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Rosuvastatin 10mg + Fenofibrate 160mg

Alkem Laboratories Ltd

Description

Description

Description

Rosuvastatin 10mg + Fenofibrate 160mg is a fixed-dose combination medication used to manage mixed dyslipidemia—a condition involving elevated levels of both cholesterol and triglycerides in the blood. It is commonly prescribed to patients who are at high risk of cardiovascular events and need both cholesterol and triglyceride control.

Rosuvastatin (10mg)

Rosuvastatin is a statin that works by inhibiting HMG-CoA reductase, an enzyme responsible for cholesterol production in the liver. It helps to:

  • Reduce LDL (bad cholesterol)

  • Increase HDL (good cholesterol)

  • Lower triglycerides moderately

Fenofibrate (160mg)

Fenofibrate belongs to the fibrate class of medications. It works by activating lipoprotein lipase and peroxisome proliferator-activated receptors (PPARs) to:

  • Significantly lower triglyceride levels

  • Increase HDL cholesterol

  • Help reduce small, dense LDL particles (which are more harmful)

When used together, Rosuvastatin and Fenofibrate offer synergistic benefits in controlling lipid abnormalities, reducing the risk of atherosclerosis, coronary artery disease, heart attack, and stroke.


Safety Advice

1. Use Only Under Medical Supervision

This combination is potent and should be used only as prescribed by a healthcare professional. Routine monitoring of blood lipid levels, liver function, and muscle enzymes is required.

2. Who Should Not Take This Combination?

Avoid use if you:

  • Have active liver disease

  • Have severe kidney impairment

  • Are pregnant or breastfeeding

  • Have a history of gallbladder disease

  • Have experienced statin- or fibrate-related muscle disorders

3. Common Side Effects

Rosuvastatin may cause:

  • Muscle pain or weakness

  • Headache

  • Abdominal discomfort

  • Elevated liver enzymes

Fenofibrate may cause:

  • Indigestion

  • Nausea

  • Back pain

  • Mild abdominal pain

These side effects are usually mild but should be discussed with your doctor if persistent.

4. Serious Side Effects (Seek Immediate Medical Help)

  • Severe muscle pain, dark urine, or fatigue (possible rhabdomyolysis)

  • Yellowing of the skin or eyes (signs of liver damage)

  • Persistent abdominal pain (possible pancreatitis)

  • Sudden decrease in urine output (kidney issues)

5. Drug Interactions

Avoid combining with:

  • Other statins or fibrates (increases muscle damage risk)

  • Blood thinners (e.g., warfarin)

  • Immunosuppressants (e.g., cyclosporine)

  • Alcohol (increases liver and muscle side effect risks)

Inform your doctor of all current medications, including over-the-counter drugs and supplements.

6. Lifestyle and Monitoring

  • Adopt a low-fat, heart-healthy diet

  • Exercise regularly

  • Avoid alcohol and smoking

  • Monitor liver function, lipid profile, and creatine kinase (CK) levels as advised


Storage Instructions

  • Store at room temperature (below 25°C or 77°F)

  • Keep in a cool, dry place, away from direct sunlight and moisture

  • Do not refrigerate or freeze

  • Store in the original blister pack or container

  • Keep out of reach of children and pets

Check for the expiration date and do not use if the tablets appear discolored, broken, or have an unusual odor.


Conclusion

The Rosuvastatin 10mg + Fenofibrate 160mg combination is highly effective in treating patients with combined high cholesterol and triglyceride levels, offering a dual mechanism of action for comprehensive lipid control. It is especially beneficial for individuals at high risk for cardiovascular disease. Proper medical supervision, regular monitoring, and a healthy lifestyle are key to ensuring its safety and effectiveness.

Note: This information is intended for educational purposes and should not replace professional medical advice. Always consult a healthcare provider for personalized guidance.

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