Atorvastatin-Darnitsa - the medicine reducing the level of cholesterol and triglycerides in blood serum.

Indications

Prevention of cardiovascular diseases at adults.

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, low level of lipoproteins of the high density (LPVP) or presence of early coronary heart disease in the family anamnesis.:

• 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.

For patients with diabetes of the II type 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, medicine it is shown for:

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

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.

At adult patients.

As addition to a diet to reduce the increased 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 dislipidimiya.

As addition to a diet for treatment of patients with the increased level 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 cases when observance of a diet is insufficiently effective.

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

At children.

As addition to a diet for reduction of level of the general cholesterol, LDL cholesterol and apolipoprotein B at boys and 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 are as follows:

a) LDL cholesterol remains to  of 190 mg/dl (4.91 mmol/l) or;

b) cholesterol of  LDL of 160 mg/dl (4.14 mmol/l) and:

• in the family anamnesis early cardiovascular diseases are available;
• two or more other risk factors of developing cardiovascular diseases are available for the patient of infantile age.

Structure

• active ingredient: atorvastatin;
• 1 tablet contains atorvastatin calcium, in terms of atorvastatin 10 mg;
• other components: calcium a carbonate with povidone, cellulose microcrystalline, lactose monohydrate, sodium lauryl sulfate, krospovidon, magnesium stearate, opadray II 85F white.

Contraindication

• Active disease of a liver which can include permanent increase in levels of hepatic transaminases of an unknown etiology.
• Hypersensitivity to any of components of this medicine.
• Pregnancy.
• feeding Period breast.

Side reactions

Five most widespread undesirable reactions at the patients receiving treatment atorvastatiny who led to phase-out of an atorvastatin and met frequency above group of placebo: myalgia (0.7%), diarrhea (0.5%), nausea (0, 4%), increase in level of alaninaminotranspherase (ALT) (0.4%) and liver enzymes (0.4%).

At the patients receiving treatment atorvastatiny in placebo - controlled researches (n=8755), most often observed such undesirable reactions (frequency of cases of 2% or more and above, than in group of placebo), irrespective of a causal relationship: nasopharyngitis (8, 3%), arthralgia (6.9%), diarrhea (6.8%), extremity pain (6.0%) and infection of urinary tract (5.7%).

Route of administration

Lipidemia and the mixed dislipidemiya

Recommended initial dose of an atorvastatin makes 10 or 20 mg of 1 times a day. For the patients demanding considerable decrease in level of LDL cholesterol (more than 45%), therapy can be begun with a dosage of 40 mg of 1 times a day. Dose range of medicine is ranging from 10 up to 80 mg of 1 times a day. Medicine can be applied a single dose at any time and irrespective of food. The initial and maintenance dose of an atorvastatin 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 it is necessary to analyze levels of lipids within from 2 to 4 weeks and as appropriate to modify a dose.

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

Recommended initial medicament dose makes 10 mg/days; usual range of doses is from 10 to 20 mg orally 1 time a day. Drug doses should be selected individually according to the recommended treatment purpose. It is necessary to carry out correction of a dose with an interval of 4 weeks or more.

Homozygous family hypercholesterolemia

Dose of an atorvastatin for patients with a homozygous family hypercholesterolemia makes from 10 to 80 mg/days Atorvastatin it is necessary to apply as addition to other hypolipidemic methods of treatment (for example, aferez LDL) or if hypolipidemic methods of treatment are inaccessible.

Feature of use

Use during pregnancy or feeding by a breast

Atorvastatin is contraindicated to pregnant women as safety of its use is not established to pregnant women and there is no obvious advantage of intake of lipidosnizhayushchy medicines during pregnancy.

when feeding by a breast.

Safety and efficiency of use of medicine are established to

by

for children from 10 to 17 years with a heterozygous family hypercholesterolemia as addition to a diet for decrease in the general cholesterol, the LDL level and level of apolipoprotein B when after adequate attempt of a dietotherapy are noted:

• LDL cholesterol ≥ 190 mg/dl (4.91 mmol/l) or
• LDL cholesterol ≥ 160 mg/dl (4.14 mmol/l) and:

in the family anamnesis relatives of the first or second degree have a family hypercholesterolemia or early cardiovascular diseases;

• two or more other risk factors of cardiovascular diseases are available.

Indications of an atorvastatin are confirmed to

on the basis of researches:

Placebo-controlled clinical trial lasting 6 months with participation of 187 children after the beginning of periods aged from 10 up to 17 years. The patients receiving treatment atorvastatiny in a dose of 10 mg or 20 mg daily had generally a similar profile of undesirable reactions to it, as at the patients receiving placebo. In this narrow controlled research the significant influence of medicine on growth or puberty at guys or on duration of a menstrual cycle at girls was not revealed.

Three-year open uncontrollable research with participation of 163 children aged from 10 up to 15 years with a heterozygous family hypercholesterolemia for which chose a dose for achievement of target level of LDL cholesterol <130 mg/dl (3.36 mmol/l). Safety and efficiency of use of an atorvastatin at decrease in LDL cholesterol usually correspond to the indicators observed at adult patients despite restriction of the plan of an uncontrollable research.

consultation of girls after the beginning of periods concerning contraception Is necessary for

if it is relevant to the patient.

Long-term efficiency of therapy atorvastatiny, the incidence begun in the childhood for reduction and mortality at adult age, is not established.

Safety and efficiency of therapy atorvastatiny is not established to

for children 10 years with a heterozygous family hypercholesterolemia are younger.

Homozygous family hypercholesterolemia

Clinical performance of an atorvastatin in doses up to 80 mg/days during 1 year was estimated by

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

Ability to influence speed of response at control of motor transport or other mechanisms

Has very insignificant impact on speed of response at control of motor transport or work with other mechanisms.

Overdose

Specific treatment of overdose. At 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 an atorvastatin with proteins of blood plasma it is not necessary to expect considerable strengthening of clearance of medicine by means of a hemodialysis.

to Store

in original packing at a temperature not above 25 °C. To store out of children's reach.