Properties
- Form
- tableti
- Dosage mg
- 20
- Pack
- 28
What is it?
International Nonproprietary Name - rosuvastatin Clinical-pharmacological group: Metabolic disorders → Lipid metabolism regulators → Cholesterol synthesis inhibitors Composition: Each tablet contains the active substance rosuvastatin, 5, 10, 20 mg, in the form of rosuvastatin calcium. Excipients: lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, hypromellose, glyceryl triacetate, titanium dioxide (E171), red iron oxide (E172), purified water. Indications for use: - Primary hypercholesterolemia (type IIa, including familial heterozygous hypercholesterolemia) or mixed hypercholesterolemia (type IIb) as an adjunct to diet, when diet and other non-medicinal methods of treatment (e.g., physical exercise, weight reduction) are insufficient. - Familial homozygous hypercholesterolemia, as an adjunct to diet and other cholesterol-lowering therapies (e.g., low-density lipoprotein apheresis), or when such therapies are ineffective for the patient. Dosage and administration: For oral administration. Tablets should not be chewed or crushed; they should be swallowed whole with water. Can be taken at any time of day, regardless of food intake. For a 5 mg dose, the 10 mg rosuvastatin tablet should be divided in half. Before starting treatment with rosuvastatin, the patient should start a standard hypolipidemic diet and continue to follow the diet during treatment. The dose of the drug should be selected individually, according to the goals of therapy and response to treatment, taking into account current recommendations regarding target lipid levels. For patients starting the drug and switching from other HMG-CoA reductase inhibitors to rosuvastatin treatment, the recommended starting dose should be 5–10 mg once daily. When selecting the starting dose, individual cholesterol levels and the potential risk of cardiovascular complications should be considered, as well as the potential risk of side effects. If necessary, the dose can be increased after 4 weeks. Due to the potential for side effects, at a dose of 40 mg, compared to other lower doses of the drug, increasing the dose to 40 mg, after receiving a higher than recommended starting dose, after 4 weeks of therapy, may only occur in patients with severe hypercholesterolemia and a high risk of cardiovascular complications (especially in patients with familial hypercholesterolemia) for whom the desired result was not achieved at a dose of 20 mg and who will be under specialist supervision (in lipidology, diabetology, or cardiology clinics). Special careful observation is recommended for patients taking 40 mg. It is not recommended to prescribe a dose of 40 mg to patients who have not previously consulted a specialist. After 2-4 weeks of therapy and/or when taking increased doses of rosuvastatin, it is necessary to control lipid metabolism indicators (if necessary, the dose should be adjusted). Elderly patients: Dose adjustment is not required. Patients with renal insufficiency: Dose adjustment is not required in patients with mild or moderate renal insufficiency. Administration of all doses of rosuvastatin is contraindicated in patients with severe renal insufficiency (creatinine clearance less than 30 ml/min). Administration of the drug at a dose of 40 mg is contraindicated in patients with moderate renal impairment (creatinine clearance less than 60 ml/min).
