Rozustat – hypolipidemic means.

Indications

Treatment of a hypercholesterolemia

Increased, to teenagers and children aged from 10 years with primary hypercholesterolemia (the IIa type, including with a heterozygous family hypercholesterolemia) or the mixed dislipidemiya (IIb type) as addition to a diet, when observance of a diet and use of other non-medicament means (for example, is insufficient.

At a homozygous family hypercholesterolemia as addition to a diet and other lipidosnizhayushchy remedies (for example, to a LDL aferez) or in cases when such treatment is inadmissible.

Prevention of cardiovascular disturbances

Prevention of considerable cardiovascular disturbances at patients to whom, by estimates, the high risk of the first case of cardiovascular disturbance as addition to correction of other risk factors threatens.

Structure

• active ingredient: rosuvastatin;
• 1 tablet, film coated, contains 10 mg of rosuvastatin (in the form of rosuvastatin calcium);
• other components: microcrystalline cellulose; lactose, monohydrate; calcium hydrophosphate; gipromeloza; kropovedon; magnesium stearate;
• film cover: Opadry Pink 03K540028: gipromeloza, titan dioxide (E 171), triacetin, ferrous oxide (E 172).

Contraindication

• to patients with hypersensitivity to rosuvastatin or any of medicament excipients;
• to patients with a liver disease in an active phase, including an unknown etiology (steady increase in level of transaminases in blood serum and increase in level of any transaminase in serum is more than 3 times higher than the upper bound of norm);
• to patients with a heavy renal failure (clearance of creatinine <30 ml/min.);
• to patients with a myopathy;
• to patients who accept cyclosporine;
• to patients with already available factors of development of miotoksichesky complications;
• during pregnancy or feeding by a breast and also to the women of reproductive age who are not applying appropriate means of contraception;
• infantile age up to 10 years.

Side reactions

from the immune system of reaction of hypersensitivity, including a Quincke's disease.

from an endocrine system – sugar diabet1.2.

from nervous system – a headache, dizziness.

from the digestive tract (DT) – a constipation, nausea, an abdominal pain, pancreatitis, diarrhea.

Route of administration

Before an initiation of treatment a standard holesterinosnizhayushchy diet which should be observed also during treatment. The dose should be selected individually, depending on the purpose of therapy and efficiency of treatment, applying the existing recommendations.

Razustat can be accepted at any time, irrespective of food.

Tablet should not be chewed or split up. To swallow of a tablet entirely, washing down with water.

Treatment of a hypercholesterolemia

Recommended initial dose makes 5 or 10 mg, orally once a day as for the patients who were earlier not applying statine and for the patients who were earlier applying other inhibitors of GMG-KoA-reduktazy. At selection of an initial dose it is necessary to consider the individual level of cholesterol at patients and future cardiovascular risk and also potential risk of development of side reactions (see further). If necessary in 4 weeks the dose can be increased. As at use of a dose of 40 mg the side reactions arise more often than at use of smaller doses, it is necessary to titrate a dose to 40 mg only for patients with a heavy hypercholesterolemia and high cardiovascular risk (including for persons with a family hypercholesterolemia) at which it was not succeeded to achieve desirable result at doses of 20 mg and which have to be under observation. At the beginning of use of a dose of 40 mg the observation of the expert is recommended.

Feature of use

Use during pregnancy or feeding by a breast

Safety of use of Rozustat during pregnancy or feeding by a breast was not studied therefore Razustat of contraindications during pregnancy or feeding by a breast.

for fetation, the potential risk of inhibition of GMG-KoA-reduktazy exceeds possible advantage of use of medicament during pregnancy. If the patient is pregnant during medicament use, treatment should be stopped.

Children

does not recommend Rozustat's use to children up to 10 years.

only within one year. After 52 weeks of use of the studied medicament of any influence on growth, body weight, BMI or sexual development it is not revealed.

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

did not conduct a research on definition of influence of rosuvastatin on ability to drive the car and other mechanical means. If to proceed from pharmakodinamichesky properties of rosuvastatin, then the probability of such influence is insignificant. However when driving and other means it is necessary to consider that during treatment there can be dizziness.

Overdose

Specific treatment at overdose. Symptomatic treatment. In case of need to take the supporting measures. It is necessary to check the KFK levels and to carry out the test for functionality of a liver. The advantage of carrying out a hemodialysis is improbable.

to Store

at a temperature not above 25 °C in original packing.

to Store

out of children's reach.