Liprimar

Liprimar – hypolipidemic medicine.

Form of release and structure

Liprimar release in the form of tablets, film coated: white, elliptic, on a break – white color a kernel; with an engraving on two parties depending on a dosage – "10" and "PD 155" / "20" and "PD 156" / "40" and "PD 157" / "80" and "PD 158" (on 10 and 20 mg – on 10 pieces in blisters, on 3 and 10 blisters in a cardboard pack; on 7 pieces in blisters, on 2 blisters in a cardboard pack; on 40 and 80 mg – on 10 pieces in blisters, on 10 blisters in a cardboard pack; on 7 pieces in blisters, on 2 or 4 blisters in a cardboard pack).

Is a part of 1 tablet:

• Active ingredient: аторвастатин – 10, 20, 40 or 80 mg (in the form of calcic salt);
• Auxiliary components: calcium carbonate – 33/66/132/264 mg, microcrystallic cellulose – 60/120/240/480 mg, monohydrate of lactose – 32,8/65,61/131,22/262,44 mg, croscarmellose sodium – 9/18/36/72 mg, polysorbate 80 – 0,6/1,2/2,4/4,8 mg, a hypro rod – 3/6/12/24 mg, magnesium stearate – 0,75/1,5/3/6 mg;
• Film cover: Opadry white YS-1-7040 (a gipromelloza – 66,12%, polyethyleneglycol – 18,9%, titanium dioxide – 13,08%, talc – 1,9%) – 4,47/8,94/17,88/35,76 mg, an emulsion of a simetikon (симетикон – 30%, stearin emulsifier – 0,075%, sorbic acid, water) – 0,03/0,06/0,12/0,24 mg, candellila wax – 0,08/0,16/0,32/0 mg.

Indications to use

• Primary hypercholesterolemia, including a heterozygous single and family hypercholesterolemia (on Fredrikson's classification – the IIa type);
• The mixed (combined) lipidemia (on Fredrikson's classification – the IIa and IIb types);
• Disbetalipoproteinemiya (on Fredrikson's classification – type III) (as addition to a diet);
• The endogenous family gipertriglitseridemiya (on Fredrikson's classification – type IV) showing resistance to a diet;
• Family homozygous hypercholesterolemia at insufficient efficiency of a diet and other not pharmacological therapeutic methods;
• Cardiovascular complications at the patients without clinical signs of coronary heart disease but having several risk factors of its emergence including arterial hypertension, age are more senior than 55 years, nicotine addiction, low concentration of Hs-LPVP (cholesterol of lipoproteids of high density) in a blood plasma, a diabetes mellitus, genetic predisposition, including against the background of a dislipidemiya (for primary prevention);
• Cardiovascular complications at patients with coronary heart disease for reduction of total rate of mortality, a stroke, a myocardial infarction, repeated hospitalization concerning stenocardia and need for revascularization (for secondary prevention).

Contraindications

Absolute:

• Active diseases of a liver or increase in serumal activity of transaminases (it is more than by 3 times in comparison with the upper bound of norm) not clear etiology;
• Age up to 18 years (because of insufficiency of clinical data on safety and Liprimar's efficiency for this age group of patients);
• Pregnancy and period of a lactation;
• Hypersensitivity to drug components.

Relative (drug it is necessary to appoint with care):

• Alcohol abuse;
• Instructions in the anamnesis on a liver disease.

During therapy women of reproductive age need to use adequate methods of contraception.

Route of administration and dosage

Before Liprimar's use it is necessary to try to achieve control of a hypercholesterolemia by means of a diet, exercise stresses and a degrowth of a body from patients with obesity, and also therapy of the main disease.

The patient at purpose of drug should recommend observance of a standard gipokholesterinemichesky diet during all course.

Liprimar accept inside, once a day, regardless of meal and time of day.

Depending on the initial maintenance of Hs-LPNP, the purpose of treatment and individual reaction the dose can vary from 10 mg to 80 mg (as much as possible).

At the beginning of therapy and/or during increase in a dose each 2-4 weeks it is necessary to control the maintenance of lipids in plasma and, according to it, to carry out dose adjustment.

For most of patients the daily dose of Liprimar at the combined (mixed) lipidemia and primary hypercholesterolemia makes 10 mg. As a rule, therapeutic action is shown for 14 days, reaching a maximum within a month. At long therapy the effect remains.

At a homozygous family hypercholesterolemia Liprimar appoint 80 mg in a daily dose.

The patient with a liver failure the dose of drug is reduced under constant control of activity of aspartate aminotransferase and alaninaminotranspherase.

Functional disturbances of kidneys in a blood plasma or extent of reduction of maintenance of Hs-LPNP do not exert impact on concentration of an atorvastatin therefore dose adjustment is not required to such patients.

At co-administration with cyclosporine the maximum dose of Liprimar makes 10 mg.

Side effects

As a rule, Liprimar is well had, the arising disturbances have passing and easy character.

During therapy development of the following side effects is possible (≥1% – often; ≤1% – infrequently):

• Central nervous system: often – a headache, sleeplessness, an asthenic syndrome; infrequently – a peripheral neuropathy, dizziness, an indisposition, paresthesias, amnesia, a hypesthesia;
• Alimentary system: often – a lock, dyspepsia, nausea, an abdominal pain, diarrhea, a meteorism; infrequently – anorexia, vomiting, pancreatitis, hepatitis, cholestatic jaundice;
• Skeletal and muscular system: often – a mialgiya; infrequently – a myopathy, a dorsodynia, myotonia, arthralgias, a miositis, рабдомиолиз;
• System of a hemopoiesis: infrequently – thrombocytopenia;
• Metabolism: infrequently – a hyperglycemia, a hypoglycemia, increase in level of a serumal kreatinfosfokinaza;
• Allergic reactions: infrequently – a toxic epidermal necrolysis (Lyell's disease), skin rash, a small tortoiseshell, an itch, violent rash, anaphylactic reactions, a mnogoformny exudative erythema (including Stephens-Johnson's syndrome);
• Others: infrequently – increased fatigue, peripheral hypostases, impotence, increase in body weight, a sonitus, a stethalgia, a secondary renal failure, an alopecia.

Special instructions

After Liprimar's use it can be noted moderate increase in serumal activity of alaninaminotranspherase and aspartate aminotransferase, permanent increase in serumal level of hepatic transaminases (without development of jaundice or other clinical manifestations). At reduction of a dose, drug withdrawal (temporary or full) activity of hepatic transaminases usually is returned to initial level. In most cases patients can continue therapy in a reduced dose without any clinical effects.

Indicators of function of a liver need to be controlled prior to treatment, in 6 and 12 weeks after the beginning of use of Liprimar or after increase in a dose, and also throughout all course of therapy.

Drug is cancelled at the expressed increase in activity of a kreatinfosfokinaza, in the presence of the assumed or confirmed myopathy. At Liprimar's appointment along with immunodepressants, fibrata, erythromycin, antifungal drugs (derivatives of azoles) or niacin in hypolipidemic doses it is necessary to consider that at the same time the probability of development of a myopathy increases. Regular observation of a condition of patients is necessary for detection of weakness or muscle pains, in particular within the first months of therapy and during the periods of increase in doses of any drug. In need of carrying out a combination therapy it is necessary to consider the possibility of use of the specified medicines in lower initial and maintenance doses.

At Liprimar's use exceptional cases of emergence of a rabdomioliz with the acute renal failure caused by a myoglobinuria are described. At emergence of signs of a possible myopathy or existence of risk factors of emergence of a renal failure against the background of a rabdomioliz (for example, at a heavy acute infection, arterial hypotension, injuries, metabolic, endocrine and electrolytic disturbances and uncontrollable spasms, carrying out extensive surgical intervention) therapy is recommended to be cancelled completely or to interrupt temporarily.

At emergence of inexplicable weakness or muscle pains, in particular, if they are followed by fever or an indisposition, it is necessary to consult with the specialist.

Medicinal interaction

At simultaneous use of Liprimar with some drugs there can be following effects:

• Cyclosporine, fibrata, erythromycin, кларитромицин, antifungal drugs (derivatives of azoles) and niacin in hypolipidemic doses: increase in risk of development of a myopathy;
• CYP3A4 isoenzyme inhibitors: increase in concentration of an atorvastatin in a blood plasma;
• OATP1B1 inhibitors (for example, cyclosporine): increase in bioavailability of an atorvastatin;
• Erythromycin, кларитромицин, CYP3A4 inhibitors, diltiazem, grapefruit juice: increase in concentration of an atorvastatin in a blood plasma;
• Itrakonazol: increase in AUC value (total concentration of substance in a blood plasma) an atorvastatina;
• CYP3A4 cytochrome isoenzyme inductors: decrease in concentration of an atorvastatin in a blood plasma;
• Kolestipol: decrease in concentration of an atorvastatin in plasma, however hypolipidemic effect of a combination of drugs surpasses that each of them separately;
• Digoxin: increase in its concentration at Liprimar's reception in high doses (control of a condition of patients is necessary);
• Oral contraceptives with the maintenance of Norethisteronum and ethinylestradiol: increase in AUC of these substances.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 25 °C.

Period of validity – 3 years.