apo B, non-HDL-C, VLDL-C, VLDL-TG, LDL-C/HDL-C, total-C/HDL-C, non-HDL-C/HDL-C, & Apo B/Apo A-I ratios & increases Apo A-I in adults. Adults w/ isolated hypertriglyceridemia (Fredrickson type IV hyperlipidemia); primary dysbetalipoproteinemia (Fredrickson type III hyperlipoproteinemia). Decreases total-C & LDL-C in adults w/ HoFH as adjunct to other lipid-lowering treatments (eg, LDL apheresis) or alone if such treatments are unavailable. Slows progression of atherosclerosis in adults as part of treatment strategy to decrease total-C & LDL-C to target levels. Decreases total-C, LDL-C & Apo B levels in childn & adolescents 10-17 yr (boys Tanner stage ≥II, & girls at least 1 year post-menarche) w/ heterozygous familial hypercholesterolemia if after adequate trial of diet therapy the following findings are present: LDL-C >90 mg/dL, or LDL-C >160 mg/dL & there is +ve family history of premature CV disease or ≥2 other CV risk factors are present in the patient. Decreases risk of stroke, MI & arterial revascularization procedures in individuals w/o clinically evident CHD but w/ increased risk of CV disease based on age (≥50 yr in men & ≥65 yr women), hsCRP ≥2 mg/L, & presence of at least 1 additional CV disease risk factor eg, HTN, low HDL-C, smoking, or family history of premature CHD.

Adult Dose range: 5-40 mg daily as single dose at any time of the day. Usual starting dose: 10-20 mg once daily. 40 mg dose is only recommended in patients w/ severe hypercholesterolemia at high CV risk (particularly w/ familial hypercholesterolemia), who do not achieve treatment goal using 20 mg dose, & in whom routine follow-up will be performed. Hyperlipidemia (including heterozygous familial hypercholesterolemia), mixed dyslipidemia, isolated hypertriglyceridemia, slowing of progression of atherosclerosis Initially 10 mg once daily. Severe hypercholesterolemia (including heterozygous familial hypercholesterolemia) 20 mg once daily. Homozygous familial hypercholesterolemia Initially 20 mg once daily. Primary prevention of CV disease 20 mg once daily. Childn & adolescent 10-17 yr Heterozygous familial hypercholesterolemia Initially 5 mg once daily. Usual dose range: 5-20 mg once daily. Adjustments should be made at intervals of ≥4 wk. Max: 20 mg once daily. Patient w/ predisposing factors to myopathy, Asian patients & elderly >70 yr Initially 5 mg once daily. Concomitant use w/ ciclosporin Limit dose to 5 mg once daily, gemfibrozil, lopinavir/ritonavir & atazanavir/ritonavir Limit dose to 10 mg once daily. Renal impairment: Mild Usual dose range, moderate 5 mg once daily.

May be taken with or without food.

Hypersensitivity. Patients w/ active liver disease including unexplained, persistent elevations in serum transaminases & any serum elevation exceeding 3 x ULN; myopathy. Severe renal impairment (CrCl <30 mL/min). Women who are or may become pregnant. Lactation. 40 mg: Patients w/ predisposing factors for myopathy/rhabdomyolysis including 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, situations where increase in plasma levels may occur, Asian patients, concomitant use of fibrates.

Discontinue use if markedly elevated creatine kinase (CK) levels occur or myopathy is diagnosed or suspected; patient is suspected to have developed ILD. Temporarily w/hold therapy in any patient w/ acute, serious condition suggestive of myopathy or predisposing to development of renal failure secondary to rhabdomyolysis eg, sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, & electrolyte disorders, or uncontrolled seizures. Cases of myopathy & rhabdomyolysis w/ acute renal failure secondary to myoglobinuria. Reports of fatal & non-fatal hepatic failure. Increased HbA1c & fasting serum glucose levels. Increased risk of DM in patients w/ fasting glucose 5.6-6.9 mmol/L. Patients w/ predisposing factors for myopathy eg, age ≥65 yr, inadequately treated hypothyroidism, renal impairment, situations where increase in plasma levels may occur; who consume substantial quantities of alcohol &/or w/ history of liver disease. Perform LFTs prior to initiation of therapy, & if signs or symptoms of liver injury occur. Monitor patients who develop increased transaminase levels until abnormalities have resolved. Dip-stick +ve proteinuria & microscopic hematuria. Asian patients. Concomitant use w/ some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, ciclosporin, lopinavir/ritonavir, or atazanavir/ritonavir; drugs that may decrease levels or activity of endogenous steroid hormones eg, ketoconazole, spironolactone & cimetidine. Not recommended in childn <10 yr. Childn 8-10 yr w/ HoFH.

Asthenia, edema, flu syndrome; abdominal pain, constipation, diarrhea, dyspepsia, nausea, pancreatitis; fatal & non-fatal hepatic failure, hepatitis, jaundice; DM, dipstick +ve proteinuria, microscopic hematuria, thyroid function abnormalities, elevations in liver transaminases, CK, glucose, glutamyl transpeptidase, alkaline phosphatase, & bilirubin; arthralgia, back pain, myalgia, myopathy including myositis, rhabdomyolysis w/ myoglobinuria & acute renal failure, tendon disorders sometimes complicated by rupture; cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion), depression, dizziness, headache, insomnia, nightmares, paresthesia, polyneuropathy, sexual dysfunction, sleep disturbances; cough, dyspnea, exceptional cases of ILD especially w/ long-term therapy, pharyngitis, rhinitis, sinusitis; hypersensitivity reactions including angioedema, pruritus, rash, urticaria, SJS; UTI.

Increased exposure w/ ciclosporin; gemfibrozil. Increased AUC w/ PI combinations lopinavir/ritonavir & atazanavir/ritonavir. Increased INR w/ coumarin anticoagulants. Increased risk of skeletal muscle effects w/ niacin (≥1 g daily). Increased risk of myopathy w/ fenofibrates. Decreased plasma conc w/ antacid eg, Al & Mg hydroxide. Decreased AUC_0-24 & C_max w/ erythromycin. Increased plasma conc of ethinyl estradiol & norgestrel.

Dyslipidaemic Agents

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

Rx