Rosart

Rosart is a lipid-lowering drug related to the group of satin (substances that reduce the concentration of "bad" cholesterol and increase the amount of "good").

In addition to therapeutic purposes, the drug is also prescribed as prevention of atherosclerosis, caused by a high content of fat-like compounds. The main task that must be solved with high cholesterol is achievement hypolipidemic effect in a short period of time with the use of a minimum amount drugs.

According to physicians, Rosart is one of the few drugs against atherosclerosis, which are suitable for the above qualities.

Clinical and pharmacological group

Lipid-lowering drug.

Terms of sale from pharmacies

It is possible to buy under the prescription of the doctor.

Price

How much does Rosart cost in pharmacies? The average price is at the level of450 rubles.

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Composition and form of release

The drug Rosart is available in the form of a tablet for oral (oral) administration. They are film-coated, have a round shape, biconvex surface and white (for a dose of 5 mg) or pink (for a dose of 10, 20 and 40 mg) color.

Rosart contains the active ingredientrosuvastatinin the amount of 0, 20 and 40 milligrams, as well as auxiliary substances:

• microcrystalline cellulose;
• crospovidone;
• calcium hydrogen phosphate dihydrate;
• lactose monohydrate;
• magnesium stearate.

The rosacea tablet consists of:

• hypromellose;
• titanium dioxide;
• lactose monohydrate;
• macrogol;
• triacetin.

Tablets are packaged in a blister for 10 pieces. Cardboard pack contains 3 or 9 blisters, as well as instruction on the use of the drug.

pharmachologic effect

The hypolipidemic drug included in the group of statins. The maximum concentration of rosuvastatin in the blood is noted five hours after taking the tablets. The therapeutic effect is manifested a week after the start of use, after two weeks reaches 90 percent of the maximum, after a month it becomes maximum and then remains constant.

Rosuvastatin is absorbed mainly by the liver, where the synthesis of cholesterol is carried out. 90 percent of the dose of the medicine is excreted through the intestine, the remaining 10 percent through the kidneys.

Indications for use

The main medical indication for taking Rosart tablets are the following:

• hypertriglyceridemia (type IV according to Fredrickson) - in the form of a supplement to the diet;
• primary hypercholesterolemia (type IIa by Fredrickson), including heterozygous hereditary hypercholesterolemia, or combined (mixed) hyperlipidemia (type IIb by Fredrickson) - as a supplement to the diet, exercise and decreased body weight;
• homozygous form of hereditary hypercholesterolemia in the absence of sufficient effect from diet and other therapies, aimed at lowering the level of lipid concentration (including LDL-apheresis) or with individual intolerance of such species treatment;
• primary prevention of cardiovascular complications (infarction, stroke, arterial revascularization) in adults without clinical signs of ischemic disease (IHD), but with the prerequisites for its development (age for men over 50 and for women over 60, concentration of C-reactive protein 2 mg / L and higher for presence of at least one of the additional risk factors: arterial hypertension, low cholesterol-HDL, early onset of CHD in the family history, smoking).

In addition, Rosart is prescribed as a supplement to the diet to patients who are shown therapy for lowering the total cholesterol and LDL cholesterol in order to slow the progression atherosclerosis.

Contraindications

Tablets Rosart at a dose of 5, 10 and 20 mg per day should not be taken with:

• liver diseases;
• myopathy;
• disorders of kidney function;
• intolerance to lactose, glucose-galactose malabsorption; deficiency of lactase;
• increased sensitivity to the components of the drug;
• women of reproductive age who do not use effective methods of contraception;
• persons under 18 years.

In a daily dose of 40 mg, the drug is also not recommended for:

• hypothyroidism;
• renal failure;
• drinking alcohol;
• simultaneous reception of fibrates;
• use in patients;
• presence of muscular diseases;
• persons of the Mongoloid race.

Intended use for pregnancy and lactation

The drug Rosart is contraindicated in pregnancy and lactation.

The use of Rosart in women of reproductive age is possible only if reliable methods of contraception are used and if the patient is informed of the possible risk of treatment for the fetus.

Since cholesterol and substances synthesized from cholesterol are important for the development of the fetus, potential risk of inhibiting HMG-CoA reductase exceeds the benefit of the drug during use pregnancy. In the case of diagnosing pregnancy during the treatment with Rosart, the drug should be stopped immediately, and the patients are warned about the potential risk to the fetus.

Data on the allocation of rosuvastatin to breast milk are not available, so when lactation period, taking into account the possibility of undesirable phenomena in infants, it is necessary to resolve the issue of cessation of the breast feeding.

Dosage and route of administration

As indicated in the instructions for use Rosest are taken orally, without chewing or grinding, swallowing whole, with water, regardless of the time of day and food intake.

Before starting therapy with Rosart, the patient should begin to follow the standard lipid-lowering diet and continue to observe it during treatment.

The dose of the drug should be selected individually depending on the indications and therapeutic response, taking into account the current generally accepted recommendations for target lipid concentrations. The recommended initial dose of RosArt for patients starting to take the drug, or for of patients transferred from other HMG-CoA reductase inhibitors is 5 or 10 mg 1 once / day. When choosing the initial dose should be guided by the concentration of cholesterol in the patient and take into account risk of developing cardiovascular complications, and it is also necessary to assess the potential risk of developing side effects reactions. If necessary, after 4 weeks, the dose of the drug may be increased.

In connection with the possible development of side effects when taking a dose of 40 mg compared with lower doses of the drug, the final titration to the maximum dose 40 mg should be given only in patients with severe hypercholesterolemia and a high risk of cardiovascular complications (especially in patients with hereditary hypercholesterolemia) in whom a dose of 20 mg did not achieve the target cholesterol concentration and which would be medical supervision.

It is recommended especially careful monitoring of patients receiving the drug in a dose of 40 mg. After 2-4 weeks of therapy and / or increasing the dose of the drug, control of lipid metabolism parameters is necessary.

1. In elderly patients older than 70 yearsthe recommended initial dose of RosArt is 5 mg, no other dose adjustment is required.
2. In patients with hepatic insufficiencyon the Child-Pugh scale below 7, dose adjustment is not required. In patients with values ​​of 8 and 9 on the Child-Pugh scale, a preliminary assessment of renal function should be performed. Experience with rosuvastatin in patients with hepatic insufficiency above 9 points on the Child-Pugh scale is not available. Rosuvastatin is contraindicated in patients with liver disease in the active phase.
3. With renal insufficiency of mild or moderate severitycorrection of the dose is not required. The initial dose of 5 mg is recommended for patients with moderate renal insufficiency (CC less than 60 ml / min). Patients with renal insufficiency of moderate severity (CK less than 30-60 ml / min) administration of the drug in a dose of 40 mg is contraindicated. Taking Rosalt is contraindicated in any dose to patients with severe renal failure (QC less than 30 mL / min).
4. Known varietiesgenetic polymorphism, which can lead to an increase in the systemic concentration of rosuvastatin. In patients with identified specific polymorphism, lower daily doses of rosuvastatin are recommended.
5. The initial recommended dose forpatients predisposed to the development of myopathy, is 5 mg. The use of the drug in a dose of 40 mg in such patients is contraindicated.
6. In patients of the Mongoloid race, an increase in the systemic concentration of rosuvastatin is possible. The initial recommended dose of the drug for patients of the Mongoloid race is 5 mg. The use of the drug in a dose of 40 mg in such patients is contraindicated.

Combination Therapy

Rosuvastatin is a substrate for various transport proteins (eg, OATP1B1 and BCRP). Increased risk of myopathy, including rhabdomyolysis, while taking rosuvastatin with medicinal drugs that increase the concentration of rosuvastatin in blood plasma due to their interaction with transport proteins. This group of substances include cyclosporine, HIV protease inhibitors, including a combination of ritonavir with atazanavir, lopinavir and / or tipranavir.

If this is possible, a decision should be made on the appointment of alternative therapy and, if necessary, temporarily stop taking rosuvastatin. In the case when simultaneous administration can not be avoided, the possible risk of interaction and the potential benefit of co-treatment should be carefully evaluated.

Side effect

Side effects are rare. The following side effects should be reported to the doctor if they persist or worsen:

• depression;
• pain in the joints;
• cough;
• constipation;
• heartburn;
• dizziness;
• problems with sleep;
• loss of memory or forgetfulness;
• confusion of consciousness.

The following side effects are more serious. If they are present, Rosart should be discontinued and immediately consult a doctor. Such adverse reactions include:

• pain in the right upper abdomen;
• nausea;
• extreme fatigue;
• unusual bleeding or bruising;
• muscle pain or weakness;
• fever;
• chest pain;
• yellowing of the skin or eyes;
• darkening of urine;
• loss of appetite;
• influenza-like symptoms;
• sore throat, chills, or other signs of infection.

If any signs of an allergic reaction develop, you need to contact emergency medical help immediately:

• shortness of breath or swallowing;
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles or legs;
• rash;
• hives;
• itching;
• hoarseness;
• numbness or tingling in the fingers and toes.

Overdose

With a slight excess of the recommended therapeutic dose of Rosart tablets, the pharmacokinetics of rosuvastatin does not change. In case of severe overdosage, gastric lavage, intestinal sorbents intake, as well as symptomatic therapy under medical hospital conditions are performed.

There is no specific antidote.

special instructions

The risk of myopathy, including rhabdomyolysis, increases with simultaneous administration of rosuvastatin with the following medicinal agents: cyclosporin, HIV protease inhibitors, including combinations of ritonavir with atazanavir, tipranavir, and / or lopinavir. Therefore, consideration should be given to the appointment of alternative therapies, and if necessary, the use of rosuvastatin to temporarily discontinue therapy.

When applying Rosarta in a dose of 40 mg, it is necessary to regularly monitor the indicators of kidney function.

When determining the activity of CKC, the presence of factors that could impair the reliability of results, including physical exertion, should be excluded. Patients with a significant increase in the initial activity of CK should be re-examined after 5-7 days. In case of confirmation of a fivefold excess of the activity level of CKK, the use of the drug is contraindicated.

Special care should be taken in appointing Rosarth to patients with risk factors for development myopathy or rhabdomyolysis, carefully assessing the ratio of expected benefits and potential risks from therapy. In this category of patients, clinical observation should be ensured throughout the course of treatment. You can not start taking tablets with the initial activity of CK 5 times the upper limit of the norm.

The doctor should inform the patient of the possible appearance of muscle pains, malaise, fever, muscle weakness or spasms and the need for immediate consultation for health institution. With a significant increase in the activity of CKK or muscle symptoms, therapy should be discontinued. With the disappearance of symptoms and restoration of the activity index of CKK, it is possible to re-administer the drug in smaller doses.

1-2 times a month should monitor the lipid profile and, taking into account its results, adjust the dose of Rosart.

If you have a history of liver disease and alcohol abusers, it is recommended that before the start of therapy and after three months of using the drug, a determination of liver function parameters is recommended. If the activity of liver enzymes in the serum is 3 times higher than the upper limit of the norm, you should lower the dose or stop taking Rosart.

Since combinations of HIV protease inhibitors with ritonavir cause an increase in the systemic level of rosuvastatin, careful consideration should be given to reducing the concentration of lipids in blood, consider a possible increase in the concentration of rosuvastatin in the blood plasma at the beginning of treatment, and during the period of increasing the dose of the drug, to carry out appropriate correction dose.

It is necessary to cancel Rosarta if there is a suspicion of interstitial lung disease, which can be manifested by shortness of breath, unproductive cough, weakness, weight loss, fever.

Interaction with other drugs

Rosartum with simultaneous reception with some medicines can provoke the appearance of undesirable reactions:

1. Admission Rosarta with Cyclosporine - the latter drug stimulates a multiple increase in system exposure of rosuvastatin, therefore patients who are prescribed ciclosporin should take Rosart in a minimal dosage - no more than 5 milligrams in day.
2. Hemofibrozil (Gemfibrozil) - significantly increases the systemic exposure of rosuvastatin. In connection with the observed increased risk of myopathy / rhabdomyolysis, combined therapy of Rosartha and Gemfibrozil should be avoided. The maximum dosage should not exceed 10 milligrams per day.
3. Protease inhibitors - a joint application of Rosarta with certain protease inhibitors in combination with ritonavir has various effects on rosuvastatin, or rather on the effect of the substance on organism. Protease inhibitors in combinations: lopinavir / ritonavir and atazanavir / ritonavir can increase the systemic exposure of rosuvastatin up to three times. For these combinations, the dose of Rosartha should not exceed 10 milligrams once a day.

Reviews

We offer you to get acquainted with the opinions of people who used the drug Rosart:

1. Natalia. I accept rozart the 4th day. There is a significant reduction in pressure and possibly from this and severe headaches, in the evening in the occipital part, a thromium in the front of the head. And as there were pains in a stomach or belly. I take 1 night at a time, cholesterol,.
2. Svetlana. I drink pills rozart the 5th day. I have a significant reduction in pressure and possibly from this and severe headaches, in the evening in the nape of the neck, and in the morning in front of the head. I take 1 tb.Na. night, the level of cholesterol,.
3. Sasha.At the time of starting the "Rosarta cholesterol was, (with the age of 44 years). After a week of taking cholesterol, it dropped to 4. This surprised me, to put it mildly. The doctor said to continue the reception for up to a month. But with further reception worsened overall health, there was pharyngitis, the throat burned with fire, and also a strong cough. Decided to stop taking Rosarta.

Analogues

Structural analogs for the active substance:

• Akorta;
• The Cross;
• Mertenil;
• Rosystark;
• Rosuvastatin;
• Rosewood;
• Rosulip;
• Roxer;
• Tevastor.

Before buying an analogue, consult your doctor.

Shelf life and storage conditions

The shelf life of Rozart tablets is 2 years, they must be stored in intact factory packaging, dark, dry, inaccessible to children at an air temperature not exceeding + 30 ° C.

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