Rosustar® 10/20/40 mg film-coated tablets. Formulation: Each coated tablet contains 10, 20, and 40 mg of rosuvastatin. Indications: Treatment of hypercholesterolemia in adults, adolescents and children from 6 years. Including primary hypercholesterolemia (type IIa that includes heterozygous familial hypercholesterolemia), mixed dyslipidemia (type IIb) or homozygous familial hypercholesterolemia. In the prevention of major cardiovascular events. Dosage: Treatment of hypercholesterolemia: Initial dose recommended 5 or 10 mg orally once a day. It can be done after 4 weeks, if necessary. Prevention of cardiac events: in the study on reducing the risk of cardiac events, a dose of 20 mg per day is applied. Pediatric population between 6 and 17 years old:
- Familial heterozygous hypercholesterolemia: (Tanner Stage <II-V) The recommended starting dose for children and adolescents with heterozygous familial hypercholesterolemia is 5 mg per day. In children 6 to 9 years of age: with heterozygous familial hypercholesterolemia, the usual dose range is 5-10 mg once a day. The safety and efficacy of doses above 10 mg have not been studied in this population. In children 10 to 17 years of age: with heterozygous familial hypercholesterolemia, the usual dose range is 5-20 mg orally once a day. The safety and efficacy of doses above 20mg have not been studied in this population. -Homozygous family hypercholesterolemia: in children 6 to 17 years of age with homozygous familial hypercholesterolemia, the maximum recommended dose is 20 mg once a day. An initial dose of 5 to 10 mg once a day of age, weight and previous treatment with statins is recommended. The safety and efficacy of using Rosustar® in children under 6 years of age have not been studied. Contraindications: hypersensitivity to rosuvastatin or any of the other components of the product; active liver disease including persistent elevations of serum transaminases, severe renal insufficiency, myopathy, patients receiving concomitant ciclosporin, during pregnancy and lactation and in women of childbearing age who do not use adequate contraceptive measures. Precautions for use: Proteinuria has been observed in patients treated with high doses of rosuvastatin, in particular 40 mg. Effects on skeletal muscle have been reported, for example, myalgia, myopathy and, in rare cases, rhabdomyolysis in patients treated with rosuvastatin in particular at doses greater than 20 mg. Very rare cases of rhabdomyolysis have been reported with the use of ezetimibe in combination with inhibitors of HMG-CoA reductase. As with other inhibitors of HMG-CoA reductase, the rate of reports of rhabdomyolysis associated with rosuvastatin during post-marketing use is higher with the 40 mg dose. Use with caution in patients who consume excessive amounts of alcohol and / or have a history of liver disease. Rosuvastatin should not be co-administered with systemic formulations of fusidic acid or at least during the first 7 days after the suspension of treatment with fusidic acid. Some exceptional cases of interstitial lung disease have been reported with some statins. Some evidence suggests that statins as a class of medication increase blood glucose, and in some patients, who have a high future risk of developing diabetes, can produce a level of hyperglycemia for which it is appropriate to institute formal treatment. Most common Adverse Events: diabetes, headache, dizziness, constipation, nausea, abdominal pain, myalgia, asthenia, proteinuria. The adverse reactions observed with Rosustar® are generally mild and transient and depend on the dose. CDS 06 May 2019.