Gemfibrozilo Stada

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Gemfibrozilo Stada

Method of action: Lipid Modifying Agents

Treatment option:

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 Gemfibrozilo Stada

Property Description
Active ingredient Gemfibrozil (INN)
Form Tablets (Oral formulation)
Pharmacological class Fibrate (Fibric acid derivative)
Common use Management of dyslipidemia
Origin Synthetic, Chemically derived

What is Gemfibrozilo Stada and its Composition?

Gemfibrozilo Stada is a single-ingredient, synthetic prescription medicine containing the active chemical substance Gemfibrozil (INN), marketed by the manufacturer Stada. This product is an oral formulation, specifically presented as tablets. The active component, Gemfibrozil, is a chemically derived molecule, classified as a carboxylic acid, and is not of natural origin. The product is defined as a single-entity medicine, relying exclusively on the Gemfibrozil molecule for its therapeutic effect via the oral route of administration.

Pharmacological Classification: The Fibrate Class

Gemfibrozilo Stada belongs to the fibrate pharmacological class, chemically categorized as a fibric acid derivative. More broadly, it is classified as a lipid-modifying agent or hypolipidaemic agent due to its recognized role in regulating fats in the bloodstream. This classification means Gemfibrozil works primarily by engaging the Peroxisome proliferator-activated receptor alpha (PPAR-α) pathway, a mechanism that is clinically recognized for its focus on modifying triglyceride metabolism.

General Purpose and Core Therapeutic Role

The general purpose of Gemfibrozilo Stada is to help manage dyslipidemia, a medical condition characterized by abnormal levels of fats circulating in the blood. The medicine achieves this by supporting the body's processes that break down and remove excess lipids. Gemfibrozil’s therapeutic role is to reduce high plasma triglyceride levels. The medication's primary benefit is helping to correct the lipid imbalance in the bloodstream, often used when hypertriglyceridemia (excess triglycerides) is the prevailing issue, thereby helping restore a healthier lipid profile.

Regulatory References

  1. Gemfibrozil Drug Information (MedlinePlus)

What side effects are possible with Gemfibrozilo Stada?

Possible Side Effects and Safety Information

Adverse Reactions

The most very common adverse reaction reported with gemfibrozil is dyspepsia (indigestion). Common effects, typically affecting the gastrointestinal tract, include abdominal pain, diarrhea, nausea, vomiting, constipation, and flatulence. Other common reactions involve the nervous system (headache, vertigo) and skin (eczema, rash, fatigue).

Serious Adverse Reactions

Though rare, clinically significant adverse reactions have been documented, primarily involving the musculoskeletal, hepatobiliary, and hematopoietic systems. These include myopathy and rhabdomyolysis (severe muscle breakdown), cholelithiasis (gallstones) and cholecystitis, pancreatitis, and severe blood disorders such as severe anemia and leucopenia. Rare cases of hepatitis and cholestatic jaundice have also been reported.

Safety Restrictions and Monitoring

Gemfibrozilo Stada is strictly contraindicated in patients with severe hepatic impairment, severe renal impairment, and pre-existing gallbladder or biliary tract disease. It is also contraindicated for use alongside specific medications, including simvastatin, repaglinide, or dasabuvir, due to a significantly increased risk of muscle toxicity or severe hypoglycemia.

Monitoring is required throughout treatment. Physicians must periodically check liver function tests (discontinuation is required for persistent abnormalities) and perform complete blood counts during the initial months. Muscle symptoms require immediate assessment, including Creatine Phosphokinase (CPK) levels, and treatment interruption if rhabdomyolysis is suspected. Caution is advised in patients with mild-to-moderate renal impairment or uncontrolled hypothyroidism.

Overdose and Emergency Response

The official regulatory information defines the overdosage profile of Gemfibrozil by listing specific clinical manifestations and specifying critical, life-threatening signs that necessitate an immediate emergency response. All suspected cases, regardless of severity, require seeking professional medical attention.

Overdose Manifestations and Emergency Action

Classification Manifestation/Required Action (Official Labeling)
Documented Manifestations Symptoms reported in overdosage cases include nausea, vomiting, abdominal cramps, diarrhea, joint pain, and muscle pain (myalgia).
Urgent Help Required When Emergency services must be called immediately if the affected individual has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened.
Mandated Action Seek emergency medical attention. Contacting the Poison Help line is also required guidance in overdosage situations.

The documented manifestations of overdosage generally involve gastrointestinal disturbances and musculoskeletal complaints. In terms of clinical management, regulatory documents specify that treatment must be symptomatic and supportive. This approach is mandated because the official prescribing information does not document a specific antidote for Gemfibrozil overdosage. No specific differential management guidance is provided for particular populations.

Therapeutic Uses of Gemfibrozilo Stada

What Gemfibrozilo Stada Treats: Main Uses and Benefits

Gemfibrozilo Stada is commonly used in situations involving the management of specific lipid disorders, and is considered relevant in conditions where functional stability becomes affected. The medicine is primarily relevant for conditions characterized by severe elevation of triglycerides (hypertriglyceridemia), and may be part of symptomatic management for primary hyperlipoproteinemia Type IV, Type V, and combined Type IIb.

The core therapeutic support contributes to easing the overall symptom load related to systemic imbalance. This is relevant in contexts involving heightened systemic burden. Furthermore, it is commonly used for managing low High-Density Lipoprotein (HDL) cholesterol. This supports general well-being during symptomatic phases.

“The medication is considered relevant in contexts involving long-term support for managing symptoms linked to organ-specific functional stress.”

Quick Fact: Relevant for Systemic Imbalance
Relevant for: Conditions marked by severe elevation of triglycerides and low HDL.
Patient Benefit: May assist with reducing the risk of Pancreatitis.

Regulatory References

  1. NIH DailyMed official label

Eligibility and Restrictions for Use

This section outlines the official eligibility requirements and exclusions for Gemfibrozilo Stada (gemfibrozil) based strictly on regulatory prescribing information.

Absolute Contraindications

Use is strictly prohibited in patients with the following conditions or co-medications:

  • Hepatic impairment (any degree of liver dysfunction, including primary biliary cirrhosis).
  • Severe renal impairment (severely compromised kidney function).
  • Pre-existing gallbladder or biliary tract disease (e.g., gallstones).
  • Known hypersensitivity to gemfibrozil or other fibrates.
  • Concomitant use with simvastatin, repaglinide, dasabuvir, or rosuvastatin 40 mg.

Population-Specific Restrictions

Population Eligibility Status (Official Labeling)
Pediatric Population Not Recommended (Safety and efficacy are not established).
Pregnancy Reserved (Use only if benefits clearly outweigh risks).
Lactation Avoided (Safety in nursing infants is not established).
Mild to Moderate Renal Impairment Restricted (Requires caution and a reduced initial dose).

Eligibility is also contingent upon the adequate control of other conditions, such as hypothyroidism or diabetes mellitus, prior to and during treatment. Use is generally established for adults who do not have the above exclusionary conditions.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The interaction profile for Gemfibrozil (the active substance in Gemfibrozilo Stada) is defined by its effects on drug metabolism and transport, as documented in regulatory information. Co-administration with certain substances is restricted due to risks of increased drug exposure or additive toxicity.

Formally Contraindicated Combinations

Official labeling contraindicates the combination of Gemfibrozil with several medicinal products, including Simvastatin and other statins (like the 40 mg dose of Rosuvastatin) due to a significantly heightened risk of myopathy and rhabdomyolysis. The co-administration of Gemfibrozil with Repaglinide and Dasabuvir is also forbidden.

Pharmacokinetic and Pharmacodynamic Effects

Gemfibrozil is documented as a strong inhibitor of the metabolic enzyme CYP2C8 and the hepatic uptake transporter OATP1B1. This inhibition increases the systemic exposure of co-administered medicines that are substrates for these pathways. This includes some statins and certain antidiabetic agents.

Through a separate effect, Gemfibrozil potentiates the effects of Coumarin-type anticoagulants (e.g., Warfarin), increasing the potential for bleeding and requiring careful monitoring.

Administration Requirements

Interaction with certain substances requires a mandated separation of administration time. Bile Acid Sequestrants (e.g., Colestipol) must be taken at least 2 hours apart from Gemfibrozil to prevent reduced absorption of Gemfibrozil. Furthermore, the combination with Colchicine is associated with an increased risk of myopathy, which is specifically highlighted as being greater in elderly patients and those with renal dysfunction.

Mechanism of Action

How Gemfibrozilo Stada Works

The mechanism of action of Gemfibrozilo Stada, containing Gemfibrozil, is driven by its influence on mechanisms governing lipid metabolism, primarily through gene transcription and enzyme activity. The compound alters how the liver and other tissues handle lipoproteins.


Activating the PPAR- alpha Receptor and Regulating Fat Genes

Gemfibrozil functions as a specific agonist for the Peroxisome Proliferator-Activated Receptor-alpha (PPAR- alpha), a nuclear receptor that acts as a key regulator of metabolic genes. By activating PPAR- alpha, the drug directly modulates the transcription of various genes, simultaneously increasing the production of fat-clearing enzymes like Lipoprotein Lipase (LPL) and reducing the supply of raw materials the liver uses to synthesize circulating fat particles.


Accelerating Triglyceride Breakdown and VLDL Clearance

The resultant increase in LPL activity, coupled with the downregulation of the LPL inhibitor Apolipoprotein C-III (ApoC-III), accelerates the breakdown (catabolism) and removal of Very Low-Density Lipoproteins (VLDL) and other triglyceride-rich particles from the bloodstream. This combined increase in the fat-clearing process results in a systemic reduction in plasma triglyceride concentration.


Effect on HDL Synthesis and Cholesterol Transport

The PPAR- alpha mechanism also upregulates the synthesis of key structural components, Apolipoprotein A-I (ApoA-I) and ApoA-II. These proteins are structural components necessary for the assembly of High-Density Lipoprotein (HDL) cholesterol. This action contributes to the function of the Reverse Cholesterol Transport pathway, resulting in an increase in the concentration of circulating HDL-cholesterol.

Dosage and Administration Information

How to Use Gemfibrozilo Stada: Official Administration Guidelines

Gemfibrozilo Stada is prescribed as part of a therapeutic plan and must be used according to specific instructions to ensure proper administration.


Administration Route and Standard Dosing

The medicine is designed for oral use and is supplied as 600 mg tablets. The standard adult regimen requires a total daily dose of 1200 mg. This total is administered in two divided doses of 600 mg each.


Frequency and Timing Instructions

Frequency: The standard dose is taken twice daily.

Timing: A critical instruction is to take the medicine in relation to meals. Each 600 mg dose must be taken 30 minutes before the morning meal and 30 minutes before the evening meal.


Population-Specific Use Rules

Patient Population Official Use Recommendation
Older Adults (over 65) Use the standard adult dose range.
Renal Impairment Treatment must be initiated at a reduced dose of 900 mg daily.
Pediatric Patients Not recommended due to insufficient data.

Course Duration and Special Conditions

Gemfibrozilo Stada is intended as an adjunct to diet. If a sufficient therapeutic response in blood lipid levels is not achieved after three months of treatment, the medication should be discontinued or reviewed. Furthermore, if patients are also taking bile acid-binding resins, Gemfibrozil should be administered 2 hours or more apart from the resin.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Gemfibrozilo Stada

Evidence for Primary Prevention of Heart Problems

The use of Gemfibrozil was studied for primary prevention in research exploring patterns in the occurrence of a first major cardiovascular event (like a heart attack). The research primarily consisted of large-scale, long-term Randomized, Double-Blind, Placebo-Controlled Trials (RCTs). These studies were evaluated in middle-aged men (typically 40–55 years) who had elevated cholesterol but no history of heart disease.

Researchers monitored the occurrence of major cardiovascular events over long follow-up durations. Studies reported measurements describing a pattern of lower plasma triglycerides and higher HDL-C levels in the observed group. The findings describe patterns observed in the studies but research does not determine whether an individual will respond similarly, as study results reflect the specific conditions under which they were conducted.

Evidence for Patients with Established Heart Disease

Gemfibrozil was observed in studies exploring patterns related to the recurrence of cardiovascular events in patients who had already experienced a heart event. Research for this scenario included major long-term RCTs. These studies explored populations of adult men who had confirmed coronary heart disease (CHD) and who were characterized by a specific lipid profile: low HDL-C and non-elevated LDL-C.

Research describes patterns related to the occurrence of major cardiovascular events observed over the study period. Trials reported consistent measurements describing shifts toward higher HDL-C levels and lower triglyceride levels.

Evidence for Managing Very High Triglycerides

Gemfibrozil was studied for the management of conditions characterized by very high serum triglycerides. This evidence contributes to understanding symptom patterns, particularly concerning the risk of acute Pancreatitis. Clinical trials and supporting data research examined how quickly and to what extent plasma triglyceride levels shifted in the studies.

Studies reported substantial measurements describing patterns of lower measurements in these severely elevated plasma triglycerides. Research also describes patterns related to both triglyceride measurements and the incidence of Pancreatitis observed in high-risk patients. However, some evidence derived from settings with varying symptom burdens also noted that an increase in LDL-C levels was observed in some studies in specific patients with high triglycerides.

Key Studies & References

  1. Label: GEMFIBROZIL tablet - DailyMed (NIH/FDA regulatory information)

Frequently Asked Questions (FAQ)

Common questions about Gemfibrozilo Stada (FAQ)


Q: Is Gemfibrozilo Stada a type of statin?

No, according to official product information, Gemfibrozil is classified as a fibrate, which is a distinct class of lipid-regulating medicine from statins. Regulatory documents also state that Gemfibrozil is strictly prohibited for co-administration with certain statins (like simvastatin) due to a heightened risk of serious muscle damage.


Q: How quickly should I expect to see lower cholesterol numbers after starting Gemfibrozilo Stada?

Regulatory labeling indicates that a sufficient therapeutic response in blood lipid levels should typically be achieved within three months of starting treatment. If measurable benefit is not observed after this period, the need for continued medication should be reviewed by a healthcare professional.


Q: Is it normal to feel slightly nauseous when first starting Gemfibrozilo Stada?

Official information lists nausea as a common adverse reaction, meaning it is reported in a range of patients. This type of common side effect often involves the gastrointestinal tract.


Q: Is it safe for women who are planning pregnancy to take Gemfibrozilo Stada?

The safety of this medication for women who are planning a pregnancy is not specifically detailed in the official labeling. Use during established pregnancy is reserved (only if the potential benefits clearly outweigh the risks). Therefore, any use must be discussed with a healthcare professional.


Q: Why is Gemfibrozilo Stada sometimes combined with other cholesterol medicines?

Gemfibrozil may be used alongside certain other lipid-regulating treatments, such as bile acid-binding resins, to achieve a comprehensive lipid-lowering effect. If Gemfibrozil is used alongside certain other agents, like bile acid-binding resins, specific administration timing is required according to the official product labeling to prevent reduced absorption.


Q: Are there any specific foods or drinks I should avoid while on Gemfibrozilo Stada?

Official regulatory information emphasizes that this medicine is an adjunct to diet, meaning it is designed to work as part of an overall lipid-lowering plan. While specific foods or drinks are not restricted in the labeling, patients are advised to follow the appropriate dietary recommendations provided by their healthcare professional.


Q: Does Gemfibrozilo Stada help with 'bad' cholesterol (LDL) or 'good' cholesterol (HDL) more?

According to official product information, the primary action of Gemfibrozil is to significantly decrease triglycerides and to increase High-Density Lipoprotein (HDL) cholesterol ('good' cholesterol). While there may be modest effects on Low-Density Lipoprotein (LDL) cholesterol, official labeling notes that in some clinical studies involving patients with severely elevated triglycerides, a rise in LDL-C levels was observed.


Q: How long does Gemfibrozilo Stada stay in your system?

The medicine is quickly processed by the body. Pharmacokinetic data indicates that Gemfibrozil reaches its peak blood concentration in 1 to 2 hours and has a short plasma half-life of approximately 1.5 hours following multiple doses.


Q: Are headaches a common side effect of Gemfibrozilo Stada?

Yes, official safety information lists headache as a common adverse reaction, meaning it is reported in a range of patients (1% to 10%). Common side effects often involve the nervous system.


Q: Is Gemfibrozilo Stada a blood thinner?

No, Gemfibrozil is not categorized as a blood thinner. However, regulatory documents warn that it can potentiate the effects of Coumarin-type anticoagulants (blood thinners like Warfarin). If taken with a Coumarin-type anticoagulant, careful monitoring and dose adjustments of the anticoagulant may be required according to official labeling.


Q: Why is Gemfibrozilo Stada sometimes prescribed for people who have already had a heart attack?

Clinical studies have included patients with established coronary heart disease (CHD), exploring patterns related to the recurrence of cardiovascular events in this specific group of patients who had certain lipid profiles.


Q: Can Gemfibrozilo Stada cause dizziness or make me feel tired?

Official safety information lists both vertigo (dizziness) and fatigue (tiredness) as common adverse reactions, meaning they are reported in a range of patients (1% to 10%).


Q: Is there a generic version of Gemfibrozilo Stada available?

Yes, regulatory authorities have approved generic versions of the Gemfibrozil 600 mg tablet. The generic form contains the same active ingredient as Gemfibrozilo Stada.


Q: Is the effect of Gemfibrozilo Stada permanent after stopping the treatment?

No, according to regulatory information, when the medication is discontinued, blood cholesterol and triglyceride levels may increase again. A physician may recommend continuing a healthy diet and other lifestyle changes to help maintain the benefits.


Q: Are there any long-term side effects associated with Gemfibrozilo Stada?

The official safety profile includes rare, but serious, long-term concerns such as the risk of gallstones (cholelithiasis). Regulatory documents indicate that due to the risk of severe blood disorders, periodic blood counts are part of the monitoring process during the initial months of therapy. Animal studies also noted effects on tumor growth and fertility.


Q: Does Gemfibrozilo Stada affect sleep patterns?

Official regulatory documents list depression as a rare psychiatric adverse reaction. While not a direct sleep disorder, psychiatric side effects may potentially affect an individual's sleep habits.


Q: Can taking Gemfibrozilo Stada affect my mood or mental health?

Official safety information reports depression and a decreased libido as rare psychiatric adverse reactions, meaning they occur in less than 0.1% of patients.


Q: Why is my doctor concerned about my triglyceride levels?

The primary clinical concern associated with very high triglyceride levels is the increased risk of developing pancreatitis (severe inflammation of the pancreas). Gemfibrozil is specifically used to manage this risk in patients with severely elevated triglycerides.


Q: Does Gemfibrozilo Stada contain lactose or gluten?

Official product labeling lists the active ingredient and other excipients (inactive ingredients). The full list of inactive ingredients (excipients) can be found in the official product labeling for patients with known allergies or sensitivities.


Q: Is it okay to exercise intensely while taking Gemfibrozilo Stada?

The official labeling promotes exercise as a positive lifestyle change. However, a serious safety concern associated with this drug is the risk of myopathy (muscle damage). The occurrence of unexplained muscle pain, tenderness, or weakness requires prompt assessment by a healthcare professional.


Q: Is it important to take Gemfibrozilo Stada at the exact same time every day?

The key instruction is to take each dose 30 minutes before the morning meal and 30 minutes before the evening meal. Official guidelines emphasize that the critical timing for proper absorption and effectiveness is relative to the meal, rather than the consistency of the clock time.


Q: What does 'fibrates' mean in relation to Gemfibrozilo Stada?

Fibrates are the pharmacological class, or group of medicines, to which Gemfibrozil belongs. This class of medicine is specialized in modifying lipids, primarily by speeding up the natural processes that break down and remove excess fats, especially triglycerides, from the bloodstream.

How should Gemfibrozilo Stada be stored and disposed of?

How to Store and Dispose of Gemfibrozilo Stada?

The official storage and disposal requirements for Gemfibrozilo Stada tablets are governed by regulatory guidelines to ensure product stability and safety. The medication must be kept at a controlled room temperature, typically defined as 20 C to 25 C, and requires protection from light and humidity. It is prohibited to expose the tablets to freezing temperatures.

Storage Requirements

Constraint Type Official Requirement
Temperature & Environment Store between 20 C and 25 C; protect from light and humidity.
Container & Integrity Keep in the original container, tightly closed; do not use if the blister is torn.
Child Safety Must be kept out of the sight and reach of children, locked away in a safe location.

Disposal

Unused or expired tablets should not be discarded in household waste or wastewater. For disposal, individuals are required to consult a healthcare professional or follow the specific instructions and local regulations for discarding pharmaceutical products.

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

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