Varostin Special Precautions

Renal Effects: Proteinuria, detected by dipstick testing and mostly tubular in origin, has been observed in patients treated with higher doses of Rosuvastatin, in particular 40 mg, where it was transient or intermittent in most cases. Proteinuria has not been shown to be predictive of acute or progressive renal disease. The reporting rate for serious renal events in post-marketing use is higher at the 40 mg dose. An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40 mg.
Skeletal Muscle Effects: Effects on skeletal muscle e.g. myalgia, myopathy and, rarely, rhabdomyolysis have been reported in Rosuvastatin-treated patients with all doses and in particular with doses > 20 mg. Very rare cases of rhabdomyolysis have been reported with the use of ezetimibe in combination with HMG CoA reductase inhibitors. A pharmacodynamic interaction cannot be excluded and caution should be exercised with their combined use.
Creatinine Kinase Measurement: Creatinine Kinase (CK) should not be measured following strenuous exercise or in the presence of a plausible alternative cause of CK increase which may be confound interpretation of the result. If CK levels are significantly elevated at baseline (>5 x ULN) a confirmatory test should be carried out within 5-7 days. If the repeat test confirms a baseline CK >5 x ULN, treatment should not be started.
Race: Pharmacokinetic studies show an increase in exposure in Asian subject with Caucasians.
Protease Inhibitors: The concomitant use with protease inhibitors is not recommended. Lactose intolerance patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine.
Interstitial Lung Disease: Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy. Presenting features can include dyspnea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.
Diabetes Mellitus: In patients with fasting glucose 5.6 to 6.9 mmol/L, treatment with Rosuvastatin has been associated with an increased risk of diabetes mellitus.