Nomipi 20 mg is used in the treatment of hypercholesterolemia.
One film-coated tablet contains:
Rosuvastatin calcium equivalent to 20 mg of rosuvastatin.
Excipients: lactose monohydrate, microcrystalline cellulose, sodium bicarbonate, croscarmellose sodium, magnesium stearate.
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-drug measures (e.g., physical 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 therapies (e.g., LDL apheresis) or when such treatments are inadequate.
Prevention of cardiovascular diseases. Significant prevention of cardiovascular complications in patients assessed to be at high risk of a first cardiovascular event, as an addition to correction of other risk factors.
Before starting treatment, patients should be placed on a standard hypocholesterolemic diet which should be maintained during therapy. Dosage is individualized based on treatment goals and patient response.
The medication can be taken at any time of the day, with or without food.
Treatment of hypercholesterolemia:
The recommended starting dose for statin-naïve patients or those treated with other HMG-CoA reductase inhibitors is 5 or 10 mg orally once daily. The starting dose is selected considering individual cholesterol levels and future cardiovascular risk, as well as potential risk for side effects. If necessary, dosage may be increased after 4 weeks of treatment. Increasing dosage up to 40 mg may be considered only for patients with severe hypercholesterolemia and high cardiovascular risk (especially hereditary hypercholesterolemia) who did not achieve desired results on 20 mg. Patients on 40 mg dose should be monitored closely.
Prevention of cardiovascular events:
To reduce the risk of cardiovascular diseases, the drug is used at a dose of 20 mg/day.
Pediatric patients:
Use in children and adolescents should be under specialist supervision.
Children and adolescents aged 6–17 years (Tanner stages < II-V):
Heterozygous familial hypercholesterolemia:
The usual starting dose is 5 mg daily.
In children aged 6 to 9 years, the usual dose is 5–10 mg orally once daily. Safety and efficacy of doses above 10 mg have not been studied in this group.
In children aged 10 to 17 years, the usual dose is 5–20 mg orally once daily. Safety and efficacy of doses above 20 mg have not been studied in this group.
Titration should be based on individual response and tolerance according to pediatric treatment guidelines. Children and adolescents should be on a cholesterol-lowering diet before and during rosuvastatin therapy.
Homozygous familial hypercholesterolemia:
In children aged 6–17 years, the maximum recommended dose is 20 mg once daily.
The starting dose is recommended at 5–10 mg daily depending on age, weight, and previous statin use. Titration up to 20 mg should be based on individual response and tolerance, according to pediatric treatment guidelines. Children and adolescents should be on a cholesterol-lowering diet before and during therapy.
Experience with doses above 20 mg in this population is limited.
Children under 6 years:
Safety and efficacy have not been established, so Nomipi is not recommended for children under 6 years.
Elderly patients:
For patients older than 70 years, a starting dose of 5 mg is recommended. No other dose adjustment based on age is necessary.
Patients with renal impairment:
No dose adjustment is needed in patients with mild to moderate renal impairment. The recommended starting dose is 5 mg for patients with moderate renal impairment (creatinine clearance).
Patients with hepatic impairment:
Systemic exposure to rosuvastatin is not increased in patients with Child-Pugh scores of 7 or less. Increased bioavailability was noted in patients with scores of 8 or 9. Experience in patients with scores above 9 is lacking. Nomipi is contraindicated in patients with active liver disease.
Race:
In patients of Asian origin, increased systemic exposure has been observed. The recommended starting dose is 5 mg. Therapy with 40 mg dose is contraindicated in these patients.
Genetic polymorphism:
Certain genetic polymorphisms increase rosuvastatin exposure. Patients with such polymorphisms are recommended to use a lower daily dose.
Patients predisposed to myopathy:
In patients at risk of myopathy, the recommended starting dose is 5 mg. In some such patients, 40 mg dose is contraindicated.
Concomitant use with other drugs:
Rosuvastatin is a substrate for various transport proteins. The risk of myopathy (including rhabdomyolysis) increases when rosuvastatin is co-administered with drugs that may increase rosuvastatin plasma concentration via interactions with these transport proteins (e.g., cyclosporine, certain protease inhibitors including ritonavir, atazanavir, lopinavir, and/or tipranavir). Where possible, alternative drugs should be considered. If co-administration is unavoidable, the benefits and risks of combination therapy and dose adjustment should be carefully evaluated.
Store at a temperature not exceeding 25ºC in the original packaging.
Keep out of reach of children.
