Closely supervise initiation of doses >20 mg; periodically re-evaluate the long-term risk/benefit for individual patient. Increased exposure in Asian patients. Recommended to assess renal function during routine follow-up in patients treated w/ 40 mg dose; w/ unexplained persistent proteinuria during routine urinalysis. Skeletal muscle effects (eg, myalgia, myopathy, rhabdomyolysis). Additional neuromuscular & serologic testing may be necessary in case of immune-mediated necrotising myopathy; treatment w/ immunosuppressants may be required. Do not measure creatine kinase (CK) following strenuous exercise or in presence of plausible alternative cause of increased CK. Patient w/ pre-disposing factors for myopathy/rhabdomyolysis (eg, renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor, alcohol abuse, age ≥65 yr, situations where increased plasma levels may occur, concomitant use of fibrates & niacin). Treat underlying disease prior to initiating therapy in patients w/ secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome. Discontinue use if CK levels are markedly elevated (>10 x ULN) or if muscular symptoms are severe & cause daily discomfort (even if CK levels are ≤10 x ULN). Increased risk of myositis & myopathy in patients receiving other HMG-CoA reductase inhibitors w/ fibric acid derivatives including gemfibrozil, ciclosporin, nicotinic acid, azole antifungals, PIs & macrolides. Dose should not exceed 10 mg daily when used in combination w/ fibrates or lipid-lowering doses of niacin (≥1 g daily). Temporarily w/hold in any patient w/ acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders; or uncontrolled seizures). Possible increased HbA1c & serum glucose levels; may exceed threshold for DM diagnosis. Patients who consume excessive quantities of alcohol &/or have history of liver disease. Perform LFTs before & at 3 mth following both initiation of treatment & any increase of dose & periodically (semi-annually) thereafter. Monitor patients w/ increased transaminases levels until abnormalities resolve; discontinue use or reduce dose if serum transaminases level is >3 ULN. Concomitant use w/ PIs. Dizziness may occur when driving vehicles or operating machines. Women of child-bearing potential should use appropriate contraceptive measures. Childn & adolescents 10-17 yr.
Sign Out
