Lipodemin 40
Cardiology

Lipodemin 40

Lipodemin 40

Lipodemin 40 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 40

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 (heterozygous familial and non-familial) and mixed dyslipidemia (type IIa and IIb according to the classification of Fredrickson)

The recommended initial dose of atorvastatin is 10 or 20 mg once a day. Apply Lipodemin in the appropriate dosage form. 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 10–17 years)

The recommended initial dose of Lipodemin is 10 mg/day; the maximum recommended dose is 20 mg/day (doses in excess of 20 mg have not been studied in this group of patients). 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 therapies (e.g. LDL apheresis) or if lipid-lowering therapies 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 plasma concentrations or lower 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 patients with HIV 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 recommended 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

The safety and efficacy of the drug for patients aged 1017 with heterozygous familial hypercholesterolemia were investigated in a controlled clinical study lasting 6 months in adolescent boys and girls after the onset of menstruation. Patients treated with Lipodemin had a generally shaped profile of adverse reactions, such as those treated with placebo. Infectious diseases were those undesirable phenomena that were most often observed in both groups, regardless of the cause-effect relationship. In this group of patients, doses greater than 20 mg were not studied. 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. Adolescent girls should be advised on acceptable contraceptive methods during the treatment period of lipodemin.

Lipodemin has not been studied in controlled clinical trials that included adolescent patients or patients under the age of 10 years.

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 familial hypercholesterolemia, which included 8 pediatric patients.

Contraindications

  • Active liver disease, which may include a sustained increase in hepatic transaminase activity of unknown etiology.
  • Hypersensitivity to any of the components of the drug.

Composition

Діюча речовина: atorvastatin;

1 таблетка містить аторвастатину кальцію 41,44 мг, що відповідає 40 мг аторвастатину.

Допоміжні речовини: Манітол, целюлоза мікрокристалічна, кросповідон, натрію карбонат безводний, повідон, метіонін, магнію стеарат.

Оболонка: суміш для плівкового покриття Opadry White 03F28446 (гіпромелоза, титану діоксид (Е 171), макрогол), тальк.

Release form

Packaging. 10 tablets in a blister, 3 blisters in a pack.

Dosage form. Film-coated tablets.

Basic physical and chemical properties: white elliptical tablets with a biconvex surface, coated with an embossed “40” and “A” on the other side.

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. 320 dated 6/04/2016.

Registration Certificate No. UA/13501/01/03.

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