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active ingredient: 1 film-coated tablet contains 5mg, 10mg, 15mg, 20mg, 30mg or 40mg of rosuvastatin (as rosuvastatin calcium);
excipients: microcrystalline cellulose, lactose, crospovidone, colloidal silicon dioxide, magnesium stearate film shell: methacrylate copolymer, macrogol 6000, titanium dioxide (E 171), lactose.
– Primary Hypercholesterolemia (IIa type, including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when diet and other non-pharmacological treatments (eg exercise, weight loss) are not sufficient
– Homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering therapy (eg, LDL-apheresis), or when such therapy is not appropriate to the patient
– As an adjunct to diet to slow the progression of atherosclerosis in adult patients as part of treatment to reduce the levels of total cholesterol (TC) and LDL-C to target levels
– Prevention of cardiovascular events in adult patients with an increased risk of atherosclerotic cardiovascular disease as an adjuvant therapy.
Dosing & Administration
Before starting therapy with the patient should be on a standard diet with low cholesterol content and continue to adhere to this diet during treatment. Dose is determined individually depending on the purposes of therapy, the patient’s response to treatment. The recommended initial daily dose is from 5 mg to 10 mg taken once a day. The dose is the same for patients taking statins for the first time, and moving from another inhibitor therapy HMG – CoA reductase. When selecting the starting dose should be considered the original individual cholesterol levels and existing cardiovascular risk, as well as the potential risk of adverse reactions.
If necessary, the dose may be increased after 4 weeks. Given the increasing frequency of reports of adverse reactions when receiving a 40 mg dose compared with lower doses, the increase in the daily dose to 30 mg or 40 mg should be considered only for patients with severe hyperlipidemia and high cardiovascular risk (in particular, in familial hypercholesterolemia) who did not manage to achieve target lipid levels while taking lower doses, and that will be supervised. Particular attention is needed at the start of patients receiving doses of 40 mg or 30 mg.
For doses of 5 mg, 10 mg and 20 mg:
– Hypersensitivity to rosuvastatin or to any component of the drug
– Liver disease in the active phase, a persistent increase in serum transaminases and any increase in transaminases serum more than 3 times the upper limit of norms
– Pronounced renal dysfunction (creatinine clearance less than 30 ml / min)
– Concomitant use of cyclosporine
– Pregnancy and lactation
– Women of childbearing age in the absence of adequate methods of concentration contraception
For doses above 20 mg and 40 mg, additional contraindications:
– Myopathy or factors predisposing to the development of myopathy, hereditary myopathy in a personal or family history – Moderate renal impairment (creatinine clearance <60 ml / min)
– Anamnestic indications miotoksicheskie effects while taking other inhibitors
– alcohol addiction
– Situations in which may increase plasma concentrations of drug
– Asian race patients
– Simultaneous reception of fibrates
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