Nomipi tablet 10mg #30

Form

tableti

Dosage mg

10

Pack

30

NomiPi Tablet 10mg Composition: Each film-coated tablet contains: Rosuvastatin calcium, equivalent to 10 mg Rosuvastatin. Excipients: Lactose monohydrate, microcrystalline cellulose, sodium bicarbonate, crospovidone, magnesium stearate; Indication: Treatment of hypercholesterolemia. In adults, adolescents, and children aged 6 years and older 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 insufficient. In adults, adolescents, and children aged 6 years and older with homozygous familial hypercholesterolemia, as an adjunct to diet or other lipid-lowering therapy (e.g., LDL apheresis) or when such treatment is insufficiently effective. Prevention of cardiovascular complications. Prevention of major cardiovascular events in patients who are estimated to be at high risk of their first cardiovascular event, as an adjunct to correction of other risk factors. Dosage and administration: Before initiating treatment, patients should be placed on a standard cholesterol-lowering diet, which should be maintained throughout the treatment period. The dose should be individualized according to the treatment goal and the patient's response to therapy. The drug can be taken at any time of the day, regardless of food intake. Treatment of hypercholesterolemia. The recommended starting dose for patients who have not previously used statins or have been taking other HMG-CoA reductase inhibitors is 5 or 10 mg orally once daily. When selecting the starting dose, the patient's cholesterol level and future risk of cardiovascular complications, as well as the potential risk of adverse reactions, should be considered. If necessary, the dose can be increased after 4 weeks of treatment. Dose escalation to a maximum of 40 mg may be considered only in patients with severe hypercholesterolemia and a high risk of cardiovascular complications (especially in hereditary hypercholesterolemia) who have not achieved the desired therapeutic outcome with a 20 mg dose. Patients taking 40 mg of the drug should be monitored. Prevention of cardiovascular events. To reduce the risk of developing cardiovascular disease, the drug is used at a dose of 20 mg/day. Pediatric patients. Use in children and adolescents should be under the supervision of specialists. Children and adolescents aged 6-17 years (Tanner stages < II-V). Heterozygous familial hypercholesterolemia. In children and adolescents with heterozygous familial hypercholesterolemia, the usual starting dose is 5 mg per day. In children aged 6 to 9 years with heterozygous familial hypercholesterolemia, the usual dose is 5-10 mg orally once daily. The safety and efficacy of doses greater than 10 mg have not been studied in this population. In children aged 10 to 17 years with heterozygous familial hypercholesterolemia, the usual dose is 5-20 mg orally once daily. The safety and efficacy of doses greater than 20 mg have not been studied in this population. Titration should be performed according to the individual response and tolerance of pediatric patients, in accordance with pediatric treatment recommendations. Children and adolescents should be on a standard cholesterol-lowering diet before starting treatment with rosuvastatin; this diet should be continued during treatment with rosuvastatin. Homozygous familial hypercholesterolemia. In children aged 6-17 years with homozygous familial hypercholesterolemia, the maximum recommended dose is 20 mg once daily. A starting dose of 5 mg to 10 mg per day is recommended, depending on age, weight, and prior statin use. Titration to a maximum dose of 20 mg once daily should be performed in pediatric patients according to individual response and tolerability, in accordance with pediatric treatment recommendations. Children and adolescents should be on a cholesterol-lowering diet before starting treatment with rosuvastatin; this diet should be continued during treatment with rosuvastatin. Experience with doses above 20 mg in this population is limited. Children under 6 years of age. Since the safety and efficacy of the drug in children under 6 years of age have not been studied, NomiPi is not recommended for use in children under 6 years of age. Elderly patients. In patients >70 years of age, a starting dose of 5 mg is recommended. No other dose adjustment is required with age. Patients with renal impairment. Dose adjustment is not required in patients with mild to moderate renal impairment. The recommended starting dose is 5 mg in patients with moderate renal impairment (creatinine clearance). Patients with hepatic dysfunction. Systemic exposure to rosuvastatin was not increased in patients with a Child-Pugh score of 7 or less. In patients with a Child-Pugh score of 8 and 9, an increase in systemic bioavailability was observed. There is no experience with the use of the drug in patients with a Child-Pugh score of 9 or higher. NomiPi is contraindicated in patients with active liver disease. Race. Patients of Asian origin have shown increased systemic exposure to the drug. The recommended starting dose in these patients is 5 mg. Therapy with a 40 mg dose is contraindicated. Genetic polymorphism. Specific types of genetic polymorphism are known to increase rosuvastatin exposure. In patients with such specific types of polymorphism, a lower daily dose of NomiPi is recommended. Patients predisposed to myopathy. In patients predisposed to myopathy, the recommended starting dose is 5 mg. A dose of 40 mg is contraindicated in some such patients. Concomitant use of other drugs. Rosuvastatin is a substrate of various transporter proteins. The risk of myopathy (including rhabdomyolysis) increases when rosuvastatin is co-administered with certain drugs that may increase plasma concentrations of rosuvastatin as a result of interaction with these transporter proteins (including with cyclosporine and certain protease inhibitors, combinations with ritonavir-atazanavir, lopinavir and/or tipranavir). If possible, alternative drugs should be considered, and if necessary, temporary discontinuation of rosuvastatin therapy. If concomitant use of these drugs with rosuvastatin is unavoidable, the benefits and risks associated with combination therapy and rosuvastatin dose adjustment should be carefully considered. Storage conditions: Store at a temperature not exceeding 25°C in the original packaging. Keep out of reach of children.