Rosacard

Rosukard is a medicinal product whose main effect is to reduce the concentration of certain fractions of lipids (mainly low-density lipoproteins) in tissues and fluid media of the body.

The drug belongs to the group of satin (this is a hypolipidemic group of medicines, the mechanism of action is directed to suppress the enzyme of HMG-CoA reductase).

The main active substance - rosuvastatin, also in tablets contain auxiliary substances - microcrystalline cellulose (dietary fiber), milk sugar, croscarmellose sodium, magnesium stearate and pyrogenic silicon dioxide.

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 Rosukard cost in pharmacies? The average price is at the level of400 rubles.

Composition and form of release

The drug is available in the form of a tablet for oral administration (oral administration), coated with a film coat. They have a pink color, an oblong shape and a biconvex surface. The main active component of the tablets is rosuvastatin, its content in one tablet is 10, 20 and 40 mg.

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It also includes auxiliary substances, which include:

Hypromellose.
Microcrystalline cellulose.
Talc.
Colloidal silicon dioxide.
Macrogol 6000.
Magnesium stearate.
Titanium dioxide.
Lactose monohydrate.
Crosscarmellose sodium.

Tablets Rosacard 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

Rosacard belongs to the group of statins. It inhibits HMG-CoA reductase, an enzyme that converts HMG-CoA to mevalonate.

In addition, this drug increases the number of LDL receptors on hepatocytes, which increases the intensity of catabolism and the capture of LDL and causes inhibition of VLDL synthesis, reducing the total content of VLDL and LDL. The drug reduces the concentration of LDL-C, HDL-cholesterol, high-density cholesterol, X-VLDL, TG, apolipoprotein B, TG-VLDL, total Xc, and also increases the content of ApoA-1 and X-HDL. In addition, it reduces the ratio of ApoB to ApoA-1, Xc-non-HDL and Xc-HDL, Xc-LDL and Xc-HDL, total Xc and Xc-HDL.

The main effect of the Rosicard is directly proportional to the prescribed dosage. The therapeutic effect after the beginning of treatment is noticeable in a week, about a month later it becomes maximum, and then becomes stronger and becomes permanent.

The maximum concentration of the main active substance in the plasma is established after 5 hours. Absolute bioavailability is 20%. The degree of connection with blood plasma proteins is about 90%.

With regular use, the pharmacokinetics do not change.

Rosacard is metabolized through the liver. Well penetrates the placental barrier. The main metabolites are N-dysmethyl and lactone metabolites.

The half-life is approximately 19 hours, but it does not change if the dosage of the drug is increased. Plasma clearance of an average of 50 l / h. Approximately 90% of the active substance is excreted intestine unchanged, the rest - through the kidneys.

Sex and age on the pharmacokinetics of Rosicard are not influenced. However, it depends on race. In Indians, the maximum concentration and the average value of AUC are approximately 1.3 times higher than in the representatives of the Caucasoid race. AUC in people of the Mongoloid race is 2 times larger.

Indications for use

The use of Rosemary is indicated in the following diseases:

Hereditary homozygous hypercholesterolemia.
Lipoprotein lipase deficiency, which was formed against the defectiveness of the enzyme and activator of apo-protein CII. This condition often occurs in diabetes mellitus.
Primary heterozygous (hereditary) hypercholesterolemia according to Fredrickson. In addition to drug therapy, the patient is recommended a low-carbohydrate diet and special physical training to reduce body weight.
As inhibition of lipid metabolism and accompanying deposition of cholesterol on the inner walls of blood vessels. Therapy with Rosacarp reduces Xs and Xc-LDL.

The drug is widely recommended for the prevention of cardiovascular diseases (myocardial infarction, stroke, angina pectoris, persistent arterial hypertension). Rosemary also helps patients who have undergone arterial revascularization. Tablets are not prescribed if the patient has symptoms of acute ischemia.

Contraindications

For tablets 10 and 20 mg:

patients who are predisposed to the development of myotoxic complications;
simultaneous administration of cyclosporine;
joint application with HIV protease inhibitors;
women of reproductive age who do not use adequate methods of contraception;
pregnancy;
lactation period (breastfeeding);
liver disease in the active phase, or a steady increase in the activity of hepatic transaminases in the serum (more than 3 times as compared with IGN) of an unknown genesis;
hepatic failure (severity from 7 to 9 on the Child-Pugh scale);
increase in the concentration of CK in the blood more than 5 times compared with VGN;
hereditary diseases such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption (due to the presence of lactose in the composition);
severe renal dysfunction (KK less than 30 ml / min);
myopathy;
age under 18 years (effectiveness and safety not established);
hypersensitivity to the components of the drug.

For tablets 40 mg (supplement to contra-indications for tablets 10 and 20 mg). The presence of the following risk factors for the development of myopathy / rhabdomyolysis:

conditions that may lead to an increase in the plasma concentration of rosuvastatin;
myotoxicity against the background of the use of other inhibitors of HMG-CoA reductase or fibrates in the anamnesis;
hypothyroidism;
renal failure of moderate severity (CK 30-60 ml / min);
excessive use of alcohol;
simultaneous reception of fibrates.

Carefully:

For tablets 10 and 20 mg:

With liver diseases in history; sepsis; arterial hypotension; extensive surgical interventions; injuries; heavy metabolic, endocrine or electrolyte violations; uncontrolled convulsions; with mild and moderate renal insufficiency; hypothyroidism; when using other inhibitors of HMG-CoA reductase or fibrates; history of muscle toxicity; hereditary muscle diseases in the anamnesis; with simultaneous appointment with fibrates; states under which the increased concentration of rosuvastatin in blood plasma; in patients over the age of 65; in patients of the Mongoloid race; at excessive use of alcohol.

For tablets 40 mg:

With renal insufficiency of mild degree (SC more than 60 ml / min); liver diseases in anamnesis; sepsis; arterial hypotension; extensive surgical interventions; injuries; severe metabolic, endocrine or electrolyte disorders; uncontrolled convulsions; in patients over the age of 65 years.

Intended use for pregnancy and lactation

Rosacard is contraindicated in pregnancy and lactation.

The use of the drug 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.

Dosage and route of administration

As indicated in the instructions for use Rosewood taken internally. Tablets should be swallowed whole, without chewing and grinding, with water, at any time of the day, regardless of food intake. Before starting therapy with the drug, 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 the drug Rosukard for patients starting to take the drug, or for patients, translated from the administration of other inhibitors of HMG-CoA reductase, is 5 or 10 mg 1 time / day. If you need to take the drug Rosukard in a dose of 5 mg, you should divide the tablet 10 mg into two parts according to the risk.
When choosing the initial dose should be guided by the content of cholesterol in the patient and take into account the risk of developing cardiovascular complications, as well as the potential risk of side effects. If necessary, after 4 weeks, the dose of the drug may be increased.
In connection with the possible development of side effects, the final titration to a maximum dose of 40 mg should be performed only in patients with severe hypercholesterolemia and high risk cardiovascular complications (especially in patients with hereditary hypercholesterolemia) who did not achieve the target cholesterol concentration when taking the drug at a dose of 20 mg. Such patients should be under medical supervision. It is recommended especially careful monitoring of patients receiving the drug in a dose of 40 mg.

Do not administer a dose of 40 mg to patients who have not previously consulted a doctor. After 2-4 weeks of therapy and / or with an increase in the dose of Rosukard, it is necessary to monitor the lipid metabolism (if necessary, dose adjustment is required).

In case of violations of kidney function

In patients with severe renal insufficiency (KK less than 30 ml / min), the use of the drug Rosukard is contraindicated.

In patients with moderate-grade renal failure (CK 30-60 ml / min), the use of the drug Rosukard in a dose of 40 mg / day is contraindicated.

In patients with mild renal insufficiency, dose adjustment is not required; the recommended initial dose of the drug Rosukard - 5 mg / day.

With violations of liver function

The drug is contraindicated in patients with liver disease in the active phase.

With caution should prescribe the drug for liver disease in history.

Side effect

The frequency of side effects when using Rosicard depends on the dose. As a rule, the side effects are insignificant and pass independently. During treatment with the drug, there was an increase in the concentration of bilirubin, glucose, as well as the activity of alkaline phosphatase and gamma-glutamyltransferase.

Urinary system: often - urinary tract infections, proteinuria, decreasing during treatment and not related to kidney disease; very rarely - hematuria;
Genital organs and mammary gland: very rarely - gynecomastia;
Endocrine system: often - type 2 diabetes mellitus;
Skin and subcutaneous tissue: frequency unknown - Stevens-Johnson syndrome;
Hemopoietic system: rarely - thrombocytopenia;
Digestive system: often - abdominal pain, nausea, constipation; infrequently - vomiting; rarely - pancreatitis; frequency unknown - diarrhea;
Respiratory system: frequency unknown - dyspnoea, cough;
Liver and biliary tract: very rarely - jaundice, hepatitis;
Musculoskeletal system: often - myalgia; rarely - rhabdomyolysis, myopathy; very rarely - tendonitis (sometimes with a rupture of tendons), arthralgia; frequency unknown - immuno-mediated necrotizing myopathy;
Mental disorders: the frequency is unknown - depressive disorder;
Nervous system: often - dizziness, headache; very rarely - memory loss, peripheral neuropathy; frequency unknown - nightmarish dreams, insomnia and other sleep disorders;
Laboratory indicators: infrequently - increased plasma concentrations of glycosylated hemoglobin, increased serum creatine phosphokinase activity (depends on the dose and passes after the drug is discontinued); rarely - transient increase in alanine aminotransferase and aspartate aminotransferase;
Allergic reactions: infrequently - hives, itching, rashes on the skin; rarely - reactions of hypersensitivity, including angioedema;
Other reactions: often - asthenic syndrome; frequency unknown - peripheral edema.

When using some statins, the following undesirable effects were also noted: single cases of interstitial lung disease (with prolonged treatment), erectile dysfunction and type 2 diabetes mellitus (the frequency of its development depended on the presence or absence of risk factors).

Overdose

With the simultaneous administration of several daily doses, the pharmacokinetic parameters of rosuvastatin do not change.

In the event of an overdose of the drug, the following measures are recommended: to carry out symptomatic therapy to maintain the functions of life important organs and systems, as there is no specific treatment; periodically monitor the liver function and the activity of CK. Hemodialysis is ineffective.

special instructions

During therapy, especially with dose adjustment, it is necessary to monitor the lipid profile every 2-4 weeks and, if necessary, change the dose of Rosacard.

Before the appointment of the drug and three months after the start of treatment it is recommended to determine the indicators of liver function.

When applying Rosukarda in a dose of 40 mg should monitor the performance of kidneys.

In case of sudden appearance of muscle pains, spasms or muscle weakness, you should immediately consult a doctor.

It is necessary to establish observation and carry out regular monitoring of biochemical parameters in patients at risk for developing diabetes mellitus (body mass index more than 30 kg / m2, fasting glucose concentration is 5.6-6.9 mmol / L, history of arterial hypertension, hypertriglyceridemia).

Patients who take Rosacard should be careful when driving vehicles and controlling mechanisms, as during the treatment, dizziness may develop.

Interaction with other drugs

With the combined use of Rosacard with certain substances / preparations, development of such effects (AUC - total plasma concentration of the substance, Cmax is the maximum concentration of the substance in the blood, INR is the international normalized ratio):

antacids containing aluminum / magnesium hydroxide: decreased plasma concentration of rosuvastatin (to reduce the severity this interaction is recommended to use antacids about 2 hours after taking Rosukard);
cyclosporine: the action of rosuvastatin is increased (due to slowing of its excretion, increase in AUC and Cmax) with a constant concentration of cyclosporine;
erythromycin: reduced action of rosuvastatin (due to increased intestinal motility, AUC and Cmax decrease);
antagonists of vitamin K: at the beginning of the use of Rosicard and with increasing doses, MHO increases, with the withdrawal of treatment and a decrease in dose - decreases (MHO monitoring recommended);
oral contraceptive drugs: increases the AUC of ethinyl estradiol and norgestrel (this interaction should be considered when selection of the dose, it should also take into account the likelihood of a similar effect in hormone replacement therapy);
gemfibrozil: the effect of rosuvastatin is increased (AUC and Cmax are increased 2-fold);
HIV protease inhibitors: the effect of rosuvastatin is significantly enhanced (a combined use is not recommended).

Reviews

We offer you to familiarize yourself with the reviews of people using the drug Rosukard:

Natalia. I drank a month Rosukard, first started headaches (which I never had) seizures, now permanent, I am saved only by spasmolytic drugs, sleep only with sleeping pills and nightmares every night. The doctor advises not to stop drinking, but I most likely will refuse the drug. they say there are more modern means of cholesterol.
Liuba. There is not a single drug that would have been without pimples! Statins must be taken necessarily, if you want to live... They do not give cholesterol to be deposited on the walls of blood vessels. You just need to pick up the dose and follow the liver tests... I've been drinking for 3 years. Cholesterol was almost 7, and now 4, 5. Be healthy!
Ksenia. Rosicard is a good drug. The doctor appointed the grandmother for prevention. The drug showed the effect after about the first month of use. In our case it is important that it can be taken with other medicines. The state of health improved and, most importantly, there were no side effects. We did not notice any shortcomings.