Fenofibrate Capsules USP (Micronized) 200mg

Fenofibrate Capsules USP (Micronized) 200mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Fenofibrate Capsules USP (Micronized) 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Fenofibrate Capsules USP (Micronized) 200mg
  Each hard-gelatin capsule contains:
  Fenofibrate USP …………………….200mg
  Excipients………………………………q.s.
  Colour: Titanium Dioxide

THERAPEUTIC INDICATIONS:

Fenofibrate is indicated as an adjutant to diet and other non-pharmacological treatment (e.g., exercise, weight reduction) for the following:

– Treatment of severe hypertriglyceridemia with or without low HDL cholesterol.

– Mixed hyperlipidemia when a statin is contraindicated or not tolerated.

– Mixed hyperlipidemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage:  Keep the container tightly closed in order to protect from moisture. Store in the original package. Do not store above 25°C.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

When considering a pharmaceutical company for medications like Fenofibrate Capsules, several essential factors come into play. Taj Pharmaceuticals, based in India, is one potential option, but the selection should hinge on a thorough evaluation of various key considerations. First and foremost, the quality and regulatory compliance of the pharmaceutical company are of paramount importance. Ensuring that Taj Pharmaceuticals maintains stringent manufacturing standards and adheres to regulatory guidelines is essential. Quality is critical for the effectiveness and safety of medications like Fenofibrate Capsules, which are prescribed to manage lipid disorders. Fenofibrate is a medication typically prescribed by healthcare providers to manage high levels of cholesterol and triglycerides in the blood. Consequently, the choice of manufacturer should align closely with your healthcare provider’s recommendations and the prescription provided. Trust in the quality and reliability of the manufacturer is pivotal, as the effectiveness of lipid management can have a significant impact on overall health. Affordability and accessibility are also significant considerations when evaluating pharmaceutical companies. Medication costs can vary, and understanding your budget and insurance coverage is essential in determining the most cost-effective option for obtaining Fenofibrate Capsules. The reliability of the supply chain is crucial, especially for individuals managing chronic conditions such as hyperlipidemia. Ensuring that the chosen pharmaceutical company, such as Taj Pharmaceuticals, maintains a dependable supply chain is essential for consistent access to Fenofibrate Capsules when needed. While patient reviews and feedback may not always be readily available for all medications, they can provide valuable insights into the experiences of individuals who have used a specific brand or manufacturer’s product. However, it’s essential to consider these insights in conjunction with guidance from healthcare providers. Ultimately, the decision regarding which pharmaceutical company to choose for Fenofibrate Capsules should be made in consultation with your healthcare provider. They can consider your unique medical history, the specific lipid disorder being treated, and your response to the medication when recommending a particular brand or manufacturer. When selecting a pharmaceutical company for Fenofibrate Capsules, it’s crucial to weigh factors such as quality, prescription guidance, cost, accessibility, and consultation with healthcare providers. This comprehensive approach ensures that you receive the most appropriate and effective treatment for managing lipid disorders while prioritizing safety and efficacy.

What are Fenofibrate Capsules and its use:

Fenofibrate Capsules are a medication commonly prescribed to manage lipid disorders, specifically high levels of cholesterol and triglycerides in the blood. Here’s an overview of Fenofibrate Capsules and their uses:

Fenofibrate Capsules: Fenofibrate is the active ingredient in these capsules. It belongs to a class of medications known as fibrates, which are lipidregulating drugs.

Uses of Fenofibrate Capsules:

• Hypertriglyceridemia: Fenofibrate Capsules are primarily used to treat hypertriglyceridemia, a condition characterized by elevated levels of triglycerides in the blood. High triglyceride levels are associated with an increased risk of cardiovascular disease.
• Mixed Dyslipidemia: They are also used in individuals with mixed dyslipidemia, a condition marked by high triglycerides and high levels of lowdensity lipoprotein cholesterol (LDLC) in the blood. Mixed dyslipidemia is a common lipid disorder associated with cardiovascular risk.
• Primary Hypercholesterolemia: Fenofibrate may be prescribed in cases of primary hypercholesterolemia, where elevated levels of LDLC are the primary concern.
• Prevention of Cardiovascular Events: In some cases, Fenofibrate Capsules may be used as part of a comprehensive approach to reduce the risk of cardiovascular events, such as heart attacks and strokes, in individuals with specific risk factors and lipid profiles.

It’s important to note that Fenofibrate Capsules are not typically used as a firstline treatment for high cholesterol or triglycerides. They are usually prescribed when dietary and lifestyle modifications alone are insufficient in managing lipid disorders, or when the risk of cardiovascular events remains high despite other interventions. Fenofibrate works by decreasing the production of triglycerides in the liver and increasing the removal of triglycerides from the blood. Additionally, it can improve the balance of lipoproteins in the blood, which contributes to better cardiovascular health. The use of Fenofibrate Capsules should be under the guidance and prescription of a healthcare provider, who will determine the appropriate dosage and treatment duration based on the individual’s lipid profile and overall health. It’s important to follow the prescribed treatment plan and engage in healthy lifestyle practices, such as a hearthealthy diet and regular exercise, as part of lipid management.

How do Fenofibrate Capsules work?

Fenofibrate Capsules work by targeting lipid metabolism in the body, specifically by affecting the levels of triglycerides and certain cholesterol particles in the blood. Here’s how Fenofibrate Capsules work:

• Decreasing Triglyceride Production: Fenofibrate primarily acts to lower elevated triglyceride levels in the blood. Triglycerides are a type of fat (lipid) that circulates in the bloodstream and can accumulate at high levels when dietary intake exceeds the body’s energy needs. High triglyceride levels are associated with an increased risk of cardiovascular disease.
• Enhancing Triglyceride Clearance: Fenofibrate increases the clearance of triglycerides from the blood. It does so by increasing the activity of lipoprotein lipase, an enzyme that helps break down triglycerides into smaller fatty acids. This process allows the body to remove excess triglycerides from the bloodstream more efficiently.
• Modifying Lipoprotein Profiles: Fenofibrate can improve the balance of different lipoproteins in the blood. Lipoproteins are particles that transport cholesterol and triglycerides. Fenofibrate primarily affects the following:
  Reduction in Triglycerides: Fenofibrate significantly reduces triglyceride levels in the blood, especially in individuals with hypertriglyceridemia.
  Increase in High-Density Lipoprotein (HDL) Cholesterol: Fenofibrate may raise HDL cholesterol levels, which is considered beneficial for cardiovascular health. HDL is often referred to as “good” cholesterol because it helps remove excess cholesterol from the blood vessels.
  Modest Decrease in Low-Density Lipoprotein (LDL) Cholesterol: While the primary effect of Fenofibrate is on triglycerides, it may also lead to a slight reduction in LDL cholesterol levels, although the decrease is generally less significant compared to other cholesterol-lowering medications.
• Anti-Inflammatory Effects: Some studies suggest that Fenofibrate may have anti-inflammatory properties, which can be beneficial for individuals with certain metabolic and cardiovascular conditions.

It’s important to note that Fenofibrate Capsules are typically prescribed when lifestyle modifications (such as dietary changes and exercise) alone are insufficient in managing lipid disorders, particularly high triglycerides. The medication is often used in combination with a heart-healthy lifestyle to reduce the risk of cardiovascular events. The specific mechanism of action may vary slightly among different fibrates, but the overall goal is to improve lipid profiles and reduce the risk of cardiovascular disease in individuals with dyslipidemia. The dosage and duration of Fenofibrate treatment are determined by a healthcare provider based on the individual’s lipid profile and overall health. Regular monitoring is often recommended to assess the effectiveness of the medication and ensure its safety.

Benefits of Fenofibrate Capsules:

• Lowering Triglyceride Levels: One of the primary benefits of Fenofibrate Capsules is their ability to significantly reduce elevated triglyceride levels in the blood. High triglyceride levels are a risk factor for cardiovascular disease.
• Improving Lipid Profiles: Fenofibrate can enhance lipid profiles by increasing high-density lipoprotein (HDL) cholesterol, often referred to as “good” cholesterol, and modestly decreasing low-density lipoprotein (LDL) cholesterol. This can contribute to better cardiovascular health.
• Reducing Cardiovascular Risk: By addressing high triglycerides and improving overall lipid profiles, Fenofibrate Capsules can help reduce the risk of cardiovascular events, such as heart attacks and strokes, particularly in individuals with hypertriglyceridemia.
• Combating Mixed Dyslipidemia: Fenofibrate is useful in treating mixed dyslipidemia, a condition characterized by high triglycerides and high LDL cholesterol levels in the blood.
• Combination Therapy: Fenofibrate is sometimes used in combination with other cholesterol-lowering medications, such as statins, to achieve comprehensive lipid management.

Common Side Effects of Fenofibrate Capsules:

• Gastrointestinal Disturbances: Nausea, abdominal pain, and diarrhea are common side effects of Fenofibrate Capsules. Taking the medication with food may help reduce these symptoms.
• Skin Reactions: Skin rash and itching can occur in some individuals.
• Muscle Pain: Muscle pain and weakness are potential side effects, although they are less common than with some other lipid-lowering medications like statins.
• Liver Enzyme Elevations: Fenofibrate may lead to mild elevations in liver enzyme levels in blood tests. Regular monitoring of liver function is often recommended during treatment.
• Blood Changes: Fenofibrate can affect blood cell counts, including decreases in hemoglobin and hematocrit levels. Regular blood tests may be needed to monitor these changes.
• Pancreatitis: Although rare, fenofibrate can increase the risk of pancreatitis (inflammation of the pancreas). Symptoms of pancreatitis include severe abdominal pain, nausea, and vomiting. If these symptoms occur, medical attention is required immediately.
• Gallstones: Fenofibrate may increase the risk of developing gallstones in some individuals.
• Kidney Function: In rare cases, fenofibrate may affect kidney function, leading to changes in serum creatinine levels. Regular kidney function monitoring may be recommended.

It’s important to note that while Fenofibrate Capsules offer several benefits in managing lipid disorders, individual responses to the medication can vary. Healthcare providers carefully consider the potential risks and benefits of using Fenofibrate Capsules and monitor patients for adverse reactions during treatment. Patients should report any unusual or severe side effects to their healthcare provider, and it’s crucial to follow the prescribed treatment plan and engage in healthy lifestyle practices, such as a heart-healthy diet and regular exercise, as part of lipid management.

Frequently Asked Questions About Fenofibrate Capsules:

Certainly, here are some frequently asked questions (FAQs) about Fenofibrate Capsules:

1. What are Fenofibrate Capsules, and what do they treat?

Fenofibrate Capsules are medications used to manage lipid disorders, specifically high levels of triglycerides and, to some extent, cholesterol in the blood. They are used to reduce the risk of cardiovascular disease.

2. How does Fenofibrate work to lower triglycerides and cholesterol?

Fenofibrate primarily works by reducing triglyceride production, increasing triglyceride clearance, and modifying lipoprotein profiles in the blood. It can increase highdensity lipoprotein (HDL) cholesterol (the “good” cholesterol) and modestly lower lowdensity lipoprotein (LDL) cholesterol.

3. Who should take Fenofibrate Capsules?

Fenofibrate Capsules are typically prescribed to individuals with hypertriglyceridemia (high triglyceride levels) or mixed dyslipidemia (high triglycerides and high LDL cholesterol) who are at risk of cardiovascular disease. They are used when lifestyle modifications alone are insufficient.

4. Is Fenofibrate Capsules a substitute for a healthy lifestyle and diet?

No, Fenofibrate Capsules are not a substitute for a hearthealthy lifestyle. They are most effective when used in combination with dietary changes, regular exercise, and other lifestyle modifications to manage lipid disorders effectively.

5. Can Fenofibrate Capsules be used in combination with other lipid lowering medications?

Yes, Fenofibrate Capsules can be used in combination with other medications, such as statins, to achieve comprehensive lipid management. This approach is often recommended when necessary.

6. Are there dietary restrictions when taking Fenofibrate Capsules?

While there are no specific dietary restrictions, it’s advisable to follow a hearthealthy diet low in saturated and trans fats, cholesterol, and excess sugars. Your healthcare provider or a registered dietitian can provide dietary guidance.

7. Are there potential side effects of Fenofibrate Capsules?

Yes, Fenofibrate Capsules can have side effects, including gastrointestinal symptoms (nausea, abdominal pain), skin rash, muscle pain, liver enzyme elevations, and, rarely, pancreatitis. It’s important to report any unusual or severe side effects to your healthcare provider.

8. Is Fenofibrate safe during pregnancy or breastfeeding?

Fenofibrate is not recommended during pregnancy and breastfeeding due to potential risks to the developing fetus or infant. Consult your healthcare provider for guidance on alternative treatments if needed.

9. How often should I have my blood lipid levels monitored while taking Fenofibrate Capsules?

The frequency of blood lipid level monitoring varies depending on individual circumstances. Your healthcare provider will determine the appropriate schedule based on your response to treatment.

10. Can I stop taking Fenofibrate Capsules once my lipid levels improve?

It’s essential to continue taking Fenofibrate Capsules as prescribed by your healthcare provider, even if your lipid levels improve. Stopping the medication prematurely can lead to a resurgence of high triglycerides or cholesterol levels.

These FAQs provide general information about Fenofibrate Capsules, but individual responses to medications can vary. Always consult your healthcare provider for personalized guidance and information based on your specific medical condition and treatment plan. Your healthcare provider can monitor your progress and make adjustments to your treatment as needed.

As Fenofibrate Capsules Exporters; We can cater to export business queries from the following geographies. We are exporting our Fenofibrate Capsules product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Fenofibrate Capsules Regulatory Documents:

• Certificate of Analysis (COA)
• Method of Analysis (MOA)
• Stability Data (Accelerated stability / Long-term stability / Zone 4b)
• CTD Dossier / ACTD Dossiers / eCTD Dossiers
• Certificate of Pharmaceuticals Product (COPP)
• Free Sale Certificate (FSC)

Contact the most reliable manufacturer of Fenofibrate Capsules, Taj Pharmaceuticals Limited to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274