Lipanthyl 300

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Lipanthyl 300

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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 Lipanthyl 300

To establish the identity of the medication, here are the essential details regarding its composition and classification.

Property Description
Active Ingredient Fenofibrate
Form Oral hard capsule
Pharmacological Class Fibrate / Antihyperlipidemic agent
Common Use Modifying abnormal blood lipid levels (Dyslipidemia)
Origin Synthetic compound

What Type of Medicine is Lipanthyl 300 and What is it Made Of?

Lipanthyl 300 is a prescription-only antihyperlipidemic agent used for the modification of abnormal fat levels in the blood. The single active ingredient is Fenofibrate, a synthetic compound classified in the fibrate pharmacological class, which is clinically recognized for its distinct mechanism compared to statins. This distinction means the medicine offers a specialized therapeutic option for managing certain lipid imbalances. Fenofibrate acts as a prodrug, meaning it must be converted in the body to its active therapeutic form, Fenofibric acid.


Understanding the General Purpose of Lipanthyl 300

The general purpose of Lipanthyl 300 is the comprehensive regulation of the blood's lipid profile, primarily addressing combined dyslipidemia characterized by elevated fats and cholesterol. The medication’s core effect results in the significant reduction of elevated triglyceride levels and the enhancement of beneficial High-Density Lipoprotein (HDL) cholesterol. Fibrates are a component of medical practice used for their efficacy in lowering plasma triglycerides, which is a key component of lipid management. This action confirms the medicine's role in helping to rebalance fats and fatty substances circulating in the blood of adult patients.


Form and Formulation: The Role of the Capsule

Lipanthyl 300 is supplied as an oral hard capsule, specifically engineered for reliable ingestion and systemic absorption. Because the active compound Fenofibrate is virtually insoluble in water, this particular formulation employs technologies, such as micronized or nanoparticle technology, to ensure consistent absorption and improved bioavailability. This manufacturing approach ensures the reliable delivery and conversion of the prodrug to Fenofibric acid necessary for its lipid-modifying effect.

Regulatory References

  1. Fenofibrate DailyMed/FDA Information
  2. MedlinePlus Fenofibrate Information

What side effects are possible with Lipanthyl 300?

Possible Side Effects and Safety Information

The safety profile for Fenofibrate (the active ingredient in Lipanthyl 300) is structured around official regulatory classifications to describe the nature and frequency of possible adverse reactions.

Adverse effects are documented according to the affected system-organ classes. For example, Hepatobiliary disorders may include increases in liver enzymes (transaminases) or, less commonly, the formation of gallstones (cholelithiasis). Gastrointestinal disturbances, such as abdominal pain, nausea, and flatulence, are among the most frequently observed effects.

Frequency Classification of Adverse Reactions

Classification Example Adverse Reactions (Regulatory Data)
Common (ge 1/100 to < 1/10) Gastrointestinal disturbances, increases in liver transaminases.
Uncommon (ge 1/1,000 to < 1/100) Headache, Pancreatitis, Myalgia (muscle pain), Thromboembolism.
Rare (ge 1/10,000 to < 1/1,000) Hepatitis, Hypersensitivity reactions, decreases in blood cell counts (Anemia, Leukopenia).

Serious Adverse Reactions and Constraints

Regulatory documents list certain rare but serious adverse reactions, including Rhabdomyolysis (severe muscle breakdown), Pancreatitis, and Venous Thromboembolism (blood clots in the veins). The official safety profile also notes constraints related to exposure duration: increases in liver enzymes are often transient and may be more likely at the start of treatment or during dose titration, according to regulatory data.

The medicine is contraindicated by regulatory authorities in individuals with severe renal impairment, active liver disease, and pre-existing gallbladder disease. Furthermore, there is a documented increased risk of serious muscle toxicity when Fenofibrate is used alongside HMG-CoA Reductase Inhibitors (Statins).

Overdose and Emergency Response

The official regulatory documentation for fenofibrate (Lipanthyl 300) indicates that there is limited experience regarding acute overdosage in humans. Due to this constraint, no specific set of symptoms is formally recognized solely for acute overdosage. However, management must address the potential for severe adverse reactions known to be associated with the drug, particularly myopathy and rhabdomyolysis, which affect the musculoskeletal and renal systems.

When to Seek Immediate Medical Help

It is a mandatory instruction from regulatory authorities to seek immediate medical attention or contact emergency services immediately if an overdosage is suspected. This urgent action is required because, while no specific antidote is known, prompt medical intervention allows for immediate symptomatic and supportive treatment.

Official Management and Monitoring

The officially defined management strategy includes close monitoring of the patient’s vital signs and clinical status. Because of the risk of severe muscle toxicity, monitoring of serum creatine kinase (CK) concentration and liver function is also necessary. Regulatory prescribing information notes that procedural steps may include the elimination of unabsorbed drug by emesis or gastric lavage. Furthermore, due to the drug’s high plasma protein binding, hemodialysis should not be considered as it is unlikely to be an effective measure.

Therapeutic Uses of Lipanthyl 300

Lipanthyl 300 is commonly used to address conditions involving abnormal blood fat levels, generally referred to as dyslipidemia. The medication is commonly used, alongside diet, for managing conditions such as Primary Hypercholesterolemia or Mixed Dyslipidemia. This is considered relevant within its therapeutic domain.


Managing Abnormal Blood Fat Patterns

This medicine is applied across domains where additional symptomatic support is needed to address symptom clusters related to systemic imbalance and is used for managing the related symptom clusters of elevated triglycerides and insufficient levels of HDL cholesterol. It is relevant for managing conditions presenting with systemic discomfort where multiple abnormal fat levels cluster together.

“The drug is commonly used when supportive symptom management is appropriate to address a combination of high triglycerides and low beneficial cholesterol.”

The medication is also commonly used to help with Severe Hypertriglyceridemia, where fat levels are critically high and pose an acute risk. This provides support that helps ease the overall symptom burden by reducing these high fat levels and may assist with managing the potential risks associated with excessively high fat levels. Furthermore, it is considered relevant for managing the specific lipid patterns seen in adult patients with Type 2 Diabetes and Metabolic Syndrome.

Quick Fact: Relief for Severe Hypertriglyceridemia
Used in contexts involving heightened systemic burden, Lipanthyl 300 supports the patient during difficult episodes by easing distress related to critically high fat levels.

Regulatory References

  1. DailyMed NIH overview on Fenofibrate

Eligibility and Restrictions for Use

Official Eligibility Rules for Lipanthyl 300 (Fenofibrate)

Lipanthyl 300 is an approved medication for use in adult patients (18 years and older). Regulatory guidelines define specific conditions and populations that restrict or prohibit its use.


Absolute Contraindications

The medicine must not be used if any of the following conditions are present, as stated in official labeling:

  • Active liver disease, including biliary cirrhosis, or persistent, unexplained elevations in liver enzymes.
  • Severe renal impairment, generally defined as an eGFR < 30 mL/min/1.73m^2 (including patients on dialysis).
  • Known gallbladder disease.
  • Known photoallergy or phototoxic reaction to fibrates or ketoprofen.
  • Known hypersensitivity to fenofibrate or any excipients.

Restricted or Limited Eligibility

Population Eligibility Status (Regulatory Wording)
Pediatric Patients (Under 18) Not recommended; safety and efficacy are not established.
Pregnant/Breastfeeding Women Not recommended during pregnancy; Contraindicated during breastfeeding.
Mild to Moderate Renal Impairment Conditional use; requires a mandatory dose reduction.
Elderly Patients (Geriatric) Use is permitted, but dosage selection must be based on renal function.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Lipanthyl 300 (fenofibrate) has officially documented interactions that require close monitoring or specific adjustments when co-administered with certain medications. These constraints are primarily defined by the drug's effect on other medicines or an increased risk of specific toxicities.


Documented Interacting Medicinal Products and Categories

Category or Product Nature of Interaction and Regulatory Constraint
Oral Anti-coagulants (Coumarin derivatives) Fenofibrate enhances their effect. The anti-coagulant dose must be reduced initially (approx. one-third) and followed by frequent INR monitoring to manage the increased bleeding risk.
HMG-CoA Reductase Inhibitors (Statins) / Other Fibrates The risk of serious muscle toxicity (e.g., rhabdomyolysis) is significantly increased. This combination requires caution and close monitoring for muscle-related symptoms.
Immunosuppressants (e.g., Ciclosporin) Concomitant use has been associated with reversible renal function impairment. Close monitoring of kidney function is required, and fenofibrate must be stopped if laboratory parameters are severely altered.
Bile Acid Binding Resins These can interfere with fenofibrate absorption. Administration must be separated by taking fenofibrate at least one hour before or four to six hours after the resin.

Mechanistic Basis and Other Notes

Fenofibric acid, the active metabolite, is identified as a weak to mild-to-moderate inhibitor of specific Cytochrome P450 (CYP) enzymes, notably CYP2C9. Co-administered medications with a narrow therapeutic index that are metabolized by this pathway should be carefully monitored, and their dose may need adjustment. The drug may also interact with Glitazones and Colchicine, necessitating specific monitoring procedures.

Mechanism of Action

Nuclear Receptor Agonism and Genetic Regulation

The action of Lipanthyl 300, via its active metabolite fenofibric acid, begins with the selective agonism (activation) of the Peroxisome Proliferator-Activated Receptor alpha (PPARalpha) in metabolically active tissues. This nuclear receptor acts as a master transcriptional regulator, binding to DNA segments (PPREs) to directly alter the production of enzymes and proteins that control fat transport. The mechanism alters the cellular machinery responsible for lipid metabolism over time.


Enhancing Fat Breakdown and Clearance

The transcriptional effect of PPARalpha activation leads to a critical two-part cascade in plasma fat processing. It significantly upregulates the enzyme Lipoprotein Lipase (LPL), which is crucial for the breakdown of circulating fats, while simultaneously downregulating Apolipoprotein C-III (Apo C-III), an inhibitor of LPL. This dual action dramatically enhances the catabolism (breakdown and removal) of triglyceride-rich VLDL and chylomicrons, resulting in the core physiological effect of enhanced fat clearance from the bloodstream.


Lipoprotein Particle Remodeling

Beyond fat breakdown, the drug's mechanism also structurally alters fat-carrying particles. It upregulates the structural components of HDL (Apo A-I and Apo A-II), supporting the formation of HDL particles and increasing the component proteins associated with reverse cholesterol transport. The mechanism also promotes a shift in LDL particles toward larger, more buoyant forms, which demonstrate altered susceptibility to physiological processes, contributing to a defined alteration in fat transport particle composition throughout the body.

Dosage and Administration Information

How to Use Lipanthyl 300: Official Administration Guidelines

Lipanthyl 300, which contains the active ingredient fenofibrate, is administered via the oral route as a prescription medicine. The usage protocol is defined by official labeling, covering dosing, frequency, and administration conditions.


Administration Scope

Feature Official Instruction
Route of administration Oral (by mouth).
Dosing schedule The usual adult dose for mixed dyslipidemia is a single daily dose of 145 mg or 160 mg, depending on the specific formulation being used. A lower starting dose (e.g., 48 mg once daily) is often utilized for severe hypertriglyceridemia.
Timing in relation to meals This is formulation-specific: some products require administration with food for adequate absorption, while others may be taken with or without food.
Preparation requirements The capsule or tablet must be swallowed whole and must not be crushed, broken, dissolved, or chewed to preserve the intended delivery mechanism.
Age-group administration rules The medicine is not recommended for pediatric patients. For adults with mild to moderate renal impairment, a lower initial dose is required; use is generally avoided in severe impairment.
Missed-dose rules If a dose is missed, patients are instructed not to take an extra dose and should resume the treatment schedule with the next planned dose.

Procedural Structure

The official administration protocol requires ingesting the assigned dose orally once daily, strictly adhering to the specific meal timing mandated by the formulation. To ensure proper absorption, the medicine must be swallowed intact. The protocol establishes a long-term management strategy where the initial dose is maintained for four to eight weeks before lipid levels are formally assessed for potential dose adjustment. Furthermore, fenofibrate must be administered either at least 1 hour before or 4 to 6 hours after a bile acid binding resin to prevent impaired absorption.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Lipanthyl 300

Lipanthyl 300 (fenofibrate) was studied for use in the context of abnormal blood fat patterns, with the evidence primarily derived from controlled clinical trials and large, long-term research projects. Research efforts examined specific fat and cholesterol biomarkers and long-term health outcomes.


Evidence for Modifying Core Lipid Markers (Primary Hypercholesterolemia & Mixed Dyslipidemia)

This research area involved short-term, controlled clinical trials. Researchers examined outcomes related to systemic imbalance by measuring key lipid biomarkers, including Triglyceride (TG) levels, Low-Density Lipoprotein (LDL) cholesterol, and High-Density Lipoprotein (HDL) cholesterol. The core studies supporting regulatory assessment reported measurements of changes in these lipid biomarkers over short-term durations.

However, the evidence gathered in this general population is limited by the short follow-up durations. Since this research primarily relies on tracking biomarkers rather than tracking long-term clinical events, long-term effects are not fully established.


Long-Term Research: Studies in High-Risk Populations (Type 2 Diabetes and Atherogenic Dyslipidemia)

Fenofibrate was evaluated in research exploring Type 2 Diabetes and atherogenic dyslipidemia in large-scale, long-term Randomized Controlled Trials (RCTs). Research examined both macrovascular outcomes (composite endpoints for major cardiovascular events) and microvascular outcomes (e.g., diabetic eye disease and non-traumatic amputations).

Trials reported how symptoms evolved in the observed populations regarding microvascular outcomes, with some trials describing patterns related to retinopathy and amputations. However, findings were mixed for the primary macrovascular composite endpoint, with the primary composite macrovascular outcome not being reached in the overall trial populations studied. Research indicates that patterns related to some outcomes were observed when studies explored specific patient subgroups.

Key Studies & References Fenofibrate (DailyMed NIH overview on Fenofibrate)

Frequently Asked Questions (FAQ)

Common questions about Lipanthyl 300 (FAQ)

Q: What does the '300' in Lipanthyl 300 refer to?

The number "300" typically refers to the strength of the active ingredient, fenofibrate, usually measured in milligrams (mg). Fenofibrate is available in various strengths and formulations, such as those labeled as 145 mg or 160 mg in different markets, all containing the same active substance.


Q: What are the official approved uses of Lipanthyl 300?

Regulatory documents state that Lipanthyl 300 is approved for use alongside a diet to help adults manage abnormal blood fat levels, specifically by reducing high levels of triglycerides and low-density lipoprotein cholesterol (LDL-C). For individuals with severe hypertriglyceridemia, it is indicated to lower extremely high triglyceride levels.


Q: How does Lipanthyl 300 help with cholesterol?

Official information describes that Lipanthyl 300 works by activating a specific receptor in the body that helps regulate fat and cholesterol. This process enhances the breakdown and removal of fat-carrying particles from the bloodstream. This action is associated with both lowering LDL-C (sometimes called 'bad cholesterol') and raising HDL-C ('good cholesterol').


Q: What is the difference between Lipanthyl 300 and a statin?

Lipanthyl 300 is classified as a fibrate, and its primary action involves managing blood fats, mainly triglycerides, by activating a receptor called PPAR\alpha. Statins, which are a different class of medicine, work mainly by limiting the liver’s production of cholesterol. While both are used for managing blood lipids, their core mechanisms of action are distinct.


Q: Do I need to change my diet while taking Lipanthyl 300?

Regulatory information states that this medicine is indicated as an adjunct to diet. This means that any appropriate dietary measures used to lower blood fats, which should be started before taking the medicine, must be continued throughout the treatment period.


Q: What kind of diet changes are generally expected when starting Lipanthyl 300?

Official guidance indicates that patients are instructed to adhere to an appropriate lipid-lowering diet before starting the medicine, and this diet should be continued during treatment. The core expectation is adherence to dietary measures designed to help manage blood fat levels.


Q: How quickly does Lipanthyl 300 start to work?

Pharmacological studies indicate that the active form of the medicine, fenofibric acid, typically reaches stable levels in the bloodstream within about five days of starting treatment. This suggests the medicine is consistently available to begin its fat-modifying effect relatively quickly.


Q: What is the expected timeline to see blood test changes from Lipanthyl 300?

Official guidelines recommend that a patient's lipid levels be checked via blood tests after the initial dose has been maintained for a period of four to eight weeks. This timeframe allows for a formal assessment of whether the medicine is having the desired effect on blood fat levels.


Q: What are the common side effects of Lipanthyl 300?

Regulatory data lists the most frequently reported adverse reactions. These commonly include gastrointestinal disturbances, such as nausea, abdominal pain, vomiting, or flatulence. Increases in liver enzymes (transaminases) are also classified as a common occurrence.


Q: Can Lipanthyl 300 cause muscle pain?

Regulatory data lists Myalgia (muscle pain) as an uncommon side effect. Unexplained muscle pain, tenderness, or weakness are symptoms noted in official warnings that require specific attention due to the rare risk of a serious muscle condition.


Q: What are the signs of a possible allergic reaction to Lipanthyl 300?

Official safety data confirms that rare but serious hypersensitivity reactions have been reported. Signs can include immediate reactions like anaphylaxis (a severe, sudden allergic reaction) and angioedema (swelling beneath the skin). Delayed, severe skin reactions have also been documented in post-marketing reports.


Q: What does the term 'hypertriglyceridemia' mean in simple language?

Hypertriglyceridemia is a medical term used to describe a condition where a person has an elevated or abnormally high concentration of triglycerides in their blood. Triglycerides are a common type of fat carried in the bloodstream, and Lipanthyl 300 is indicated to help reduce these levels.


Q: Does Lipanthyl 300 affect my blood sugar levels?

Regulatory documents mention the medicine's use in managing abnormal blood fats for patients with Type 2 diabetes mellitus. Some fenofibrate formulations have a specific indication related to reducing the progression of diabetic retinopathy, a condition affecting the eyes in people with diabetes.


Q: How long is Lipanthyl 300 usually taken for?

According to regulatory guidance, this medicine is intended to be used as a long-term treatment in combination with diet, with its ongoing efficacy monitored periodically through testing. It is not typically prescribed as a short-term course of medication.


Q: Is it necessary to take Lipanthyl 300 at the same time every day?

The medicine is prescribed as a single daily dose. Taking once-daily medications at a consistent time each day is generally considered a way to help maintain stable levels in the blood.


Q: Are there different forms of Lipanthyl 300 available?

Yes, the active ingredient fenofibrate is available in various approved oral forms, which may include different types of tablets and capsules, and are manufactured in multiple strengths, such as 145 mg or 160 mg formulations.


Q: Does Lipanthyl 300 contain lactose or gluten?

Some formulations of fenofibrate are known to contain lactose (a type of sugar). The excipients, or inactive ingredients, are formulation-specific, and patients with specific intolerances, such as to lactose, should refer to the patient information leaflet or packaging of their specific product for a full list of excipients.


Q: Is Lipanthyl 300 considered a high-risk medication?

As a prescription-only medicine, it has defined warnings and restrictions. Official documents list specific contraindications (reasons not to use it), such as severe kidney or liver disease. It also has warnings about the increased risk of serious muscle toxicity when taken with certain other drugs, which necessitates caution and close monitoring.


Q: Why do official documents mention regular blood tests when taking Lipanthyl 300?

Regular blood tests are recommended primarily because the medicine is known to cause temporary increases in liver enzymes and can sometimes affect kidney function. Monitoring these tests is required to check for possible adverse effects and to ensure the medicine is working effectively without causing harm.


Q: What kind of monitoring is typically recommended with Lipanthyl 300?

The monitoring protocol involves regular checks of serum lipid values (such as total cholesterol, LDL-C, and triglycerides) to assess effectiveness. Additionally, the regular checking of liver function (transaminases) and renal function (creatinine) is required to ensure safety.


Q: Does alcohol use affect Lipanthyl 300?

Official warnings note that heavy alcohol intake is a factor listed in regulatory documents that may predispose individuals to certain serious side effects. Additionally, alcohol can be a cause of elevated blood fat levels, which should be managed before therapy with fenofibrate begins.


Q: Can Lipanthyl 300 affect my vision?

Regulatory information for some fenofibrate products includes an indication related to reducing the progression of diabetic retinopathy in patients with Type 2 diabetes. This relates to a specific ophthalmologic condition studied in patients with diabetes, rather than general vision-related side effects.


Q: Is Lipanthyl 300 available in generic form?

Yes, the active ingredient, fenofibrate, is widely available in generic formulations. These generic versions are supplied as both tablets and capsules across various strengths.


Q: Is it normal to feel tired when first starting Lipanthyl 300?

The official product characteristics list known side effects, which include headaches as an uncommon event. However, general fatigue or tiredness is not specifically listed as a common or uncommon adverse reaction in the authoritative regulatory data.


Q: What are the main findings from clinical trials on Lipanthyl 300?

Clinical research examined the drug’s ability to modify blood fat and cholesterol biomarkers. Long-term studies in high-risk groups, such as people with Type 2 diabetes, also explored cardiovascular and microvascular outcomes. Findings related to certain microvascular complications were observed in these trials.

How should Lipanthyl 300 be stored and disposed of?

How to Store and Dispose of Lipanthyl 300

Storage of Lipanthyl 300 (fenofibrate) must adhere strictly to regulatory conditions to ensure stability.

Storage Conditions

Requirement Specific Condition
Temperature Store at Controlled Room Temperature (20 C to 25 C / 68 F to 77 F).
Environmental Must be protected from moisture and not refrigerated or frozen.
Packaging Keep the medicine in its original container and tightly closed.
Child Safety Store out of the sight and reach of children.

Disposal Instructions

Unused or expired Lipanthyl 300 must not be thrown away with household trash or disposed of via wastewater. Disposal should be carried out through an authorized medicine take-back program or in accordance with specific local pharmaceutical waste regulations.

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

Equivalent of Lipanthyl 300 found in:

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