Roswin Special Precautions

Skeletal Muscle Effects: Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including rosuvastatin. These risks can occur at any dose level, but are increased at the highest dose (40 mg).
Use with caution in patients with predisposing factors for myopathy (e.g., age ≥65 years, inadequately treated hypothyroidism, renal impairment, situations where an increase in plasma levels may occur).
The risk of myopathy during rosuvastatin treatment may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, ciclosporin, lopinavir/ritonavir, or atazanavir/ritonavir (see Interactions).
Discontinue rosuvastatin if markedly elevated creatine kinase (CK) levels occur or myopathy is diagnosed or suspected. Temporarily withhold rosuvastatin therapy 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, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures).
Advise patients taking rosuvastatin to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.
Liver Enzyme Abnormalities and Monitoring: Perform liver function tests before the initiation of rosuvastatin therapy, and if signs or symptoms of liver injury occur.
Increases in serum transaminases [alanine aminotransferase (ALT), aspartate aminotransferase (AST)] have been reported with HMG-CoA reductase inhibitors, including rosuvastatin. In most cases, elevations were transient and resolved or improved on continued therapy or after a brief interruption of therapy. Patients who develop increased transaminase levels should be monitored until the abnormalities have resolved. If transaminase levels rise to greater than 3 times the upper limit of normal (ULN) and persist, dose reduction or discontinuation of rosuvastatin is recommended.
There have been postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including rosuvastatin. Promptly interrupt rosuvastatin therapy if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment. If an alternate etiology is not found, do not restart rosuvastatin.
Use with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
Renal Effects: In clinical studies, dip-stick positive proteinuria and microscopic hematuria were observed in patients treated with rosuvastatin. These findings were predominant in patients taking rosuvastatin 40 mg, when compared to lower doses of rosuvastatin or comparator HMG-CoA reductase inhibitor, although it was generally transient and was not associated with worsening renal function. Although the clinical significance of this finding is unknown, consider dose reduction in patients on rosuvastatin therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing.
Endocrine Effects: Increases in HbA_1c and fasting serum glucose levels have been associated with HMG-CoA reductase inhibitors, including rosuvastatin.
Although studies have shown that rosuvastatin alone does not reduce basal plasma cortisol concentration or impair adrenal reserve, caution should be exercised if rosuvastatin is administered concomitantly with drugs that may decrease the levels or activity of endogenous steroid hormones such as ketoconazole, spironolactone and cimetidine.
Interstitial Lung Disease: Exceptional cases of interstitial lung disease have been observed with some statins, particularly with long-term therapy. Presenting features include dyspnea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). Discontinue statin therapy if it is suspected that a patient has developed interstitial lung disease.
Diabetes Mellitus: Rosuvastatin treatment has been associated with an increased risk of diabetes mellitus in patients with fasting glucose 5.6 to 6.9 mmol/L.
Race: Pharmacokinetic studies show an increase in exposure in Asian subjects compared with Caucasians. The increased systemic exposure should be taken into consideration when treating Asian patients whose hypercholesterolemia is not adequately controlled at doses up to 20 mg daily (see Pharmacology: Pharmacokinetics under Actions and Contraindications).
Use in Children: Experience in pediatric patients 8 to 10 years old with homozygous familial hypercholesterolemia is limited. Rosuvastatin is not recommended in children less than 10 years old.
Use in the Elderly: Elderly patients are at higher risk of myopathy; rosuvastatin should be used with caution in the elderly.