Crestor Special Precautions

Liver: As with other HMG-CoA reductase inhibitors, Rosuvastatin (CRESTOR) should be used with caution in patients who consume excessive quantities of alcohol and/or have a history of liver disease.
Skeletal muscle: As with other HMG-CoA reductase inhibitors, effects on skeletal muscle, e.g. myalgia, myopathy and, rarely, rhabdomyolysis, have been reported in patients treated with rosuvastatin. As with other HMG-CoA reductase inhibitors, the reporting rate for rhabdomyolysis in post-marketing use is higher at the highest marketed dose. Patients who develop any signs or symptoms suggestive of myopathy should have their CK levels measured. Rosuvastatin (CRESTOR) therapy should be discontinued if CK levels are markedly elevated (>10xULN) or if myopathy is diagnosed or suspected. There have been very rare reports of an immune-mediated necrotising myopathy clinically characterized by persistent proximal muscle weakness and elevated serum creatine kinase during treatment or following discontinuation of statins, including rosuvastatin. Additional neuromuscular and serologic testing may be necessary. Treatment with immunosuppressive agents may be required.
Statins may in rare instances induce or aggravate myasthenia gravis or ocular myasthenia (see Adverse Reactions) including reports of recurrence when the same or a different statin was administered. Rosuvastatin (CRESTOR) should be used with caution in patients with these conditions and should be discontinued if they are induced or aggravated.
In Rosuvastatin (CRESTOR) trials there was no evidence of increased skeletal muscle effects when Rosuvastatin (CRESTOR) was dosed with any concomitant therapy. However, an increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with ciclosporin, fibric acid derivatives (including gemfibrozil), nicotinic acid, azole antifungals and macrolide antibiotics.
Rosuvastatin (CRESTOR) should be prescribed with caution in patients with pre-disposing factors for myopathy, such as, renal impairment, advanced age and hypothyroidism, or situations where an increase in plasma levels may occur (see Interactions and Pharmacology: Pharmacokinetics under Actions).
Rosuvastatin (CRESTOR) should be temporarily withheld in any patient with an acute serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures).
Diabetes Mellitus: As with other HMG-CoA reductase inhibitors, increases in HbA1c and serum glucose levels have been observed in patients treated with rosuvastatin, and in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus, primarily in patients already at high risk for developing diabetes (see Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
Race: Pharmacokinetic studies show an increase in exposure in Asian subjects compared with Caucasians (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Effects on ability to drive and use machines: Pharmacology testing revealed no evidence of a sedative effect of Rosuvastatin (CRESTOR). From the safety profile, Rosuvastatin (CRESTOR) is not expected to adversely affect the ability to drive or use machines.
Use in Children: Children and adolescents 6 to 17 years of age: The evaluation of linear growth (height), weight, BMI (body mass index), and secondary characteristics of sexual maturation by Tanner staging in paediatric patients taking rosuvastatin is limited to a two year period (see Pharmacology: Pharmacodynamics under Actions).