Роксера

Quick links to important sections

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.

Overview of Роксера

What is Роксера (Rosuvastatin)?

Property Description
Active ingredient Rosuvastatin
Form Film-coated tablets
Pharmacological class Statin (HMG-CoA reductase inhibitor)
Common use Managing high blood cholesterol (dyslipidemia)
Origin Synthetic chemical compound

Overview: What Type of Medicine is Роксера?

Роксера is a prescription medicine containing the active ingredient Rosuvastatin, which belongs to the class of medicines known as Statins. The medication is a fully synthetic compound, administered orally as a film-coated tablet.

Rosuvastatin is effective in reducing abnormal lipid levels and is used for the management of high cholesterol, known as hypercholesterolemia. Роксера is typically prescribed as part of a comprehensive strategy for patients requiring improved blood lipid management.

Роксера: Purpose and General Mechanism

The general purpose of Роксера is to improve a patient's overall lipid profile by interfering with the body's internal cholesterol production. Rosuvastatin acts primarily in the liver, where it works by blocking the HMG-CoA reductase enzyme. This targeted action is highly selective and results in a reduction in the amount of cholesterol the body produces internally.

By decreasing internal synthesis, the medication helps the body clear excess 'bad' cholesterol (LDL-C) from the bloodstream more effectively. This mechanism is key to helping reduce the cardiovascular risks associated with elevated blood fats.

What side effects are possible with Роксера?

Possible Side Effects and Safety Information

The safety profile for Роксера (Rosuvastatin) is officially documented by government regulatory agencies and organizes risks by frequency, system affected, and severity.

Frequency-Classified Adverse Reactions

Adverse reactions are classified based on the rates reported in clinical trials and postmarketing surveillance. Reactions noted as Common (occurring at a rate ge2% and greater than placebo in trials) include headache, nausea, myalgia (muscle pain), asthenia (weakness or lack of energy), and constipation.

Serious and System-Organ Class Effects

The most clinically significant and serious effects involve the musculoskeletal system and the liver.

System-Organ Class Serious Adverse Reactions
Musculoskeletal Rhabdomyolysis (severe muscle breakdown, potentially leading to acute renal failure), Myopathy, and Immune-Mediated Necrotizing Myopathy (IMNM).
Hepatobiliary Fatal and non-fatal hepatic failure and persistent, significant elevations in liver transaminase enzymes.

Safety-Related Restrictions and Considerations

The medicine is officially contraindicated (prohibited) for use in patients with active liver disease (including unexplained, persistent elevations in liver enzymes) and during pregnancy and lactation.

Specific population risks are also identified. The risk of myopathy and rhabdomyolysis is higher in patients aged 65 years or greater and those with renal impairment. Furthermore, the dose of rosuvastatin may require limitation when used concomitantly with certain medications (e.g., cyclosporine, specific protease inhibitors) due to an increased risk of muscle injury.

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — Official Regulatory Information for Rosuvastatin (Роксера)

Overdose Scope

Category Official Regulatory Statement
Documented overdose presentations Overdose exposure is primarily associated with the risk of severe adverse reactions rather than acute symptoms. Documented findings include marked elevations in Creatine Kinase (CK) levels and hepatic transaminases (ALT/AST).
Physiological systems affected Primary concerns involve the Skeletal Muscle System, leading to Rhabdomyolysis, and the Renal System, resulting in Acute Renal Failure secondary to myoglobinuria.
Population-specific overdose notes Patients with severe renal impairment and individuals of Asian descent have been noted to have increased systemic exposure to Rosuvastatin, which heightens the potential for dose-related severe adverse effects in an overdose situation.
When immediate medical help is required Immediate medical attention is required for any suspected overdose due to the potential for life-threatening complications.

Resulting Overdose Structure

Official overdose statements:

  • In the event of an overdose, there is no specific antidote available, and all treatment must be symptomatic and supportive.
  • The explicit regulatory guidance is to contact a poison control center (or local emergency medical service) for management guidance.
  • Severe exposure risks include Rhabdomyolysis and Acute Renal Failure. Close monitoring of CK levels and Liver Function Tests is required.
  • Hemodialysis is officially stated as not expected to be beneficial for clearing Rosuvastatin because the drug is highly protein-bound.

Connection to the overall overdose profile: Regulatory documentation defines the Rosuvastatin overdose profile by the absence of a specific antidote and the focus on managing severe, dose-related systemic risks. The mandated emergency actions emphasize seeking immediate help and utilizing supportive care to mitigate the potential for life-threatening complications such as rhabdomyolysis and acute renal failure.

Therapeutic Uses of Роксера

What Роксера Treats: Main Uses and Benefits

The primary role of Роксера is to offer supportive symptom management by addressing underlying systemic factors. The medication is used for managing conditions characterized by periods of heightened symptoms and is applied in clinical settings marked by heightened patient distress. It is commonly used in scenarios where additional symptomatic support is needed.


Core Therapeutic Domains

Роксера is relevant for conditions involving episodic or fluctuating manifestations that can interfere with daily comfort. It focuses on easing symptoms related to systemic imbalance by helping manage noticeable physiological strain. It is often used when symptoms intensify and supportive relief is needed during phases of increased distress or discomfort.

This assistance assists with maintaining functional stability and supports general well-being, helping patients cope more steadily with symptom fluctuations.

Quick Facts

  • Relief Domain: Used for managing symptoms related to systemic imbalance.
  • Condition Context: Applicable in conditions involving episodic or fluctuating manifestations.
  • Patient Benefit: Supports general well-being during symptomatic phases.

Key Benefits

Роксера is commonly used across conditions presenting with acute or disruptive episodes linked to heightened physiological stress. The supportive relief offered may help ease the overall symptom burden and contribute to improved comfort during symptomatic periods.

Eligibility and Restrictions for Use

Eligibility Profile: Who Can and Cannot Use Роксера (Rosuvastatin)

Official regulatory documents define strict population eligibility for Роксера based on age, physiological status, and pre-existing medical conditions.


Populations for Whom Use is Contraindicated

The medicine must not be used in patients with the following absolute contraindications:

  • Active liver disease, including unexplained, persistent elevations in hepatic transaminase levels exceeding three times the Upper Limit of Normal (ULN).
  • Pregnancy or in women of childbearing potential not using appropriate contraception.
  • Breastfeeding mothers.
  • Severe renal impairment (creatinine clearance < 30 mL/min).
  • Known hypersensitivity to rosuvastatin or any product components.
  • Pre-existing myopathy or those receiving concomitant ciclosporin.

Age-Related and Conditional Eligibility

Population Group Regulatory Status Restriction/Limitation
Adults Established Standard approved use.
Pediatric Patients Established for HeFH and HoFH Minimum age is generally mathbf6 to mathbf8 years, depending on the condition and regulatory region.
Older Adults (Aged mathbf>70 years) Special Consideration A mathbf5 mg starting dose is often recommended.
Asian Patients Special Consideration A mathbf5 mg starting dose is recommended due to potential for increased exposure.

The highest mathbf40 mg dose is specifically contraindicated in patients with risk factors for muscle toxicity, including moderate renal impairment (creatinine clearance < 60 mL/min), uncontrolled hypothyroidism, or hereditary muscular disorders.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Rosuvastatin's interaction profile is documented in regulatory labeling and involves substances that either increase the drug's plasma concentration or increase the risk of muscle toxicity.

Classification Interacting Medicines/Substances
Formal Contraindication Ciclosporin (due to significantly increased exposure). The combination with certain Hepatitis C Antivirals (e.g., Sofosbuvir/Velpatasvir/Voxilaprevir) is also generally not recommended/contraindicated.
Reinforced Risk Fibrates (Gemfibrozil), Colchicine, and Niacin (ge 1 g/day) due to an additive risk of skeletal muscle effects (myopathy).
Exposure Modification HIV Protease Inhibitors (e.g., Atazanavir/Ritonavir, Lopinavir/Ritonavir) and Kinase Inhibitors (e.g., Regorafenib) increase rosuvastatin plasma levels by inhibiting the OATP1B1 and BCRP transport proteins.
Effect on Other Drugs Coumarin Anticoagulants (e.g., Warfarin) require frequent monitoring of the International Normalized Ratio (INR), as Rosuvastatin is documented to prolong the INR.

Regulatory Constraints

Regulatory documents mandate specific restrictions for certain co-administrations. For instance, aluminum and magnesium hydroxide antacids interfere with absorption, requiring Rosuvastatin to be taken at least two hours after the antacid. Furthermore, the maximum approved dose of Rosuvastatin is often restricted ( 5 mg or 10 mg daily) when co-administered with strong transporter inhibitors to mitigate the increased systemic exposure.

Mechanism of Action

How Роксера Works: Mechanisms of Action

Molecular Inhibition of Endogenous Cholesterol Synthesis

The drug's primary action involves its competitive inhibition of the HMG-CoA reductase enzyme, which is the key rate-limiting step in the liver's internal cholesterol production pathway (the mevalonate pathway). This action engages the cellular regulatory system to immediately limit the supply of internally synthesized cholesterol.


Accelerated Clearance via Receptor Up-Regulation

The resulting depletion of the liver's intracellular cholesterol pool triggers a key, secondary cascade: the up-regulation and increased activity of LDL receptors on the liver cell surface. This increases the liver's capacity to bind and rapidly clear LDL-C particles from the systemic circulation, leading to a substantial physiological modification in circulating LDL-C concentration.


Modulation of Systemic Inflammatory Markers (Pleiotropic Effect)

Beyond its primary effects on lipid metabolism, the mechanism exerts non-lipid pleiotropic effects by modulating downstream isoprenoid intermediates of the mevalonate pathway. This influences other physiological processes, including those related to inflammation, which is evidenced by the drug's effect on the concentration of systemic markers like C-Reactive Protein ( CRP).

Dosage and Administration Information

How to Use Роксера

Rosuvastatin, the active ingredient in Роксера, is administered as an oral film-coated tablet once daily. The usage follows specific procedures for administration and dose management. The medicine can be taken at any time of day and consumption is flexible, meaning it can be taken with or without food.


Official Dosing and Scheduling

Instruction Principle of Use
Route & Frequency Oral, administered as a single dose once daily.
Standard Dose Range The dosing range is 5 mg to 40 mg once daily.
Starting Dose Typically initiated at 10 mg or 20 mg once daily.
Dose Adjustment Adjustments in dosage are made at intervals of 4 weeks or more, based on the patient's response as assessed by lipid level testing.

Administration Constraints and Specific Populations

Tablet Handling: The tablet must be swallowed whole and must not be altered, such as by crushing, chewing, or dissolving it.

Missed Dose: If a scheduled dose is missed, it is recommended that the patient not take an extra dose or double the dose. Treatment must continue with the next scheduled daily dose.

Population Adjustments: Specific patient populations require lower starting and maximum doses. For instance, in patients with severe kidney impairment, the starting dose is 5 mg and the daily dose should not exceed 10 mg. A 5 mg starting dose is also recommended for older adults (over 70 years) and should be considered for patients of Asian ancestry.

Recent Clinical Evidence

Research evidence / Overview of studies for Роксера (Rosuvastatin)

This section summarizes the official research evidence for Роксера, focusing on the design and aims of key clinical trials, systematic reviews, and meta-analyses, as reported in authoritative scientific sources. The text remains strictly a non-advisory overview of the research landscape.


Evidence for Management of High Cholesterol (Dyslipidemia)

Early research for Rosuvastatin includes numerous short-term, randomized controlled trials (RCTs) and systematic reviews. These studies was studied for how Rosuvastatin was associated with changes in specific biomarkers in the blood, including in studies of adults diagnosed with elevated LDL-C ('bad' cholesterol) or mixed dyslipidemia. Researchers focused on measuring differences in circulating blood fat levels and monitored HDL-C ('good' cholesterol).

What remains uncertain: A notable research limitation is that the evidence for initial regulatory evaluation focused predominantly on changes in blood markers (surrogate endpoints) over shorter follow-up durations. Comparative evidence is lacking regarding long-term major clinical outcomes (heart attack, stroke) specifically for this drug versus all other statin therapies.

Evidence for Risk Reduction in High-Risk Patients

Large-scale, long-term research was conducted and evaluated the time to first occurrence of major clinical events in patient populations identified as having high cardiovascular risk. This research explores outcomes related to systemic or functional imbalance.

A large randomized, placebo-controlled trial was observed in this area, which research examined individuals who had specific risk factors, including high levels of the inflammatory biomarker high-sensitivity C-reactive protein (hs-CRP). The trial reported that fewer major cardiovascular events were observed in the Rosuvastatin group compared to the placebo group over the median 1.9-year follow-up period; the study was terminated early based on pre-specified criteria.

What remains uncertain: The finding's applicability may be limited as the research is primarily derived from a single trial with very specific entry criteria. Consequently, data for certain groups remain insufficient, and research does not determine whether an individual will respond similarly to the patterns observed in the trial.

Key Studies & References

  1. Rosuvastatin Treatment for Pediatric Patients with Heterozygous Familial Hypercholesterolemia (CHARON Study)

Frequently Asked Questions (FAQ)

Common questions about Роксера (FAQ)

Q: Does it matter what time of day I take the drug (morning/evening)?

A: Official prescribing information indicates that this medicine may be taken at any time of day, as a single dose. Consumption is also flexible regarding meals, meaning it can be taken with or without food. Official information emphasizes the importance of consistent daily administration, regardless of the time of day.

Q: How quickly will I see an effect on my cholesterol levels?

A: Regulatory documents state that an assessment of cholesterol levels is often clinically appropriate as early as four weeks after starting treatment. The timeline allows for the assessment of initial response, which informs the healthcare provider if a dosage adjustment is appropriate.

Q: Can I drink alcohol while on rosuvastatin?

A: Official product information notes that consuming large amounts of alcohol may increase the documented risk of liver-related issues, which is a known potential side effect of statins. Regulatory-proximal information suggests that limiting or avoiding alcohol intake may help mitigate this risk. Any concerns about alcohol use may be discussed with a healthcare provider.

Q: What is the role of rosuvastatin in preventing heart disease and atherosclerosis (plaque buildup)?

A: Beyond lowering 'bad' cholesterol (LDL-C), the drug is officially indicated for slowing the progression of atherosclerosis, which is the buildup of plaque in the arteries. The medicine is described as part of a comprehensive strategy used in individuals with high cardiovascular risk.

Q: What is the most common side effect?

A: Based on clinical trials, several adverse reactions were frequently reported (occurring at a rate of 2% or greater). The most common documented side effects include headache, nausea, constipation, muscle pain (myalgia), and general weakness or lack of energy (asthenia). These findings are documented in the official safety profile of the medicine.

Q: Can I stop taking it once my cholesterol levels are normal?

A: The official guidance emphasizes that this medicine is typically prescribed for chronic conditions and long-term risk reduction. Treatment should be continued unless otherwise advised by a healthcare provider, even if cholesterol levels appear to be within the target range.

Q: Is it safe to take this drug for the rest of my life?

A: This medicine is indicated for long-term conditions like primary hyperlipidemia, suggesting a potentially chronic duration of therapy. Potential long-term safety considerations are subject to ongoing assessment and monitoring by a healthcare provider. The duration of treatment is determined based on individual health status and risk factors.

Q: Why are there different doses (5mg, 10mg, 20mg, 40mg)?

A: The official dose range allows for personalization of treatment. The recommended dose is determined by the healthcare provider based on the patient's specific indication for use and their individual cardiovascular risk factors. Dosage is determined based on the assessment of a patient's risk factors and response, in pursuit of appropriate therapeutic objectives.

Q: Do I need to check my cholesterol every month?

A: Official information states that cholesterol levels are typically assessed when clinically appropriate. The frequency of monitoring is determined by the healthcare provider based on the clinical response and specific monitoring needs, following initial testing.

Q: Does this medicine affect the kidneys?

A: Official labeling notes that dosage modification is needed for patients who have severe kidney impairment. Furthermore, a serious but rare muscle condition called rhabdomyolysis, which is associated with statins, can potentially lead to kidney damage.

Q: What should I do if I forget a dose?

A: Regulatory instructions specify that if a scheduled dose is missed, the patient should not take an extra dose. Official instructions specify that the subsequent dose should not be doubled. Treatment should continue by simply taking the next scheduled daily dose as planned.

Q: Can I eat grapefruit or drink grapefruit juice?

A: Official patient information notes that unlike some other medicines in the statin class, the consumption of grapefruit or grapefruit juice is generally considered safe while taking this medication. Specific dietary concerns may be addressed with a healthcare provider.

Q: What is the significance of the advice to disclose all other medicines and supplements to my doctor?

A: The disclosure of all current medicines, vitamins, and supplements is crucial because rosuvastatin has the potential to interact with many other substances. Full disclosure is necessary because it allows for appropriate risk evaluation prior to using the medication.

Q: Can this drug cause muscle pain (myalgia)?

A: Yes, muscle aches and pains (myalgia) are among the most frequently reported adverse reactions observed in clinical trials. Patients are typically informed about the potential for more serious muscle-related concerns. Any unexplained muscle pain is a finding that may warrant discussion with a healthcare provider.

Q: Can rosuvastatin cause tiredness or general weakness (asthenia)?

A: General weakness or lack of energy, known as asthenia, is listed as one of the frequently reported adverse reactions from clinical trials. Official information documents this finding for patients who may experience this side effect.

Q: Can it affect my memory or concentration?

A: Postmarketing reports have noted instances of cognitive impairment, which includes memory loss, forgetfulness, and confusion. Regulatory information describes these effects as generally non-serious and reversible once the medication is stopped. Changes in memory or cognition are findings that may warrant discussion with a healthcare provider.

Q: Is rosuvastatin a prodrug or an active drug?

A: Pharmacological studies indicate that rosuvastatin is administered as the active drug itself. Unlike some other medicines in the statin class, it does not require initial activation by the liver before it can begin its cholesterol-lowering action.

Q: Does rosuvastatin require a special diet?

A: Official indications state that rosuvastatin is intended to be used as an adjunct (addition) to diet. This means the medicine is meant to be combined with a heart-healthy diet and lifestyle modifications, such as increased exercise, to achieve the overall therapeutic goals for managing blood lipids.

Q: Can I take vitamins or other nutritional supplements while on this drug?

A: Official guidance strongly advises telling a healthcare provider about all vitamins, minerals, herbal products, and other nutritional supplements being used. This disclosure allows for the evaluation of potential interactions between the supplement and the medication.

Q: Are there any data on its use in children or adolescents?

A: Yes, official labeling provides dosing recommendations for pediatric patients based on the specific condition being treated, such as familial high cholesterol. The dosing guidelines start for certain ages depending on the specific diagnosis.

Q: Can rosuvastatin cause sexual side effects, like erectile dysfunction or decreased libido?

A: Official sources have reported that side effects of unknown incidence can include decreased sexual ability or a reduction in libido. These are findings that may warrant discussion with a healthcare provider.

Q: Is there a risk of high blood sugar or diabetes?

A: Regulatory documents note that increases in blood sugar markers, specifically HbA1c and fasting serum glucose levels, have been reported with statin use. Patients with pre-existing diabetes or associated risk factors may undergo closer monitoring.

Q: What is the risk of an allergic reaction (hypersensitivity)?

A: The medicine is contraindicated in patients who have a known hypersensitivity to the active substance or any of its components. Symptoms such as swelling or difficulty breathing are described as findings that require prompt medical evaluation.

Q: Can this medicine cause unexplained bruising or bleeding?

A: Unexplained or unusual bleeding and bruising is documented as a potentially serious side effect associated with the medicine. These findings are documented as potentially serious side effects and may warrant clinical evaluation.

Q: Does rosuvastatin cause dry mouth?

A: Dry mouth has been reported as a less common side effect in patient information. Patients experiencing this or other non-frequently reported effects should mention them during their medical consultations.

Q: Does rosuvastatin interfere with sleep?

A: Difficulty sleeping, or insomnia, has been reported as a documented side effect. If sleep disturbances persist or are disruptive, these are findings that may warrant discussion with a healthcare provider.

Q: Should I avoid driving or operating heavy machinery?

A: Official patient counseling suggests that patients experiencing dizziness or weakness (asthenia) should refrain from driving or operating machinery until those symptoms have resolved. This is because these symptoms are documented side effects that could affect safety.

Q: I have type 2 diabetes. Are there any studies on rosuvastatin in this population?

A: The drug's official labeling references changes in blood sugar, specifically an increase in HbA1c and glucose levels. The drug’s labeling notes that specific monitoring may be used for individuals with or at risk for diabetes.

Q: I have heard rosuvastatin is particularly good for reducing triglycerides. Is this true?

A: Official labeling for rosuvastatin includes its indication as an adjunct to diet for the treatment of hypertriglyceridemia (high levels of triglycerides). This indicates its recognized role in lowering elevated triglycerides, in addition to its primary role in lowering 'bad' cholesterol.

Q: Is this a hydrophilic or lipophilic statin?

A: Pharmacological data classifies rosuvastatin as a hydrophilic statin. This technical designation refers to the drug's solubility, meaning it is more water-soluble than fat-soluble.

Q: Is it required to take a combination of diet and exercise with rosuvastatin?

A: Official indications state that the drug is to be used as an adjunct to diet. The official indication defines the drug as an adjunct to diet, suggesting the overall management strategy includes appropriate lifestyle changes, such as a heart-healthy diet and exercise.

How should Роксера be stored and disposed of?

The storage and disposal of Rosuvastatin (Роксера) tablets must adhere strictly to regulatory requirements to preserve product quality and safety.

Official Storage Requirements

Item Requirement
Temperature Store at Controlled Room Temperature, 20 C to 25 C (68 F to 77 F).
Protection The tablets must be protected from moisture.
Child Safety Keep out of the reach and sight of children.

Official Disposal Instructions

Unused or expired Роксера must be disposed of according to local regulatory requirements. It is officially advised that the medicine must not be discarded via wastewater or household waste to prevent environmental contamination.

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

Available in countries:

Equivalent of Роксера found in:

A-Z Index: