Кливас

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Medically reviewed

Rosario Oropesa

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.

Overview of Кливас

Quick Facts: Rosuvastatin

Property Description
Active ingredient Rosuvastatin calcium
Form Oral Tablet
Pharmacological class Statin (HMG-CoA Reductase Inhibitor)
Common purpose Modification of blood lipid levels
Origin Synthetic compound

What Type of Medicine is Кливас (Rosuvastatin)?

Кливас is a synthetic prescription medicine whose active compound is Rosuvastatin calcium. It belongs to the therapeutic class of HMG-CoA Reductase Inhibitors, commonly referred to as Statins. This classification defines the drug's core function: selectively and competitively inhibiting the enzyme that controls a critical step in the liver's internal synthesis of cholesterol.

Rosuvastatin is clinically recognized for being a high-potency compound within the Statin group. Its structure is unique, featuring a sulfonyl functional group and being highly hydrophilic, which is thought to increase its targeted uptake by liver cells compared to other members of this class. The drug is supplied as an Oral Tablet and is intended for simple oral administration as a single-ingredient product.


The General Purpose of This Statin Drug

The general purpose of this medication is to help patients effectively manage and correct hyperlipidemia, which involves elevated levels of blood fats like cholesterol and triglycerides. By inhibiting cholesterol production, the drug significantly lowers circulating levels of LDL-C (low-density lipoprotein cholesterol, or "bad cholesterol").

The primary benefit of this action is its role in cardiovascular disease prevention. The primary use of this HMG-CoA reductase inhibitor is to reduce lipid levels in adults and certain pediatric patients. This medication is an established tool for modifying a patient's lipid profile to reduce the long-term risk factors associated with the accumulation of cholesterol.

What side effects are possible with Кливас?

Possible side effects and safety information

The official safety profile for rosuvastatin (Кливас) is structured by government regulatory bodies, classifying potential adverse reactions based on their frequency and the physiological systems affected. These classifications establish the documented risk profile of the medicine without providing clinical advice.

Documented Adverse Reactions

The frequency framework defines adverse reactions across several categories. Common side effects, occurring in at least 1/100 patients, may include headache, muscle pain (myalgia), general weakness (asthenia), nausea, abdominal pain, and constipation. The common category also includes the documentation of new-onset diabetes mellitus.

Less frequent reactions, classified as Rare, include serious events such as myopathy (muscle disease) and rhabdomyolysis (severe muscle breakdown). Rare events also include pancreatitis, increased hepatic transaminases, and hypersensitivity reactions, such as angioedema. Events such as jaundice (hepatitis) and peripheral nerve damage (polyneuropathy) are classified as Very Rare.

Safety Constraints and Special Populations

Official labeling highlights several safety constraints. The medicine is contraindicated in patients with known hypersensitivity to rosuvastatin, those with active liver disease (including unexplained persistent elevations in liver enzymes), and women who are pregnant or breastfeeding.

Regulatory documents also identify specific populations and conditions where the risk profile may be altered. Advanced age (over 65 years) and renal impairment are documented as predisposing risk factors for myopathy and rhabdomyolysis. Furthermore, studies have noted increased systemic exposure to rosuvastatin in patients of Asian ancestry.

Overdose and Emergency Response

Overdose Scope: Official Regulatory Information

Domain Official Regulatory Statement
Documented overdose presentations No specific, acute symptomatic profile is explicitly documented or described in the official Overdosage sections of the labeling.
Physiological systems affected (as stated in label) Management protocols focus on the potential for severe toxicity affecting skeletal muscle and hepatic (liver) function.
Dose-related or exposure-related factors (if applicable) Overdose management is framed around mitigating risk; specific toxic dose levels are not defined in the overdose section.
Population-specific overdose notes (if applicable) No specific management instructions for overdose in different patient populations are explicitly provided in the official Overdosage section.
Emergency-response statements (as written in official documents) The explicit instruction is to contact a poison control center for management of a suspected drug overdose.
When immediate medical help is required (label-derived phrasing only) Urgent medical help is required when an overdose is suspected, necessitating the institution of symptomatic and supportive measures as required.

Overdose Classifications (High-Level)

Classification Type Official Regulatory Statement
Severity classification (as defined in official documents) Management is oriented toward mitigating the risk of severe complications, specifically rhabdomyolysis and subsequent acute renal failure.
Regulatory basis (EMA / FDA / etc.) The basis for this information is the U.S. Food and Drug Administration (FDA) Prescribing Information and other national regulatory monographs.
Overdose-context constraints (as defined in official documents) There is no specific antidote, and hemodialysis is not expected to be of benefit due to the drug's high plasma protein binding.

Resulting Overdose Structure

Official overdose statements:

  • Treatment for overdosage is entirely symptomatic and consists of supportive measures instituted as required.
  • Monitoring must include assessment of Creatine Kinase (CK) levels and liver function tests due to the documented potential for severe adverse reactions.
  • Immediate withdrawal of the medication is required.

Connection to the overall overdose profile (2–4 sentences): Regulatory documents define the overdose profile by outlining the necessary emergency actions and monitoring requirements to mitigate the risk of severe systemic toxicity. Because the label states that no specific antidote is available, the regulatory mandate is to immediately seek medical attention for supportive clinical management, focusing particularly on preventing rhabdomyolysis and hepatic dysfunction. The official instructions strictly mandate specific laboratory testing to guide treatment.

Therapeutic Uses of Кливас

Quick Facts: Approved Uses

  • Primary Hyperlipidemia: Helps manage high blood cholesterol levels in adults.
  • Heterozygous Familial Hypercholesterolemia (HeFH): Used for patients with this inherited condition to support cholesterol reduction.
  • LDL-C Reduction: Assists in lowering low-density lipoprotein cholesterol (LDL-C), often referred to as “bad cholesterol.”

Кливас (Clivas) is a prescription medicine indicated for the treatment of adults who have primary hypercholesterolemia. This includes individuals with heterozygous familial hypercholesterolemia (HeFH), a genetic condition that results in significantly elevated cholesterol levels.

Its main therapeutic use is to reduce low-density lipoprotein cholesterol (LDL-C) in the bloodstream. Healthcare providers may recommend this medication as an adjunct to diet and statin therapy, meaning it is generally used alongside existing treatment regimens. By consistently supporting the reduction of LDL-C, this medication may contribute to the overall management of cardiovascular risk factors in patients requiring additional cholesterol lowering.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Кливас (Rosuvastatin) — Official Regulatory Information

Rosuvastatin eligibility is strictly defined by regulatory bodies based on age, reproductive status, organ function, and pre-existing conditions.

Category Regulatory Status
Populations for whom use is allowed Adults; Pediatric patients (7 to 17 years) for specific familial hypercholesterolemia types.
Populations for whom use is contraindicated Women who are pregnant or may become pregnant; Nursing mothers; Patients with active liver disease; Patients with known hypersensitivity to the drug.

Age-related eligibility rules: Adult patients are the primary approved population. Pediatric use is restricted by a minimum age, often 7 to 10 years, depending on the specific inherited cholesterol disorder. Safety and efficacy have not been established in children younger than this minimum age.

Condition-specific eligibility rules: Use is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min) and in those with myopathy or conditions pre-disposing them to rhabdomyolysis. Use is generally not recommended in patients with moderate or severe hepatic impairment.

Eligibility-related restrictions: The highest dose (40 mg) is formally contraindicated for patients with myopathy risk factors, including moderate renal impairment, hypothyroidism, or a personal history of muscular disorders. Use with concomitant cyclosporine is also contraindicated.

Connection to the overall eligibility profile: Official labeling defines who must not use the medicine through absolute contraindications relating to reproductive status, liver disease, and specific muscular or kidney function deficits. Eligibility is conditional upon the absence of these risk factors.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the clinically significant interaction patterns for Rosuvastatin that are formally documented in government regulatory prescribing information.


Contraindicated Combinations and Restrictions

The co-administration of Rosuvastatin with Sofosbuvir/velpatasvir/voxilaprevir is officially contraindicated. Use with Cyclosporine is highly restricted due to significantly increased Rosuvastatin systemic exposure, often requiring a mandated maximum daily dose of 5 mg. When undergoing therapy with Fusidic Acid (oral or injectable), Rosuvastatin treatment must be temporarily discontinued as stated in official labeling.


Exposure-Modifying and Pharmacodynamic Interactions

Rosuvastatin is a substrate for the OATP1B1 and BCRP transporters. Co-administration with inhibitors of these transporters, such as Gemfibrozil or certain Antiviral Protease Inhibitors (e.g., Lopinavir/Ritonavir), causes an elevation in the drug's plasma concentration. These pharmacokinetic interactions necessitate mandated dose restrictions defined in the regulatory documents.

Pharmacodynamic interactions exist with other agents that increase the risk of muscle damage. The co-administration of Rosuvastatin with Fibrates, Niacin (ge 1 g/ day), or Colchicine carries an officially documented additive risk of myopathy and rhabdomyolysis. For patients taking Coumarin Anticoagulants (e.g., Warfarin), the combination prolongs the International Normalized Ratio (INR), requiring diligent monitoring.

Timing and Population Notes

The absorption of Rosuvastatin is reduced by Aluminum and Magnesium Hydroxide antacids; therefore, Rosuvastatin must be administered at least two hours before the antacid. Official labeling also notes that Asian patients and individuals with specific SLCO1B1 genetic variants are documented to have increased systemic exposure.

Mechanism of Action

The mechanism of action of Кливас (Rosuvastatin) is defined by its influence on enzyme activity and subsequent cellular feedback loops in the liver and vascular system.

Molecular Inhibition of Hepatic Cholesterol Synthesis

The drug acts as a selective and competitive inhibitor of the HMG-CoA reductase enzyme. This interaction within the mevalonate pathway restricts the liver's internal production of cholesterol.

Feedback-Driven Systemic Clearance

The resulting intracellular cholesterol deficit triggers a compensatory mechanism. Liver cells upregulate their surface expression of LDL receptors (LDL-R) to seek out replacement cholesterol. This action accelerates the uptake and breakdown (catabolism) of Low-Density Lipoprotein Cholesterol (LDL-C) from the bloodstream, leading to a reduction in circulating LDL-C levels.

Pleiotropic Modulation of Vascular Signaling

Beyond lipid regulation, the enzyme blockade also limits the synthesis of certain signaling molecules called isoprenoids. This secondary mechanism modulates biological activity within the walls of blood vessels, resulting in an alteration of endothelial function and a decrease in markers of vascular inflammation (139 words)

Dosage and Administration Information

How to Use Кливас (Rosuvastatin): Official Administration Guidelines

Кливас, whose active ingredient is rosuvastatin, is an oral tablet intended for continuous, long-term administration. The usage instructions, including dosing and special conditions, are strictly defined by regulatory authorities.


Dosing and Frequency

The approved dosage range for adults is 5 mg to 40 mg administered orally once daily. The typical starting dose is either 10 mg or 20 mg. The 40 mg dose is reserved for patients who have not achieved their specific therapeutic goals with the 20 mg dose. Dose adjustments, where necessary, must be made at least 4 weeks or more after the previous dose to allow for proper lipid analysis.


Administration Requirements

Administration Scope Official Guidelines
Route of Administration Oral.
Timing in Relation to Meals May be taken with or without food, at any time of day.
Preparation Requirements Tablets must be swallowed whole with water and should not be crushed, dissolved, or chewed.
Special Procedural Condition If taking aluminum and magnesium hydroxide antacids, administer Rosuvastatin tablets at least two hours before the antacid.

Population-Specific Use

Dosage modifications are mandatory for specific patient populations. For patients diagnosed with severe renal impairment (creatinine clearance less than 30 mL/min), the starting dose is limited to 5 mg once daily and should not exceed 10 mg once daily. In patients of Asian descent, consideration should be given to initiating therapy with the lower 5 mg dose due to documented increased systemic exposure.

Missed-Dose Rules

If the daily dose is missed, regulatory guidance instructs patients to skip the missed dose and resume the regular once-daily schedule with the next planned dose; an extra dose should not be taken to compensate.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Кливас (Rosuvastatin)

The evidence base for Rosuvastatin is primarily built on official clinical studies, including Randomized Controlled Trials (RCTs), comparative trials, and systematic scientific reviews. These studies contribute to understanding what has been observed so far in specific patient groups, according to official regulatory and peer-reviewed scientific sources. The findings describe group patterns, not personal outcomes, and research does not determine whether an individual will respond similarly.


Evidence for Use in Managing Elevated Blood Lipids

Research exploring the profile of Rosuvastatin when evaluated for lipid changes involved short-term RCTs that evaluated adult populations with high cholesterol levels. The studies focused on measurable lipid biomarkers as the primary outcome axis, monitoring changes in LDL-C ("bad cholesterol"), Total Cholesterol, and Triglycerides. The studies conducted during these defined time intervals reported measurements indicating changes measured during the study period in lipid biomarker levels, including a pattern of change in LDL-C across various studied doses.


Evidence for Cardiovascular Risk Reduction

To assess the research scenarios involving cardiovascular events, Rosuvastatin was evaluated in a large-scale, multi-year, placebo-controlled RCT. This trial involved high-risk individuals without established heart disease, particularly those with elevated levels of the inflammatory marker high-sensitivity C-Reactive Protein (hsCRP). The primary outcome monitored was the composite endpoint of Major Adverse Cardiovascular Events (MACE). The large-scale trial monitored the occurrence of these events, reporting measurements indicating a pattern of difference in the incidence of the composite MACE endpoint when comparing the group receiving the medicine to the placebo group. Data for individuals with normal hsCRP but other risk factors remain insufficient and rely on extrapolation from the general statin class evidence.


Research Gaps and Remaining Uncertainties

Evidence is limited regarding the very long-term outcomes (many decades) associated with initiating therapy during childhood for familial hypercholesterolemia. While medium-term follow-up (two to five years) was conducted, long-term effects are not fully established. Comparative evidence is also lacking from large-scale RCTs that directly compare Rosuvastatin against other high-potency statins to monitor specific differences in cardiovascular event rates for secondary prevention.

Key Studies & References

  1. Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) Trial Design
  2. An Efficacy and 2-Year Safety Study of Open-label Rosuvastatin in Children and Adolescents (Aged From 6 to Less Than 18 Years) With Familial Hypercholesterolaemia (CHARON Study details)

Frequently Asked Questions (FAQ)

Common questions about Кливас (FAQ)


Q: Через какое время начинает действовать Кливас? (How soon does Кливас start to work?)

Studies indicate that the therapeutic response, which is the lowering of cholesterol, typically begins within one week of starting treatment. About 90% of the maximum therapeutic effect is generally achieved after two weeks, with the full, final response usually measured after four weeks of consistent use. Official guidance notes that the lipid profile is typically assessed approximately four weeks after initiating the drug or adjusting the dose to monitor the effectiveness of the therapy.


Q: Можно ли принимать Кливас постоянно? (Can Кливас be taken permanently?)

Кливас is classified as a medicine intended for continuous, long-term administration as an adjunct to diet. The official prescribing information does not set a formal maximum time limit for the duration of its use. Regulatory documents describe the medication as being intended for continuous, long-term administration, but the overall duration of therapy is determined by the healthcare provider.


Q: Помогает ли Кливас от головной боли? (Does Кливас help with headaches?)

No, this medicine is not indicated for the treatment of headache. Official documentation categorizes headache as one of the commonly reported side effects observed in clinical trials, rather than a condition it is intended to treat.


Q: Может ли Кливас вызвать сонливость? (Can Кливас cause drowsiness?)

Drowsiness is not listed in official regulatory documents as a frequent or common side effect of the medicine. However, dizziness is noted as a common adverse reaction that some patients may experience while taking this medicine.


Q: Можно ли пить кофе во время приема Кливаса? (Can I drink coffee while taking Кливас?)

Official administration guidelines state that Кливас tablets may be taken with or without food. There are no specific warnings or restrictions documented in the official prescribing information regarding the consumption of caffeine or coffee.


Q: Нужно ли принимать Кливас утром или вечером? (Should I take Кливас in the morning or evening?)

Кливас is intended to be taken as a single dose once daily, and official instructions specify that it may be taken at any time of the day. The drug's long elimination half-life supports a steady effect regardless of the time of administration.


Q: Правда ли, что Кливас вызывает привыкание? (Is it true that Кливас is addictive?)

Кливас belongs to the therapeutic class of statins (HMG-CoA reductase inhibitors) and is not classified as a controlled substance by regulatory bodies. The official drug information does not describe the medicine as being addictive or habit-forming.


Q: Как долго можно принимать Кливас без перерыва? (How long can I take Кливас without a break?)

The medicine is approved for continuous, long-term administration. The official prescribing information does not specify a mandated time limit for use or require routine breaks from treatment.


Q: Можно ли принимать Кливас с витаминами и БАДами? (Can Кливас be taken with vitamins and supplements?)

Regulatory documents list specific interactions with certain prescribed drugs and supplements like Niacin (in high doses) and Fibrates. However, specific warnings about most common vitamins are generally not included. The official documentation emphasizes the importance of informing the healthcare provider about all concomitant medicines and supplements being used.


Q: Можно ли принимать Кливас при вождении автомобиля? (Can I take Кливас while driving?)

Official labeling states that the drug has no or negligible influence on the ability to drive or operate machinery. However, the guidance notes that a person's ability to drive or use machinery may be affected if they experience side effects like dizziness.


Q: Повышается ли артериальное давление от Кливаса? (Does Кливас raise blood pressure?)

Raising blood pressure is not documented in the official regulatory information as an anticipated or observed side effect of the medicine. The primary purpose of the drug is to modify lipid levels, not to affect blood pressure.


Q: Влияет ли Кливас на результаты анализов крови? (Does Кливас affect blood test results?)

Yes, official labeling notes that the drug can affect the results of certain laboratory tests. This includes the possibility of increasing liver enzymes (hepatic transaminases), as well as changes in blood sugar (glucose) and HbA1c levels. Regulatory documents note that laboratory monitoring of liver function and lipids is generally performed during therapy.


Q: Почему Кливас иногда назначают для целей, не указанных в инструкции? (Why is Кливас sometimes prescribed for purposes not listed in the instructions?)

Official regulatory agencies approve the medicine for specific uses, which are called the approved indications. Using the drug for a purpose not listed in the official labeling is known as off-label use. The official product information does not support, promote, or discuss off-label use.


Q: Можно ли делить таблетку Кливас пополам? (Can the Кливас tablet be cut in half?)

The official instructions for administration state that the tablets must be swallowed whole with water. They should not be crushed, dissolved, broken, or chewed.


Q: Есть ли специальные требования к питанию при приеме Кливаса? (Are there special dietary requirements when taking Кливас?)

Кливас is officially indicated for use as an adjunct to diet intended to lower cholesterol. Official labeling describes the medicine as an adjunct to a cholesterol-lowering diet. The medicine can be taken with or without food.


Q: Что делать, если появилась сыпь после приема Кливаса? (What should I do if I get a rash after taking Кливас?)

Official documents list rash, itching, and hives as uncommon adverse reactions. Serious allergic reactions, such as angioedema (swelling beneath the skin), are rare but documented. The official guidance reports that immediate medical attention may be needed if a rash or any signs of a hypersensitivity reaction occur.


Q: Правда ли, что Кливас может повлиять на настроение? (Is it true that Кливас can affect mood?)

Official safety documents list depression as a possible adverse reaction that has been reported with statin use, but the frequency is classified as 'unknown.' This indicates that a clear cause-and-effect relationship has not been formally established.


Q: Существуют ли аналоги Кливаса с тем же действующим веществом? (Are there analogues of Кливас with the same active ingredient?)

The active substance in Кливас is rosuvastatin. Once the patent for the original drug expires, regulatory agencies permit the introduction of other products (generics) containing the same active ingredient. These products must meet regulatory criteria for quality, safety, and bioequivalence.


Q: Как Кливас выводится из организма? (How is Кливас removed from the body?)

The elimination half-life of rosuvastatin is approximately 19 hours. Pharmacokinetic studies show that the vast majority of the drug and its metabolites—about 90%—are primarily eliminated from the body through the intestines (feces).


Q: Влияет ли прием Кливаса на вес тела? (Does taking Кливас affect body weight?)

Changes in body weight are not listed in the official regulatory documents as either a common or rare side effect. Clinical trial data do not establish a direct link between taking the medication and changes in body weight.


Q: Какая категория безопасности у Кливаса? (What is the safety category of Кливас?)

In jurisdictions using the TGA classification (Australia), the drug is categorized as Pregnancy Category D. The regulatory documents consistently list the medication as contraindicated during pregnancy and breastfeeding.


Q: Есть ли данные о долгосрочном использовании Кливаса? (Is there data on the long-term use of Кливас?)

The safety and efficacy of the medication have been evaluated in clinical studies, including large-scale trials focused on cardiovascular risk reduction that span several years. The medicine is indicated for long-term therapy.


Q: В чем особенность Кливаса по сравнению с генериками? (What is the feature of Кливас compared to generics?)

Generic versions contain the same active ingredient and are required by regulatory authorities to be bioequivalent to the original product in terms of safety and effectiveness. Regulatory documents require that generic versions containing rosuvastatin be bioequivalent to the original product in terms of safety and effectiveness.


Q: Влияет ли время суток на эффективность Кливаса? (Does the time of day affect the effectiveness of Кливас?)

No. Due to its long elimination half-life, the drug provides sustained effectiveness over a 24-hour period. Official guidelines confirm that it may be taken at any time of day without impacting its cholesterol-lowering effect.


Q: Что делать, если симптомы не улучшаются после начала приема Кливаса? (What should I do if symptoms do not improve after starting Кливас?)

Official administration instructions direct that the lipid profile should be assessed, often around four weeks after starting the medicine or adjusting the dose. The results of these laboratory tests are used by the healthcare provider to determine the next steps in therapy, which may include dosage adjustment.


Q: В чем разница между Кливасом и другими лекарствами от похожих проблем? (What is the difference between Кливас and other medicines for similar problems?)

Кливас belongs to the statin class of medicines, which all work similarly to lower cholesterol. A key feature of its active ingredient, rosuvastatin, is its classification as a high-potency statin in its approved dosage range. Its chemical structure is also distinct, being highly hydrophilic (water-soluble).


Q: Можно ли принимать Кливас, если есть проблемы с желудком? (Can I take Кливас if I have stomach problems?)

Gastrointestinal issues like abdominal pain, nausea, and constipation are listed as common side effects of the drug. Official prescribing information does not list common chronic stomach illnesses, such as gastritis, as absolute contraindications.

How should Кливас be stored and disposed of?

Storage and Disposal Requirements for Кливас (Rosuvastatin)

Кливас tablets must be stored according to specific regulatory conditions to maintain their integrity and effectiveness.


Storage Conditions

Requirement Description
Temperature Store at a temperature below 30°C (86°F).
Protection Keep the tablets protected from moisture and humidity by storing them in their original container or packaging.
Child Safety Keep out of the sight and reach of children at all times.

Disposal Instructions

Unused or expired Кливас should not be thrown into household trash or flushed down the toilet. Disposal must comply with local pharmaceutical waste regulations and should utilize a drug take-back program when available, as recommended by health authorities.

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

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