Riglodem
Primary hypercholesterolemia (type IIa, including familial heterozygous hypercholesterolemia) or mixed hypercholesterolemia (type IIb) as an adjunct to diet when diet and other non-drug treatments (eg, exercise, weight loss) are inadequate.
Riglodem 10 mg: Each film-coated tablet contains:
active substance:
Rosuvastatin calcium equivalent to rosuvastatin 10 mg
excipients: microcrystalline cellulose, lactose monohydrate, tribasic calcium phosphate, povidone K25, magnesium stearate; shell composition: hypromellose (E15), polyethylene glycol 400, titanium dioxide.
Riglodem 20 mg: Each film-coated tablet contains:
active substance:
Rosuvastatin calcium equivalent to rosuvastatin 20 mg
excipients: microcrystalline cellulose, lactose monohydrate, tribasic calcium phosphate, povidone K25, magnesium stearate;
shell composition: hypromellose (E15), polyethylene glycol 400, titanium dioxide, iron oxide (red).
Primary hypercholesterolemia (type IIa, including familial heterozygous hypercholesterolemia) or mixed hypercholesterolemia (type IIb) as an adjunct to diet when diet and other non-drug treatments (eg, exercise, weight loss) are inadequate;
- familial homozygous hypercholesterolemia as an adjunct to diet and other cholesterol-lowering therapy (eg, LDL apheresis), or when such therapy is not appropriate for the patient.
- prevention of cardiovascular complications in adult patients with an increased risk of developing atherosclerotic cardiovascular disease as adjuvant therapy.
Before and during therapy with Riglodem, the patient should follow a standard lipid-lowering diet. The dose of the drug should be selected individually depending on the goals of therapy and response to treatment, taking into account current recommendations for target lipid concentrations.
Inside, do not chew or crush the tablet, swallow it whole with water.
May be administered with or without food.
The recommended starting dose for patients starting to take the drug, or for patients transferred from taking other HMG-CoA reductase inhibitors, should be 5 or 10 mg of Riglodem 1 time per day.
When choosing an initial dose, one should be guided by the level of cholesterol and take into account the possible risk of cardiovascular complications, and it is also necessary to evaluate the potential risk of side effects. If necessary, the dose may be increased after 4 weeks of taking the drug. Increase the dose of the drug gradually.
Due to the possible development of side effects at a dose of 40 mg, increasing the dose to a maximum of 40 mg should only be considered in patients with severe hypercholesterolemia and at high risk of cardiovascular disease.
vascular complications (especially in patients with familial hypercholesterolemia), who did not achieve the desired result of therapy when taking a dose of 20 mg. Monitoring of patients receiving the drug at a dose of 40 mg is recommended.
It is not recommended to prescribe a dose of 40 mg to patients who have not previously taken the drug. After 2-4 weeks of therapy and / or with an increase in the dose of Riglodem, monitoring of lipid metabolism is necessary (if necessary, dose adjustment is required).
Prevention of cardiovascular complications in adult patients with an increased risk of developing atherosclerotic cardiovascular disease as adjuvant therapy:
The recommended dose is 20 mg once a day.
Application in children.
In pediatric practice, the drug should be prescribed exclusively by a specialist.
Children and adolescents from 6 to 17 years old (Tanner developmental stage ˂II – V).
Heterozygous familial hypercholesterolemia:
The initial daily dose for children and adolescents with heterozygous familial hypercholesterolemia is 5 mg per day.
For children aged 6 to 9 years, the usual dose range is 5 to 10 mg orally once a day. The safety and efficacy of the drug at a dose of more than 10 mg in the treatment of this population have not been studied.
For children aged 10 to 17 years, the usual dose range is 5-20 mg orally once a day. The safety and efficacy of the drug at a dose of more than 20 mg in the treatment of this population have not been studied.
Increasing the dose is carried out taking into account the individual response and tolerance, according to the recommendations for use in pediatric practice. Before starting therapy with Riglodem, the child should be prescribed a standard low-cholesterol diet, and the diet should be followed during the period of therapy.
Homozygous hereditary hypercholesterolemia:
For children aged 6 to 17 years with homozygous hereditary hypercholesterolemia, the recommended dose is 20 mg once daily.
The recommended starting dose is 5-10 mg, depending on age, body weight and previous use of rosuvastatin. Before starting treatment with Riglodem, children and adolescents should be on a standard cholesterol-lowering diet, which should also be followed during treatment.
Experience with the drug in children under 6 years of age is limited. Therefore, treatment with rosuvastatin in children under 6 years of age is not recommended.
Elderly patients:
Dose adjustment is not required. Patients over 70 years of age are recommended an initial dose of 5 mg.
Patients with renal insufficiency:
In patients with mild or moderate renal insufficiency, dose adjustment is not required, the recommended initial dose of the drug is 5 mg. In patients with moderate renal impairment (creatinine clearance less than 60 ml / min), the use of the drug at a dosage of 40 mg is contraindicated. In patients with severe renal insufficiency (creatinine clearance less than 30 ml / min), the use of the drug Riglodem is contraindicated.
Patients with liver failure:
There is no experience of using the drug in patients with a score above 9 on the Child-Pugh scale.
Race:
In patients of the Mongoloid race, an increased systemic exposure of rosuvastatin was noted. The recommended initial dose for patients of the Mongoloid race is 5 mg. The use of a dose of 40 mg in such patients is contraindicated.
Patients predisposed to myopathy:
The appointment of the drug at a dose of 40 mg is contraindicated in patients predisposed to the development of myopathy.
The recommended starting dose for this group of patients is 5 mg.
Concomitant Therapy:
Rosuvastatin is a substrate for various transport proteins (eg OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when rosuvastatin is taken concomitantly with certain medicinal products that may increase late
Composition
Riglodem 10 mg: Each film-coated tablet contains:
active substance:
Rosuvastatin calcium equivalent to rosuvastatin 10 mg
excipients: microcrystalline cellulose, lactose monohydrate, tribasic calcium phosphate, povidone K25, magnesium stearate; shell composition: hypromellose (E15), polyethylene glycol 400, titanium dioxide.
Riglodem 20 mg: Each film-coated tablet contains:
active substance:
Rosuvastatin calcium equivalent to rosuvastatin 20 mg
excipients: microcrystalline cellulose, lactose monohydrate, tribasic calcium phosphate, povidone K25, magnesium stearate;
shell composition: hypromellose (E15), polyethylene glycol 400, titanium dioxide, iron oxide (red).
Indications for use
Primary hypercholesterolemia (type IIa, including familial heterozygous hypercholesterolemia) or mixed hypercholesterolemia (type IIb) as an adjunct to diet when diet and other non-drug treatments (eg, exercise, weight loss) are inadequate;
- familial homozygous hypercholesterolemia as an adjunct to diet and other cholesterol-lowering therapy (eg, LDL apheresis), or when such therapy is not appropriate for the patient.
- prevention of cardiovascular complications in adult patients with an increased risk of developing atherosclerotic cardiovascular disease as adjuvant therapy.
Mode of application
Before and during therapy with Riglodem, the patient should follow a standard lipid-lowering diet. The dose of the drug should be selected individually depending on the goals of therapy and response to treatment, taking into account current recommendations for target lipid concentrations.
Inside, do not chew or crush the tablet, swallow it whole with water.
May be administered with or without food.
The recommended starting dose for patients starting to take the drug, or for patients transferred from taking other HMG-CoA reductase inhibitors, should be 5 or 10 mg of Riglodem 1 time per day.
When choosing an initial dose, one should be guided by the level of cholesterol and take into account the possible risk of cardiovascular complications, and it is also necessary to evaluate the potential risk of side effects. If necessary, the dose may be increased after 4 weeks of taking the drug. Increase the dose of the drug gradually.
Due to the possible development of side effects at a dose of 40 mg, increasing the dose to a maximum of 40 mg should only be considered in patients with severe hypercholesterolemia and at high risk of cardiovascular disease.
vascular complications (especially in patients with familial hypercholesterolemia), who did not achieve the desired result of therapy when taking a dose of 20 mg. Monitoring of patients receiving the drug at a dose of 40 mg is recommended.
It is not recommended to prescribe a dose of 40 mg to patients who have not previously taken the drug. After 2-4 weeks of therapy and / or with an increase in the dose of Riglodem, monitoring of lipid metabolism is necessary (if necessary, dose adjustment is required).
Prevention of cardiovascular complications in adult patients with an increased risk of developing atherosclerotic cardiovascular disease as adjuvant therapy:
The recommended dose is 20 mg once a day.
Application in children.
In pediatric practice, the drug should be prescribed exclusively by a specialist.
Children and adolescents from 6 to 17 years old (Tanner developmental stage ˂II – V).
Heterozygous familial hypercholesterolemia:
The initial daily dose for children and adolescents with heterozygous familial hypercholesterolemia is 5 mg per day.
For children aged 6 to 9 years, the usual dose range is 5 to 10 mg orally once a day. The safety and efficacy of the drug at a dose of more than 10 mg in the treatment of this population have not been studied.
For children aged 10 to 17 years, the usual dose range is 5-20 mg orally once a day. The safety and efficacy of the drug at a dose of more than 20 mg in the treatment of this population have not been studied.
Increasing the dose is carried out taking into account the individual response and tolerance, according to the recommendations for use in pediatric practice. Before starting therapy with Riglodem, the child should be prescribed a standard low-cholesterol diet, and the diet should be followed during the period of therapy.
Homozygous hereditary hypercholesterolemia:
For children aged 6 to 17 years with homozygous hereditary hypercholesterolemia, the recommended dose is 20 mg once daily.
The recommended starting dose is 5-10 mg, depending on age, body weight and previous use of rosuvastatin. Before starting treatment with Riglodem, children and adolescents should be on a standard cholesterol-lowering diet, which should also be followed during treatment.
Experience with the drug in children under 6 years of age is limited. Therefore, treatment with rosuvastatin in children under 6 years of age is not recommended.
Elderly patients:
Dose adjustment is not required. Patients over 70 years of age are recommended an initial dose of 5 mg.
Patients with renal insufficiency:
In patients with mild or moderate renal insufficiency, dose adjustment is not required, the recommended initial dose of the drug is 5 mg. In patients with moderate renal impairment (creatinine clearance less than 60 ml / min), the use of the drug at a dosage of 40 mg is contraindicated. In patients with severe renal insufficiency (creatinine clearance less than 30 ml / min), the use of the drug Riglodem is contraindicated.
Patients with liver failure:
There is no experience of using the drug in patients with a score above 9 on the Child-Pugh scale.
Race:
In patients of the Mongoloid race, an increased systemic exposure of rosuvastatin was noted. The recommended initial dose for patients of the Mongoloid race is 5 mg. The use of a dose of 40 mg in such patients is contraindicated.
Patients predisposed to myopathy:
The appointment of the drug at a dose of 40 mg is contraindicated in patients predisposed to the development of myopathy.
The recommended starting dose for this group of patients is 5 mg.
Concomitant Therapy:
Rosuvastatin is a substrate for various transport proteins (eg OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when rosuvastatin is taken concomitantly with certain medicinal products that may increase late