active ingredient: rosuvastatin; 1 film-coated tablet contains 5 mg of rosuvastatin in the form of 5.20 mg of rosuvastatin calcium; excipients: lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate film shell: lactose monohydrate, hypromellose, glycerol triacetate, titanium dioxide (E 171), for tablets of 5 mg – iron oxide yellow (E 172).
– Treatment of hypercholesterolemia
– Adults, adolescents and children aged 10 years with primary hypercholesterolemia (type IIa including with heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when diet and the use of other non-drug products (eg exercise, reducing body weight) is insufficient.
– In homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering treatments (eg LDL apheresis) or when such treatment is inappropriate.
– Prevention of cardiovascular disorders
– Prevention of significant cardiovascular disorders in patients, estimated-risk first case of cardiovascular disorders, as an adjunct to correction of other risk factors.
– Patients with hypersensitivity to rosuvastatin or any of the excipients of the drug;
– Patients with active liver disease, including persistent elevations of serum transaminases of unknown etiology and any transaminase elevations in serum, which is three times higher than the upper limit of normal (ULN);
– Patients with severe renal impairment (creatinine clearance <30 mL / min);
– In patients with myopathy;
– Patients who are simultaneously receiving cyclosporine;
– During pregnancy and breastfeeding, and women of reproductive age who are not using adequate contraception.
40 mg dose is contraindicated in patients with a predisposition to myopathy / rhabdomyolysis.
Factors such risk include:
– Moderate renal impairment (creatinine clearance <60 mL / min);
Dosage & Administrations
Before treatment, the patient must assign a standard hypocholesterolemic diet, which he must adhere to and during treatment. The dose should be individualized according to goal of therapy and patient response to treatment, following the recommendations of current guidelines generally.
Crestor drug can be taken at any time of the day regardless of the meal.