Rosmi

Rosuvastatin Ca

Adjunctive therapy to diet in adults w/ primary hypercholesterolemia (Type IIa including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (Type IIb). Homozygous familial hypercholesterolemia as an adjunct to diet & other lipid lowering treatments, or if treatments are not appropriate. Slow or delay progression of atherosclerosis. Reduction of total mortality & risk of major CV events on adults w/ increase risk of atherosclerotic CV disease based on presence of CV disease risk markers. Reduction of total cholesterol, LDL-C & Apo B in childn & adolescents 6-17 yr w/ heterozygous familial hypercholesterolemia.

Statin-naive patients or patients switched from another HMG CoA reductase inhibitor Recommended starting dose: 5 or 10 mg once daily. Dose can be adjusted to 20 mg after 2-4 wk. Heterozygous familial hypercholesterolemia Childn 10-17 yr 5-20 mg once daily, 6-9 yr 5-10 mg once daily. Asian Recommended starting dose: 5 mg once daily.

May be taken with or without food.

Hypersensitivity. Active liver disease, including unexplained, persistent elevations in hepatic aminotransferase (transaminase) conc. Severe renal impairment. Pregnancy & lactation.

Hypersensitivity reactions. Increased risk of myopathy & rhabdomyolysis in patients w/ predisposing factors for myopathy eg, advance age (≥65 yr), renal impairment, inadequately treated hypothyroidism. Concomitant use w/ niacin, gemfibrozil, cyclosporine, ritonavir-boosted atazanavir & lopinavir/ritonavir. Monitor baseline creatinine kinase (CK) conc in adults at increased risk of developing adverse musculoskeletal effects (eg, patients w/ personal or family history of statin intolerance or muscle disease, patients receiving concomitant therapy w/ myotoxic drugs) before initiating therapy. Discontinue use if CK becomes markedly elevated or if myopathy is diagnosed or suspected. Perform LFTs prior to initiation of therapy & repeat as clinically indicated (eg, presence of manifestations suggestive of liver damage). Promptly interrupt treatment if serious liver injury &/or hyperbilirubinemia or jaundice occurs. Patients who consume substantial amounts of alcohol &/or have a history of chronic liver disease. Contraindicated in patients w/ active liver disease. Transient dipstick-positive proteinuria & microscopic hematuria in patients receiving 40 mg dose. Increase in HbA1c & fasting serum glucose conc. Cognitive & hepatic impairment.

Headache, myalgia, asthenia, constipation, dizziness, nausea, abdominal pain, DM.

Decreased peak plasma conc & area under the plasma conc-time curve (AUC) w/ Al & Mg hydroxide containing antacids & erythromycin. Increased peak plasma conc & AUC w/ azole antifungals (eg, fluconazole & itraconazole), cyclosporine, eltrombopag, ezetimibe, gemfibrozil, simeprevir, ritonavir-boosted atazanavir, darunavir & tipranavir; fosamprenavir, lopinavir & lomitapide. Increased risk of myopathy &/or rhabdomyolysis w/ colchicine & gemfibrozil. Increase peak plasma conc & AUC of digoxin & OCs (eg, ethinyl estradiol w/ norgestrel). Increased AUC w/ dronedarone. May increase risk of myopathy w/ fenofibrate, niacin, simeprevir, & ritonavir-boosted atazanavir, lopinavir. Potentiate effects of coumarin derivative 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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