Description overdue on 09/19/2014
- Latin name: Rozucard
- ATC code: C10AA07
- Active substance: Rosuvastatin (Rosuvastatin)
- Manufacturer: Zentiva (Czech Republic)
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications Rozukarda
- Contraindications
- Side effects
- Instructions for use Rozukarda (method and dosage)
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Analogs
- Reviews
- Price, where to buy
Composition
Rosuvastatin - Active substance of the drug. In addition, it contains the following additional components: magnesium stearate, lactose monohydrate, MCC, croscarmellose sodium, colloidal silicon dioxide.
The structure of the film coating contains: iron oxide red dye, hypromellose, titanium dioxide, macrogol 6000, talc.
Product form
Oval tablets coated pink and dark pink, or light pink.
Pharmacological action
The drug is hypolipidemic agent.
Pharmacodynamics and pharmacokinetics
Rozukard belongs to the group statins . It inhibits HMG-CoA reductase - An enzyme which converts HMG-CoA at mevalonate .
Furthermore, this means increases the number of LDL receptors on hepatocytes That increases the rate of catabolism and capture LDL and inhibits synthesis VLDL By reducing the total content VLDL and LDL . The drug reduces the concentration LDL-C . cholesterol, high-density nelipoproteinov . LDL-VLDL . TG . apolipoprotein B . VLDL-TG . total cholesterol And increases the ApoA-1 and HDL-C . In addition it reduces the ratio Ups and ApoA-1 . XC-neLPVP and HDL-C . LDL-C and HDL-C . total cholesterol and HDL-C .
The main action Rozukarda directly proportional to the assigned dose. The therapeutic effect is noticeable after the start of treatment in a week, in a month it becomes a maximum, and then strengthened and made permanent.
The maximum concentration of the main active ingredient in the plasma is established after 5 hours. Absolute bioavailability is 20%. The degree of connection with plasma proteins - about 90%.
With regular use does not change the pharmacokinetics.
Metabolised Rozukard through the liver. It penetrates through the placenta . Main metabolites - N-dismetil and lactone metabolite .
The half-life - about 19 hours, while it does not change if the dosage of the drug increased. Plasma clearance average - 50 l / h. Approximately 90% of the active substance is derived through the intestine intact, the remaining part - through the kidneys.
Gender and age on the pharmacokinetics of Rozukarda no effect. However, it depends on the race. Indians have maximum concentration and average value AUC above about 1, 3-fold, than Caucasians. AUC the people of the Mongoloid race in 2 times more.
Indications Rozukarda
Indications Rozukarda following:
- Primary Hypercholesterolemia or mixed dyslipidemia - A drug used as an adjunct to diet when diet alone is not sufficient food;
- need to slow development atherosclerosis - A drug used as an adjunct to diet as part of a treatment to reduce the level of total cholesterol and LDL into the normal range;
- family homozygous hypercholesterolaemia - A drug used as an adjunct to diet or as a component of lipid-lowering therapy;
- the need to prevent complications in the functioning of the cardiovascular system at an increased risk of atherosclerotic cardiovascular disease - drug is used as part of therapy.
Contraindications
The drug should not be used when:
- hypersensitivity to its components;
- severe kidney disease;
- liver disease in active phase;
- myopathy ;
- pregnancy ;
- Lactation .
Rozukard also contraindicated in women of reproductive age who do not use contraceptive measures.
The dose of 40 mg should not be taken for people with factors that contribute to the development myopathy and rhabdomyolysis , namely:
- impaired kidney function moderate;
- inherited muscle diseases in an individual or family history ;
- alcoholism;
- hypothyroidism ;
- miotoksichnostyu Provoked HMG-CoA reductase or fibrates , at history .
At risk, moreover, patients are Mongoloid races, as well as those who take fibrates . This dosage is contraindicated in situations that can cause an increase in the content of the drug in the blood plasma.
Side effects
Adverse reactions of the drug may be as follows:
- nervous system: headache . asthenic syndrome . dizziness ;
- respiratory system: cough, dyspnea ;
- Musculoskeletal system: myalgia ;
- skin and subcutaneous tissue: peripheral edema . Stevens-Johnson syndrome ;
- laboratory parameters: transient increase in activity serum CK depending on the dosage;
- allergic reactions: itch . hives Rash;
- digestive system: nausea, pain in the abdomen, constipation , Vomiting, diarrhea ;
- endocrine system: type II diabetes ;
- urinary system: proteinuria , Urinary tract infection.
In rare cases, peripheral neuropathy . pancreatitis , Memory loss, hepatitis . jaundice . myopathy . rhabdomyolysis . angioedema . hematuria . transitory increase AST activity and ALT .
Instructions for use Rozukarda (method and dosage)
Pre-course Rozukarda patient must switch to the standard gipolipidemicescoe diet, which must be maintained during the entire treatment. Dosages are determined individually in each case depending on disease and patient.
For those who are appointed Rozukard, instruction on the application reports that it can be used at any time, before or after a meal.
With hypercholesterolemia the initial dose recommended by experts - 5 or 10 mg orally. Instructions for use Rozukarda provides its reception 1 per day. Selecting the starting dose should take into account individual performance cholesterol, the likelihood of adverse reactions, as well as the risk of developing cardiovascular disease. After 4 weeks, it can be changed. At doses of 40 mg requires monitoring and adjustment specialist if necessary.
For the prevention of cardiovascular diseases in the recommended daily dose of 20 mg.
For children over 10 years Familial Hypercholesterolemia initial dosage usually - 5 mg / day. During the treatment it is possible to gradually increase, but not to exceed 20 mg. Titration It made depending on individual tolerance. Before the course of the preparation you need to follow a standard diet to reduce cholesterol in the body. During treatment Rozukardom also required to adhere to the system power.
For patients in the elderly (over 70 years) are typically assigned dosage is 5 mg.
For people with mild or moderate renal impairment at the beginning of the course is prescribed in most cases, 5 mg. During the treatment the dosages can not be higher than 40 mg. When expressed renal dysfunction this medication is contraindicated.
For patients Mongoloid race, and those who are predisposed to myopathy Recommended starting dose is 5 mg. Receiving a dose of 40 mg is strictly contraindicated.
Overdose
When used in high doses of the drug side effects worse.
Assign symptomatic treatment. There should be level control CK and liver. Hemodialysis ineffective.
Cooperation
Cyclosporine combined with its value increases Rozukardom AUC about 7 times. Take more than 5 mg are not recommended.
Gemfibrozil and others lipid-lowering drugs in combination with Rozukardom causes an increase in its maximum concentration and AUC approximately doubled. Increased risk of myopathy . The maximum dose of the combination with Gemfibrozil - 20 mg. When interacting with fibrates the dosage of 40 mg is not allowed, an initial dose of - 5 mg.
The interaction of the drug with Protease inhibitors may increase exposure Rosuvastatin. Not recommended the use of this combination HIV-infected patients.
The combination Erythromycin and reduces Rozukarda AUC the last 20%, and the maximum concentration of - 30%.
In conjunction with the present drug Lopinavir and ritonavir enhances its performance equilibrium AUC and maximum concentration.
Vitamin K antagonists by reaction with Rozukardom cause increased international normalized ratio .
Ezetimibe Simultaneously with rosuvastatin may provoke the appearance of side effects.
Antacids medication with aluminum hydroxide or magnesium reduces the content of the drug in the organism approximately half. So between their reception to take a break, a minimum of 2 hours.
When combined with Rozukarda Oral contraceptives means necessary to monitor the status of patients.
Terms of sale
The drug is sold in pharmacies strictly on prescription.
Storage conditions
Store this medication should be in the original packaging, in a well-protected from moisture and light. The temperature should be 25 degrees.
Shelf life
The drug should be stored no longer than 2 years.
Analogs Rozukarda
- Vasilip
- Roxer
- Rosuvastatin
- Merten
- Crestor
- Torvakard
Analogs Rozukarda sold in pharmacies as follows:
- Klivas ;
- Merten ;
- Rozart ;
- Sandoz Rosuvastatin ;
- Rozulip ;
- Crestor ;
- Roxer ;
- Romazik ;
- Roviks ;
- Fastrong .
All of them are available in tablet form. Price analogues varies depending on the content of the active substance and the amount of platelets in the pack. In general, most of the cost is higher. That's why doctors so often prescribe Rozukarda counterparts.
Reviews Rozukarde
Reviews Rozukarde mostly positive. This tool is often advised by doctors. It is quite affordable, so its purchase is not difficult. Those who already have been treated with this drug, leave reviews about Rozukarde, which reported that the drug helped them maintain normal cholesterol levels and stop the progression of the disease.
Price Rozukarda
Price Rozukarda considered very affordable compared to many peers. The exact cost of the drug depends on the content of the active substance in the tablets. Thus, the price Rozukard 10 mg packaged with 3 plates - about 500 rubles in Russia and 100 in Ukraine hryvnia. And the price Rozukard 20 mg packaged with 3 plates - about 640 rubles in Russia and 150 in Ukraine hryvnia.
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