Indications

Hyperlipidaemias, Prophylaxis of cardiovascular events in high-risk patients

Contraindication

Active liver disease or unexplained persistent elevated serum transaminases. Severe renal impairment. Concomitant use w/ ciclosporin and gemfibrozil. Pregnancy and lactation. Hypersensitivity. Unexplained and persistent liver function abnormality, primary biliary cirrhosis, pre-existing gallbladder disease. Hepatic and severe renal impairment. Lactation.

Special Precautions

Patients w/ predisposing factors for myopathy (e.g. untreated hypothyroidism, renal impairment), history of chronic liver disease and alcoholism. Monitoring Parameters Monitor creatine kinase (CK) periodically and LFT. Discontinue treatment if there is significant or persistent increase in CK levels, serum aminotransferase levels or evidence of myopathy. Increased risk of cholelithiasis, pancreatitis, skeletal muscle effects. Patient at risk of rhabdomyolysis. Renal impairment. Pregnancy. Monitoring Parameters Monitor LFTs, renal function and blood cell counts periodically during the 1st 12 mth of therapy.

Side Effects

Headache, dizziness, constipation, nausea, vomiting, abdominal pain, myalgia, chest pain, peripheral oedema, depression, insomnia, rash, paraesthesia, asthenia, abnormal LFT, elevated serum transaminase levels.Abnormal LFTs (e.g. increased ALT, AST), increased creatinine kinase concentrations, abdominal pain, back pain, headache, asthenia, diarrhoea, nausea, constipation, resp disorder, rhinitis, flu syndrome, muscle pain, tenderness or weakness, urticaria, rash. Mild to moderate decreases in Hb, haematocrit and leukocyte counts.

Drug Interactions

May increase serum levels of warfarin and oral contraceptives. May increase serum levels w/ itraconazole, HIV protease inhibitors. May decrease serum levels w/ erythromycin and antacids. May increase risk of myopathy w/ fenofibrate, niacin.Decreased absorption w/ bile acid sequestrants (e.g. colestyramine). May increase risk of ciclosporin-induced nephrotoxicity. Increased risk of muscle toxicity w/ HMG-CoA reductase inhibitors (e.g. simvastatin). May increase risk of bleeding w/ oral anticoagulants.

Route of Administration

Oral

Dosage

As directed by the physician