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Розукард

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Розукард

Quick Facts

Property Description
Active ingredient Rosuvastatin Calcium
Form Oral Solid (Tablet/Capsule)
Pharmacological class Statins (HMG-CoA Reductase Inhibitor)
General purpose Lipid-lowering agent
Origin Synthetic

What is Розукард? Classification and Core Composition

Розукард is a specific trade name for a synthetic, single-ingredient, prescription-only pharmaceutical preparation utilized to manage elevated cholesterol and lipid levels in adults. Its active pharmaceutical ingredient is Rosuvastatin, often supplied as Rosuvastatin Calcium, and it belongs to the widely utilized pharmacological class known as Statins.

Rosuvastatin is classified as an HMG-CoA reductase inhibitor, meaning it works by competitively blocking the key enzyme in the liver responsible for the body's natural synthesis of cholesterol. This core mechanism is clinically recognized for its reliable efficacy in reducing lipid production. As a synthetic compound, Розукард is consistently formulated as an oral drug in the solid dosage form of tablets or capsules, intended for convenient administration via the oral route.

Розукард’s Primary Purpose: Managing Blood Lipids

The main purpose of Розукард is to serve as a hypolipidemic agent, reducing harmful fat levels to help mitigate risks associated with cardiovascular health. Statins are a class of medication that helps lower LDL cholesterol and triglycerides.

The drug achieves this vital function by significantly lowering the concentration of undesirable substances like LDL cholesterol (often termed "bad cholesterol") and triglycerides circulating in the bloodstream. By reducing the liver's internal cholesterol synthesis, the drug compels the organ to actively remove more circulating LDL cholesterol. Consequently, Розукард provides a crucial benefit by helping to re-establish a healthier lipid profile, which is critical for individuals requiring active, long-term pharmacological control of hyperlipidemia and related chronic lipid disorders.

Regulatory References

  1. MedlinePlus Statins Overview
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What side effects are possible with Розукард?

Possible Side Effects and Safety Information

This information reflects the adverse reactions and safety statements formally documented in governmental regulatory sources for Rosuvastatin (the active ingredient in Розукард).

Serious Adverse Reactions

Although rare, some side effects are considered serious and clinically significant, including: Rhabdomyolysis (severe muscle tissue breakdown), Myopathy (muscle disease, including myositis), Hepatitis (liver inflammation) and Jaundice (yellowing of the skin/eyes), Pancreatitis, and severe Hypersensitivity Reactions such as angioedema (swelling of the face, tongue, and throat) and severe skin reactions (e.g., SJS/TEN).

Common Adverse Reactions

The following are frequently documented side effects (occurring in ge 1/100 to <1/10 patients):

  • Headache, Dizziness
  • Constipation, Nausea, Abdominal pain
  • Myalgia (muscle pain), Asthenia (weakness)
  • Diabetes mellitus

Safety-Related Restrictions and Contraindications

Regulatory documents specify that this medicine is strictly Contraindicated (must not be used) in patients with the following conditions:

  • Active liver disease or unexplained, persistent elevation of liver enzymes.
  • Severe renal impairment (kidney function).
  • Myopathy (pre-existing muscle disorder).
  • During pregnancy, attempted pregnancy, or breastfeeding.
  • Hypersensitivity to the active substance or any excipients.

Specific caution and sometimes lower starting doses are necessary for certain populations, including those of Asian origin and individuals over 70 years of age.

Safety Monitoring Notes

The medicine's regulatory profile requires monitoring of Liver Function Tests (LFTs) and Creatine Kinase (CK) levels to detect early signs of liver and muscle damage, which are the main systemic safety risks. The 40 mg dose is restricted for use only in patients who have not achieved their treatment goal on a 20 mg dose and are under routine follow-up.

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Overdose and Emergency Response

The official regulatory guidance for Rosuvastatin overdose focuses on the high risk of acute myotoxicity and associated systemic complications. Should overdose be suspected, immediate action is mandated to seek urgent medical attention, which includes contacting emergency services, such as calling 911, or contacting a Poison Control center.

Documented manifestations of toxic exposure are primarily related to the skeletal muscle system and may present as myalgia, unexplained muscle pain or weakness, nausea, and abdominal pain. Regulatory documents specifically warn that overdose carries the risk of progressing to rhabdomyolysis—severe muscle breakdown—and subsequent acute renal failure (kidney damage).

If toxicity is suspected, the medication must be immediately discontinued. Management relies entirely on symptomatic and supportive measures, as no specific antidote is known. Furthermore, hemodialysis does not significantly enhance the drug's clearance from the body. Monitoring of Creatine Kinase (CK) levels and renal function is required during the acute phase due to the risk of severe outcomes. Patients with severe renal impairment and Asian subjects are noted in regulatory information to have increased systemic exposure, which is a factor in potential toxicity.

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Therapeutic Uses of Розукард

What Розукард Treats: Main Uses and Benefits

Розукард is commonly used to help with symptoms related to systemic imbalance associated with abnormal blood fat levels. This therapeutic focus is applied across domains where additional symptomatic support is needed for conditions that are chronic, including primary hypercholesterolemia, mixed dyslipidemia, and certain genetic disorders such as Familial Hypercholesterolemia.

The medication may assist with maintaining functional stability in high-risk individuals who experience symptoms related to systemic imbalance. It is generally used in contexts associated with increased cardiovascular risk for individuals who have multiple risk factors. As part of a comprehensive management plan, it is commonly used to help with managing conditions involving chronic plaque buildup (atherosclerosis).

“This medicine is considered relevant for easing the impact of symptoms related to long-term vascular risk, particularly in high-risk patient contexts.”


Quick Fact: Relief for Dyslipidemia
Розукард contributes to easing the overall symptom load associated with abnormal blood fat levels, which is essential for managing chronic lipid disorders.

Regulatory References

  1. NIH MedlinePlus Drug Information
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Eligibility and Restrictions for Use

Who Can and Cannot Use Розукард? Official Eligibility

Eligibility for Розукард (Rosuvastatin) is strictly defined by regulatory authorities and based on a patient's medical status, age, and physiological condition. The medicine is primarily approved for use in adults and certain children/adolescents (typically aged 6 or older) diagnosed with specific types of familial hypercholesterolemia. Use is not recommended for children under six years of age.

Absolute Contraindications

Розукард must not be used by the following patient groups, as stated in official labeling:

  • Patients with active liver disease or unexplained, persistent elevation of liver enzymes.
  • Women who are pregnant, who may become pregnant, or who are breastfeeding.
  • Patients with an established condition of myopathy (muscle disease).
  • Individuals with known hypersensitivity to rosuvastatin or any component of the formulation.

Condition-Based Restrictions

Restrictions also apply based on organ function and risk factors. Patients with severe renal impairment must use the medicine under strict limitations. The highest 40 mg dose is contraindicated in Asian patients, those with moderate kidney impairment, and individuals with factors predisposing them to muscle toxicity, such as uncontrolled hypothyroidism or a history of hereditary muscular disorders.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents describe specific interaction patterns for Rosuvastatin (Розукард), primarily concerning the risk of increased systemic exposure and potential additive muscle toxicity. The combination of Rosuvastatin and Ciclosporin is formally contraindicated by regulatory authorities due to a significant increase in rosuvastatin plasma concentration, largely mediated by the inhibition of the OATP1B1 and BCRP drug transporters.

Interactions that increase rosuvastatin exposure, such as those with certain antiviral agents (e.g., Lopinavir/Ritonavir) and the lipid-modifying agent Gemfibrozil, require strict dosage limitations as defined in the official prescribing information. Co-administration with other fibrates or high-dose Niacin carries a documented additive risk of skeletal muscle effects, a pharmacodynamic interaction.

Interacting Substance/Condition Officially Documented Constraint
Aluminum/Magnesium Antacids Rosuvastatin must be administered at least 2 hours after the antacid
Coumarin Anticoagulants Requires INR monitoring upon initiation or dose change
Moderate Renal Impairment The 40 mg dose is contraindicated

For Asian patients, increased systemic exposure is a documented population-specific consideration that may require specific restrictions. Furthermore, the official label notes that rosuvastatin clearance is not dependent on CYP3A4 to a clinically significant extent.

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Mechanism of Action

Inhibition of the Liver's Cholesterol Production

The core mechanism of Rosuvastatin is the competitive inhibition of the enzyme 3-hydroxy-3-methylglutaryl-coenzyme A ( HMG-CoA) reductase within hepatocytes. This enzyme functions as the rate-limiting step of the mevalonate pathway, which is necessary for the body's internal cholesterol synthesis. By blocking the enzyme's active site, the drug halts the conversion of HMG-CoA, thereby reducing the concentration of cholesterol inside the liver cell. This physiological deficit is necessary as it initiates a compensatory feedback loop.

Enhanced Clearance of Circulating Lipoproteins

The reduction of internal cholesterol triggers the liver to compensate by increasing the synthesis and display of Low-Density Lipoprotein ( LDL) receptors on its surface. These upregulated receptors actively capture and remove Low-Density Lipoprotein Cholesterol ( LDL-C) particles from the bloodstream. This physiological cascade results in a significant reduction in the concentration of LDL-C in the plasma, which is the system-level consequence of the drug's action.

Modulation of Systemic Vascular Pathways

Beyond its effects on lipid levels, the mechanism also influences vascular pathways. Rosuvastatin engages mechanisms that modulate the blood vessel lining (endothelium) and contribute to the attenuation of certain systemic inflammatory processes. This secondary physiological action modulates pathways related to vascular regulation, which contributes to the overall systemic effect.

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Dosage and Administration Information

Official Administration Guidelines

Розукард (Rosuvastatin) is administered orally as a single, film-coated tablet once daily. The tablet should be swallowed whole and can be taken at any time of day, with or without food. The general dose range for adults is 5 mg to 40 mg once daily.


Dosing and Titration Regimens

The usual starting dose is 10 mg once daily, although a 5 mg starting dose is available and often considered for certain patient groups. The dose is adjusted based on treatment response, with adjustments made after a minimum period of four weeks. The maximum approved dose of 40 mg is reserved only for patients who have not reached their treatment goals on the 20 mg dose, and its initiation is typically recommended under specialist supervision.


Population-Specific Use and Conditions

Specific guidelines for administration exist for certain populations. For patients with severe renal impairment (not on hemodialysis), the recommended starting dose is 5 mg once daily, and the daily dose must not exceed 10 mg. A 5 mg starting dose is also advised for patients of Asian ancestry due to observed increases in rosuvastatin plasma concentrations. Additionally, for older adults (over 70 years), initiation with a 5 mg dose is recommended.

If a dose is missed, the standard procedure is to skip the forgotten dose entirely and resume the normal once-daily schedule with the next planned dose, rather than attempting to take an extra dose. The tablet must also be administered at least two hours before an antacid containing aluminum or magnesium hydroxide.

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Recent Clinical Evidence

Розукард (Rosuvastatin): Recent Clinical Evidence

Розукард contains the active substance rosuvastatin, which belongs to the class of medications known as statins (HMG-CoA reductase inhibitors). Research evidence supports the role of rosuvastatin in lipid modification and the reduction of certain cardiovascular risks in specific patient populations.

Efficacy in Lipid Modification

Clinical trials consistently indicate that rosuvastatin is associated with a substantial reduction in low-density lipoprotein cholesterol (LDL-C), often referred to as "bad" cholesterol, in adults with elevated lipid levels. Studies have shown a dose-related effect, where higher doses generally correlate with greater percentage reductions in LDL-C and total cholesterol. Rosuvastatin has also been observed to be associated with a modest increase in high-density lipoprotein cholesterol (HDL-C), or "good" cholesterol.

Cardiovascular Event Outcomes

Evidence from large-scale clinical trials and meta-analyses supports the use of rosuvastatin for both primary prevention (in individuals without established cardiovascular disease but with risk factors) and secondary prevention (in individuals with established disease, such as coronary artery disease).

  • Secondary Prevention: In patients with established coronary artery disease, rosuvastatin treatment is associated with a reduced risk of major adverse cardiovascular events, including non-fatal heart attack, stroke, and the need for coronary revascularization procedures.
  • Primary Prevention: In studies involving individuals at risk but without clinical signs of cardiovascular disease, rosuvastatin was observed to be associated with a lower incidence of major cardiovascular events.

Comparative Findings

Some studies comparing rosuvastatin to other potent statins, like atorvastatin, in patients with coronary artery disease have shown comparable efficacy concerning the composite outcomes of all-cause death, myocardial infarction, stroke, or revascularization over the duration of the trials. It has been noted that while rosuvastatin may result in lower average LDL-C levels during treatment, certain comparative trials have indicated that its use was associated with a higher incidence of new-onset type 2 diabetes requiring medication and cataract surgery compared to atorvastatin in the studied populations. These findings underscore the importance of individual patient risk assessment.

Key Studies & References

  1. Cardiovascular disease: risk assessment and reduction, including lipid modification - NICE Clinical Guideline NG238 (Major Clinical Guideline)
  2. Rosuvastatin-Based Lipid-Lowering Therapy for the Control of LDL Cholesterol in Patients at High Vascular Risk (Systematic Review/Meta-analysis)
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Frequently Asked Questions (FAQ)

Common questions about Розукард (FAQ)


Q: What is the main difference between Розукард and other similar cholesterol medicines (statins)?

A: Regulatory documents describe Розукард (rosuvastatin) as a statin with high LDL-C reducing efficacy. It is noted that its breakdown in the body is not dependent on the CYP3A4 enzyme to a clinically significant extent, which can sometimes be a factor in drug interactions. Certain clinical trials have shown efficacy comparable to other potent statins in reducing major cardiovascular events, though specific long-term differences in adverse events have been noted in some studies.


Q: Does taking Розукард mean I can stop following a low-cholesterol diet?

A: No. According to the official product information, Розукард is specifically indicated for use as an adjunct to diet for reducing elevated cholesterol levels. It is intended to complement, not replace, a cholesterol-lowering diet.


Q: How long does it typically take for Розукард to start showing its effects on blood tests?

A: Regulatory documents state that a therapeutic response in cholesterol reduction is generally observed within one week of initiating treatment. Most patients usually reach approximately 90% of the maximum response within 2 to 4 weeks.


Q: Is it necessary to take Розукард for the rest of my life, even if my cholesterol levels improve?

A: Official prescribing information describes treatment with rosuvastatin as typically being for the long term. If the use of the medicine is stopped, cholesterol levels generally return to the elevated levels they were at before treatment began.


Q: Is there a known interaction between Розукард and alcohol consumption?

A: Official labeling contains cautionary statements regarding this. There is a documented risk for patients who consume substantial quantities of alcohol, as this practice may increase the potential for developing liver problems (hepatotoxicity) while taking Розукард.


Q: Are there specific foods or drinks, like grapefruit juice, that should be avoided when taking Розукард?

A: Unlike some other medications in the statin class, the metabolism of rosuvastatin is not dependent on the CYP3A4 pathway to a clinically significant extent. Therefore, there is no specific warning in the official labeling regarding the consumption of grapefruit juice.


Q: Can Розукард cause memory loss, forgetfulness, or cognitive side effects?

A: Post-marketing reports associated with the statin class of medicines have included rare instances of cognitive impairment. These effects, such as memory loss, forgetfulness, and confusion, are typically not considered serious and are described as reversible upon stopping treatment.


Q: Can Розукард affect the function of the liver, and what are the symptoms to look out for?

A: Regulatory guidance indicates that Liver Function Tests (LFTs) are required for monitoring, as the medicine can potentially affect liver function. Serious adverse reactions such as hepatitis (liver inflammation) and jaundice (yellowing of the skin/eyes) are documented.


Q: How is Розукард different from a brand name version, assuming the ingredients are the same?

A: Розукард is a specific trade name for the active ingredient rosuvastatin. Regulatory agencies require that all medicines with the same active ingredient, including generic equivalents, meet strict standards for quality, strength, and stability. They must also be demonstrated as bioequivalent to the original product.


Q: What happens if I need to have major surgery while taking Розукард?

A: Official guidelines recommend that treatment with rosuvastatin may need to be temporarily discontinued for a short period before undergoing major surgery or if a patient develops any acute, serious medical condition that predisposes them to potential muscle toxicity.


Q: Does Розукард have a warning about driving or operating machinery?

A: Розукард has been associated with common side effects such as dizziness and headache. Official documents advise that patients should be aware of these potential effects when considering driving or operating complex machinery.


Q: Does taking Розукард make my existing high cholesterol completely 'cured'?

A: No. Розукард is described in official documentation as a medicine used for the long-term management of elevated lipid levels and for reducing cardiovascular risk. It is not classified as a cure for high cholesterol.


Q: Is it true that Розукард helps to slow down the buildup of plaque in the arteries?

A: The drug’s action in lowering LDL cholesterol is understood to contribute to the reduction in the progression of atherosclerosis, which is the buildup of plaque in the arteries. Studies support its use for reducing major adverse cardiovascular events.


Q: Are there any known long-term side effects associated with taking Розукард for many years?

A: Yes, official regulatory documents note specific risks observed in some studies. These include an association with a higher incidence of new-onset type 2 diabetes mellitus and an increased requirement for cataract surgery compared to some other lipid-lowering agents in the populations studied.


Q: Is it possible to take Розукард and still have high cholesterol?

A: Yes, achieving target cholesterol levels is not always guaranteed. The maximum 40 mg dose is specifically reserved for patients who have not reached their desired treatment goal with lower doses of the medicine.


Q: Can Розукард interact with hormone replacement therapy (HRT) or certain contraceptives?

A: Official studies have documented an interaction between rosuvastatin and oral contraceptives. Co-administration can lead to an increase in the plasma levels of the contraceptive hormones, and this interaction is noted in the official prescribing information.


Q: What is the difference between familial hypercholesterolemia and other types of high cholesterol treated by Розукард?

A: Розукард is approved to treat several types of high cholesterol. Familial hypercholesterolemia is a specific form of the condition that is often inherited. Other forms are usually acquired due to environmental or lifestyle factors. The drug works through the same mechanism to lower harmful cholesterol levels in both cases.


Q: What are the signs of a serious muscle problem related to Розукард, such as rhabdomyolysis?

A: Official labeling notes that signs of a serious muscle problem should be reported promptly. These signs include unexplained muscle pain, tenderness, or weakness that is persistent. This is especially important if it is accompanied by systemic symptoms such as fever or a general feeling of malaise.


Q: What are the specific signs of liver problems that require immediate medical attention?

A: Official safety information indicates that signs of potential severe liver problems should be reported promptly. These serious signs can include developing jaundice (yellowing of the skin or eyes), unusual fatigue, or persistent unexplained loss of appetite.


Q: What is the difference between LDL and HDL cholesterol in the context of Розукард treatment?

A: Low-Density Lipoprotein (LDL) cholesterol is often referred to as 'bad' cholesterol because high levels can contribute to cardiovascular risk. High-Density Lipoprotein (HDL) cholesterol is often referred to as 'good' cholesterol because it helps remove excess cholesterol from the body. Розукард works primarily to lower LDL cholesterol.


Q: What happens if I suddenly stop taking Розукард?

A: Official documentation indicates that cholesterol levels generally return to pre-treatment levels if the use of rosuvastatin is discontinued. This is a reason that any change in treatment should be managed under the direction of a healthcare professional.

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How should Розукард be stored and disposed of?

Official Storage and Disposal Requirements

The preservation of Розукард (rosuvastatin calcium) is governed by specific regulatory requirements to maintain its stability and effectiveness.

Storage Condition Official Requirement
Temperature Store at a temperature not exceeding 30 C or at controlled room temperature (15 C to 30 C).
Environmental Keep the medicine in a dry place and protected from light.
Packaging Keep the tablets in their original container with the lid tightly closed to ensure stability and protect from moisture.
Child Safety The product must be stored out of the sight and reach of children.
Stability Do not use the tablets after the expiration date. Specific formulations in containers may have a limited in-use period (e.g., 60 or 90 days) after opening.

Disposal Instructions

All unused or expired Розукард must be discarded in accordance with local requirements. The U.S. Food and Drug Administration (FDA) recommends using a formal drug take-back program as the preferred method for disposal. Rosuvastatin is not on the FDA's list of medicines recommended for immediate flushing down the toilet.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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