Название документа

tablets "Krestor" are applied at the following indications:

  • treatment of a hypercholesterolemia:
    • to adults, teenagers and children is more senior than 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 physical exercises, decrease in body weight) is insufficient;
    • at a homozygous family hypercholesterolemia as addition to a diet and other lipidosnizhayushchy remedies (for example an afereza ​​ LDL) or in cases when such treatment is inappropriate;
  • prevention of cardiovascular disturbances: prevention to considerable cardiovascular disturbances at patients to whom, by estimates, the high risk of the first case of cardiovascular disturbance, in addition to correction of other risk factors threatens.

Structure

Active ingredient - rosuvastatin (one tablet, coated, contains 10 mg of rosuvastatin in the form of 10.40 mg of rosuvastatin of calcium).

Excipients: lactose, monohydrate; microcrystalline cellulose; calcium phosphate; krospovidon; magnesium stearate; film cover: lactose, monohydrate; gipromelloza; glycerin triacetate; titan dioxide (E 171), ferrous oxide red (E 172).

Contraindication

  • to patients with hypersensitivity to rosuvastatin or any of medicine excipients;
  • to patients with an active disease of a liver, including steady increases in serumal transaminases of an unknown etiology and any increases in transaminases in blood serum that three times exceed the upper bound of norm (UBN);
  • to patients with a heavy renal failure (clearance of creatinine <30 ml/minute);
  • to patients with a myopathy;
  • to patients who at the same time receive cyclosporine;
  • during pregnancy and feeding by a breast and also to women, reproductive age which do not use appropriate contraceptives.

Route of administration

to the patient should appoint by

Before an initiation of treatment a standard gipokholesterinemichesky diet to which he has to adhere also during treatment. The dose should be selected individually, depending on the purpose of therapy and the response of the patient to treatment, being guided by the recommendations of the current standard managements.

Krestor Medicine can be accepted at any time, irrespective of meal.

Treatment of a hypercholesterolemia

Recommended initial dose makes 5 or 10 mg orally once a day as for patients who did not apply statines earlier, and transferred to medicine on intake of other inhibitor of GMG-KoA-reduktazy. When choosing an initial dose it is necessary to consider cholesterol levels at each certain patient and risk of cardiovascular disturbances in the future and also a likelihood of development of side reactions. If necessary it is possible to raise a dose to the following level in 4 weeks. Considering that against the background of use of medicine in a dose of 40 mg, undesirable reactions arise more often than at smaller doses, finally patients need to titrate a dose to the maximum dose of 40 mg with a heavy hypercholesterolemia and high risk of cardiovascular disturbances (in particular at patients with a family hypercholesterolemia) at which it was not succeeded to achieve the treatment goal at use of a dose of 20 mg and which will be under regular observation. During initiation of intake of medicine in a dose of 40 mg supervision of experts is recommended.

Prevention of cardiovascular events

In a research reduction of risk of cardiovascular events medicine applied in a dose 20 mg a day.

Children by

medicine Use to children only the expert has to carry out

.

is Applied to children and teenagers aged from 10 up to 17 years (boys at a stage of development of the II and above on Tannera and girls at whom periods began less than a year ago).

Initial daily dose for children and teenagers with a heterozygous family hypercholesterolemia makes 5 mg a day. The medicament is usually taken orally in doses from 5 mg to 20 mg once a day.

should Raise a dose according to the individual response of the child to treatment and tolerance of medicine, following recommendations about treatment of children. Before therapy by rosuvastatin children and teenagers should appoint a standard gipokholesterinemichesky diet which patients have to observe also during treatment. Safety and efficiency of medicine in doses more than 20 mg in this population were not investigated.

Experience of treatment of children aged up to 10 years is limited to medicine use a small amount of patients (aged from 8 up to 10 years) with a homozygous family hypercholesterolemia. Thus, the medicament "Krestor" is not recommended to be used to children up to 10 years.

by

Feature of use

Pregnant

Research of influence of Krestor medicine on ability to drive the car and to work with mechanisms was not conducted. However, considering pharmakodinamichesky properties of medicine, it is improbable that Krestor to influence on such ​​ ability. At control of motor transport or work with other mechanisms it is necessary to consider a possibility of dizziness during treatment.

Overdose

is not present

Specific treatment of overdose. In case of overdose of the patient it is necessary to treat symptomatic and in case of need to host the supporting actions. It is necessary to control functions of a liver and the UK levels. The efficiency of a hemodialysis is improbable.

Side effects

Undesirable phenomena which are noted at use of the medicament "Krestor", usually easy and temporary. In controlled clinical trials less than 4% of the patients receiving Krestor left a research because of side reactions.

by

gave the most frequent undesirable reactions to rosuvastatin according to clinical trials and wide experience of postregistration use Below.

Endocrine disorders: frequent (from ≥ 1/100 to <1/10) - diabetes.

from nervous system: frequent (from ≥ 1/100 to <1/10) - a headache, dizziness.

from digestive tract: frequent (from ≥ 1/100 to <1/10) - a constipation, nausea, abdominal pain.

from skeletal muscles and connective tissue: frequent (from ≥ 1/100 to <1/10) - myalgia.

Storage conditions

to Store

at a temperature not above 30 °C, out of children's reach.

Expiration date - 3 years.

Characteristics
Active ingredients Rosuvastatin
Amount of active ingredient 10 mg
Applicant AstraZeneca
Code of automatic telephone exchange C10AA07 Rosuvastatin
Interaction with food It doesn't matter
Light sensitivity Not sensitive
Market status Original
Origin Chemical
Prescription status According to the prescription
Primary packing blister
Producer ASTER OF ZENEKA YUK LIMITED
Quantity in packing 28 tablets (2 blisters on 14 pieces)
Release form tablets for internal use
Route of administration Oral
Sign Import
Storage temperature from 5 °C to 30 °C
Trade name Krestor

Reviews Krestor of the tab. of p/o of 10 mg No. 28

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Krestor of the tab. of p/o of 10 mg No. 28

  • Product Code: 182397
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