Rosuvastatin

The drug is taken orally. Do not chew a tablet or crush it, swallow it whole, drinking plenty of water, it can be taken at any time of the day, regardless of the meal. If necessary, taking the drug in a dose of 5 mg should be divided tablet with a dosage of 10 mg.

Before starting treatment with Cardiolip, the patient should begin to follow a standard cholesterol-lowering diet and continue to follow it during treatment. The dose of the drug should be chosen individually depending on the goals of therapy and the therapeutic response to treatment, taking into account the current recommendations on target lipid levels.

The recommended initial dose for patients starting to take the drug, or for patients transferred from taking other HMG-CoA reductase inhibitors, should be 5 mg (1/2 tablet 10 mg) or 10 mg of the drug 1 time per day.

At the same time taking cardiolip with gemfibrozil, fibrates, nicotinic acid in a dose of more than 1 g / day, the recommended initial dose of the drug is 5 mg (1/2 pills of 10 mg).

When choosing the initial dose, one should be guided by the individual cholesterol level and take into account the possible risk of cardiovascular complications, as well as the potential risk of side effects. If necessary, the dose may be increased to a maximum after 4 weeks.

Due to the possible development of side effects when taking a dose of 40 mg, compared with lower doses of the drug, increasing the dose to 40 mg, after an additional dose of the dose above the recommended initial dose during 4 weeks of therapy, can be carried out only in patients the degree of hypercholesterolemia and a high risk of cardiovascular complications (especially in patients with familial hypercholesterolemia) who have not achieved the desired result of therapy when taking a dose of 20 mg cha Especially careful monitoring of patients receiving the drug at a dose of 40 mg is recommended.

It is not recommended to use a dose of 40 mg in patients who have not previously consulted a doctor. After 2-4 weeks of therapy and / or with an increase in the dose of the drug, control of lipid metabolism indices is necessary (if necessary, dose adjustment is required).

Elderly patients: dose adjustment is not required.

In patients with mild to moderate renal insufficiency, dose adjustment is not required. The use of all dosages of the drug in patients with severe renal insufficiency (CC less than 30 ml / min) is contraindicated. Use of the drug in a dose of 40 mg is contraindicated in patients with moderately impaired renal function (CC less than 60 ml / min). Patients with moderately impaired renal function are recommended an initial dose of 5 mg (1/2 pills of 10 mg).

Patients with liver failure: Rosuvastatin is contraindicated in patients with liver disease in the active phase. Experience with the use of the drug in patients with liver failure above 9 on the Child-Pugh scale is absent.

Special populations

When studying the pharmacokinetic parameters of rosuvastatin in patients belonging to different ethnic groups, an increase in the systemic concentration of rosuvastatin among Japanese and Chinese was observed. This fact should be taken into account when Rosuvastatin is used in this group of patients. At doses of 10 mg and 20 mg, the recommended starting dose for patients of the Asian race is 5 mg (1/2 pills of 10 mg). The drug is contraindicated in a dose of 40 mg in patients of the Asian race.

Patients predisposed to myopathy

The drug is contraindicated in a dose of 40 mg in patients with factors indicating a predisposition to the development of myopathy. When applying doses of 10 mg and 20 mg, the recommended initial dose for this group of patients is 5 mg (1/2 pills of 10 mg).

When used with gemfibrozil, the dose of the drug should not exceed 10 mg / day.

Before initiating therapy and throughout the entire period of treatment, a standard lipid-lowering diet should be observed.During treatment, every 2 to 4 weeks, the lipid profile should be monitored and, according to it, the dose of the drug should be adjusted if necessary.

With the use of rosuvastatin in all doses, and in particular at a dose in excess of 20 mg, short-term proteinuria can be observed. In patients taking the drug in a dose of 40 mg, it is recommended to monitor indicators of renal function.

Patients taking rosuvastatin in a dose exceeding 20 mg may experience myalgia, myopathy, and rarely, rhabdomyolysis. Determination of CPK activity should not be carried out after intense physical exertion or in the presence of other possible reasons for increasing CPK, which may lead to an incorrect interpretation of the results. With an increase in CPK 5 times higher than the upper limit of normal after 5-7 days should be repeated measurement. It is not necessary to begin therapy if the repeated test confirms the initial increased activity of KFK more than 5 times in comparison with the upper limit of norm.

In patients at risk of developing myopathy / rhabdomyolysis, it is necessary to consider the ratio of risk and possible benefit of therapy and to carry out clinical observation throughout the course of treatment.

The patient should be informed of the need to immediately report to the doctor in cases of sudden onset of muscle pain, muscle weakness or spasms, especially in combination with indisposition and fever. In such patients, CPK activity should be monitored. Therapy should be discontinued if the activity of CPK is increased by more than 5 times compared with the upper limit of the norm, or if the muscular symptoms are pronounced and cause daily discomfort (even if the activity of CPK is 5 times less than the upper limit of the norm). If the symptoms disappear, and the activity of CPK returns to normal, consideration should be given to the repeated use of the drug or other HMG-CoA reductase inhibitors in smaller doses under close medical supervision. Routine monitoring of CPK in the absence of rhabdomyolysis symptoms is not appropriate.

An increase in the incidence of myositis and myopathy was reported in patients taking other HMG-CoA reductase inhibitors in combination with fibrin acid derivatives, including gemfibrozil, cyclosporine, nicotinic acid in lipid-lowering doses, azole antifungal agents, HIV protease inhibitors and macrolide antibiotics. Gemfibrozil increases the risk of myopathy in combination with certain inhibitors of HMG-CoA reductase. Thus, the simultaneous use of rosuvastatin and gemfibrozil is not recommended. The balance of risk and potential benefit should be carefully weighed when rosuvastatin is used together with fibrates or nicotinic acid in lipid-lowering doses.

It is recommended to determine the indicators of liver function before the start of therapy and 3 months after the start of therapy. If the activity of liver transaminases in serum is 3 times higher than the upper limit of normal, the dose of the drug should be reduced or discontinued.

With a combination of hypercholesterolemia and hypothyroidism or nephrotic syndrome, the treatment of major diseases should be carried out before starting treatment with rosuvastatin.

There was an increase in the plasma concentration of rosuvastatin in patients of the Asian race compared with patients of the European race.

In patients with a blood glucose concentration of 5.6 to 6.9 mmol / l, rosuvastatin therapy was associated with an increased risk of developing type 2 diabetes.

Women of reproductive age should use adequate methods of contraception.

During treatment, dizziness, weakness may occur, so care must be taken when driving and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed.