Tablets "Torvakard ^® " are applied by Christal at indications which are provided below.

Prevention to cardiovascular diseases

For adult patients without clinically apparent coronary heart disease, but with several risk factors of developing coronary heart disease, such as age, smoking, arterial hypertension, LPVP low level or presence of early coronary heart disease in the family anamnesis, "Torvakard ^® " is shown to Christal for:

• reduction of risk of developing of a myocardial infarction;
• reduction of risk of developing of a stroke;
• reduction of risk of holding procedures of revascularization and stenocardia.

and without clinically apparent coronary heart disease, but with several risk factors of developing coronary heart disease, such as retinopathy, albuminuria, smoking or arterial hypertension, medicament "Torvakard ^® " is shown to Christal by

For patients with diabetes of the II type for:

• reduction of risk of developing of a myocardial infarction;
• reduction of risk of developing of a stroke.

"Torvakard ^® " is shown to Christal by

For patients with clinically apparent coronary heart disease for:

• reduction of risk of developing of a non-lethal myocardial infarction;
• reduction of risk of developing of a lethal and non-lethal stroke;
• reduction of risk of holding procedures of revascularization;
• reduction of risk of hospitalization in connection with stagnant heart failure;
• reduction of risk of developing of stenocardia.

Lipidemia

As addition to a diet for reduction of increase in level of the general cholesterol, LDL cholesterol, apolipoprotein B and triglycerides and also for increase in level of LPVP cholesterol at patients with primary hypercholesterolemia (heterozygous family and single) and the mixed dislipidemiya (the IIa and IIb types on Fredrikson's classification).

As addition to a diet for treatment of patients with the increased levels of triglycerides in blood serum (type IV on Fredrikson's classification).

For treatment of patients with primary disbetalipoproteinemiya (type III on Fredrikson's classification) in case observance of a diet is insufficiently effective.

For reduction of the general cholesterol and LDL cholesterol at patients with a homozygous family hypercholesterolemia as addition to other hypolipidemic methods of treatment (for example an afereza ​​ LDL) or if such methods of treatment are inaccessible.

As addition to a diet for reduction of levels of the general cholesterol, LDL cholesterol and apolipoprotein B at boys and at girls after the beginning of periods aged from 10 up to 17 years with a heterozygous family hypercholesterolemia, if after the corresponding dietotherapy results of analyses such: LDL cholesterol remains ≥ 190 mg/dl or LDL cholesterol ≥ 160 mg/dl and in the family anamnesis there are early cardiovascular diseases or two or more other risk factors of developing cardiovascular diseases are present at the patient of children's age.

Structure

Active ingredient - atorvastatin (in the form of an atorvastatin of calcium of trihydrate). One tablet supports an atorvastatin of 10 mg (it is equivalent to a calcium atorvastatin to a trigidrata of 10.823 mg).

Excipients: calcium a carbonate, cellulose microcrystalline, lactoses monogirat, the hydroxypropyl cellulose low-substituted, K12 povidone, silicon dioxide colloidal anhydrous, magnesium stearate; film cover: gipromelloza, polyethyleneglycol 6000, titan dioxide (E 171), talc, ferrous oxide yellow (E 172), lactoses monohydrate.

Contraindication

• an active disease of a liver which can include steady increase in activity of hepatic transaminases of an unknown etiology;
• hypersensitivity to any of components of this medicine;
• pregnancy and period of feeding by a breast;
• reproductive age of the patient if contraceptive means are not applied.

Route of administration

Lipidemia (heterozygous family and single) and the mixed dislipidemiya (the IIa and IIb type on Fredrikson's classification)

Recommended initial dose of medicament makes 10 or 20 mg of 1 times a day. For patients who demand considerable decrease in level of LDL cholesterol (more than for 45%) the therapy can be begun with a dosage of 40 mg of 1 times a day. The dosed medicament range "Torvakard ^® Christal" is ranging from 10 to 80 mg of 1 times a day. The medicament can be taken a single dose in any hours and irrespective of meal. Initial and maintenance doses "Torvakard ^® Christal" should be selected individually depending on the purpose of treatment and the answer. After an initiation of treatment and/or after titration of a dose of medicament it is necessary to analyze levels of lipids during the period from 2nd to 4 weeks and as appropriate to modify a dose.

Heterozygous family hypercholesterolemia at patients of children's age (10-17 years)

Recommended initial dose of medicament "Torvakard ^® Christal" makes 10 mg/days; the maximum recommended dose - 20 mg/days (the doses exceeding 20 mg in this group of patients were not investigated). Doses of medicament should be selected individually, for treatment. It is necessary to carry out correction of a dose with an interval of 4 weeks or more.

Homozygous family hypercholesterolemia

a medicament Dose "Torvakard ^® Christal" for patients with a homozygous family hypercholesterolemia makes from 10 to 80 mg a day. Drug should be used as addition to other hypolipidemic methods of treatment (for example an afereza ​​ LDL) or if hypolipidemic methods of treatment are inaccessible.

Simultaneous hypolipidemic therapy

"Torvakard ^® Christal" can be applied with sekvestrant of bile acids. The combination of inhibitors of GMG-KoA-reduktazy (statines) and fibrat should be used in general with care.

Children

Safety and efficiency of medicament for patients at the age of 10-17 years with a heterozygous family hypercholesterolemia was investigated by

Feature of use

in controlled clinical trial lasting 6 months at teenage boys and girls after the beginning of periods. The patients receiving treatment atorvastatiny had in general a similar profile of side reactions such, as at patients who received placebo. Infectious diseases were those side reactions which were most often observed in both groups irrespective of assessment of relationship of cause and effect. In this group of patients doses more than 20 mg were not investigated. In this narrow controlled research the significant influence of medicament on growth or puberty of boys or on duration of a menstrual cycle at girls was not revealed. Teenage girls should be consulted rather acceptable methods of contraception during the treatment period atorvastatiny.

Atorvastatin not of an issledovaa in controlled clinical trials which included patients of teenage age or patients aged up to 10 years.

Clinical performance of medicament in doses to 80 mg/days within 1 year was estimated by

in an uncontrollable research at patients with a homozygous family hypercholesterolemia which included 8 patients of children's age.

Drivers

Drug carries out very insignificant influence on speed of response at control of motor transport or work with other mechanisms.

Overdose

is not present

Specific treatment of overdose of an atorvastatin. In case of overdose of the patient it is necessary to treat symptomatic and if necessary to take the supporting measures. Because of high extent of linking of medicament with proteins of plasma it is not necessary to expect increase in clearance of an atorvastatin by means of a hemodialysis.

Side effects

Clinical side reactions arising at 2% of patients and more who received treatment by any dose of an atorvastatin, and with a frequency, above, than placebo, irrespective of a causal relationship: nasopharyngitis, arthralgia, diarrhea, extremity pain, infection of urinary tract, dyspepsia, nausea, musculoskeletal pains, muscular spasms, myalgia, insomnia, pharyngolaryngeal pain.

Storage conditions

to Store

out of children's reach. Does not demand special storage conditions.

Expiration date - 2 years.