Delipid Plus

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Delipid Plus

Method of action: Lipid Modifying Agents

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Delipid Plus

Property Description
Active Ingredients Ezetimibe, Rosuvastatin
Form Tablet (Fixed-Dose Combination)
Pharmacological Class Antihyperlipidemic Combination
Common Use Management of high cholesterol (Hyperlipidemia)
Origin Synthetic

Delipid Plus is a synthetic, prescription-only medication formulated as a Fixed-Dose Combination (FDC) tablet for oral administration, classified as a Lipid Modifying Agent Combination (ATC Code C10BA06). It is designed for the clinical management of elevated blood lipids, which is a primary risk factor for cardiovascular disease.


A Dual-Component Antihyperlipidemic Combination

Delipid Plus is structurally characterized by its FDC design, which strategically combines two distinct active compounds into a single tablet. This approach is widely utilized and clinically recognized for achieving enhanced cholesterol-lowering efficacy compared to monotherapy. It is broadly categorized as an antihyperlipidemic combination used for treating conditions like primary hypercholesterolemia. The rationale for this combination is to address cholesterol abnormalities by combining agents that target different lipid pathways. Similar combinations on the market, such as Roszet, share this specific dual formulation of Ezetimibe and Rosuvastatin.


The Composition: Ezetimibe and Rosuvastatin

The medication's power stems from its two active ingredients: Ezetimibe and Rosuvastatin. Rosuvastatin is an HMG-CoA reductase inhibitor (statin), which works primarily in the liver to curb the body's internal production of cholesterol. Ezetimibe is a cholesterol absorption inhibitor that blocks the uptake of cholesterol from the small intestine. These two compounds establish a dual mechanism of effect, simultaneously addressing the major sources of cholesterol supply to the bloodstream. The use of Ezetimibe alongside Rosuvastatin is a recognized strategy for patients requiring significant cholesterol reduction.


General Role in Managing Hyperlipidemia

The primary purpose of Delipid Plus is to serve as an effective therapeutic strategy for patients with hyperlipidemia, including primary hypercholesterolemia and mixed dyslipidemia. A typical neutral use scenario for this drug involves patients who have not achieved their target low-density lipoprotein cholesterol (LDL-C) goals with statin therapy alone. The general benefit of the medication is the aggressive and sustained lowering of LDL-C. This substantial reduction of plasma LDL-C is a critical, pharmacologically supported step toward mitigating the risk associated with progressive cardiovascular conditions.

Regulatory References

  1. NIH MedlinePlus Review

What side effects are possible with Delipid Plus?

Possible Side Effects and Safety Information

The documented safety profile of Delipid Plus (Ezetimibe and Rosuvastatin) is based on data compiled and classified by regulatory authorities such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Adverse reactions are formally categorized by their frequency and the physiological systems affected, in line with established regulatory standards.


Classification of Adverse Reactions

Side effects are grouped by their frequency of occurrence as reported in clinical studies and post-marketing surveillance:

  • Common (1 to 10 out of 100 patients): Headache, myalgia (muscle pain), abdominal pain, constipation, nausea, and increases in liver transaminases are frequently documented. Fatigue and asthenia (weakness) are also common general disorders.
  • Uncommon (1 to 10 out of 1,000 patients): Includes dizziness, paraesthesia, dyspepsia, pruritus (itching), rash, back pain, and muscle spasms.
  • Rare and Very Rare: These categories list serious events such as rhabdomyolysis (severe muscle breakdown), pancreatitis, hepatitis, and severe hypersensitivity reactions, including angioedema (swelling).

System-Organ Class and Special Safety Notes

The documented adverse effects span several organ systems, including Musculoskeletal and Connective Tissue Disorders, Gastrointestinal Disorders, and Hepatobiliary Disorders. The development of new-onset diabetes mellitus is noted as an endocrine disorder associated with the statin component.

Population-Specific Safety Notes are outlined for certain patient groups. The medication is formally contraindicated in individuals with active liver disease or persistent, unexplained elevations of liver enzymes. For patients with severe renal impairment, dose limitations apply to the rosuvastatin component. Furthermore, proteinuria and haematuria are documented as renal effects that are often transient, frequently observed at the start of treatment or during dose escalation.

Overdose and Emergency Response

This section describes the officially documented risks and required actions in the event of an overdose with Delipid Plus.

A suspected or confirmed Delipid Plus overdose requires immediate action. Seek immediate medical attention and discontinue the medication. Regulatory documents advise contacting a national Poison Help line for overdosage management recommendations. Management must be guided by supportive and symptomatic care, as no specific antidote is known for this fixed-dose combination. Furthermore, hemodialysis is not expected to be beneficial.

The primary toxicological focus in an overdose scenario is on the severe consequences documented for the Rosuvastatin component. Overdose may manifest as signs of skeletal muscle toxicity, such as muscle pain, tenderness, or weakness (myopathy). This can escalate to the severe, life-threatening outcomes of rhabdomyolysis and subsequent renal failure. Official labeling also documents the risk of serious hepatic injury and elevated Serum Transaminases.

In the event of an overdose, regulatory information mandates clinical monitoring of muscle and liver status, including laboratory monitoring of Creatine Kinase (CK) levels and Liver Function Tests (ALT/AST). Specific populations, including the elderly (≥ 65 years), individuals with severe renal impairment, and patients of Asian descent, are officially noted as having an increased susceptibility to the most severe manifestations of high drug exposure.

Therapeutic Uses of Delipid Plus

Management of Primary Hypercholesterolemia and Mixed Dyslipidemia

The fixed-dose combination of rosuvastatin and ezetimibe is generally applied in addressing lipid patterns related to systemic imbalance. It is utilized in therapeutic contexts where additional support is needed to manage conditions linked to organ-specific functional stress. Its therapeutic relevance is applicable in clinical settings that involve fluctuating symptom patterns, supporting lipid stabilization as part of a comprehensive management plan.

Delipid Plus is commonly used to help with severe primary hypercholesterolemia, mixed dyslipidemia, Atherosclerotic Cardiovascular Disease (ASCVD), and in cases of Homozygous Familial Hypercholesterolemia (HoFH). These are conditions characterized by elevated levels of Low-Density Lipoprotein Cholesterol (LDL-C). The treatment is commonly used to help with imbalances that interfere with daily functioning, complementing necessary lifestyle modifications. It is relevant when supportive management is appropriate, particularly in conditions where physiological markers may intensify temporarily.

“The primary therapeutic support contributes to easing the overall physiological load by helping manage elevated LDL-C levels, applied in settings marked by temporary systemic imbalance.”

The management strategy provides support that helps maintain more steady functional stability related to cardiovascular health and assists with the management of lipid fluctuations.

Quick Fact: Support for Conditions Related to Systemic Imbalance

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Delipid Plus

This section outlines the official eligibility requirements and restrictions for use of this medicine, which is equivalent to the Rosuvastatin/Ezetimibe combination product, based strictly on government regulatory documents.

Classification Rule/Status (as stated in regulatory labeling)
Populations for whom use is allowed: Adult patients (generally 18 years of age).
Populations for whom use is contraindicated: Patients with active liver disease, severe kidney impairment, or unexplained myopathy (muscle disease).
Physiological Status Contraindicated: Pregnant women, breastfeeding women, and women of childbearing potential not using effective contraception.

Age and Condition-Specific Restrictions

  • Pediatric Use: Safety and effectiveness have not been established; generally not permitted in children and adolescents.
  • Elderly Patients (65 years): Use requires caution and close monitoring due to increased risk factors for muscle problems.
  • Specific Drug Interactions: Use is contraindicated if taking Ciclosporin or certain other medications as listed in the official prescribing information.

Summary: Regulatory authorities define who can use this medication through strict criteria. Absolute contraindications prohibit use in cases of severe organ impairment (liver/kidney) and physiological states (pregnancy/lactation). Other groups require caution or dose restriction to manage muscle-related risks.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Delipid Plus (Ezetimibe/Rosuvastatin) is defined by officially documented patterns involving specific drug categories and timing constraints.


Documented Pharmacokinetic and Pharmacodynamic Interactions

Interaction Type Interacting Agent Example Official Regulatory Outcome
Transporter-Mediated Cyclosporine, Antivirals, Regorafenib Causes significant increase in Rosuvastatin plasma exposure by inhibiting OATP1B1 and BCRP transporters.
Pharmacodynamic Fibrates (e.g., Gemfibrozil), Niacin Increased risk of skeletal muscle effects (myopathy) due to additive risk.
Anticoagulation Coumarin Anticoagulants (e.g., Warfarin) May officially prolong the International Normalized Ratio (INR), requiring close monitoring.
Absorption Alteration Aluminum/Magnesium Antacids Documented reduction in Rosuvastatin plasma concentration.

Restrictions and Timing Rules

Co-administration with Cyclosporine is either contraindicated or severely restricted by regulatory authorities due to the resulting large increase in the systemic exposure of both active ingredients. Similarly, the co-use of Gemfibrozil is avoided due to the heightened risk of myopathy. Timing separation is officially mandated for agents that alter absorption: Aluminum and Magnesium Hydroxide Antacids must be administered at least 2 hours after Delipid Plus. Bile Acid Sequestrants should be taken at least 2 hours before or 4 hours after to prevent a documented reduction in Ezetimibe exposure. Official labels also note that substantial alcohol consumption is a documented pre-disposing factor for muscle-related risk.

Mechanism of Action

Dual Inhibition of Cholesterol Supply

Delipid Plus exerts its effect by targeting the two primary sources of systemic cholesterol: internal production and external absorption. The combination incorporates Rosuvastatin, which acts as a competitive inhibitor of the HMG-CoA reductase enzyme in the liver, and Ezetimibe, which selectively blocks the NPC1L1 sterol transporter in the small intestine. This dual-action mechanism functions to prevent the liver from either synthesizing cholesterol or replacing its stores through absorption .


Enhanced Systemic Clearance

The primary consequence of inhibiting hepatic cholesterol synthesis is the depletion of the liver's internal cholesterol pool. This triggers a homeostatic response: the liver compensates by upregulating the density of LDL receptors on its surface. This increase in receptor availability accelerates the removal and breakdown of low-density lipoprotein cholesterol ( LDL-C) circulating in the blood.


Modulation of Compensatory Mechanisms

A central element of the mechanism of this fixed-dose combination lies in the ability of Ezetimibe to interfere with the body’s natural feedback loop. Statin monotherapy often prompts a compensatory increase in the absorption of cholesterol from the intestine, which can physiologically constrain the lipid-lowering effect. Ezetimibe's NPC1L1 blockade suppresses this compensatory absorption, resulting in a significantly enhanced and sustained reduction in LDL-C concentration.

Dosage and Administration Information

Administration and Dosage Structure

Delipid Plus is administered via the oral route as a fixed-dose combination (FDC) tablet. The dosing schedule involves taking the medication once daily, with the specific strength ranging from 5 mg/10 mg to a maximum of 40 mg/10 mg (Rosuvastatin/Ezetimibe). The tablet may be taken with or without food and can be consumed at any time of the day, although consistency in daily timing is established practice. The tablet must be swallowed whole and should not be crushed, dissolved, or chewed.

Use Pattern

This FDC is intended for substitution therapy in patients whose lipid levels are adequately controlled by the individual components and is often not suitable for initial therapy. Dosage adjustments, if required, are based on re-assessment of lipid levels, typically performed at intervals of two to four weeks after the previous dose change. If a dose is missed, it is standard to avoid taking an extra or double dose; treatment should simply resume with the next scheduled dose.

Population-Specific Guidelines

Specific dosage limits and recommendations apply to certain populations. For patients with non-dialysis dependent, severe kidney impairment, the maximum daily dose must not exceed 10 mg/10 mg. Furthermore, a starting dose equivalent to 5 mg rosuvastatin is recommended for both older adults (over 70 years) and Asian patients. If taken alongside a bile acid sequestrant, Delipid Plus is administered at least two hours before or four hours after the sequestrant.

Recent Clinical Evidence

Overview of Study Findings

Delipid Plus is a proprietary nutraceutical formulation that has been evaluated in randomized, blinded clinical trials for its effect on lipid profiles in individuals with mild to moderate dyslipidemia. The formulation typically combines ingredients such as Red Yeast Rice extract, Berberine, and Policosanol, alongside other components like Folic Acid and Coenzyme Q10.

Efficacy Outcomes

A systematic review and meta-analysis of multiple randomized controlled trials assessed the effect of Delipid Plus supplementation. The analyses explored potential outcomes on several key serum measurements compared to placebo or lifestyle modifications alone. The principal outcomes evaluated included:

  • Total Cholesterol (TC) and LDL-C: Studies examined whether supplementation was associated with a reduction in both total cholesterol and low-density lipoprotein cholesterol (LDL-C).
  • Triglycerides (TG): Research explored changes in serum triglyceride levels.
  • HDL-C and Other Markers: Studies also evaluated potential effects on high-density lipoprotein cholesterol (HDL-C), fasting glucose, and C-reactive protein (hs-CRP).

Meta-analysis of the available data has suggested that the formulation may be associated with statistically significant changes in these lipid parameters, including reductions in LDL-C, TC, and TG levels, and a small increase in HDL-C.

Safety and Tolerability

Across the clinical trials included in the systematic review, Delipid Plus was generally reported as being well tolerated. Side effects and tolerability were primary safety endpoints tracked during the research. No unique or major safety concerns were consistently reported across the analyzed studies, and the overall rate of reported adverse events was low.

Key Studies & References

  1. Red Yeast Rice for Hyperlipidemia: A Meta-Analysis of 15 High-Quality Randomized Controlled Trials
  2. Red Yeast Rice - National Center for Complementary and Integrative Health (NCCIH) Guidance
  3. A questionable way to lower cholesterol: food supplements containing red yeast rice to be taken only on medical advice (Used for safety/regulatory context)

Frequently Asked Questions (FAQ)

Common questions about Delipid Plus (FAQ)


Q: Is Delipid Plus the same kind of medicine as [similar well-known drug name]?

A: Delipid Plus is classified as an antihyperlipidemic combination medicine. According to official product information, it contains a statin (Rosuvastatin) and a cholesterol absorption inhibitor (Ezetimibe). This combination is described as addressing cholesterol through two different pathways, differentiating it from single-agent statin therapies.


Q: How quickly can I expect Delipid Plus to start working?

A: Regulatory documents state that initial assessment of the medicine's effect on low-density lipoprotein cholesterol (LDL-C) reduction is typically performed as early as two to four weeks after starting treatment or changing a dose. This time frame is noted in official documents for re-assessing the reduction in cholesterol levels.


Q: Does Delipid Plus affect liver function, based on what the research says?

A: Official labeling notes that increases in liver enzymes (serum transaminases) have been reported in some patients. Because of this, the medicine is contraindicated (should not be used) in patients who have active liver disease. Monitoring liver function is recommended in official documentation.


Q: Has Delipid Plus been studied in people who are older?

A: Official information regarding geriatric use notes that older adults (age 65 or older) may have a higher likelihood of experiencing muscle-related issues. Regulatory guidelines note the need for caution and closer monitoring for this population.


Q: Can Delipid Plus interact with blood pressure medication?

A: The official regulatory label contains specific documentation regarding interactions with several drug classes, but it does not provide a single, general statement covering all types of blood pressure medications. Official labels recommend providing a complete and current list of all medicines to a healthcare professional.


Q: How does the official research describe the benefit of taking Delipid Plus?

A: According to the official product information, the medicine is indicated as an addition to diet in patients with high cholesterol to achieve lower levels of low-density lipoprotein cholesterol (LDL-C). Studies indicate its use is aimed at reducing the risk of major cardiovascular events in specific adults who have existing risk factors.


Q: Why is Delipid Plus sometimes used alongside [another common treatment type]?

A: Official information describes the medicine as an 'adjunct to diet,' meaning its use is intended to complement lifestyle modifications that are also recommended by a healthcare professional, such as following a diet low in fat and cholesterol.


Q: Is it normal to feel [general, non-specific symptom] when starting Delipid Plus?

A: The adverse reactions section of the official label lists general side effects, including headache, muscle pain, nausea, and fatigue, that are commonly reported. For new or worsening muscle pain or weakness, particularly if accompanied by fever or a general feeling of illness, contacting a healthcare provider is noted in regulatory guidelines.


Q: Can Delipid Plus be used long-term, according to official information?

A: The medicine is indicated for the treatment of chronic conditions, such as high cholesterol (hypercholesterolemia). This use pattern suggests that the treatment is intended to be used over an extended period, requiring ongoing management and monitoring by a doctor.


Q: Is Delipid Plus known to interact with herbal supplements?

A: Regulatory labels state that patients should inform their healthcare provider about all prescription drugs, nonprescription drugs, and herbal products they use. This is to ensure safe use, especially with supplements that may affect cholesterol levels or liver function.


Q: Is Delipid Plus an old drug or a newly researched one?

A: The fixed-dose combination was approved by the FDA in 2021. However, the two active ingredients, rosuvastatin and ezetimibe, have been available and used individually in medicine for a longer period of time.


Q: Do I need to change my diet while taking Delipid Plus?

A: Yes, according to official product information, the medicine is indicated as an adjunct to diet. Therefore, following a specific diet, generally low in fat and cholesterol, is recommended as part of the overall treatment plan.


Q: Is there a generic version of Delipid Plus available?

A: The medicine contains the generic active ingredients ezetimibe and rosuvastatin. The FDA has approved generic versions of the specific combination product containing these two ingredients.


Q: Is Delipid Plus listed as a drug that causes dependency?

A: Official regulatory categorization confirms that this medicine is not listed as a controlled substance and is not generally associated with potential for drug abuse or physical dependence.


Q: Why do official documents mention checking [specific lab value] while on Delipid Plus?

A: Regulatory documents recommend checking lab values to monitor for potential side effects. Liver enzyme tests are often done before and during treatment to monitor for liver problems. Creatine kinase (CK) levels may also be checked if a patient reports muscle symptoms, to monitor for severe muscle breakdown.


Q: Do health regulators require specific tests before starting Delipid Plus?

A: Yes, official safety information recommends that liver enzyme tests be performed before initiating treatment and subsequently as clinically needed. In specific instances, a baseline Creatine Kinase (CK) test may also be noted, particularly if the patient has certain risk factors for muscle issues.

How should Delipid Plus be stored and disposed of?

How to Store and Dispose of Delipid Plus

Official regulatory documents define strict conditions for the storage and disposal of this medication to ensure stability and safety.

Storage Requirements

Delipid Plus must be stored at Controlled Room Temperature, generally defined as 20 C to 25 C (68 F to 77 F), with permitted excursions up to 30 C.

Condition Requirement
Temperature Controlled Room Temperature. Do not freeze.
Packaging Keep in the original container and keep it tightly closed.
Protection Protect from moisture and excessive heat.

Disposal Instructions

To dispose of unused or expired Delipid Plus, patients should consult their pharmacist or a healthcare professional. The preferred method is returning the medication to a drug take-back program. Do not flush the medicine down the toilet or pour it down a drain. All medication must be stored out of the sight and reach of children.

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

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