Suvardio®
Inside. At any time of the day, regardless of food intake. Do not chew or crush the tablet; swallow it whole with water. Before starting therapy with Suwardio®, the patient should begin to follow a standard cholesterol-lowering diet and continue to follow it throughout the entire period of therapy.
The dose of Suwardio® is selected individually, taking into account target cholesterol concentrations and the individual therapeutic response to the therapy.
The recommended starting dose of Suwardio® is 5 mg or 10 mg once daily for both patients who have not previously taken statins and for patients switched to this drug after therapy with other HMG-CoA reductase inhibitors.
When choosing an initial dose, you should be guided by the cholesterol concentration and the possible risk of developing cardiovascular complications in a given patient, and you should also evaluate the potential risk of side effects.
If necessary, after 4 weeks you can adjust the dose of the drug. Due to the possible development of side effects with a dose of 40 mg compared to lower doses of the drug, final titration to a maximum dose of 40 mg should only be carried out in patients with severe hypercholesterolemia and a high risk of cardiovascular complications (especially in patients with hereditary hypercholesterolemia) who did not achieve the target cholesterol concentration when taking a dose of 20 mg, and who will be under medical supervision. When prescribing a dose of 40 mg, careful medical supervision is recommended.
It is not recommended to prescribe a dose of 40 mg to patients who have not previously consulted a doctor.
Elderly patients
For patients over 65 years of age, the recommended starting dose of Suwardio® is 5 mg. In other cases, dose adjustment due to age is not required.
Patients with kidney failure
In patients with mild or moderate renal failure, no dose adjustment of Suwardio® is required. The recommended initial dose of the drug is 5 mg for patients with moderate renal failure (creatinine clearance less than 60 ml/min). The use of Suvardio® in any doses is contraindicated in patients with severe renal failure (creatinine clearance less than 30 ml/min) (see section “Contraindications”).
In patients with moderate renal failure, administration of the drug at a dose of 40 mg is contraindicated (see section “Contraindications”).
Patients with liver failure
An increase in systemic concentrations of rosuvastatin in patients with a Child-Pugh score of 7 or lower was not detected. However, increased systemic concentrations of rosuvastatin were observed in patients with Child-Pugh scores of 8 and 9. In such patients, liver function should be monitored during rosuvastatin therapy. There are no data on the use of rosuvastatin in patients with a Child-Pugh score above 9. For patients with active liver disease, rosuvastatin is contraindicated (see section “Contraindications”).
Special populations
Ethnic groups
In patients of the Mongoloid race, an increase in the systemic concentration of rosuvastatin in blood plasma is possible. The recommended starting dose of Suwardio® in patients of the Mongoloid race is 5 mg. The use of the drug in a dose of 40 mg is contraindicated in such patients (see section “Contraindications”).
Patients predisposed to the development of myopathy
The recommended starting dose of Suwardio® for patients with a predisposition to the development of myopathy is 5 mg. The use of the drug in a dose of 40 mg is contraindicated in such patients (see section “Contraindications”).
Genetic polymorphism
Carriers of genotypes SLC01B1 (OATP1B1) c.521CC and ABCG2 (BCRP) c.421AA showed an increase in exposure (AUC) of rosuvastatin by 1.6 and 2.4 times, respectively, compared with carriers of genotypes SLC01B1c.521TT and ABCG2 c.421AA . For carriers of genotypes c.521CC or c.421AA, the recommended maximum dose of Suvardio® is 20 mg once a day (see Section “Pharmacokinetics”).
Associated Disorders
Rosuvastatin binds to various transport proteins (in particular, OATP1B1 and BCRP). When using Suvardio® with medicinal products (such as cyclosporine, some human immunodeficiency virus (HIV) protease inhibitors, including a combination of ritonavir with atazanavir, lopinavir and/or tipranavir) that increase the concentration of rosuvastatin in the blood plasma due to interaction with transport proteins, the risk of developing myopathy (including rhabdomyolysis) may increase (see section “Interactions with other drugs”; you must read the instructions for use of these drugs before prescribing Suvardio®). In such cases, the possibility of using alternative therapy or temporarily stopping Suwardio® should be assessed. If it is necessary to use the above drugs, the benefit-risk ratio of concomitant therapy with Suwardio® should be assessed and the possibility of reducing its dose should be considered.
Suwardio, 28 pcs., 20 mg, film-coated tablets
Proteinuria (determined using test strips), predominantly of tubular origin, was observed in patients taking high doses of rosuvastatin, especially 40 mg, but in most cases was intermittent or short-term. It has been shown that such proteinuria does not indicate the onset of acute or progression of existing kidney disease. The incidence of severe renal dysfunction increases when taking 40 mg of rosuvastatin. It is recommended to monitor renal function parameters during rosuvastatin therapy.
When using the drug Suwardio® in all doses and especially when taking the drug in a dose exceeding 20 mg, myalgia, myopathy and, in rare cases, rhabdomyolysis were identified. Rhabdomyolysis has occurred very rarely with concomitant use of ezetimibe and HMG-CoA reductase inhibitors.
In this case, pharmacological interaction between the drugs cannot be excluded, so Suwardio® and ezetimibe should be used together with caution.
The incidence of rhabdomyolysis increases when taking 40 mg of Suwardio®.
Determination of CPK activity should not be carried out after intense physical activity or in the presence of other possible reasons for increased CPK activity, which may lead to incorrect interpretation of the results obtained. If CPK activity is significantly increased before the start of therapy (>5×ULN), a repeat measurement should be taken after 5–7 days. You should not start therapy with Suwardio® if a repeat test confirms the initial CPK activity (>5×ULN).
Rosuvastatin, like other HMG-CoA reductase inhibitors, should be prescribed with extreme caution to patients with existing risk factors for myopathy/rhabdomyolysis. These factors include:
- renal failure;
- hypothyroidism (for a dose of 40 mg);
- history of myopathy (including hereditary) (for a dose of 40 mg);
- a history of myotoxicity while taking other HMG-CoA reductase inhibitors or fibrates (for a dose of 40 mg);
- alcohol abuse (for a dose of 40 mg);
— age over 65 years;
- conditions accompanied by an increase in plasma concentration of rosuvastatin (for a dose of 40 mg);
- simultaneous use of fibrates (for a dose of 40 mg).
In such patients, the balance of risk and possible benefit of therapy should be assessed and clinical monitoring should be carried out throughout the entire course of 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 ULN or muscle symptoms are severe and cause daily discomfort throughout the day (even if CPK activity is 5 times less than the ULN). If symptoms resolve and CPK activity returns to normal, restarting the drug or prescribing an alternative HMG-CoA reductase inhibitor in lower doses should be considered with careful monitoring of the patient. Regular monitoring of CK activity in patients in the absence of symptoms of rhabdomyolysis is impractical.
There were no signs of an increase in adverse events from skeletal muscles when taking the drug Suvardio® and concomitant therapy. However, an increase in the number of cases of myositis and myopathy was detected in patients taking other HMG-CoA reductase inhibitors together with fibric acid derivatives, including gemfibrozil, cyclosporine, nicotinic acid in lipid-lowering doses (more than 1 g / day), azole antifungals, protease inhibitors and macrolide antibiotics. Gemfibrozil increases the risk of myopathy when combined with certain HMG-CoA reductase inhibitors. Therefore, simultaneous use of rosuvastatin and gemfibrozil is not recommended. It is necessary to carefully evaluate the balance of risk and possible benefit when using rosuvastatin together 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.
Suwardio® should not be prescribed to patients with acute, severe illness, suspected myopathy or possible development of secondary renal failure (for example, sepsis, hypertension, surgery, trauma, metabolic syndrome, diabetes mellitus, seizures, endocrine disorders, fluid and electrolyte disorders) .
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 (if necessary, dose adjustment is required).
Like other HMG-CoA reductase inhibitors, rosuvastatin 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 and 3 months after the start of treatment. If the activity of hepatic transaminases in the blood serum is 3 times higher than the ULN, you should stop taking the drug or reduce the dose taken. The frequency of severe liver dysfunction (mainly associated with increased activity of liver transaminases) increases when taking 40 mg of the drug. In patients with secondary hypercholesterolemia due to hypothyroidism, nephrotic syndrome, therapy for the underlying disease should be carried out before starting treatment with rosuvastatin.
Pharmacokinetic studies revealed an increase in the systemic concentration of rosuvastatin among patients of the Mongoloid race compared to representatives of the Caucasian race.
Concomitant use of rosuvastatin with HIV protease inhibitors is not recommended.
Isolated cases of interstitial lung disease have been reported with some statins, especially over long periods of time. Manifestations of the disease may include shortness of breath, non-productive cough and deterioration in general health (weakness, loss of body weight and fever). If interstitial lung disease is suspected, statin therapy should be discontinued.
In patients with glucose concentrations between 5.6 and 6.9 mmol/L, drug therapy was associated with an increased risk of developing type 2 diabetes mellitus.
Special precautions when disposing of unused medicinal products.
There is no need for special precautions when disposing of unused Suwardio®.
Influence on the ability to drive vehicles and machinery.
Care must be taken when driving vehicles or engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (risk of dizziness).
