Lipodemin 20
Cardiology

Lipodemin 20

Lipodemin 20

Lipodemin 20 tablets belong to the groups of drugs that lower serum cholesterol and triglycerides. Recommended for the prevention of cardiovascular disease in adults, with hyperlipidemia in adults and children. Read more about the drug, features of use and interaction with other drugs in the instructions.

Information

Indications for use (instruction): Lipodemin 20

Adult cardiovascular disease prevention

For adult patients without a clinically pronounced coronary heart disease, but with several risk factors for coronary heart disease, such as age, smoking, arterial hypertension, low HDL or the presence of an early family history of coronary heart disease, Lipodemin is indicated for:

  • reduce the risk of myocardial infarction;
  • reduce the risk of stroke;
  • reducing the risk of revascularization and angina pectoris.

For adult patients with type II diabetes mellitus and without clinically pronounced coronary heart disease, but with several risk factors for developing coronary heart disease, such as retinopathy, albuminuria, smoking or arterial hypertension, Lipodemin is indicated for:

  • reduce the risk of myocardial infarction;
  • reduce the risk of stroke.

For adult patients with clinically severe coronary heart disease, Lipodemin is indicated for:

  • reduce the risk of non-lethal myocardial infarction;
  • reduce the risk of fatal and non-lethal stroke;
  • reduce the risk of revascularization procedures;
  • reduce the risk of hospitalization due to congestive heart failure;
  • reduce the risk of angina pectoris.

Hyperlipidemia

Adult patients

  1. As an addition to the diet, to reduce elevated levels of total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides, as well as to increase HDL cholesterol in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (types IIa and IIx according to Fred classification) .
  2. As an addition to the diet for the treatment of patients with elevated serum triglycerides (type IV according to the classification of Fredrickson).
  3. For the treatment of patients with primary dysbetalipoproteinemia (type III according to the classification of Fredrickson), in cases where dieting is not effective enough.
  4. To reduce total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis), or if such treatments are not available.

Children

As an addition to a diet to reduce levels of total cholesterol, LDL cholesterol and apolipoprotein B in children aged 10 to 17 years with heterozygous familial hypercholesterolemia, if after appropriate diet therapy the results of the tests are as follows:

a) LDL cholesterol remains ³ 190 mg / dL (4.91 mmol / L) or

b) LDL cholesterol ³ 160 mg / dl (4.14 mmol / l) and:

  • a family history of early cardiovascular disease or
  • two or more other risk factors for developing cardiovascular disease are present in a pediatric patient.

How to use

Hyperlipidemia and mixed dyslipidemia

The recommended initial dose of Lipodemin is 10 or 20 mg once a day. For patients who require a significant reduction in LDL cholesterol (by more than 45%), therapy can be started with a dosage of 40 mg once a day. The dosage range of the drug Lipodemin is in the range from 10 to 80 mg once a day. The drug can be taken in a single dose at any time and regardless of food intake. Initial and maintenance doses of Lipodemin should be selected individually depending on the purpose of treatment and response. After the start of treatment and / or after titration of a dose of Lipodemin, lipid levels should be analyzed over a period of 2 to 4 weeks and the dose should be adjusted accordingly.

Heterozygous familial hypercholesterolemia in pediatric patients (aged 10 to 17 years)

The recommended initial dose of Lipodemin is 10 mg / day, the usual dose range is from 10 to 20 mg orally 1 time per day. Doses of the drug should be selected individually in accordance with the recommended goal of treatment. Dose adjustment should be carried out at intervals of 4 weeks or more.

Homozygous familial hypercholesterolemia

The dose of Lipodemin for patients with homozygous familial hypercholesterolemia is from 10 to 80 mg per day. Lipodemin should be used as an adjunct to other lipid-lowering methods of treatment (for example, LDL apheresis), or if lipid-lowering methods of treatment are not available.

Concomitant lipid-lowering therapy

Lipodemin can be used with bile acid sequestrants. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution.

Dosage for patients with impaired renal function

Kidney disease does not affect either the concentration in the blood plasma or the decrease in LDL cholesterol when using Lipodemin; therefore, dose adjustment for patients with impaired renal function is not required.

Dosage for patients taking cyclosporine, clarithromycin, itraconazole or certain protease inhibitors

Lipodemin treatment should be avoided in patients who take cyclosporine or HIV protease inhibitors (tipranavir + ritonavir) or hepatitis C virus protease inhibitor (telaprevir). Lipodemin should be used with caution in patients with HIV who are taking lopinavir + ritonavir and used in the most appropriate dose. In patients taking clarithromycin, itraconazole, or in HIV patients who are taking saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir or fosamprenavir + ritonavir in combination, the therapeutic dose of lipodemin should be limited to 20 mg, and it is recommended that adequate clinical examinations be carried out to ensure that the use of the smallest necessary dose of Lipodemin. In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C virus protease inhibitor boceprevir, treatment with Lipodemin should be limited to a dose of 40 mg, and appropriate clinical examinations are recommended to ensure that the smallest necessary dose of Lipodemin is used.

Children

Heterozygous familial hypercholesterolemia

The safety and effectiveness of the drug Lipodemin established for children from 10 to 17 years with heterozygous familial hypercholesterolemia as an addition to a diet to reduce total cholesterol, LDL and apolipoprotein B levels, when, after an adequate attempt at diet therapy, the following are noted:

  • LDL cholesterol ≥ 190 mg/dL (4.91 mmol/L) or
  • LDL cholesterol ≥ 160 mg/dL (4.14 mmol/L) and
  • family history has familial cholesterinemia or early cardiovascular disease in relatives of the first or second degree, or
  • there are two or more other risk factors for cardiovascular disease.

Indications of atorvastatin confirmed on the basis of studies:

  1. A placebo-controlled clinical trial lasting 6 months involving 187 boys and girls aged 10 to 17 years after the onset of menstruation. Patients treated with atorvastatin at a dose of 10 mg or 20 mg daily had a generally shaped profile of adverse reactions in patients receiving placebo. In this narrow controlled study, no significant effect of the drug on the growth or puberty of boys or on the duration of the menstrual cycle in girls was revealed.
  2. A three-year open, uncontrolled study involving 163 children aged 10 to 15 years with heterozygous familial hypercholesterolemia, for whom a dose was selected to achieve a target LDL cholesterol level of <130 mg/dL (3.36 mmol/L). The safety and effectiveness of therapy with Lipodemin has not been established for children under 10 years of age with heterozygous familial hypercholesterolemia.

Homozygous familial hypercholesterolemia

The clinical efficacy of the drug in doses up to 80 mg/day for 1 year was evaluated in an uncontrolled study in patients with homozygous

Contraindications

  • active liver disease, which may include a steady increase in the activity of hepatic transaminases of unknown etiology;
  • hypersensitivity to any of the drug components;
  • pregnancy;
  • lactation period.

Composition

Active substance: atorvastatin;

1 tablet contains atorvastatin calcium 20.72 mg, which corresponds to 20 mg of atorvastatin.

Excipients: mannitol, microcrystalline cellulose, crospovidone, anhydrous sodium carbonate, povidone, methionine, magnesium stearate.

Shell: mixture for film coating Opadry White 03F28446 (hypromellose, titanium dioxide (E 171), macrogol), talc.

Release form

Packaging. 10 tablets in a blister, 3 blisters in a cardboard bundle.

Dosage form. Film-coated tablets.

Basic physical and chemical properties: white elliptical tablets with a biconvex surface, coated with an embossment of "20" and "A" on the other hand.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C out of the reach of children.

Manufacturer

Actavis Ltd, BLB 016, Industrial Zone Bublebel, Zeytun, ZTN3000, Malta.

Sanitary and hygienic conclusion

No. 464 dated 22/02/2019.

Registration Certificate No. UA/13501/01/02.

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