Rozvator tablets are used for the following indications:
Treatment of hypercholesterolemia: adults, adolescents and children over 10 years of age with primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) as an adjunct to diet when diet and other non-pharmacological measures (e.g. exercise, weight reduction) are inadequate; in homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering treatments (e.g. low-density lipoprotein apheresis) or when such treatment is inappropriate; prevention of cardiovascular events: prevention of major cardiovascular events in patients estimated to be at high risk of a first cardiovascular event, in addition to correction of other risk factors.
Composition
Active ingredient: rosuvastatin;
1 film-coated tablet contains 10 mg or 20 mg of rosuvastatin as rosuvastatin calcium;
Excipients: lactose monohydrate, microcrystalline cellulose, sodium, magnesium stearate, crospovidone;
Coating composition: Opadry pink 03B 24082 (hypromellose, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172)).
Contraindication
Hypersensitivity to rosuvastatin or any of the excipients of the drug; active liver disease, including of unknown etiology, with persistent elevation of hepatic transaminase activity, as well as an increase in the level of any transaminase in the blood serum more than 3 times the upper limit of normal; severe renal impairment (creatinine clearance <30 ml/min); myopathy; simultaneous administration of cyclosporine; pregnancy and breastfeeding, as well as women of reproductive age who do not use reliable contraception.
The 40 mg dose is contraindicated in patients with factors predisposing to the development of myopathy/rhabdomyolysis. Such factors include:
moderately severe renal impairment (creatinine clearance <60 ml/min); hypothyroidism; personal or family history of hereditary muscle diseases; history of myotoxicity while taking other HMG-CoA reductase inhibitors or fibrates; alcohol abuse; conditions that may lead to increased plasma concentrations of rosuvastatin; belonging to the Mongoloid race; simultaneous use of fibrates.
Method of application
Before starting therapy, the patient should be placed on a standard cholesterol-lowering diet and should continue to follow it during therapy. Doses should be individualized according to the goal of therapy and response, in accordance with current consensus guidelines.
Rosuvastatin can be taken at any time during the day, regardless of meals.
The tablet should not be chewed or crushed. The tablet should be swallowed whole with water. If the required dose of rosuvastatin can be obtained from Rozvator tablets of 10 mg or 20 mg, other medicinal products containing rosuvastatin in the required dosage should be used.
Application features
Pregnant women
Contraindicated.
Children
The use of the drug in children should only be carried out by a specialist.
Drivers
With caution.
Overdose
There is no specific treatment for overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures should be taken as necessary. Liver function and CK levels should be monitored. Hemodialysis is unlikely to be effective.
Side effects
Adverse events reported with Rozvator are usually mild and transient. In controlled clinical trials, less than 4% of patients receiving Rozvator withdrew from the study due to adverse reactions.
Below are the most frequent adverse reactions to rosuvastatin according to clinical studies and extensive post-marketing experience.
Endocrine disorders: common (≥ 1/100 to < 1/10) - diabetes mellitus.
Nervous system: common (≥ 1/100 to < 1/10) - headache, dizziness.
Gastrointestinal: common (≥ 1/100 to < 1/10) - constipation, nausea, abdominal pain.
Musculoskeletal and connective tissue disorders: common (≥ 1/100 to < 1/10) - muscle pain.
Interaction
During co-administration of Rozvator and cyclosporine, rosuvastatin AUC values were on average approximately 7 times higher than those observed in healthy volunteers. Rozvator is contraindicated in patients receiving cyclosporine concomitantly.
Storage conditions
Store at a temperature not exceeding 30 °C out of the reach of children.
Shelf life - 2 years.
