Supralip 145 mg

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Supralip 145 mg

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Overview of Supralip 145 mg

Quick Facts

Property Description
Active ingredient Fenofibrate
Form Film-coated tablet (often nanocrystallized)
Pharmacological class Fibric acid derivative (Fibrate)
Common use Lipid-regulating agent for dyslipidemia
Origin Synthetic

What is Supralip 145 mg and What Class Does it Belong To?

Supralip 145 mg is a synthetic prescription medication whose active ingredient is Fenofibrate, a chemical entity primarily classified as a fibric acid derivative, often referred to simply as a Fibrate. This agent functions as a hypolipidemic agent, meaning its primary therapeutic role is to help reduce and manage abnormally high levels of fats, or lipids, in the bloodstream. It is a single-ingredient compound used in the comprehensive management of lipid disorders. Fenofibrate is a synthetic compound derived from fibric acid.

The medication's classification as a Fibrate points directly to its purpose as a specialized, orally administered agent for correcting a dysregulated lipid metabolism profile. This class of drug is clinically recognized for its ability to manage mixed dyslipidemia. Fibrates are a class of drugs used to lower high levels of fats, particularly triglycerides, in the blood. The medication is primarily aimed at correcting imbalances in blood fat levels.


Active Ingredient, Form, and General Therapeutic Purpose

The core component of the medicine is Fenofibrate, presented in a 145 mg film-coated tablet that is engineered for optimized oral absorption. This specific 145 mg formulation often utilizes nanocrystallization technology, which is an advanced formulation method that reduces the particle size of the drug to enhance the rate and extent of its absorption (bioavailability) into the systemic circulation compared to older micronized forms. This technological feature is a key differentiator of this product line.

The general therapeutic purpose of this Fenofibrate formulation is to serve as a lipid-regulating agent to normalize concentrations of circulating fats in patients diagnosed with dyslipidemia, which includes conditions like excessive hypertriglyceridemia and elevated hypercholesterolemia. Fibrates, like Fenofibrate, are used for lowering elevated triglyceride levels. A typical use scenario involves its employment as an adjunct to diet and exercise for individuals whose high triglyceride levels pose cardiovascular risk. By actively regulating the production and processing of fatty substances at a cellular level, Fenofibrate is a tool for managing adverse lipid profiles.

Regulatory References

  1. MedlinePlus
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What side effects are possible with Supralip 145 mg?

Possible Side Effects and Safety Information

The safety profile of Supralip 145 mg (Fenofibrate) is defined by official regulatory documents, which classify adverse reactions based on their reported frequency and the system-organ class (SOC) affected. The most frequently observed adverse reactions, classified as Common, include abnormal liver tests (such as increased AST and ALT levels), elevated Creatine Phosphokinase (CPK) levels, and minor events like rhinitis.


Key System-Organ Classifications

Side effects are primarily documented within the Hepatobiliary Disorders (liver and gallbladder) and Musculoskeletal and Connective Tissue Disorders (muscles and joints). Uncommon side effects, reported in less than 1% of patients, include cholelithiasis (gallstone formation) and various muscle disorders like myalgia (muscle pain) and spasms.

Documented Serious Adverse Reactions

The regulatory labeling includes reports of serious, non-frequent adverse reactions. These include severe Hepatotoxicity (serious liver injury, rarely resulting in transplantation or death), severe Muscle Toxicity such as Myopathy and Rhabdomyolysis, and acute Hypersensitivity Reactions (e.g., anaphylaxis). Other serious postmarketing reports include Pancreatitis and Interstitial Lung Disease.

Safety Restrictions and Monitoring

Fenofibrate is contraindicated for individuals with pre-existing conditions such as active liver disease, severe renal impairment (eGFR less than 30 mL/ min/1.73 m^2), or known gallbladder disease. The risk of serious muscle toxicity is noted as increased in specific populations, including elderly patients, and those with diabetes or uncontrolled hypothyroidism. The incidence of transaminase elevations is described as dose-related in regulatory documents.

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Overdose and Emergency Response

Overdose and When to Seek Help

Supralip (fenofibrate) Overdose Information

There is limited specific clinical experience concerning overdosage with fenofibrate. The common symptoms reported in cases of overdose typically involve gastrointestinal distress, such as nausea and diarrhea. Due to the wide therapeutic index of fenofibrate, an overdose is generally not anticipated to be life-threatening.

In the event of a suspected overdose, there is no specific antidote. Management is supportive and symptomatic, focusing on maintaining vital signs and providing general supportive care. If the ingestion was recent, procedures such as inducing vomiting or gastric lavage may be considered to remove unabsorbed drug from the gastrointestinal tract. Due to fenofibrate's high degree of protein binding, hemodialysis is unlikely to be effective in clearing the drug from the bloodstream.

When to Seek Urgent Medical Help

If you believe you have taken more Supralip 145 mg than prescribed, you should immediately contact your local poison control center or emergency medical services, even if you do not feel unwell. Immediate medical attention is crucial for evaluation and appropriate management.

Seek emergency help immediately if you experience severe symptoms that could indicate a serious adverse reaction, regardless of dosage, including:

  • Unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark-colored urine (potential sign of rhabdomyolysis).
  • Signs of a severe allergic reaction (e.g., swelling of the face, lips, tongue, or throat, or difficulty breathing).
  • Severe abdominal pain that may radiate to the back (potential sign of pancreatitis or gallstones).
  • Yellowing of the skin or eyes (jaundice), dark urine, or upper right abdominal pain (signs of liver problems).
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Therapeutic Uses of Supralip 145 mg

What Supralip 145 mg Treats: Main Uses and Benefits

Supralip 145 mg (Fenofibrate) plays a role in managing symptoms related to systemic imbalance in blood fat concentrations, which are largely asymptomatic, and is applied in addressing conditions marked by increased physiological stress. This treatment is commonly used as an adjunct to diet and exercise in adult patients. The medication is indicated for the management of lipid disorders and severe fat elevations.

Therapeutic Focus and Benefits

The medication is primarily used to address major conditions such as Mixed Dyslipidemia and Severe Hypertriglyceridemia. It is applied in addressing high concentrations of triglycerides and low levels of protective HDL-C, and is relevant for easing symptoms related to systemic imbalance associated with acute or episodic changes in fat concentration.

“The use of this therapeutic agent supports patients by directly targeting pronounced concentrations of circulating fats, contributing to easing the overall symptom load during periods of heightened systemic burden.”

Targeting Severe Hypertriglyceridemia and Acute Risk

This medication is applied across domains where additional symptomatic support is needed, such as the management of Severe Hypertriglyceridemia. By providing supportive relief and may assist with managing pronounced triglyceride levels, the medication provides supportive relief that may assist with managing the risk of Pancreatitis, a complication associated with marked physiological stress.

Modifying Atherogenic Lipid Patterns

Fenofibrate is also relevant for easing symptoms related to systemic imbalance, as it addresses the high-risk lipid profile known as atherogenic dyslipidemia. It is used for managing low levels of protective HDL-C and is applied to ease challenging symptoms associated with imbalances in fat particle distribution. This modification may assist with maintaining a sense of stability when symptoms are more noticeable.


Quick Fact: Relief for Lipid Imbalance
Primary Target Pronounced Triglyceride levels (relevant for easing symptoms related to systemic imbalance)
Secondary Target Low protective HDL-C and symptoms related to systemic imbalance
Context of Use Conditions presenting with systemic or localized discomfort related to fat profile
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Eligibility and Restrictions for Use

Supralip 145 mg (fenofibrate) is officially approved for use exclusively in adult patients. Eligibility for the medication is strictly defined by regulatory authorities based on organ function, disease history, and life stage.

Contraindications and Absolute Non-Eligibility

Use of this medicine is contraindicated and must be avoided in populations with the following specific conditions, as stated in the official regulatory labeling:

Classification Absolute Exclusion
Organ Dysfunction Severe renal impairment (eGFR < 30 mL/min/1.73 m^2), including those on dialysis. Active liver disease (including primary biliary cirrhosis) or unexplained persistent liver function abnormalities.
Comorbidity Pre-existing gallbladder disease.
Hypersensitivity Known allergy to fenofibrate or history of photoallergy/phototoxic reaction to fibrates.
Life Stage Nursing mothers (breastfeeding women).

Restricted and Non-Recommended Use

  • Paediatric Use: The drug is not recommended for children and adolescents under 18 years of age, as the safety and efficacy have not been established in this population.
  • Renal Impairment: Patients with moderate renal impairment ( eGFR 30–59 mL/min/1.73 m^2) require dose reduction as a condition of use.
  • Pregnancy: Use is generally not recommended due to limited available human data and should only be considered if the potential benefit justifies the potential risk to the fetus.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Fenofibrate as stated in regulatory documents.

Drug–Drug Interaction Restrictions

Co-administration with HMG-CoA reductase inhibitors (Statins) should be avoided unless the benefits significantly outweigh the increased, officially documented risk of myopathy and rhabdomyolysis. This same musculoskeletal risk has also been reported with the concomitant use of Colchicine. Fenofibrate use potentiates the effect of Coumarin Anticoagulants (such as Warfarin), resulting in a prolongation of the Prothrombin Time (PT)/INR; this requires a dosage reduction of the anticoagulant. Concomitant use with Immunosuppressants (e.g., Cyclosporine) carries a risk of interaction leading to deterioration of renal function.

Pharmacokinetic and Timing Rules

Fenofibrate is classified as a mild-to-moderate inhibitor of the CYP2C9 enzyme. This affects the plasma exposure of several co-administered medicines, including increasing the systemic exposure (AUC) of drugs like Glimepiride and Pravastatin. Administration with Bile-Acid Binding Resins (sequestrants) may impede Fenofibrate absorption, and the regulatory label mandates separation by administering Fenofibrate at least 1 hour before or 4 to 6 hours after the resin. Fenofibrate absorption is officially enhanced when taken with food.

Population-Specific Notes

The documented risk of myopathy and rhabdomyolysis during co-administration with a Statin is increased in elderly patients and those with pre-existing conditions such as renal impairment, diabetes, or hypothyroidism.

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Mechanism of Action

Supralip 145 mg, containing fenofibrate, is a prodrug that undergoes rapid hydrolysis by tissue and plasma esterases to its active metabolite, fenofibric acid. The primary biological target is the peroxisome proliferator-activated receptor alpha (PPARalpha), a ligand-activated nuclear transcription factor predominantly expressed in the liver.

Fenofibric acid acts as a PPARalpha agonist, binding to the receptor and inducing the transcription of target genes. This molecular interaction initiates several intracellular pathways. It upregulates the synthesis and activity of lipoprotein lipase (LPL) and simultaneously reduces the production of apolipoprotein C-III (ApoC-III), an LPL inhibitor.

This downstream cascade results in an accelerated lipolysis and enhanced catabolism of triglyceride-rich particles, specifically very low-density lipoprotein (VLDL). Concurrently, PPARalpha activation promotes the synthesis of apolipoproteins A-I and A-II, integral components of high-density lipoprotein (HDL). The system-level physiological consequence is a substantial modulation of plasma lipid profiles, characterized by a decrease in circulating triglycerides and a shift in low-density lipoprotein (LDL) particles from small, dense to larger, more buoyant phenotypes.

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Dosage and Administration Information

How to Use Supralip 145 mg

The administration of Supralip 145 mg (Fenofibrate) follows standardized instructions focusing on the route, frequency, and specific dosing adjustments. The medicine is formulated as a film-coated tablet for oral administration and is typically prescribed as a once-daily dose.


Dosing and Administration Guidelines

Instruction Guideline
Route of Administration Oral.
Standard Daily Dose 145 mg once daily. The maximum recommended dose is 145 mg daily.
Timing Relative to Food May be taken with or without food.
Tablet Integrity The tablet must be swallowed whole. It should not be crushed, broken, dissolved, or chewed.

Procedural and Population Adjustments

General clinical protocols indicate that treatment begins while the patient is on an appropriate lipid-lowering diet. The standard dose of 145 mg is used for both primary hyperlipidemia/mixed dyslipidemia and severe hypertriglyceridemia, although a 48 mg dose is sometimes prescribed as a lower starting option for the latter indication. Dosage efficacy is reviewed based on follow-up lipid determinations conducted at four to eight-week intervals. In the event of a missed dose, the standard procedure is not to take an extra dose but to resume treatment with the next scheduled daily dose.

Kidney function is a critical factor in administration. For patients with mild to moderate kidney impairment (eGFR 30 to <60 mL/min/1.73m^2), the initial dose is reduced to 48 mg once daily. Conversely, the medication is not recommended for use in pediatric patients (under 18 years of age) as safety and efficacy have not been established. Furthermore, if treatment at the maximum recommended dose does not yield an adequate response after two months, discontinuation of therapy is typically considered.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Supralip 145 mg

Evidence for Use in Severe Hypertriglyceridemia

Research was conducted in adult patients diagnosed with very high levels of triglycerides, typically measured at 500 mg/dL or higher. Researchers examined how the study intervention was associated with changes in blood fat concentrations over defined time intervals. These trials primarily monitored shifts in blood markers such as triglyceride levels and protective HDL cholesterol. The research also explored the association between these blood marker changes and the incidence of acute complications, such as pancreatitis, which was an acute complication tracked by researchers.

Findings describe patterns observed in the studies, including measured shifts in serum triglyceride levels and associated changes in other cholesterol fractions. Patterns of measured shifts in lipid levels was observed across various trials. However, the outcomes related to the incidence of acute complications, such as pancreatitis, were often examined in relation to the changes observed in blood fat markers rather than being based on large event-based clinical trials specifically focused on this outcome. There is limited information for long-term outcomes on the overall health markers derived from studies focused solely on this event.


Evidence for Use in Mixed Dyslipidemia and Primary Hyperlipidemia

The most extensive research comes from large-scale, long-term Randomized Controlled Trials (RCTs). These studies were designed to monitor adult patients with high cardiovascular risk, frequently including those with Type 2 Diabetes Mellitus. Research examined how the study intervention was associated with changes in key lipid biomarkers and monitored the occurrence of Major Cardiovascular Events (MACE), such as non-fatal heart attack, stroke, and cardiovascular death.

Studies report how measured changes evolved in the observed populations, describing measurable changes in the lipid profile. The largest trials, which focused on cardiovascular events across the entire high-risk population, reported that the addition of the study intervention did not report a difference in clinical event rates compared to the control group. However, subgroup analyses within these large trials, which focused on patients with particularly high triglycerides and low HDL cholesterol, described patterns observed in those specific cohorts where event rates were measured.


What Remains Uncertain: Research Gaps and Limitations

Evidence quality varies across studies, and several key limitations persist within the research landscape. The primary uncertainty relates to the ability of the study intervention to consistently influence major cardiovascular event rates across the entire high-risk population, as observed in the main analyses of large RCTs. Data are still emerging for many specific long-term outcomes. Furthermore, positive patterns regarding clinical endpoints were primarily described in specific subgroup findings, which are inherently less certain than the results reported for the full trial population. Comparative evidence is lacking for how the treatment compares to newer lipid-regulating therapies in clinical event research.

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Frequently Asked Questions (FAQ)

Common questions about Supralip 145 mg (FAQ)


Q: How long do people typically need to take Supralip 145 mg?

Official product information states that fenofibrate is typically indicated for long-term treatment to manage lipid disorders. Therapy is often continued indefinitely, provided the medicine is tolerated and provides an adequate response. A healthcare provider periodically reviews the drug's efficacy.


Q: Is Supralip 145 mg a long-term maintenance drug or a temporary treatment?

Supralip 145 mg is generally considered a long-term maintenance drug intended to be used as an addition to diet and exercise. Regulatory guidelines specify that treatment should be stopped if the medication does not produce an adequate response after a two-month trial at the maximum dose.


Q: Why might a doctor prescribe Supralip 145 mg instead of another cholesterol drug?

Fenofibrate is specifically indicated for reducing elevated triglycerides and VLDL cholesterol. It is typically prescribed when these specific lipid imbalances are the primary focus of treatment. Its primary focus is on regulating triglycerides and VLDL cholesterol.


Q: How quickly does Supralip 145 mg start working after the first dose?

While the medicine begins acting immediately, the full effects on blood fat levels take time to develop. Official guidelines recommend that lipid levels be checked to determine the medicine's efficacy after 4 to 8 weeks of starting treatment.


Q: Do the effects of Supralip 145 mg last for the full 24 hours between doses?

Yes, the medicine is formulated for once-daily use. The active substance, fenofibric acid, has an elimination half-life of approximately 20 hours, which allows its effects to cover the entire 24-hour period between doses.


Q: What is the half-life of the active ingredient in Supralip 145 mg?

The active substance is fenofibric acid. According to regulatory pharmacokinetic data, this active metabolite has a plasma elimination half-life of approximately 20 hours. This property is why the medicine is typically administered once a day.


Q: What are the signs of muscle damage (myopathy) related to Supralip 145 mg?

Official safety information advises that patients be aware of signs of potential muscle toxicity, which include unusual muscle pain, tenderness, or weakness. The presence of these symptoms, especially with fever, is typically noted as a serious event that requires medical attention.


Q: What are the warning signs of gallbladder issues while on this medication?

Fenofibrate use has been associated with an increased risk of gallstone formation. The possible signs of gallbladder issues can include sudden pain in the upper right side of the belly or back, fever with chills, or yellowing of the skin or eyes.


Q: Is it common to experience headache and back pain when starting Supralip 145 mg?

Yes, based on clinical reports, headache and back pain are listed among the commonly reported side effects of fenofibrate. These effects are often reported when treatment is initiated.


Q: Why does Supralip 145 mg sometimes cause stomach pain or nausea?

Stomach pain and nausea are frequently reported gastrointestinal side effects associated with fenofibrate treatment. These effects are documented in official safety information.


Q: Is there a risk of blood clots associated with taking Supralip 145 mg?

Official documentation notes that the emergence of blood clot symptoms, such as chest pain, shortness of breath, or swelling in a limb, is a serious event that warrants medical evaluation.


Q: Can Supralip 145 mg affect a person's red or white blood cell count?

Yes, hematological changes have been reported with fenofibrate use. These can include a decrease in platelets (thrombocytopenia) or a decrease in white blood cells (agranulocytosis). Monitoring of blood cell counts is recommended during the initial phase of therapy.


Q: Does Supralip 145 mg cause weight gain or weight loss?

Weight changes are not listed as a common side effect of this medicine. However, official information notes that unexplained weight loss is a symptom noted as a serious event that warrants medical attention, as it may indicate a serious underlying issue like severe liver problems.


Q: Can a person with a history of gallbladder surgery still take this drug?

Fenofibrate is specifically contraindicated for patients with active or pre-existing gallbladder disease (cholelithiasis or cholecystitis). Official drug information does not typically restrict use solely based on a history of gallbladder removal surgery (cholecystectomy).


Q: Does a known allergy to peanuts or soy affect eligibility for Supralip 145 mg?

Some formulations of fenofibrate are known to contain soy-derived ingredients, such as lecithin, which is used as an inactive component. Individuals with a known allergy to soy or peanuts should check the inactive ingredients list for the specific product they are prescribed.


Q: Does drinking alcohol affect how Supralip 145 mg works or increase side effects?

Yes, consuming heavy amounts of alcohol can directly lead to higher triglyceride levels, which may reduce the effectiveness of the medication. Additionally, alcohol can increase the risk of serious side effects, such as liver damage and pancreatitis.


Q: Is there an interaction between Supralip 145 mg and oral contraceptives?

Studies found no clinically relevant pharmacokinetic interaction between fenofibrate and oral contraceptives. However, it is noted that the estrogens and progestogens in contraceptives can sometimes cause hypercholesterolemia.


Q: Are there any known interactions between Supralip 145 mg and supplements like fish oil?

Official drug interaction checkers indicate that there is no known interaction between fenofibrate and supplements containing fish oil (Omega-3 fatty acids). Both substances, however, may affect lipid parameters and liver enzyme levels.


Q: Why is diet and exercise still required when taking Supralip 145 mg?

Official regulatory documents indicate that fenofibrate is prescribed as adjunctive therapy to diet and exercise. This means the medicine is intended to be used in addition to, and not as a replacement for, lifestyle changes to manage blood fat levels.


Q: Is muscle pain a common side effect, or a sign of a more serious problem?

Muscle pain (myalgia) is reported as an uncommon side effect. However, muscle pain, tenderness, or weakness are also key symptoms of the serious condition known as myopathy (muscle damage). This is typically noted as a serious event that warrants medical evaluation.


Q: Does Supralip 145 mg make the skin more sensitive to sunlight?

Yes, official safety documents list photosensitivity reactions as a possible side effect of fenofibrate. This means the skin may be more susceptible to burning or damage from exposure to sunlight.


Q: Is Supralip 145 mg typically prescribed for patients over the age of 70?

The dosage regimen for older patients is similar to that of younger adults. However, regulatory warnings note that older patients have an increased risk of muscle toxicity, and therefore careful monitoring is typically required.


Q: Is a low-fat diet strictly necessary for Supralip 145 mg to be effective?

Fenofibrate is officially indicated as an adjunct to a diet restricted in saturated fat and cholesterol. The medicine is designed to work as part of this comprehensive lipid-lowering program and is not intended to work alone.

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How should Supralip 145 mg be stored and disposed of?

Storage and Disposal Requirements for Supralip 145 mg


Official Storage Conditions

Supralip 145 mg (Fenofibrate) must be stored according to regulatory labeling to maintain product stability. Store the medicine at Controlled Room Temperature, which requires the temperature to remain below 30 C (86 F). The tablets must be kept in their original container and protected from moisture.

It is mandatory to keep this medicine out of the sight and reach of children.

Disposal

Do not use the tablets after the expiration date on the package. Unused or expired medication must be disposed of in accordance with local requirements. Official guidelines typically advise against disposing of the product via wastewater or household waste.

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

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