Primary hypercholesterolaemia or mixed dyslipidemia, as an adjunct to diet, in patients who have not responded adequately to diet & other appropriate measures. Primary prevention of CV mortality & morbidity in patients w/ moderate or severe hypercholesterolemia & at high risk of 1st CV event, as an adjunct to diet. Secondary prevention of CV mortality & morbidity (MI, revascularization, ischemic stroke & TIA) in patients w/ history of MI or unstable angina pectoris & w/ either normal or increased cholesterol levels, as an adjunct to correction of other risk factors. Reduction of post transplantation hyperlipidaemia in patients receiving immunosuppressive therapy following solid organ transplantation.
Hypercholesterolemia 10-40 mg once daily. Max: 40 mg daily. CV prevention Starting & maintenance dose: 40 mg once daily.Organ transplantation (dose after transplantation) Patients receiving immunosuppressive therapy Initially 20 mg daily. May be adjusted up to 40 mg depending on the response of lipid parameters. Moderate to severe renal impairment or significant hepatic impairment Initially 10 mg daily. Concomitant therapy w/ cyclosporin Initially 20 mg once daily. Titration to 40 mg should be performed w/ caution.
Patients w/ homozygous familial hypercholesterolaemia. History of liver disease & or heavy alcohol ingestion. Promptly interrupt therapy if serious liver injury w/ clinical symptoms &/or hyperbilirubinemia or jaundice occurs during treatment; creatine kinase (CK) levels are >5x ULN. Concomitant use w/ fibrates & colchicine. Myalgia, myopathy & rhabdomyolysis. Do not co-administer w/ systemic formulation of fusidic acid or w/in 7 days of dicontinuation of fusidic acid treatment; reintroduce therapy 7 days after the last dose of fusidic acid. Measure CK levels prior to starting statin therapy in patients w/ predisposing factors (eg, renal impairment, hypothyroidism, previous history of muscular toxicity w/ a statin or fibrate, personal or familial history of hereditary muscular disorders, or alcohol abuse), patients >70 yr, & during treatment in patients developing muscular symptoms; do not restart therapy in patients w/ hereditary muscular disease. Discontinue if increases in ALT & AST >3x ULN & if ILD develops. Monitor patients at risk of DM. Dizziness may occur & affect driving or operating machinery.
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