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Rosuvastatin Tablets 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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