$69.00
Manufacturer: Slovenia
Atoris (atorvastatin) coated tablets 10 mg is a medication used to treat high cholesterol and reduce the risk of heart disease.
Description
Ingredients
active substance: 1 film-coated tablet contains 10 mg of atorvastatin in the form of calcium atorvastatin;
excipients: povidone, sodium lauryl sulfate, calcium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate;
shell: talc, polyvinyl alcohol, macrogol 3000, titanium dioxide (E 171).
Medicinal form
Film-coated tablets.
Main physicochemical properties : white, round, slightly convex, film-coated tablets.
Pharmacotherapeutic group
Hypolipidemic agents. HMG-CoA reductase inhibitors. Atorvastatin. ATX code C10A A05.
Pharmacodynamics
The drug contains the active substance atorvastatin. Atorvastatin is a selective competitive inhibitor of MMC-CoA reductase, an enzyme that determines the rate of conversion of 3-hydroxy-3-methyl-glutaryl-coenzyme A into mevalonate, which is a precursor of sterols, in particular cholesterol. Triglycerides and cholesterol in the liver are incorporated into very low-density lipoprotein (VLDL) molecules, enter the blood plasma and are transported to peripheral tissues. Low-density lipoprotein (LDL) is formed from LDL and is catabolized mainly by interaction with high-affinity LDL receptors (LDL-receptors).
Atorvastatin reduces the concentration of cholesterol in the blood plasma and lipoprotein in the blood serum by inhibiting HMC-CoA reductase, and subsequently – cholesterol biosynthesis in the liver, and also increases the number of hepatic LDL receptors on the cell surface, which leads to increased uptake and catabolism of LDL.
Atorvastatin reduces the formation of LDL and the number of LDL particles. Atorvastatin causes a pronounced and sustained increase in the activity of LDL receptors in combination with favorable changes in the quality of circulating LDL particles. Atorvastatin effectively lowers LDL cholesterol (LDL-C) in patients with homozygous familial hypercholesterolemia, a group that has not always responded to lipid-lowering therapy.
In addition to the effect on plasma lipids, atorvastatin has other effects that enhance its antiatherosclerotic effect. It suppresses the synthesis of isoprenoids – substances that act as growth factors on the proliferation of vascular smooth muscle cells, reduces plasma viscosity and the activity of some coagulation and aggregation factors. Thanks to this action, it improves hemodynamics and contributes to the normalization of blood coagulation processes. In addition, HMG-CoA reductase inhibitors affect the metabolism of macrophages and thus suppress their activation, which reduces the risk of rupture of atherosclerotic plaques.
Atorvastatin has been shown to reduce total cholesterol (30–46%), LDL-C (41–61%), apolipoprotein B (34–50%), and triglycerides (14–33%), causing variable increases in HDL-C and apolipoprotein And in the course of a study in which the dose dependence of its effect was studied. These results are consistent with data on patients with heterozygous familial hypercholesterolemia, nonfamilial forms of hypercholesterolemia, and mixed hyperlipidemia, including patients with non-insulin-dependent diabetes mellitus.
Lowering levels of total cholesterol, LDL-C, and apolipoprotein B have been shown to reduce the risk of cardiovascular complications and cardiovascular mortality.
Indications
Prevention of cardiovascular diseases
In adult patients without clinically evident coronary heart disease (CHD), but with several risk factors for CHD, such as advanced age, smoking, hypertension, low HDL levels, or a family history of early CHD, the drug is indicated for:
- reducing the risk of myocardial infarction;
- reducing the risk of stroke;
- reducing the risk of angina pectoris and the need for myocardial revascularization procedures.
In patients with type 2 diabetes mellitus and without clinically pronounced coronary heart disease, but with several risk factors for the development of coronary heart disease, such as retinopathy, albuminuria, tobacco smoking or arterial hypertension, the drug is indicated for:
- reducing the risk of myocardial infarction;
- reducing the risk of stroke.
For patients with clinically pronounced coronary heart disease, the drug is indicated for:
- reducing the risk of non-fatal myocardial infarction;
- reducing the risk of fatal and non-fatal stroke;
- reducing the risk of the need for myocardial revascularization procedures;
- reducing the risk of hospitalization due to congestive heart failure;
- reducing the risk of angina pectoris.
Hyperlipidemia
- Primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (type IIa and IIb according to the Fredrickson classification). As a dietary supplement to reduce elevated levels of total cholesterol (CHD), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B and triglycerides, and to increase high-density lipoprotein cholesterol (HDL-C).
- Hypertriglyceridemia (type IV according to the Fredrickson classification). As an adjunct to the diet for the treatment of patients with elevated serum triglyceride levels.
- Primary dysbetalipoproteinemia (type III according to the Fredrickson classification). For the treatment of patients in the event that adherence to the diet is not effective enough.
- Homozygous familial hypercholesterolemia. To reduce total cholesterol and LDL-C as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or when such treatments are not available.
- Heterozygous familial hypercholesterolemia in pediatric patients (aged 10–17 years). As an adjunct to diet to reduce CHD, LDL-C, and apolipoprotein B levels in adolescent boys and postmenstrual girls aged 10 to 17 years, if, after appropriate dietary therapy, the test results are as follows:
a) LDL cholesterol remains ≥ 190 mg/dl (³ 4.91 mmol/l) or
b) LDL cholesterol ≥ 160 mg/dl (³ 4.14 mmol/l) and:
- in the family history there are early cardiovascular diseases or
- two or more other risk factors for the development of cardiovascular diseases are present in the pediatric patient.
Contraindications
- Hypersensitivity to any ingredient of the drug.
- Liver diseases in the acute phase or persistent increase (of unknown genesis) in the levels of transaminases in blood serum by 3 times or more.
- The drug is contraindicated for pregnant women, women who are breastfeeding, and women of reproductive age who do not use appropriate methods of contraception.
Dosage and Administration
Dosage
Before starting treatment with the drug Atoris®, the level of hypercholesterolemia should be determined and compliance with an appropriate diet, physical activity, weight loss in obese patients and treatment of other major medical problems of patients should be monitored. When taking Atoris®, the patient must follow a standard diet that lowers cholesterol.
Hyperlipidemia and mixed dyslipidemia
The recommended starting dose of atorvastatin is 10 mg or 20 mg once a day. For patients who require a significant reduction in LDL cholesterol (more than 45%), therapy can be initiated at a dosage of 40 mg once daily.
The dosage range of the drug is from 10 mg to 80 mg once a day. The drug can be taken in a single dose at any time and regardless of meals. Initial and maintenance doses of the drug are selected individually, depending on the level of LDL-C, the goal of treatment and response. After starting treatment and/or after dose titration, lipid levels should be monitored for 2–4 weeks and the dose adjusted accordingly.
Heterozygous familial hypercholesterolemia in pediatric patients (aged 10 to 17 years)
The recommended starting dose of atorvastatin is 10 mg/day, the usual dose range is 10 mg to 20 mg orally once daily. Doses of the drug should be selected individually in accordance with the recommended goal of treatment. Therapeutic response appears within 2–4 weeks and is maintained during long-term therapy. Dose adjustments should be made at intervals of 4 weeks or more.
Homozygous familial hypercholesterolemia
The dose of atorvastatin for patients with homozygous familial hypercholesterolemia ranges from 10 mg to 80 mg per day. Atorvastatin should be used as an adjunct to other lipid-lowering treatments (eg LDL apheresis) or when lipid-lowering treatments are not available.
Simultaneous hypolipidemic therapy
Atoris® can be taken with bile acid sequestrants. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution.
Impaired kidney function
Kidney disease does not affect either the concentration in the blood plasma or the decrease in the level of LDL cholesterol when using the drug; therefore, adjustment of the dose of the drug for patients with impaired renal function is not required.
Liver failure
Atoris® should be used with caution in patients with impaired liver function. Atoris® is contraindicated in patients with liver disease in the acute phase.
Use in combination with other medicines
Treatment with the drug should be avoided in patients taking cyclosporine or HIV protease inhibitors (tipranavir + ritonavir), or hepatitis C virus protease inhibitor (telaprevir). It should be used with caution in patients with HIV taking lopinavir + ritonavir and used at the lowest necessary dose. For patients taking clarithromycin, itraconazole, or for HIV patients taking combinations of saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir or fosamprenavir + ritonavir, the therapeutic dose of the drug should be limited to a dose of 20 mg, and appropriate clinical examinations are recommended to ensure use of the lowest effective dose of the drug. For patients taking HIV protease inhibitor nelfinavir or hepatitis C virus protease inhibitor boceprevir, drug treatment should be limited to a dose of 40 mg,
Elderly patients
For patients over 70 years of age, when using the recommended doses of atorvastatin, the effectiveness and safety of therapy should be evaluated taking into account the presence of other factors predisposing to the development of rhabdomyolysis.
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