Treatment of hypercholesterolemia. Adults, adolescents and children from 10 years of age with primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) as an adjunct to the diet, when dieting and the use of other non-medicinal products (such as exercise, weight loss) is insufficient. For homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering treatments (such as LDL apheresis) or in cases where such treatment is inappropriate. Prevention of cardiovascular disorders. Prevention of significant cardiovascular events in patients who are estimated to be at high risk for their first case of cardiovascular events, as an adjunct to correcting other risk factors.
Composition and form of release
Active ingredient: rozuvastatin.
Rozuvastatin-C3 is produced in the form of tablets (10 mg).
This is a remedy that corrects fat metabolism. The active ingredient selectively and competitively inhibits the HMG-CoA reductase enzyme, which catalyzes the conversion of HMG-CoA into a cholesterol precursor in the liver. Promotes an increase in the number of LDL receptors on the surface of liver cells, increasing catabolism and seizure. It also slows down the production of VLDL, thereby reducing the total content of “bad fats” in the blood.
Rozuvastatin-C3 is prescribed:
- with homozygous hereditary hypercholesterolemia – as an addition to diet, other lipid-lowering pharmaceuticals;
- for the treatment of primary hypercholesterolemia (type IIa, including heterozygous hereditary hypercholesterolemia);
- for the treatment of mixed dyslipidemia (type IIb) – as an addition to the diet when non-pharmacological methods are ineffective;
- for the prevention of cardiovascular complications;
- to reduce the risk of developing severe cardiovascular complications in adults at high risk of developing them.
You can not prescribe Rozuvastatin-C3:
- with intolerance to the components of the drug;
- with hepatobiliary diseases in the active phase;
- with chronic kidney disease at stages 4-5 (creatinine excretion rate <30 ml / minute);
during pregnancy / lactation, planning pregnancy;
- with pathology of muscle tissue;
- while taking cyclosporine;
with a predisposition to myopathy, rhabdomyolysis.
Application during pregnancy and lactation
Method of administration and dosage
Rozuvastatin-C3 is taken orally whole, without chewing, with water, regardless of the meal.
The standard starting dose for the treatment of hypercholesterolemia is 5 mg or 10 mg once a day. If necessary, it is allowed to increase the dose after 4 weeks. Due to the high likelihood of side effects, increasing the dose to 40 mg should be considered only in patients with severe hypercholesterolemia, a high risk of cardiovascular complications (for example, hereditary hypercholesterolemia), when it was not possible to achieve the target values when using lower doses.
For the prevention of cardiovascular complications, 20 mg per day is indicated.
Symptomatic therapy, control of hepatic parameters, CPK level is recommended.
- Blood test changes: thrombocytopenia.
- Immune disorders: allergies, including angioedema.
- Endocrine disorders: diabetes mellitus.
- Mental disorders: depression.
- Neurological disorders: headache, polyneuropathy, insomnia, dizziness, peripheral neuropathy, amnesia, nightmares.
- Respiratory disorders: shortness of breath, cough.
- Digestive Disorders: Pancreatitis, abdominal pain, nausea, constipation / diarrhea.
- Hepatobiliary disorders: jaundice, hepatitis, increased activity of liver transaminases.
- Dermatological disorders: rash, Stevens-Johnson syndrome, urticaria, pruritus.
- Musculoskeletal disorders: myalgia, rhabdomyolysis, myopathy, myositis, arthralgia, tendon rupture, immune-mediated necrotizing myopathy.
- Urinary disorders: hematuria.
- Sexual disorders: gynecomastia.
- General disorders: edema, asthenic syndrome.
Storage conditions and periods
It is required to store Rozuvastatin-C3 at room temperature (15-25 ° C) for no more than 2 years.