Rosuvastatin-Teva 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 tablet contains 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin in the form of rosuvastatin calcium;
Excipients:
Core: microcrystalline cellulose, lactose, crospovidone, povidone, sodium stearyl fumarate;
Coating for 5 mg tablets: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), black iron oxide (E 172), sunset yellow FCF (E 110);
Coating for tablets of 10 mg, 20 mg and 40 mg: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), carmoisine (E 122), indigotine (E 132).
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 treatment, the patient should be placed on a standard cholesterol-lowering diet, which he should continue to follow during treatment. The dose should be individualized depending on the goal of therapy and the patient's response to treatment, guided by the recommendations of current generally accepted guidelines.
Rosuvastatin-Teva can be taken at any time of the day, regardless of meals.
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
Immune system: hypersensitivity reactions, including angioedema. Endocrine system: diabetes mellitus (frequency depends on the presence of risk factors - fasting glucose ≥5.6 mmol / l, BMI> 30 kg / m 2, elevated triglyceride levels, history of hypertension). Psychiatric: depression. Nervous system: peripheral neuropathy, sleep disorders, including insomnia and nightmares, headache, dizziness, polyneuropathy, memory loss. Respiratory, thoracic and mediastinal: cough, shortness of breath. Gastrointestinal tract: constipation, nausea, abdominal pain, pancreatitis, diarrhea. Digestive system: jaundice, hepatitis, increased levels of hepatic transaminases. Skin and subcutaneous tissue disorders: itching, rash, urticaria, Stevens-Johnson syndrome. Musculoskeletal, connective tissue and bone disorders: muscle pain, myopathy (including myositis), rhabdomyolysis, lupus-like syndrome, muscle ruptures, immune-mediated necrotizing myopathy, arthralgia, tendon disorders, sometimes complicated by their rupture. Renal and urinary disorders: hematuria. Reproductive system and breast disorders: gynecomastia. Blood disorders: thrombocytopenia. General disorders: asthenia, edema.
Interaction
During co-administration of Rosuvastatin and cyclosporine, rosuvastatin AUC values were on average approximately 7 times higher than those observed in healthy volunteers. The drug is contraindicated in patients receiving cyclosporine concomitantly.
Storage conditions
For 5 mg tablets, store at a temperature not exceeding 25 °C out of the reach of children.
For 10 mg, 20 mg, 40 mg tablets, store at a temperature not exceeding 30 °C in a place inaccessible to children.
Keep the blister in the cardboard box to protect from moisture and light.
Shelf life - 2 years.
