Roseystar
Renal effects
Proteinuria, predominantly of tubular origin, was observed in patients taking high doses of rosuvastatin, especially 40 mg, which in most cases was intermittent or short-term. Such proteinuria does not indicate the occurrence of acute or progressive kidney disease. The incidence of serious renal dysfunction increases with 40 mg rosuvastatin. In such patients, it is recommended to monitor renal function indicators during treatment with the drug.
From the musculoskeletal system
When using the drug in all dosages, especially over 20 mg, myalgia, myopathy and, in rare cases, rhabdomyolysis were detected.
Determination of creatine phosphokinase (CPK)
Determination of CPK activity should not be carried out after intense physical exercise or in the presence of other possible reasons for increased CPK activity, which may lead to incorrect interpretation of the results. If the initial CPK level is significantly elevated (more than 5 times the upper limit of normal), a repeat measurement should be taken after 5-7 days. Therapy should not be started if repeated measurements confirm the initial CPK level (5 times higher than the upper limit of normal).
Before starting therapy
The drug, like other HMG-CoA reductase inhibitors, should be prescribed with caution to patients with existing risk factors for myopathy/rhabdomyolysis. The risk/benefit ratio of therapy should be assessed and clinical monitoring should be carried out throughout the course of treatment.
During therapy
It is recommended that patients be informed to immediately notify their physician if they experience unexpected muscle pain, muscle weakness, or cramps, especially when accompanied by malaise or fever. In such patients, it is imperative to monitor CPK activity. Treatment should be discontinued if CPK activity is more than 5 times the upper limit of normal or if muscle symptoms are severe and cause daily discomfort, even if CPK activity is 5 times less than the upper limit of normal. If symptoms disappear and CPK activity returns to normal, re-prescribing Rosystarc or other HMG-CoA reductase inhibitors in lower doses should be considered with careful monitoring of the patient. Regular monitoring of CPK activity in the absence of symptoms is impractical.
Very rare cases of immune-mediated necrotizing myopathy have been reported with clinical manifestations of persistent proximal muscle weakness and increased serum CPK levels during treatment or upon discontinuation of statins, including rosuvastatin. Additional studies of the muscular and nervous system, serological studies, and therapy with immunosuppressive drugs may be required.
There were no signs of increased effects on skeletal muscles with the use of rosuvastatin and concomitant therapy. However, an increase in the incidence of myositis and myopathy has been reported in patients taking other HMG-CoA reductase inhibitors with fibric acid derivatives, including gemfibrozil, cyclosporine, niacin, antifungals, protease inhibitors and macrolide antibiotics. Gemfibrozil increases the risk of myopathy when used together with certain HMG-CoA reductase inhibitors. Therefore, simultaneous use of rosuvastatin and gemfibrozil is not recommended. The risk/benefit ratio should be carefully assessed when co-administering rosuvastatin with fibrates or nicotinic acid in lipid-lowering doses (more than 1 g/day). Concomitant use of rosuvastatin at a dose of 40 mg and fibrates is contraindicated. 2-4 weeks after the start of treatment and/or when the dose of the drug is increased, monitoring of lipid metabolism parameters is necessary, and if necessary, dose adjustment is required.
Liver
Like other HMG-CoA reductase inhibitors, the drug should be prescribed with extreme caution to patients who abuse alcohol or have a history of liver disease. It is recommended to determine liver function indicators before starting therapy and 3 months after starting therapy. If the activity of “liver” transaminases in the blood serum is 3 times higher than the upper limit of normal, you should stop taking the drug or reduce its dose. In patients with secondary hypercholesterolemia due to hypothyroidism or nephrotic syndrome, therapy for the underlying disease should be carried out before starting treatment with rosuvastatin.
Ethnic groups
Pharmacokinetic studies revealed an increase in systemic concentrations of rosuvastatin among patients of Chinese and Japanese origin compared with those obtained among Caucasian patients.
HIV protease inhibitors
Concomitant use of rosuvastatin with HIV protease inhibitors is not recommended.
Lactose
The drug should not be used in patients with lactase deficiency, galactose intolerance and glucose-galactose malabsorption.
Interstitial lung disease
Isolated cases of interstitial lung disease have been reported with some statins, especially over long-term use. Manifestations of the disease may include shortness of breath, dry cough and deterioration in general health (weakness, weight loss and fever). If interstitial lung disease is suspected, statin therapy should be discontinued.
Diabetes mellitus type 2
For patients with glucose concentrations from 5.6 to 6.9 mmol/l, the use of rosuvastatin leads to an increased risk of developing type 2 diabetes mellitus.
Impact on the ability to drive vehicles and machinery
Studies have not been conducted to study the effect of rosuvastatin on the ability to drive vehicles and machines. Based on the pharmacodynamic properties of the drug, it can be assumed that rosuvastatin should not have such an effect, however, it must be taken into account that dizziness may occur during treatment.
