Surotin Special Precautions

Hepatic effect of Rosuvastatin; increase in serum aminotransferase [i.e., AST (SGOT), ALT (SGPT)] concentration have been reported in patients receiving statins, including Rosuvastatin. These increases usually were transient and resolved or improved with continued therapy or after interruption of therapy.
Liver function test should be performed prior to initiation of Rosuvastatin therapy. And liver function test should be repeated as clinically indicated (e.g., presence of manifestations suggestion of liver damage).
If serious liver injury with clinical manifestations and/or hyperbilirubinemia or jaundice occurs, Rosuvastatin therapy should be promptly interrupted. If an alternate etiology is not found, Rosuvastatin therapy should not be restarted.
Rosuvastatin should be used with caution in patients who consume substantial amounts of alcohol and/or have a history of chronic liver disease.
Rosuvastatin is contraindicated in patients with active liver disease, including unexplained, persistent elevations in serum aminotransferase concentration.
Myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported in patients receiving statins, including Rosuvastatin. These adverse effects can occur at any dosage, but the risk is increased with the highest dosage of Rosuvastatin (40 mg daily).
Rosuvastatin should be used with caution in patients with predisposing factors for myopathy (e.g., advance age (65 years old), renal impairment, inadequately treated hypothyroidism). The risk of myopathy may be increased when Rosuvastatin is used concomitantly with other antilipemic agents (niacin or certain is used fibric-acid derivatives [i.e., gemfibrozil]), cyclosporine or other myotoxic drugs (e.g., colchicine).
It is reasonable to obtain baseline CK concentrations in adult at increased risk of developing adverse musculoskeletal effect before initialing statin therapy. During statin therapy, it is reasonable to measure CK concentration in adults experiencing muscle symptoms (e.g., pain, tenderness, stiffness, cramping, and weakness).
Rosuvastatin should be discontinued if CK concentrations become markedly elevated or if myopathy is diagnosed or suspected. Rosuvastatin therapy should be temporarily withheld in any patients experiencing an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, or electrolyte disorder, uncontrolled seizures).
Proteinuria and hematuria has been reported in patients receiving Rosuvastatin. This finding was more frequent in patients taking Rosuvastatin 40 mg when compared to lower doses.