Rosuvastatin pills 20mg №60

Indications

- primary hypercholesterolemia according to Fredrickson's classification (type IIa, including familial heterozygous hypercholesterolemia) or mixed hypercholesterolemia (type IIb) as a supplement to the diet when diet and other non-drug therapies (eg exercise, weight loss) are insufficient;

- familial homozygous hypercholesterolemia as an adjunct to diet and other lipid-lowering therapy (for example, LDL-apheresis), or in cases when such therapy is not sufficiently effective;

- hypertriglyceridemia (type IV according to Fredrickson's classification) as a supplement to the diet;

- to slow the progression of atherosclerosis as a supplement to the diet in patients who have been shown therapy to reduce the concentration of total cholesterol and LDL-C;

- primary prevention of major cardiovascular complications (stroke, heart attack, arterial revascularization) in adult patients without clinical signs of CHD, but with an increased risk of its development (age over 50 years for men and over 60 years for women), increased concentration of C-reactive protein (≥ 2 mg / l) in the presence of at least one of the additional risk factors such as hypertension, low concentrations of HDL-C, smoking, family history of early onset of coronary artery disease.

Dosing regimen

Inside, do not chew or crush the pill, swallow whole, washed down with water.The drug can be administered at any time of the day, regardless of the time of the meal.

Before initiating rozuvastatin therapy, the patient should begin to follow the 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 concentrations.

The recommended initial dose for patients beginning to take the drug, or for patients transferred from taking other HMG-CoA reductase inhibitors, should be 5 or 10 mg of the drug Rosuvastatin 1 time / day. When choosing the initial dose, one should be guided by the individual cholesterol content 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 (see the Pharmacodynamics section).

In connection with the possible development of side effects when taking a dose of 40 mg, compared with lower doses of the drug (see the section "Side Effects"), increasing the dose to 40 mg, after an additional dose of the dose above the recommended initial dose within 4 weeks therapy, can be performed only in patients with severe hypercholesterolemia and with a high risk of cardiovascular complications (especially in patients with familial hypercholesterolemia),who have not achieved the desired result of treatment when taking a dose of 20 mg, and which will be under the supervision of a specialist (see section "Special instructions"). Especially careful monitoring of patients receiving the drug at a dose of 40 mg is recommended.

It is not recommended to prescribe a dose of 40 mg to patients who have not previously visited a doctor.

After 2-4 weeks of therapy and / or with an increase in the dose of the drug Rosuvastatin, lipid metabolism monitoring is necessary (dose adjustment is necessary if necessary). The use of the drug in a higher dose than 40 mg is not justified due to increased side effects and in most cases is not recommended.

Elderly patients

No dose adjustment required.

Patients with renal failure

In patients with mild to moderate renal insufficiency, dose adjustment is not required. In patients with severe renal failure (CC less than 30 ml / min.), The use of the drug Rosuvastatin is contraindicated. Use of the drug in a dose of 40 mg is contraindicated in patients with moderately impaired renal function (CC 30-60 ml / min) (see the section "Specific instructions", "Pharmacodynamics"). Patients with moderate renal impairment are recommended an initial dose of 5 mg.

Patients with liver failure

Rosuvastatin is contraindicated in patients with liver disease in the active phase (see section "Contraindications").

Special populations. Ethnic groups

When studying the pharmacokinetic parameters of rosuvastatin in patients belonging to different ethnic groups, there was an increase in the systemic concentration of rosuvastatin among Japanese and Chinese (see the section "Special Instructions"). This fact should be taken into account when prescribing Rosuvastatin for these groups of patients. When prescribing doses of 10 and 20 mg, the recommended initial dose for patients of the Mongoloid race is 5 mg. The prescription of the drug in a dose of 40 mg to patients of the Mongoloid race is contraindicated (see section "Contraindications").

Genetic polymorphism

In carriers of the SLCO1B1 genotypes (OATP1B1) c.521CC and ABCG2 (BCRP) p.421AA, there was an increase in exposure (AUC) to rosuvastatin compared with the carriers of the SLCO1B1 genotypes c.521TT and ABCG2 p.421CC. For patients carrying genotypes p.521CC or p.421AA, the recommended maximum dose of Rosuvastatin is 20 mg 1 time / day (see the sections "Pharmacokinetics", "Special Instructions" and "Interaction with Other Drugs and Other Types of Drug Interactions").

Patients predisposed to myopathy

The drug is prescribed in a dose of 40 mg in patients with factors that may indicate a predisposition to the development of myopathy (see section "Contraindications"). At purpose of doses of 10 and 20 mg the recommended initial dose for this group of patients makes 5 mg (see the section "Contraindications").

Concomitant therapy

Rosuvastatin binds to various transport proteins (in particular, OATP1B1 and BCRP).When rosuvastatin is used together with medications (such as cyclosporine, some HIV protease inhibitors, including a combination of ritonavir with atazanavir, lopinavir and / or tipranavir), which increase the concentration of rosuvastatin in plasma due to interaction with transport proteins, myopathy may increase (including rhabdomiolysis (see sections "Special Instructions" and "Interaction with other medicinal products and other types of drug interactions"). In such cases, you should evaluate the possibility of prescribing alternative therapy or the temporary cessation of taking the drug Rosuvastatin. If the use of the above preparations is necessary, the ratio of benefits and risks of concomitant therapy with Rosuvastatin should be evaluated and the possibility of reducing its dose should be considered (see the section "Interaction with other drugs and other types of drug interactions").

Side effect

The side effects observed when taking the drug Rosuvastatin, usually expressed slightly and pass on their own. As with the use of other inhibitors of HMG-CoA reductase, the frequency of side effects is mainly dose-dependent.

The incidence of adverse effects is presented in accordance with the classification of the World Health Organization: often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); very rarely (<1/10000), unspecified frequency (cannot be calculated from the available data).

The immune system: rarely, hypersensitivity reactions, including angioedema.

Endocrine system: often - type 2 diabetes.

From the side of the central nervous system: often - headache, dizziness.

From the digestive tract: often - constipation, nausea, abdominal pain; rarely - pancreatitis.

From the skin: infrequently - pruritus, rash, urticaria.

From the musculoskeletal system: often myalgia; rarely - myopathy (including myositis), rhabdomyolysis.

Other: often - asthenic syndrome.

From the urinary system

Patients treated with rosuvastatin may have proteinuria. Changes in the amount of protein in the urine (from the absence or trace amounts to ++ or more) are observed in less than 1% of patients receiving 10-20 mg of the drug, and in approximately 3% of patients receiving 40 mg of the drug. A slight change in the amount of protein in the urine was noted when taking a dose of 20 mg. In most cases, proteinuria diminishes or disappears during therapy and does not mean the onset or the progression of an existing kidney disease.

From the musculoskeletal system

When using the drug Rosuvastatin in all doses, and especially when taking doses of the drug in excess of 20 mg, the following effects on the musculoskeletal system were reported: myalgia, myopathy (including myositis), in rare cases - rhabdomyolysis with or without acute renal failure.

A dose-dependent increase in the activity of creatine phosphokinase (CPK) is observed in an insignificant number of patients taking rosuvastatin.In most cases, it was minor, asymptomatic and temporary. In the case of increased activity of CPK (more than 5 times compared with the upper limit of the norm), therapy should be suspended (see the section "Special Instructions").

Liver

With the use of rosuvastatin, a dose-dependent increase in the activity of liver transaminases is observed in a small number of patients. In most cases, it is insignificant, asymptomatic and temporary.

Laboratory values

When using the drug Rosuvastatin, the following changes in laboratory parameters were also observed: an increase in the concentration of glucose, bilirubin, the activity of gamma-glutamyl transpeptidase, alkaline phosphatase, thyroid dysfunction.

Post-marketing application

The following side effects have been reported in the post-marketing use of Rosuvastatin:

From the hemopoietic system: unspecified frequency - thrombocytopenia.

From the digestive tract: very rarely - jaundice, hepatitis; rarely, increased activity of liver transaminases; unspecified frequency - diarrhea.

From the musculoskeletal system: very rarely - arthralgia; unspecified frequency - immune-mediated necrotizing myopathy.

From the side of the central nervous system: very rarely - loss or loss of memory; unspecified frequency - peripheral neuropathy.

On the part of the respiratory system: unspecified frequency - cough, shortness of breath.

From the urinary system: very rarely - hematuria.

From the skin and subcutaneous fat: unspecified frequency - Stevens-Johnson syndrome.

On the part of the reproductive system and the breast: unspecified frequency - gynecomastia.

Other: unspecified frequency - peripheral edema.

When using certain statins, the following side effects were reported: depression, sleep disturbance, including insomnia and nightmares, sexual dysfunction, hyperglycemia, and an increase in the concentration of glycated hemoglobin. It was reported on isolated cases of interstitial lung disease, especially with prolonged use of drugs (see section "Special instructions").

Contraindications

For the drug in a daily dose of 5 mg, 10 mg and 20 mg:

- · hypersensitivity to rosuvastatin or any of the components of the drug;

- · lactose intolerance , lactase deficiency or glucose-galactose malabsorption (the product contains lactose);

- · children's age up to 18 years;

- · liver disease in the active phase, including a persistent increase in serum transaminase activity and any increase in serum transaminase activity (more than 3 times compared with the upper limit of normal);

- · severe renal dysfunction (CC less than 30 ml / min);

- · myopathy and predisposition to the development of myotoxic complications;

- · simultaneous administration of cyclosporine;

- · in women: pregnancy, breastfeeding period, lack of adequate methods of contraception.

For the drug in a daily dose of 40 mg:

- · hypersensitivity to rosuvastatin or any of the components of the drug;

- · lactose intolerance, lactase deficiency or glucose-galactose malabsorption (the product contains lactose);

- · children's age up to 18 years;

- · simultaneous administration of cyclosporine;

- · in women: pregnancy, breastfeeding period, lack of adequate methods of contraception;

- · liver disease in the active phase, including a persistent increase in serum transaminase activity and any increase in serum transaminase activity (more than 3 times compared with the upper limit of normal) in patients with risk factors for myopathy / rhabdomyolysis, namely:

- · renal failure of moderate severity (CC less than 60 ml / min);

- · hypothyroidism;

- · personal or family history of muscular diseases;

- · myotoxicity while taking other HMG-CoA reductase inhibitors or a history of fibrates;

- · excessive drinking;

- · conditions that can lead to increased plasma concentrations of rosuvastatin;

- · simultaneous intake of fibrates;

- · use in patients of the Mongoloid race.

Carefully

For the drug in a daily dose of 5 mg, 10 mg and 20 mg

Presence of risk of myopathy / rhabdomyolysis - renal failure