Atorvastatin (atorvastatin) Ananta coated tablets 10 mg. №30

Atorvastatin (atorvastatin) Ananta coated tablets 10 mg. №30

$12.00

Manufacturer: India

Atorvastatin 10 is used for the prevention of cardiovascular disease, as well as an adjunct to diet to reduce elevated levels of total cholesterol.

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Description

Ingredients

active ingredient: atorvastatin;

1 tablet contains atorvastatin calcium in terms of atorvastatin 10 mg;

excipients: lactose monohydrate; cellulose microcrystalline; magnesium stearate; croscarmellose sodium; corn starch; hydroxypropyl cellulose; hydroxypropyl methylcellulose; polyethylene glycol; titanium dioxide (E 171).

Dosage form

Film-coated tablets.

Basic physical and chemical properties: white or almost white round biconvex film-coated tablets.

Pharmacotherapeutic group

Lipid-lowering agents, multicomponent. HMG CoA reductase inhibitors. ATX code C10A A05.

Pharmacodynamics

Atorvastatin 10 is a synthetic lipid-lowering drug. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme that catalyzes the conversion of HMG-CoA to mevalonate, the initial and limiting step in cholesterol biosynthesis.

Atorvastatin is a selective competitive inhibitor of HMG-CoA reductase, an enzyme that determines the rate of conversion of 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol.

In animal models, atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting hepatic HMG-CoA reductase and cholesterol synthesis and by increasing hepatic LDL receptors on cell surfaces to enhance LDL uptake and catabolism; atorvastatin also reduces the production of LDL and the number of these particles.

Atorvastatin, like some of its metabolites, is pharmacologically active in humans. The main site of action of atorvastatin is the liver, which plays a major role in cholesterol synthesis and LDL clearance. The dose of the drug, in contrast to the systemic concentration of the drug, better correlates with a decrease in LDL cholesterol. Individual dose selection should be carried out depending on the therapeutic response.

Indications

Preventing cardiovascular disease in adults

For adult patients without symptomatic coronary heart disease, but with several risk factors for coronary heart disease, such as age, smoking, hypertension, low HDL, or a family history of early coronary heart disease, Atorvastatin 10 is indicated for:

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

For adult patients with type II diabetes mellitus and without symptomatic coronary heart disease, but with several risk factors for coronary heart disease, such as retinopathy, albuminuria, smoking or arterial hypertension, Atorvastatin 10 is indicated for:

  • reducing the risk of myocardial infarction
  • reducing the risk of stroke.

For adult patients with clinically severe coronary heart disease, Atorvastatin 10 is indicated for:

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

Hyperlipidemia

In adult patients

  • As an adjunct to diet to reduce elevated levels of total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides, and to increase HDL cholesterol levels in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson classification types IIa and IIb) .
  • As an adjunct to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson type IV).
  • For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson type III), in cases where dietary compliance is not effective enough.
  • To reduce total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering therapies (eg LDL apheresis), or when such treatments are not available.

In children

  • As an adjunct to a diet to reduce total cholesterol, LDL cholesterol, and apolipoprotein B in children aged 10 to 17 years with heterozygous familial hypercholesterolemia, if, after appropriate dietary therapy, test results are:
  • LDL cholesterol remains ³ 190 mg/dL (4.91 mmol/L) or
  • LDL cholesterol ³ 160 mg/dL (4.41 mmol/L) and:
  • Family history of early cardiovascular disease or
  • Two or more other risk factors for cardiovascular disease are present in a pediatric patient.

Contraindications

Active liver disease, which may include a persistent increase in liver transaminases of unknown etiology.

Hypersensitivity to any of the components of Atorvastatin 10.

Pregnancy period.

breastfeeding period.

Dosage and administration

Hyperlipidemia and mixed dyslipidemia

The recommended initial dose of the drug is 10 or 20 mg 1 time per day. For patients who require a significant reduction in LDL cholesterol (greater than 45%), therapy may be initiated at a dosage of 40 mg once daily. The dosing range for atorvastatin is 10 to 80 mg once daily. The drug can be taken as a single dose at any time and regardless of food intake. Initial and maintenance doses of the drug should be selected individually, depending on the purpose of treatment and response. After the start of treatment and / or after dose titration, lipid levels should be analyzed over a period of 2 to 4 weeks and the dose adjusted accordingly.

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

The recommended starting dose is 10 mg/day; the usual dose range is 10 to 20 mg orally once a day. Doses of the drug should be selected individually, for the purpose of treatment. Dose adjustments should be made at intervals of 4 weeks or more.

Homozygous familial hypercholesterolemia

The dose of Atorvastatin 10 in patients with homozygous familial hypercholesterolemia is 10 to 80 mg per day. The drug should be used as an adjunct to other lipid-lowering therapies (eg, LDL apheresis) or if lipid-lowering therapies are not available.

Simultaneous lipid-lowering therapy

Atorvastatin 10 can be used with bile acid sequestrants. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be prescribed with caution.

Dosing for patients with impaired renal function

Kidney disease does not affect either plasma concentrations or lowering LDL cholesterol when using the drug, therefore, dose adjustment of the drug for patients with impaired renal function is not required.

Dosing for patients taking ciclosporin, clarithromycin, itraconazole, or certain protease inhibitors

Treatment should be avoided in patients taking cyclosporine or HIV protease inhibitors (tipranavir + ritonavir) or an inhibitor of hepatitis C virus protease (telaprevir). Atorvastatin 10 should be used with caution in HIV patients taking lopinavir + ritonavir and used at the most appropriate dose. In patients taking clarithromycin, itraconazole, or patients with HIV who are taking combinations of saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir, or fosamprenavir + ritonavir, the therapeutic dose of atorvastatin should be limited to 20 mg, and appropriate clinical evaluations should be performed to ensure that the lowest required dose is used drug. Patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir.

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