Liprimar® tablets are used for the indications indicated below.
Prevention of cardiovascular disease in adults:
for adult patients without clinically significant coronary heart disease, but with several risk factors for the development of coronary heart disease, such as age, smoking, arterial hypertension, low HDL levels or the presence of early coronary heart disease in a family history, "Liprimar®" is indicated for: the risk of myocardial infarction; reduce the risk of stroke; reducing the risk of revascularization procedures and angina pectoris;
for adult patients with type II 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, smoking or arterial hypertension, Liprimar® is indicated for: reducing the risk of myocardial infarction ; reduce the risk of stroke;
for adult patients with clinically expressed ischemic heart disease "Liprimar®" is indicated for: reducing the risk of non-lethal myocardial infarction; reducing the risk of fatal and non-fatal stroke; reducing the risk of revascularization procedures; reducing the risk of hospitalization due to congestive heart failure; reduce 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 in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson types IIa and IIb) ;
as an addition to the diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson type IV);
for the treatment of patients with primary dysbetalipoproteinemia (type III according to the Fredrickson classification) in cases where diet is not effective enough;
to reduce total and LDL cholesterol in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering therapies (eg LDL apheresis) or if such treatments are not available.
Hyperlipidemia (in children): as an adjunct to 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, the test results are as follows: LDL cholesterol remains ≥ 190 mg / dL (4.91 mmol / L) or LDL cholesterol ≥ 160 mg / dL (4.14 mmol / L) and: Family history of early cardiovascular disease or two or more other risk factors for cardiovascular vascular diseases are present in a pediatric patient.
The active ingredient is atorvastatin (one tablet contains atorvastatin calcium equivalent to 10 mg of atorvastatin).
Excipients: calcium carbonate; microcrystalline cellulose; lactose monohydrate; croscarmellose sodium; polysorbate 80; hydroxypropyl cellulose; magnesium stearate; film coating material (hydroxypropyl methylcellulose, macrogol 8000, titanium dioxide (E 171), talc); simethicone emulsion (simethicone, emulsion-forming stearate, thickener, benzoic acid, sorbic acid).
Hyperlipidemia and mixed dyslipidemia
The recommended initial dose of Liprimar® is 10 or 20 mg once a day. For patients who require a significant reduction in LDL cholesterol (more than 45%), therapy can be started with a dosage of 40 mg 1 time per day. The preparation can be taken in a single dose at any time and regardless of food intake. Initial and maintenance doses of the preparation should be selected individually, depending on the purpose of treatment and response. After initiation of treatment and / or after titration of the dose of the preparation, 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 of the preparation is 10 mg / day, the usual dose range is from 10 to 20 mg orally once a day. Doses of the preparation 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 the preparation for patients with homozygous familial hypercholesterolemia ranges from 10 to 80 mg per day. Liprimar® should be used as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if lipid-lowering treatments are not available.
Simultaneous lipid-lowering therapy
Liprimar® can be used with bile acid sequestrants. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be prescribed with caution.
Children
Heterozygous familial hypercholesterolemia. The safety and efficacy of the use of the preparation "Liprimar®" have been established for children from 10 to 17 years old with heterozygous familial hypercholesterolemia as an addition to the diet to lower total cholesterol, LDL cholesterol and apolipoprotein B levels, when, after an adequate attempt at diet therapy, LDL cholesterol is noted ≥ 190 mg / dL (4.91 mmol / L) or LDL cholesterol ≥ 160 mg / dL (4.14 mmol / L) and family history of hypercholesterolemia or early cardiovascular disease in first or second degree relatives or present two or more other risk factors for cardiovascular disease.
Homozygous familial hypercholesterolemia. The clinical efficacy of the preparation in doses up to 80 mg / day for one year was evaluated in an uncontrolled study in patients with homozygous familial hypercholesterolemia, which included 8 children.
Drivers
The preparation has very little effect on the reaction rate when driving vehicles or other mechanisms.
There is no specific treatment for an overdose with Liprimar®. In case of an overdose, the patient should be treated symptomatically and supportive measures should be taken if necessary. Due to the high degree of binding of the preparation to plasma proteins, one should not expect a significant increase in the clearance of the preparation "Liprimar" using hemodialysis.
The five most common adverse reactions in patients treated with Liprimar®, which led to preparation withdrawal and occurred with a frequency higher than in the placebo group, were: myalgia (0.7%), diarrhea (0.5%) , nausea (0.4%), increased levels of alanine aminotransferase (ALT) (0.4%) and liver enzymes (0.4%).
No special storage conditions are required. Keep out of the reach of children.
Shelf life is 3 years.
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