Roswin Special Precautions

Liver: As with other HMG-CoA reductase inhibitors, rosuvastatin should be used with caution in patients who consume excessive quantities of alcohol and/or have a history of liver disease. It is recommended that liver function tests be carried out prior to, and 3 months following, the initiations of treatment with rosuvastatin. Rosuvastatin should be discontinued or the dose reduced if the level of serum transaminases is greater than 3 times the upper limit of normal. In patients with secondary hypercholesterolemia caused by the hypothyroidism or nephritic syndrome, the underlying disease should be treated prior to initiating therapy with rosuvastatin.
Skeletal Muscle: As with other HMG-CoA reductase inhibitors, effects on skeletal muscle e.g. uncomplicated myalgia, myopathy and, rarely, rhabdomyolysis, have been reported in rosuvastatin treated patients with all doses and in particular doses >20 mg. As with other HMG-CoA reductase inhibitors, the reporting rate of rhabdomyolysis is higher at the highest dose. Patients should be asked to report inexplicable muscle pain or weakness immediately, particularly if associated with malaise or fever. Creatinine Kinase (CK) levels should be discontinued if CK levels are markedly elevated (5 c ULN) or, if muscular symptoms are severe and cause daily discomfort (even if CK levels are <5 x ULN). If symptoms resolve and CK levels return to normal, then consideration should be given to-re-introducing resorvastatin or an alternative HMG-CoA reductase inhibitor at the lowest dose with close monitoring. Routine monitoring of CK levels in asymptomatic patients is not warranted.
Creatinine Kinase (CK) should not be measured following strenuous exercise or in the presence of a plausible alternative cause of CK increase which may confound interpretation of the result. If CK levels are significantly elevated at baseline >5x ULN, a confirmatory test should be carried out within 5-7 days. If the repeat test confirms a baseline CK >5x ULN, treatment should not be started.
There was no evidence of increased skeletal muscle effects in patients dosed with rosuvastatin and 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 fibric acid derivatives including gemfibrozil, cyclosporin, nicotinic acid, azole antifungals, protease inhibitors and macrolide antibiotics. Gemfibrozil increases the risk of myopathy when given concomitantly with some HMG-CoA reductase inhibitors. The benefit of further alterations in lipid levels by the combined used of rosuvastatin with fibrates or niacin should be carefully weighed against the potential risk of such combination. The 40 mg dose is contraindicated with concomitant use of a fibrate.
Rosuvastatin should be prescribed with caution in patients with pre-disposing factors for myopathy/rhabdomyolysis. Such factors include renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, age >70 years, situations where an increase in plasma levels may occur, and concomitant use of fibrates. In such patients the risks of treatments should be considered in relation to possible benefit and clinical monitoring is recommended. If CK levels are significantly elevated at baseline >5x ULN, treatment should not be started.
Rosuvastatin should not be used in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development or 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. An increased frequency or diabetes has been reported with rosuvastatin in patients with risk factors for diabetes (see SIDE EFFECTS).
Effects on ability to drive and use machines: There is no data that showed the effect of rosuvastatin on the ability to drive and use machines. However, rosuvastatin is unlikely to effect this ability. When driving vehicles or operating machines, it should be taken into account that dizziness may occur during treatment.