At the beginning of Simvastol® therapy, a transient increase in the level of "liver" enzymes is possible.
Before starting therapy, continue to conduct regular liver function tests (monitor the activity of liver enzymes every 6 weeks for the first 3 months, then every 8 weeks for the remaining first year, and then, once every six months), and also with an increase a test should be performed to determine the function of the liver. When the dose is raised to 80 mg, a test should be performed every 3 months. With a persistent increase in transaminase activity (3-fold compared with baseline), Simvastol® should be discontinued.
Simvastol®, like other HMG-CoA reductase inhibitors, should not be used at an increased risk of rhabdomyolysis and renal insufficiency (against severe acute infection, arterial hypotension, planned large surgery, trauma, severe metabolic disorders).
The abolition of lipid-lowering drugs during pregnancy does not have a significant effect on the results of long-term treatment of primary hypercholesterolemia.
Due to the fact that inhibitors of HMG-CoA reductase inhibitors inhibit the synthesis of cholesterol, and cholesterol and other products of its synthesis play an essential role in fetal development, including steroids and synthesis of cellular membranes, simvastatin may have an adverse effect on the fetus when prescribing it to pregnant women (women of reproductive age should avoid conception). If during pregnancy pregnancy occurs, the drug should be canceled, and the woman is warned about possible danger to the fetus.
The use of simvastol® is not recommended for women of childbearing age who do not use contraceptives.
In patients with reduced thyroid function (hypothyroidism) or in the presence of Some kidney diseases (nephrotic syndrome) with increasing cholesterol levels should first be carried out therapy underlying the disease. Precautions are prescribed for persons who abuse alcohol and / or have a history of liver disease.
Before and during treatment, the patient should be on a hypocholesterol diet. Simultaneous reception of grapefruit juice can increase the severity of side effects associated with taking Simvastol®, therefore, simultaneous reception should be avoided.
Simvastol® is not indicated in cases where there is hypertriglyceridemia I, IV and V types.
Treatment with simvastol® can cause myopathy, leading to rhabdomyolysis and kidney failure. The risk of this pathology increases in patients receiving simultaneously with Simvastol® one or more of the following medicines: fibrates (gemfibrozil, fenofibrate), ciclosporin, nefazodone, macrolides (erythromycin, clarithromycin), antifungal agents from the group of "azoles" (ketoconazole, itraconazole) and HIV protease inhibitors (ritonavir). The risk of developing myopathy is also increased in patients with severe renal failure. All patients starting therapy with Simvastol®; and tayuke patients who need to increase the dose of the drug should be warned about the possibility of myopathy and the need to immediately seek medical attention in the event of unexplained pain,muscle soreness, lethargy or muscle weakness, especially if it is accompanied by a malaise or fever. The drug should be discontinued immediately if myopathy is diagnosed or suspected.
In order to diagnose the development of myopathy, it is recommended that CK values be measured regularly.
When treating the drug, it is possible to increase the content of serum CK, which should be taken into account in the differential diagnosis of chest pain. The criterion for the discontinuation of the drug is an increase in serum levels of CK in more than 10 times the upper limit of the norm. In patients with myalgia, myasthenia gravis and / or a marked increase in the activity of CKK, treatment with the drug is stopped.
The drug is effective, as in. form of monotherapy, and in combination with. sequestrants of bile acids.
If the current dose is skipped, the drug should be taken as soon as possible. If it's time to take the next dose, do not double the dose.
Patients with severe renal failure receive treatment under the control of kidney function.
Duration of the drug is determined individually by the attending physician.