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Rosuvastatin is contraindicated: in patients with hypersensitivity to rosuvastatin or to any of the excipients; in patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3x the upper limit of normal (ULN); in patients with severe renal impairment (creatinine clearance <30 mL/min); in patients with myopathy; in patients receiving concomitant ciclosporin; during pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measures.
The 40 mg dose is contraindicated in patients with pre-disposing factors for myopathy/rhabdomyolysis. Such factors include: moderate renal impairment (creatinine clearance <60 ml/min); hypothyroidism; personal or family history of hereditary muscular disorders; previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate; alcohol abuse; situations where an increase in plasma levels may occur; Asian patients; concomitant use of fibrates.
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