Not to be taken if myopathy or cholelithiasis is suspected; signs & symptoms of severe skin reactions appear; creatine kinase (CK) levels are markedly elevated (>5x ULN) or if muscular symptoms are severe & cause daily discomfort (even if CK levels are ≤5x ULN). Not to be started if CK levels are significantly elevated after confirmatory test confirms baseline >5x ULN. Not to be restarted in patient who develop SJS or DRESS during treatment. Not to be used in patient w/ acute, serious condition suggestive of myopathy or predisposing to development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, or uncontrolled seizures). Rhabdomyolysis; unexplained muscle pain, tenderness, weakness. Transaminase elevations (≥3x ULN). Dizziness may occur during treatment. Patients 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 or fibrate, alcohol abuse, elderly >65 yr, situations where increase in plasma levels may occur, concomitant use of fibrates, niacin & colchicine. Patients who consume excessive quantities (>14 g/day for women, 28 g/day for men or >2 glasses of alcohol/day) of alcohol &/or have history of liver disease. Closely monitor patients for signs & symptoms of severe skin reactions. Monitor patients at risk (fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m
2, raised triglycerides, HTN). Measure CK levels in patients w/ inexplicable muscle pain, weakness or cramps associated w/ malaise or fever. Treat underlying disease in patients w/ secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome prior to therapy. Monitor INR when used in combination w/ warfarin, another coumarin anticoagulant, or fluindione. Not recommended to use in combination w/ gemfibrozil; PIs. Not to be coadministered w/ systemic fusidic acid or w/in 7 days of stopping fusidic acid treatment. May affect ability to drive or use machines. Not recommended in moderate or severe hepatic insufficiency. Women of childbearing potential should use appropriate contraceptive measures. Discontinue therapy if patient becomes pregnant during treatment. Not recommended in childn <18 yr. Rosuvastatin: Discontinue treatment if level of serum transaminases is >3x ULN; in patients using systemic fusidic acid throughout duration of fusidic acid treatment; ILD is suspected. SJS, DRESS. Skeletal muscle effects eg, myalgia, myopathy;
de novo or aggravated pre-existing myasthenia gravis or ocular myasthenia. Proteinuria particularly w/ higher doses (40 mg). Immune-mediated necrotising myopathy. May raise blood glucose levels. Increased exposure in Asian subjects; patients receiving concomitant various PIs in combination w/ ritonavir. Perform LFTs 3 mth following treatment initiation.
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